cyrilzakka/clinical-trials huggingface dataset:
Effect of Different Peep Values on Gastric Residual Volume

The aim of this study was to predict the effect of gastric antrum diameter before extubation on intra-abdominal pressure changes and consequently on the risk of pulmonary aspiration in patients undergoing elective spinal surgery under general anaesthesia in the prone position in the Neurosurgery Operating Theatre of the Ministry of Health Ankara City Hospital and to take precautions accordingly. Gastric antrum diameter and intraabdominal pressure measurements may contribute to the improvement of anaesthetic practice by reducing the risk of pulmonary aspiration and additional complications.

Prone positioning in spinal surgery is a very important issue for anaesthetists. Although there are many conditions that are taken into consideration in patient follow-up, it is a position frequently used in the treatment of pulmonary diseases other than surgery. PEEP application in the prone position is especially used in the treatment of conditions such as acute respiratory distress syndrome (ARDS). This treatment method basically aims to improve oxygenation and ventilation in the lungs. While providing improvement in the lungs, it may indirectly lead to some changes in the gastrointestinal system. Depending on PEEP levels, intra-abdominal pressure may increase and subsequently cause reflux of gastric contents or gastroparesis. The prone position itself also increases the risk of reflux. Gastric POCUS (Point of Care Ultrasound) is a noninvasive method that gives us information about the stomach contents and can be easily performed at the bedside. Both patient position and respiratory parameters, such as PEEP, may have an effect on gastric POCUS. Visualization of gastric content or detection of gastric retention allows us to predict possible pulmonary aspiration complications before extubation, and gastric POCUS may be a valuable marker before extubation in patients who remain in prone positions for a long time. The aim of this study was to determine the effect of PEEP application on the antrum diameter evaluated by gastric POCUS and the risk of aspiration before extubation in patients undergoing spinal surgery in the prone position.

Eligibility Criteria:
Inclusion Criteria

* 18-65 years of age
* ASA I-II risk group

Exclusion Criteria:

* Asthma
* COPD
* Gastroesophageal reflux
* Gastric herniation
* Gastric surgery,
* Intracranial tumor
* Epilepsy
* Neuromuscular disease
Diagnostic Performance Assessment of Qualitative Ifobt and Quantitative Ifobt for Advanced Neoplastic

In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 50-75
* Hospital El Cruce's coverage area and

Exclusion Criteria:

* those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment
* personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60
* those refuse to sign the consent form to take part in this study
Efficacy of Red Light in Vitiligo

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.

Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.

There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.

Study Objective To evaluate the potential for red light to induce repigmentation within vitiligo patches.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Localized or generalized vitiligo that involves a non mucosal or acral site.
* Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually

Exclusion Criteria:

* Patients who received treatment for vitiligo within the past 3 weeks.
* Patients known to have a photosensitivity disorder
* History of previous skin cancer.
* History of severe medical illness or immunosuppression.
* Pregnancy or breast-feeding.
EEG-based Sedation Protocol for Patients on Mechanical Ventilation Due to SARS-CoV-2 Pneumonia

Deep sedation in patients with COVID-19 may be challenging in many aspects. The use of an EEG-based protocol to guide deep sedation may be useful in this particular population, considering their unusually high sedation requirements.

In the present trial, we aim to evaluate an EEG-based protocol to guide deep sedation in patients with COVID19, using to EEG derived parameters that are displayed in the BIS monitor: Suppression Rate and Spectral Edge Frequency.

The protocol is designed to both minimize the suppression rate along with maintaining a spectral edge frequency over 10 Hz. The use of this protocol may reduce the amount of sedatives administered and, therefore, diminish the time needed for the weaning process.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* COVID-19 patient requiring mechanical ventilation

Exclusion Criteria:

* Contraindication to receive propofol or fentanyl
* Chronic Liver Disease Child C
* End-Stage Kidney Chronic Disease
Evaluation of a Polymeric Plate Derived From Castor Oil to Thermotherapy

The objective of this work is to evaluate, from volunteers viewpoint, the usability, comfort, appearance, weight, superficial temperature, and other characteristics of a polymeric plate derived from castor oil developed to thermotherapy.

The volunteers will use polymeric plate as a therapeutic resource in the shoulder area and then fill in, without interference of the researcher, some questions about the characteristics of interest.

In this study, the polymeric plate is prepared using the following procedure:

1. - the water is heated to the boiling temperature
2. - the heater is shut down
3. - the polymeric plate is immersed in water
4. - it rests in the water for 15 minutes
5. - it is inserted in a wrap

In this condition, the polymeric plate is placed on the shoulder of the volunteer and remains there for 20 minutes.

After application, the volunteer answers the questionnaire containing eight questions on a Likert scale (0 to 10) and an area of observations.

Previous laboratory tests were performed to ensure that the temperature of the polymeric plate will not cause skin burn in this application condition.

Eligibility Criteria:
Inclusion Criteria:

* Good communication and comprehension
* Skin integrity

Exclusion Criteria:

* Reduced skin sensitivity
* Disturbance in the central nervous system
Prospective Validation of the Emergency Heart Failure Mortality Risk Grade (EHMRG) Score in Patients With Acute Heart Failure in the Emergency Department

In this prospective validation study, researchers investigates accuracy of EHMRG (Emergency Heart Failure Mortality Risk Grade) score in predicting the 7th and 30th day risk of mortality in patients with acute heart failure who applying to the emergency department.

Heart failure is a serious public health problem in the world due to its high morbidity and mortality rate.Turkish Society of Cardiology conducted a prevalence study. The name of the study is HAPPY. Accordingly, the prevalence of heart failure in people over 35 years of age in Turkey is 2.9%.The prevalence of heart failure in Turkey is higher than in European countries.

The incidence of heart failure cases with no obvious symptoms is 4.9% in Turkey. Patients with a diagnosis of heart failure apply to the emergency department frequently. There are scoring studies around the world for patients' hospitalization and discharge.

EHMRG score created and validated by Douglas S. Lee et al. In our study, the accuracy of EHMRG score will be investigated prospectively in patients diagnosed with acute heart failure in the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with acute heart failure in the emergency department

Exclusion Criteria:

* Dialysis dependent patients
* Pregnant patients
* Patients brought to the emergency department with cardiac arrest
Use of Endogenous Melatonin and 6-hydroxymelatonin as Biomarkers for CYP1A2

An observational study comprising 4 sessions will be conducted in 12 healthy volunteers. During each study session (sessions 1 to 4), a 12-hour urine collection during the night (21h-9h) will be carried out by each participant. The first urine in the morning will be collected separately to be analysed independently of the 12-hour collection. 24 hours before the start of the night urine collection, volunteers will be asked to refrain from consuming alcohol and caffeinated drinks/foods, with the exception of session 3. Conversely, in session 3, subjects will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).

After each 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Understanding of French language and ability to give a written informed consent

Exclusion Criteria:

* Inability to refrain from alcohol or methylxanthine-containing beverages and foods for 24 hours
* Sensitivity to coffee or CocaCola®
* Irregular (i.e. non-daily or inconstant dosages) intake of medication or food of a CYP1A2 modulator (including tobacco)
COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers

The primary objectives of the study are:

* To evaluate the extent of effect, if any, of REGN10933+REGN10987 administration on vaccine-induced neutralizing antibody responses to SARS-CoV-2 by Moderna mRNA-1273
* To evaluate the time interval required between REGN10933+REGN10987 administration and Moderna mRNA-1273 vaccination, to ensure no meaningful impact on vaccine-induced neutralizing antibody responses to SARS-CoV-2

The secondary objectives of the study are:

* To quantify the alteration of antigen specificity of vaccine-induced SARS-CoV-2 antibody responses when administered with different dose regimens of REGN10933+REGN10987
* To evaluate the safety and tolerability of REGN10933+REGN10987 and Moderna mRNA-1273 vaccine when administered in close succession
* To assess the concentrations of REGN10933 and REGN10987 in serum over time in participants who receive REGN10933+REGN10987 and Moderna mRNA-1273 vaccine
* To evaluate the immunogenicity of REGN10933 and REGN10987 over time


Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy or has chronic medical condition(s) that are stable and well-controlled in the opinion of the investigator and that are not likely to require significant medical intervention through the end of study
2. Willing and able to comply with study visits and study-related procedures, including compliance with site precautionary requirements related to SARS-CoV-2 infection and transmission

Key Exclusion Criteria:

1. Positive RT-PCR test result for SARS-CoV-2 infection at screening or baseline
2. Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
3. COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at any time prior to screening
4. Previously received an investigational, authorized, or approved coronavirus vaccine (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
5. Currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat COVID-19
6. Received investigational or approved passive antibodies for SARS-CoV-2 infection prophylaxis ad defined in the protocol
7. Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
8. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation
9. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation
10. Medically attended acute illness or hospitalization (ie, \>24 hours) for any reason within 30 days prior to screening
11. Clinical history of myocarditis and/or pericarditis

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

This study will evaluate the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump therapy will require lower PTH doses and should normalize markers of bone turnover. We expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.

Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. We are conducting a randomized crossover study comparing twice-daily subcutaneous injections vs. PTH pump therapy. We hypothesize that pump delivery of PTH 1-34, compared to twice-daily administration, will provide smoother metabolic control of serum mineral levels and normalization of urine mineral excretion. The two arms will be divided into an inpatient and an outpatient phase. There will be three inpatient admissions, baseline, 3 months, and 6 months. Subjects will be randomized to either pump therapy or to twice daily injections at the beginning of the study and will cross over to the alternate PTH delivery system (injections vs. pump) at the conclusion of the initial 3-month treatment period.

Patients between 10 and 70 years of age who have had chronic hypoparathyroidism for at least 1 year may be eligible for this study. Participants have two 10- 12-day hospital admissions and one 5-day admission. The first two inpatient admissions are separated by 3-month outpatient periods. Outpatient monitoring will require weekly blood tests and monthly urine tests to monitor mineral levels. After third hospital admission, patients will be placed on conventional therapy.

Eligibility Criteria:
* INCLUSION CRITERIA:

This study will include patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. Twenty-four subjects will be enrolled.

EXCLUSION CRITERIA:

Subjects who meet any of the following criteria are not eligible for the study:

* Pregnancy
* Patients who are calcium infusion dependent and/or do not respond to calcitriol therapy to maintain normal levels of serum calcium will be excluded.
* Seizure disorder requiring antiepileptic medications.
Effectiveness of a Psychoeducational Group Intervention in Patients With Depression and Physical Comorbidity

The primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program carried out by primary care nurses, to improve the rate of remission and response of depression in patients with physical chronic illness (diabetes, COPD, asthma and / or ischemic heart disease). Secondarily, to assess the cost-effectiveness of the intervention, the effectiveness to improve the control of physical pathology, the impact on quality of life and the feasibility of the intervention.

Methods: a multicentre, randomized clinical trial, with two groups and 1 year follow-up evaluation. Economic evaluation study. We will study 504 patients (252 in each group), over 50 years assigned to 25 primary care teams (PC) from Catalonia (urban, semi-urban and rural) with major depression and with at least one of the diseases: diabetes mellitus type 2, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease. They will be distributed randomly into two groups. The intervention group will participate in psychoeducational groups: 12 weekly 90-minute sessions led by two nurses from PC, consisting of health education on chronic physical illness and depressive symptoms.

Main measurements: clinical remission of depression and / or response to intervention (Beck depression inventory: BDI-II). Secondary measures: improvement in control of chronic disease (blood test and physical parameters), drug compliance (test Morinsky-Green and number of packaging), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications) and feasibility of the intervention (satisfaction and compliance). Evaluations will be masked and conducted at 0, 3 and 12 months. At 6 months, patients will receive a call from nurses.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one of the following diseases: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and / or ischemic heart disease.
* Meet major depression criteria at the time of the study: Score above 13 on the BDI-II scale.
* Possibility of follow-up of one year by the same primary care team.
* At least read and write Spanish or Catalan.

Exclusion Criteria:

* Diagnosis of dementia or moderate or high cognitive impairment (5 or more errors according to the pfeiffer scale).
* Major depression with psychotic symptoms or with other serious psychiatric comorbidities.
* Moderate or high risk of suicide (6 or more points on the MINI suicide scale).
* Dependency disorders due to alcohol or other drug abuse.
* Advanced stage physical disease.
* Inability to travel to the center.
* Be receiving some psychological therapy by the Center of mental health (CSM) of reference
Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO

Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)?

Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)?

The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives:

1. To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups;
2. To estimate the rate of patient recruitment and understand barriers to recruitment; and
3. To measure and understand the reasons for crossovers or rescue by ECMO in the control group.

In addition, we will monitor safety issues, recording serious adverse events in both groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Endotracheal mechanical ventilation for ≤ 5 days
3. Early moderate-severe ARDS (Berlin Definition) - all of the following conditions for ≤ 48 hours i. PaO2/FiO2 ≤200 with PEEP \> 5 cmH2O ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload iv. within one week of a known insult of new or worsening respiratory symptoms
4. ARDS severity criterion - either 1 of:

   1. PaO2/FiO2 ≤ 150 mm Hg, on PEEP ≥ 10 cm H2O and FiO2 ≥ 0.5

Exclusion Criteria:

1. Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
2. Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
3. Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP
4. Actual body weight exceeding 1 kg per centimeter of height
5. Severe hypoxemia with PaO2/FiO2 \< 80 mmHg
6. Expected mechanical ventilation duration \< 48 hours
7. Treating team is in the process of moving to a palliative mode of care
8. Moribund patient not expected to survive 24 hours despite ongoing life-sustaining therapies
9. Confirmed diffuse alveolar hemorrhage from vasculitis
10. Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis)
11. Pregnancy - due to unknown effects of PaCO2 changes on placental blood flow