cyrilzakka/clinical-trials huggingface dataset:
Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections

This study aims to use mass spectrometry techniques to analyze exhaled patient breath in non-COVID ICU-admitted patients requiring ventilation for a rapid and accurate early detection of pulmonary diseases and inflammatory markers.

The major aim of this observational study is to validate the new technique, Orbitrap and Matrix-Assisted Laser Desorption Ionization (MALDI) mass spectrometry, to sample and analyze exhaled patient breath that may be then used in non-intensive care unit (ICU) environments where rapid virus or other respiratory pathogen detection is of great utility. The ICU permits the direct measure of ventilator-dependent patients with known pulmonary disease (by sputum, chest x-ray, and/or bronchial lavage analysis) together with a simple, pure, and concentrated breath sample (expired air via ventilator tubing) for analysis.

Sub-aim 1: Run patient samples on Orbitrap \& MALDI. Proteins in the samples will be captured and analyzed by Orbitrap and MALDI mass spectrometry. Selected proteins will be enzymatically digested into peptides and correlations to existing peptides from previous proteomic studies of exhaled breath condensates (EBC) will be examined. Candidate virus \& bacterial proteins, as well as other cellular and biomarkers, will be cataloged.

Sub-aim 2: Correlate collected analyzed sample collection during hospitalization with other hospital data that may have been collected for clinical reasons by the clinical care team, at or around the study time period (+/- 3 days), concerning for the laboratory diagnosis of respiratory disease.

Eligibility Criteria:
Inclusion Criteria:

* Non-COVID-19 adult consented patients (\>18yo) on ventilatory support in the ICU at OHSU

Exclusion Criteria:

* Patients with "severe respiratory distress" as defined by arterial pO2 of \<60 mmHg on maximal FiO2 \& optimal ventilator settings
* Patient with severe hemodynamic instability as defined by (a) receiving IV infusion of 2 or more pressors or inotropic medications (Levophed, vasopressin, phenylephrine, or epinephrine) \& (b) MAP of \<60 mmHg or SB \<80 mmHg
SLE Therapy Changes in Pregnancy and Relation to Pregnancy Outcome

to review the changes to SLE medications during pregnancy including adherence and non-adherence to the medications and correlate these to the pregnancy outcome and post-partum course of the disease.

This was a retrospective study of pregnancies in SLE patients. These patients had confirmed SLE diagnosis according to the American College of Rheumatology (ACR) criteria (5). The diagnosis of SLE was confirmed by consultant rheumatologist. These patients were followed up by consultant rheumatologist and obstetrician. The pregnancies' data were curated using the patients' medical files and notes, both paper-based and electronic, antenatal records, rheumatology and hematology clinic notes in addition to delivery and postpartum records. These data were collected including ID numbers, ages, duration of the SLE, their SLE medications before the pregnancy (names, doses and frequency) and whether the SLE was active or not in the 6 months prior to the pregnancy using systemic lupus erythematosus disease activity index (SLEDAI) score. the investigators studied Hydroxychloroquine (HCQ), prednisolone and anti-coagulants (low-dose acetylsalicylic acid; 100 mg orally once daily and low molecular weight heparins (LMWH) Enoxaparin 40 mg subcutaneously once daily) as these were the most commonly used medications. The use of these medications in the different pregnancy periods were noted and analyzed (BPG, before pregnancy; DPG, during pregnancy; PG, pregnancy; PP, post-partum). Changes in these medications were also recorded. The data was then analyzed to find out the rates of changes and discontinuation. The postpartum period was also studied similarly. The investigators correlated these alterations to the following feto-maternal outcomes; miscarriage, preterm delivery, intra-uterine growth restriction (IUGR) and intra-uterine fetal death (IUFD). The 6 months-pre-conceptual SLEDAI score was recorded and investigated in relation to the above mentioned feto-maternal outcomes and postpartum relapse. We divided the pregnancies into 2 groups; Group A, inactive SLE and SLEDAI score of 0-3; Group b, active SLE and SLEDAI score of 4-24.

Eligibility Criteria:
Inclusion Criteria:

* confirmed SLE
* completed data

Exclusion Criteria:

* doubtful diagnosis of SLE
* those with missing data
* those with medications other than prednisolone, HCQ and anticoagulants
* those with multifetal pregnancies
* those patients with confirmed other medical diseases including diabetes mellitus, hypertension, thyroid disorders, anti-phospholipid antibody syndrome (APAS), cardiac disease
* those with confirmed deep vein thrombosis (DVT) or pulmonary embolism (PE)
* those with associated hematological diseases including SLE-associated thrombocytopenia.
Exogenous Ketones and Glucose Tolerance

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to an oral glucose tolerance test in individuals with impaired fasting glucose.


Eligibility Criteria:
Inclusion Criteria:

* Not taking any medications affecting glucose metabolism.
* Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index \>28 kg/m2 OR elevated waist circumference (\>102 cm for males, \>88 cm for females)

Exclusion Criteria:

* Diagnosed with diabetes.
* Diagnosed with heart disease.
* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
* Current consumption of ketone supplements
* Pregnant or planning to become pregnant during the study (if female)
Brain Mechanisms Supporting Meditation-based Analgesia

Mindfulness meditation has been shown to reduce pain in experimental and clinical settings, and the neural mechanisms underlying this analgesia are distinct from that of placebo related beliefs in the utility of the meditation. Although previous studies have identified potential cortical and sub-cortical targets responsible for mediating these effects, the connectional relationships between them remains largely unexplored. The present study will use blood-oxygen-level dependent (BOLD) neuroimaging to assess functional connections supporting mindfulness meditation.

Mindfulness meditation, significantly reduces pain in experimental and clinical settings. Although findings from this laboratory provide novel insights into some of the brain mechanisms supporting the modulation of pain by meditation , the specific analgesic mechanisms engaged during mindfulness meditation remain poorly characterized.

To date, there are no studies that have identified the neurofunctional connections supporting mindfulness meditation-based pain relief. Employing fMRI, the objective of this study will be to determine the neural systems of action supporting mindfulness-based pain relief. The study will determine if higher order brain regions are involved in mindfulness-based analgesia. The results from this aim will identify a neural marker(s) for meditation-related pain relief, a critical step in defining how meditation reduces pain.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers between ages 18 and 65.
* Men and women of all races will be included

Exclusion Criteria:

* Subjects with a history of psychiatric or neurological disorders.
* Subjects will be excluded if they report being claustrophobic.
* Subjects with a prior history of meditation training will be excluded.
* Subjects with ferrous metal or electronic devices (e g., pacemakers) implanted in there body will be excluded.
* Pregnant subjects will be excluded.
* Subjects that demonstrate no pain to noxious temperatures (\>49°C) or excessive responses to temperatures at or below 43°C will be excluded.
The Application of Fluorescence Laparoscopy in the Treatment of Adenocarcinoma of the Esophagogastric Junction

The fluorescent laparoscopic technique would be applied to the radical resection of gastric cancer at the junction of esophagus and stomach, and compared with the traditional laparoscopic radical resection of gastric cancer to find a better surgical method for patients


Eligibility Criteria:
Inclusion Criteria:

- 1. All cases should be diagnosed as adenocarcinoma of the esophagogastric junctionncer by histology. The tumor is within 1 cm above or 2 cm below the anatomic cardia. The clinical stage is T1-3, Nx, M0 for gastric cancer which can undergo the laparoscopic surgery.

2. Eastern Cooperative Oncology Group (ECOG) scale 0-2 3. Heart, lung, liver, and kidney function can tolerate operation 4. Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent.

Exclusion Criteria:

1. history of stomach malignant disease 2. recent diagnosis of other malignant tumors (except for papillary carcinoma of the thyroid gland and basal cell carcinoma of the skin) 3. patients with obstruction, perforation, bleeding requiring emergency surgery 4. a history of abdominal surgery (which makes it difficult to perform laparoscopic procedures), severe systemic disease such as diabetes, severe chronic lung disease, cirrhosis, other malignant diseases 5. combined stomach multiple carcinomas 6. with a history of serious mental illness 7. pregnant or lactating women 8. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.

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A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening
* Male subjects agree to use contraception
* Willing and able to give written informed consent

Exclusion Criteria:

* Evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of hypersensitivity or allergy to drugs, foods, or other substances
* History or presence of abnormal electrocardiogram or hypertension
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening
* Participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening
Enhanced Child Friendly Space Interventions for Children

A 3-arm randomised controlled trial will be conducted to compare the effectiveness of a new enhanced Child Friendly Space service package with the basic Child Friendly Space service implementation, and to a waitlist control condition, within the West Nile refugee response in Uganda.

A Child Friendly Space (CFS) is an acute phase humanitarian intervention designed to provide children with a safe, supportive, and stable environment early after the onset of crisis that will promote their social and emotional well-being, as well strengthen the existing systems of protection required to support children in reaching developmental milestones. Typically, CFSs house a range of structured and unstructured activities led by trained animators in a community-designated safe area.

The basic service package offers a mixture of recreational and non-formal education activities over a twelve-week period. Each session lasts around 1.5 - 3 hours. Structured activities offered include basic literacy and numeracy lessons, life skills exercises, health and hygiene sessions, and traditional song and dance. Many activities are centered around various forms of play that enable expression and age-appropriate skill development. Unstructured free play and playground time is allocated throughout the daily session.

The enhanced service package provides 40 sequential sessions selected by CFS program staff in advance and implemented over a twelve-week period. Activities are meant to build upon and reinforce one another and are organized into seven psychosocial themes: 1) Building community: "Our space together", 2) Emotional learning: "My feelings", 3) Wellbeing and coping: "Feeling good", 4) Social support: "My friends and family", 5) Relating to others: "Being a good friend", 6) Protection and boundaries: "My safety", and 7) Building on strengths: "All my supports". Each session takes approximately 1.5 - 2 hours to facilitate and will conclude with 1-1.5 hours unstructured free play time.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver has a child between the ages 6-8
* Child is between the ages of 9-14 years

Exclusion Criteria:

* No child resides in the home between the ages of 6 and 14 years
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery

The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain medication compared to intravenous patient controlled analgesia. Participants undergoing spine surgery will be randomized into one of two groups;

- A.) General Anesthesia and postoperative Patient Controlled Analgesia and placebo IV infusion.

B.) General Anesthesia plus perioperative intravenous lidocaine infusion, and post operative Patient Controlled Analgesia.

According to a survey of 1570 U.S neurosurgeons, in the United States about 527.000 spine surgeries were done in 1999. This represents close to 65% of the procedures performed by neurosurgeons. Furthermore, the number of hospitalizations related with spine surgery has significantly increased since 1970.

IV PCA is considered the standard of care for postoperative pain control after surgery. Intravenous opioids have significant side effects such as respiratory depression, postoperative nausea and vomiting and sedation. Furthermore, they cause delayed return of bowel function and ileus.

There is the possibility of surgically inserting a catheter into the epidural space at the end of surgery. In general epidural analgesia provides excellent pain relief after surgery and decreases opioid consumption significantly und thus opioid related postoperative complications. Furthermore epidural anesthesia affects the surgical stress response and might decrease inflammatory responses after surgery, thereby improving postoperative recovery and mobilization of the patients.

Intravenous local anesthetics have potent anti-inflammatory properties. They also decrease postoperative opioid consumption. Clinical studies have shown that perioperative local anesthetic administration significantly reduces the incidence of thrombosis and postoperative pain, shortens postoperative ileus and decreases duration of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
* Elective spine surgery
* Two levels laminectomies or above with or without fusion or instrumentatioN
* General anesthesia
* Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team

Exclusion Criteria:

* contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal)
* renal impairment (serum creatinine \>2 mg/dl),
* seizure disorder requiring medication within 2 years
* planned epidural anesthesia or analgesia
Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.

In this study, hypothesis is that the severity of spasticity differs depending on the forearm position.

There are three main muscles that contribute to elbow flexor spasticity; musculus biceps brachii, musculus brachialis and musculus brachioradialis. Muscle selection in elbow flexor spasticity for botulinum toxin application has impact on treatment outcome. The superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin injection. In dynamic electromyography studies, it has been reported that brachioradialis muscle is the most common contributor one to elbow flexion spasticity, followed by biceps brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been reported to be foreground.

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. Can the target muscle selection clinically be performed instead of methods such as electromyography where equipment is required and the evaluation period is relatively long? Can semi-quantitative methods used to assess the severity of spasticity provide reliable information regarding the muscle or muscles that contribute to elbow flexor spasticity? It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation.

The aim of this study is to investigate whether the severity of spasticity differs depending on the forearm position.

Eligibility Criteria:
Inclusion Criteria:

* Elbow flexor spasticity
* Grade 1 to 3 spasticity measured with Modified Ashworth Scale
* To agree to participate in the study

Exclusion Criteria:

* \<18 years old
* Pregnancy
* Botulinum toxin injection within the last three months
* Presence of elbow contracture
* History of operation to spastic upper extremity
* Spasticity due to other causes other than stroke
* Do not agree to participate in the study
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.

When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.

The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.

Eligibility Criteria:
Inclusion Criteria:

* Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
* Obstetrician's approval of enrollment into study
* Parental consent
* Any mode of birth will be included

Exclusion Criteria:

* Obstetrician's refusal to enroll infants
* Parental refusal for consent
* Prenatally-diagnosed major congenital anomalies \[or multiple gestations\]
* Intent to withhold or withdraw care
* Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
* Mothers who are institutionalized or psychotic
Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit

The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years old
* in intensive care unit since 24h and for up to 48 hours
* with contrast medium injection

Exclusion Criteria:

* patient under renal replacement therapy
* rise in creatinine \> 26µmol/L within 48hours
* anuria within 12 hours
* cardiogenic pulmonary oedema
* pH \> 7.50 or kaliemia \< 3mmol/L
* pregnancy
Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)

To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice

These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit-risk assessment regarding major bleeding consequences of ASA exposure in general population.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-84 years
* Enrolled with the Primary Care Physician (PCP) for at least 2 years,
* To have a history of computerized prescriptions for at least 1 year prior
* To have at least one encounter/visit recorded in the last three years

Exclusion Criteria:

* To be exposed to low dose ASA before entering in the study
* Having a diagnosis of cancer before entering in the study
* Having a diagnosis of alcohol abuse before entering in the study
* Having a diagnosis of coagulopathies before entering in the study
* Having a diagnosis of esophageal varices before entering in the study
* Having a diagnosis of chronic liver disease before entering in the study
Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods

To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.


Eligibility Criteria:
Inclusion Criteria:

* Those who underwent elective cesarean section over the age of 18,
* American Society of Anesthesia I and II,
* Agree to participate in the study,

Exclusion Criteria:

* \<18 or \>45 years,
* preeclampsia,
* cardiovascular disorders,
* fetal abnormalities,
* not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
* not agreeing to participate in the study
A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182)

The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.

The duration of treatment is 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Impaction of a molar tooth requiring removal

Exclusion Criteria:

* Known allergy to the study drugs