cyrilzakka/clinical-trials huggingface dataset:
Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:

* PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
* SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria
* Beginning of IMV less than 48 hours or Clinical decision to begin IMV.
* Life expectancy \> 24 hours
* Informed consent signed

Exclusion Criteria:

No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.

* AKI prior to the onset of ARDS
* Chronic respiratory failure due to chronic respiratory diseases
* Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO
* Chronic Heart Failure
* Chronic liver disease
* Major trauma in the past 3 months
* Major surgery in the past 3 months
* Smoking and Alcohol drinking
* BMI ≥ 35
* Patients needing of VV-ECMO and VA-ECMO
* Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)
* Life expectancy \<24 hours
* Cardio Circulatory Arrest
* Neoplasm in chemotherapy/radiotherapy
* Do Not Resuscitate or Comfort Measures
* Pregnancy at ICU admission
* Refused Informed Consent by the patient or surrogate decision-maker
Local Wound Infiltration for Tracheal Reconstruction

Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The postintubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.

Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics

Local anesthetic infiltration into the surgical incision can relieve pain at the wound site after surgery, as part of multimodal analgesic approach.

Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile. Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

The aim of this study is to evaluate the intra- and postoperative efficacy of local wound infiltration versus bilateral superficial cervical plexus block with levobupivacaine for upper tracheal resection and reconstruction surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class status I or II
* Undergoing elective upper tracheal resection and reconstruction surgery

Exclusion Criteria:

* Age less than18 years
* Patients with preoperative medication included opioid
* History of allergy to the drugs used
* Coagulation disorders
* Pregnancy
* Patient refusal
* Local sepsis
* Inability to understand the study protocol or pain scale.
Comparison of Different Methods to Calculate Pendelluft by Electrical Impedance Tomography in Mechanically Ventilated Patients

The Pendelluft phenomenon is an important cause of lung damage in spontaneously breathing mechanically ventilated patients since it considerably increases the stress on the lung parenchyma in the dependent areas. It can result in a local driving pressure up to three times higher than the global driving pressure. The measurement of Pendelluft is still uncertain in the literature, and although various methods have been proposed, not all have the same meaning in terms of pulmonary overstress and overstrain. This study proposes a comparative analysis of different ways to calculate and estimate the stress imposed on the lung parenchyma by Pendelluft in terms of regional volume and local driving pressure through electrical impedance tomography.

Respiratory mechanics and regional ventilation will be monitored by electrical impedance tomography (Enlight 1800 and 2100, Timpel). Esophageal and gastric pressures will be obtained by placing an esophageal/gastric balloon cathether (Nutrivent ®), validation concerning position will be done through modified Baydur maneuver (delta esophageal/delta airway pressure = 0.8-1.2). The hardware Pneumodrive will be used to inflate the balloon and store the airway, gastric and esophageal pressures.

Initially the patients will be monitored with EIT for aproximately 30 minutes after pletismography stabilization. Then, an arterial blood-gas sample shall be collected for analysis. Next, three expiratory and three inspiratory pauses of at least two seconds will be realized with intervals of eight respiratory cycles between them, allowing plateau pressure to be recorded and global and regional driving pressure to be estimated. All this data will be stored for later analysis. The same procedures and measurements shall be made sequentially with a 50% higher pressure support and with a 50% lower pressure support.

Eligibility Criteria:
Inclusion Criteria:

* Patients under invasive mechanical ventilation intubated due to respiratory failure in pressure support mode (weaning phase)

Exclusion Criteria:

* Age less than 18 years; sedation or neuromuscular blockade; absence of respiratory effort; contraindications to esophageal balloon cathether positioning or electrical impedance tomography belt positioning; presence of pneumothorax or active air leaks; hemodynamic instability; absence of informed consent.
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults and children, and assess efficacy and safety data in Japanese pediatric patients which will fulfill the Japanese health authority requirement for approval. Data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Body weight and serum total IgE level within the dosing table range; body weight of 20 to 150 kg and serum total IgE levels of 30 to 1300 IU/mL
* Receiving asthma long-term control medications of high dose ICS (\>200 µg/day FP or equivalent) and two or more controller medications out of LTRA, theophylline, sodium cromoglycate, LABA, or OCSs 12 weeks prior to the run-in period. These medications should be kept stable for 4 weeks prior to the run-in period and during the run-in period (except for management of asthma attacks/exacerbations)
* Having 2 or more asthma exacerbations requiring treatment with a doubling of the maintenance ICS dose for at least 3 days and/or systemic (oral or IV) corticosteroids in the past; one of these exacerbations must have occurred in the previous 12 months, which is documented in the medical record
* Demonstrating inadequately controlled asthma symptoms during the last 14 day run-in period based on the patient diary which meet any of the following:

Asthma symptoms every day; Night-time symptoms in ≥2 out of the last 14 days (missing data to be treated as a day with no symptoms); Limitation of daily activities in ≥2 out of the last 14 days (missing data to be treated as a day with no limitations)

Exclusion Criteria:

* With a history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
* With positive skin reaction to the study drug at the run-in period
* With known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study drug or drug related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
* With platelet level ≤ 100,000/µL (100 x 109/L) at the run-in period
* Who are taking intra-muscular depo-steroids within 4 weeks of the run-in period
* Who are taking systemic (oral or IV) corticosteroids for reasons other than asthma within 4 weeks of the run-in period (patients with chronic OCSs use for asthma are allowed)

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of Immune Therapy for Condyloma

Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.


Eligibility Criteria:
Inclusion Criteria:All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital -

Exclusion Criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon

-
Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine

The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.

The main judgement critearia is the estimation in degree of this lordosis measured on EOS radiographies, The study includes adults patients with non traumatic cervicobrachial neuralgia caused by discal hernia free from any previous spine surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old)
* Suffering of cervicobrachial neuralgia caused by cervical hernia on MRI diagnosed by a neurosurgeon
* with social care rights

Exclusion Criteria:

* Post traumatic cervicobrachial neuralgia in the past 12 months
* Anteriority of spine surgery
* Pregnant patients
A Trial to Evaluate the Precision and Accuracy of the NBM-200 Series When Used in a Continuous Prospective Mode

The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb values obtained by the NBM system to venous values.

Each subject will be placed in a comfortable position in a temperature regulated room. Participants will have two consecutive non invasive (NBM) measurements taken which involves inserting the thumb into a ring shaped sensor. After each non invasive measurement the sensor will be removed. Each measurement takes approximately 85 seconds and involves the finger cuff inflating (to over systolic pressure) and deflating several times in quick successions in order to measure and calculate the Hb values. The two non invasive measurements will be performed using the same finger. After the NBM system testing is complete and recorded, the subject will have a venous (venipuncture) blood sample collected in order to provide two blood tests performed on two different models of routine automated complete blood count or Hb blood analyzers.

Addendum:

Reproducibility Procedure (optional) Each subject will be measured by each one of the three operators, three NBM system units, 3 times consecutively (without removal) on his right thumb and right index finger. The order of each measurement sequence will be randomized (thumb/index). There will be an intermission of 3 to 5 minutes between the 3 measurement sets taken on each participant. In case of a longer intermission, the subject will be measured again and the previous results will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Healthy volunteers
* Anemia patients

Exclusion Criteria:

* Participants under the age of 18 years
* Patients with significant deformity, degenerative changes or oedema of the thumb or index fingers
* Patients with localized infection, ulceration or skin breaks involving the fingers
* Patients with vascular disease or Raynaud's phenomenon affecting the fingers
* Participants who are unable to give informed written consent
* Pregnancy
Study of Tirzepatide in Healthy Participants

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males as determined by medical history, physical examination, and other screening procedures
* Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening
* Are willing to be available for the full duration of the study

Exclusion Criteria:

* Have known allergies to tirzepatide or related compounds
* Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study
* Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography \[CT\] scans, barium meal, being employed in a job requiring radiation exposure monitoring)
* Have participated in any clinical trial involving a radiolabeled substance within the past 12 months
Methadone for Postoperative Pain

The aim of this study is to compare the efficacy of methadone versus morphine in dealing with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than morphine for postoperative pain treatment.

Patients undergo laparoscopic cholecystectomy at Almirante Nef Naval Hospital will be recruited, between March and July 2013. The sample size was calculated to obtain an average difference of 4 mg of morphine (DE 1.5) to 3 mg of morphine (DE 1.5), with a power of 80% and a significance level of 0.05. This came down to 36 randomized patients into each group, so 86 patients will be recruited considering a 15% loss to follow up.

Before signing an informed consent, we will explain to them how to classify pain intensity numerical rating scale (NRS) and this will be evaluated periodically during the first 24 hours after surgery.

General anesthesia will be based on Remifentanil and Propofol, titrated to achieve bispectral index (BIS) between 40 and 60. Patients will be randomized into methadone group (ME) and morphine group (MO), they will receive 0.08 mg / kg bolus of methadone or 0.08 mg / kg bolus of morphine as applicable at the time of beginning surgery. Postoperative analgesia will be standard for both groups. Patient´s demographic data will be filed as well as surgical timings.

All patients will remain in the anesthetic recovery room for the first two hours , to get a record taken of vital signs and measurement of NRS at 5, 15, 30, 60 and 120 minutes. If NRS is greater than or equal to 4, 1 mg of morphine ev will be used as analgesic rescue. In room measuring NRS continue hospitalized at 4, 8, 12 and 24 hours postoperatively and were used as rescue analgesia if ketorolac 30mg ev NRS is greater than or equal to 4. The amount of morphine is registered and ketorolac rescue of both groups as well as pain assessment scores. The occurrence of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is also recorded in both groups, to be compared later as a secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy in the Almirante Nef Naval Hospital
* Patients ASA 1 or 2

Exclusion Criteria:

* Patients with renal insufficiency (creatinine\> 2.0 mg / dl)
* Patients with a history of liver failure
* Patients with BMI\> 35 kg/m2
* Patients with hypersensitivity to the drugs in question
* History of chronic use of opioids
* Need for conversion to open surgery
Micronutrient Supplementation in Patients With Heart Failure

There is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. This study is designed to investigate if supplementation with micronutrients (including high-dose vitamin D) will improve the function of the heart in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association Class II and III
* Already on or tried on best known medical treatment (ACE inhibitor and beta-blocker)
* Stable for a period of at least 6 weeks
* Left ventricular ejection fraction less than or equal to 45%

Exclusion Criteria:

* History of significant alcohol ingestion (more than 40 units per week)
* Severe renal dysfunction (GFR less than 30ml/min)
* Severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal)
* Atrial fibrillation (in the absence of a pacemaker)
* Frequent ventricular ectopics
* On waiting list for cardiac transplantation
* Uncontrolled diabetes mellitus
* Inability to give informed consent
* Estimated life span less than 12 months
* Already taking a multivitamin/mineral supplement
* Already taking a vitamin-D containing fish oil
* Woman of child-bearing potential
* History of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance
Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray

Comparing the efficacy between Lignocaine given via MADgic Atomizer and Lignocaine Pump Spray pre endotracheal intubation in adult undergoing General Anesthesia.

Comparing the efficacy of Lignocaine given via 2 device (Lignocaine Spray and MADGIC Atomizer) on hemodinamic parameters postintubations and severity grading of post operative sore throat, cough and hoarseness of voice.

Eligibility Criteria:
Inclusion Criteria:

* Adult with the age of 18 to 65 years old
* Gender of both male and female
* Planned for elective surgery scheduled at General Operation Theatre that require elective intubation for general anesthesia
* American Society Anaesthesiologist (ASA) preoperative physical status assessment of 1 and 2
* Airway assessment Malampati scoring 1and 2.

Exclusion Criteria:

* Pregnancy
* Known allergy or hypersensitivity to Lignocaine
* Pre existing sore throat or hoarseness of voice identified during preoperative assessment.
* The use of airway device other than endotracheal tube (ETT) such Laryngeal Mask airway/Supraglottic Device'
* Oral and neck surgery
Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis

Purpose: To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.

Methods: A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs). Multiple comparisons were established by employing the Bonferroni's post-hoc test for both clinical and laboratory biomarker data. The Mann-Whitney test was used to compute the p-value for intergroup comparisons. For intra-group comparisons, the p-value was computed with the help of Wilcoxon signed ranks test.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥25 years
* Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months)
* Patients having \>20 teeth diagnosed with generalized (\>30% of sites) chronic periodontitis with PD ≥ 4mm and/or CAL ≥ 4mm and vertical bone loss of at least 4 mm on radiography.

Exclusion Criteria:

* Patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months
* Any joint replacement
* Pregnancy/lactating mothers
* Patients having other forms of systemic diseases such as diabetes mellitus, hypertension or acquired immunodeficiency syndrome (AIDS)
Study of Dextromethorphan in OCD and Related Disorders

The purpose of the study is to assess the tolerability and efficacy of dextromethorphan in combination with fluoxetine for symptom relief in OCD and related disorders.

Obsessive compulsive disorder (OCD) and the related disorders body dysmorphic disorder (BDD), somatic symptom disorder (SSD) and illness anxiety disorder (IAD) are psychiatric conditions characterized by recurrent, intrusive thoughts, feelings or images (obsessions or preoccupations) and repetitive or ritualized behaviors or avoidance performed to relieve obsession or preoccupation-related anxiety. They are a significant cause of mental health-related disability, and are inadequately served by available treatments.

This study tests whether an over-the-counter cough suppressant medicine, dextromethorphan, may offer symptom relief when combined with a low dose of fluoxetine, a standard prescription treatment for OCD and related disorders.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of obsessive-compulsive disorder (OCD), body dysmorphic disorder (BDD), illness anxiety disorder (IAD) or somatic symptom disorder (SSD)
* Living within California
* Capacity to provide informed consent

Exclusion Criteria:

* Current bipolar disorder or psychotic disorder
* Active moderate or severe substance use disorder, lifetime severe substance use disorder
* Pregnant or nursing women
* Use of prescribed psychotropic medications other than fluoxetine for 2 weeks prior to study start
* Having commenced OCD-targeted exposure and response-prevention (ExRP) psychotherapy within 2 months of study start