cyrilzakka/clinical-trials huggingface dataset:
Is Effective Preoxygenation in Elderly Patients Related to Position?

The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.

Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.

Eligibility Criteria:
Inclusion Criteria:

* Age above 65 years
* ASA 1-2

Exclusion Criteria:

* heart failure
* uncooperative
* patients refusing well fitting face mask before reaching EtO2 85%
* chronic lung disease
* anemia (hb\<8gr/dl)
* BMI\>40
* neurological sequela
The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain

Low back pain (LBP) is a well known health problem in Western society that is significantly responsible for socio-economic problems like absenteeism and disability. The lifetime prevalence of LBP is 60-80% and approximately 85% of this LBP has a "non-specific" character whereby the underlying causes and risk factors cannot be demonstrated. While many people recover within a month, most individuals will have recurrence within a year with more severe symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired proprioception, the ability to discern body/limb positions and movements, may cause and maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP rely more on proprioceptive signals from the ankles due to less reliable proprioceptive input of proximal segments. Moreover, they show a decreased variability in postural control and less postural robustness, while variability is a prerequisite for optimal functioning of biological systems. However, further clarification of the neural correlates is necessary. Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with a decreased ability of the brain to process proprioceptive inputs.

The aim of this project is to clarify the central changes in individuals with recurrent non-specific low back pain and healthy controls. To evaluate these central changes MRI techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between central changes and postural control tasks will be evaluated.


Eligibility Criteria:
Inclusion Criteria persons with low back pain:

* Age: 20-50 year
* At least 6 months of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 14% on the Oswestry Disability Index
* Willingness to sign the informed consent
* Met the MRI related requirements

Inclusion Criteria healthy persons:

* Age: 20-50 year
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent
* Met the MRI related requirements

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, MS, Stroke with sequels....
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Ankle problems
* Smoking
IM-862 in Treating Patients With Recurrent Ovarian Cancer

RATIONALE: IM-862 may stop the growth of ovarian cancer by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of IM-862 in treating patients who have recurrent ovarian cancer after treatment with chemotherapy and surgery.

OBJECTIVES: I. Determine the maximum tolerated dose of IM-862 administered intranasally in patients with recurrent ovarian cancer. II. Determine the toxicity of this regimen in this patient population. III. Obtain preliminary data regarding the efficacy of this drug in these patients. IV. Evaluate the effect of this drug in serum levels of vascular endothelial growth factor and transforming growth factor in this population.

OUTLINE: This is a dose escalation study. Patients receive IM-862 intranasally daily. Treatment continues for 6 months in the absence of unacceptable toxicity or disease progression. At the physician's discretion, further treatment may be given if the patient is still responding after 6 months of treatment. The dose of IM-862 is escalated in cohorts of 10-20 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 or 5 of 20 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 20-70 evaluable patients will be accrued for this study within 6-9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent ovarian cancer Failed or relapsed after cytoreductive surgery followed by a platinum-based chemotherapy regimen Measurable or evaluable disease Recurrent disease manifested by isolated increased levels of CA-125 and no other evaluable disease eligible if CA-125 is at least 100

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT and/or AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2 times ULN Neurological: No evidence of moderate peripheral neuropathy greater than grade 1 Other: Not pregnant Fertile patients must use effective contraception No medical, social, or psychological factors interfering with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior IM-862 No concurrent biologic therapy (e.g., interleukin-2 and interferons) Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No concurrent antineoplastic cytotoxic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: No other concurrent investigational drugs
Adherence in Adolescents and Children Treated on Quetiapine

Observational study aimed to describe the adherence in a population of adolescents and children treated on quetiapine from a first psychotic episode whose more important secondary objective is to identify possible predictive factors influencing the adherence to treatment with Quetiapine


Eligibility Criteria:
Inclusion Criteria:

* At least one psychotic symptom (delusions or hallucinations) before age 18.
* Start of treatment in a maximum period of 2 years after the onset of first psychotic symptom
* Written informed consent by parents or guardians and patients.

Exclusion Criteria:

* Pregnancy or lactancy
* High risk of aggression or suicidal behaviour
* Alcohol dependence
A Phase 2b Study of Icosabutate in Fatty Liver Disease

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up

Eligibility Criteria:
Inclusion Criteria:

* Provides signed written informed consent and agrees to comply with the study protocol.
* Is a male or female aged 18 to 75 years, inclusive.
* Has a histological diagnosis of NASH prior to study entry
* Has (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning),
* Has a fibrosis score F1 to F3, inclusive (F1 capped at 30%),
* Has a Proton Density Fat Fraction (PDFF) greater than or equal to 10% on MRI at screening

Exclusion Criteria:

* Has a known history of alcohol abuse or daily heavy alcohol consumption
* Has had bariatric surgery within the past 5 years
* Has significant systemic or major illnesses other than liver disease
* Has a recent (within 6 months) history of cardiac dysrhythmias and/or cardiovascular disease
* Has uncontrolled arterial hypertension
* Positive for Hep B, Hepatitis C Virus (HCV) or HCV Polymerase Chain Reaction (PCR)
* Has type 1 diabetes mellitus
* Has diabetic ketoacidosis
* Has a history of liver decompensation
Cognitive Training RCT for Older Chinese Americans

The purpose of this study is to develop and pilot test a mHealth intervention for cognitive training that is culturally and linguistically relevant to older Chinese Americans

This is an NIH Stage 1 pilot randomized controlled trial. The purpose of this trial is to evaluate the feasibility, acceptability, and obtain preliminary effect sizes on outcomes of a cognitive training intervention. The cognitive training intervention will be app-based and will be co-developed with older Chinese Americans and adult children to ensure it is culturally and linguistically relevant.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as Chinese
* are age 60 or older
* are fluent in written and spoken Chinese and/or English
* have the visual capacity to read a smartphone or a tablet screen and have the auditory capacity to understand normal speech
* have no self-reported diagnosis of ADRD or cognitive impairment, and are capable of making an informed consent

Exclusion Criteria:

* Individuals are excluded if they are bed-ridden
* receiving chemotherapy for malignancy
* have other life-threatening illnesses
Urine Pregnancy Test Compared to Transvaginal Ultrasound (CHECK-TOP).

According to a study of the DREES (Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques), in 2013, nearly 229 000 abortions were performed in France, an increasing number.

The success rate of drug abortion before 49 days of amenorrhea, defined by the National Health Autority as a complete abortion not requiring surgery, varies from 92 to 98% depending on the pregnancy term and the dose used.

The control visit is performed between the 14th day and the 21th day post abortion. Its role is to monitor the effectiveness of the method, to verify absence of complication and to better adapt contraception to prevent another unwanted pregnancy. The choice of the method is left to the physician's discretion: β-HCG dosage, pelvic or transvaginal ultrasound.

In the Orthogenic Departement of the Croix-Rousse Hospital Lyon, France, the method performed during the control visit is transvaginal ultrasound.

To simplify the monitoring of drug abortion, a urine pregnancy test would be an attractive alternative to transvaginal ultrasound: simplicity of use, speed, ease of interpretation and low cost.

The main objective of this study is to evaluate the diagnostic value of urine pregnancy test CHECK TOP compared to transvaginal ultrasound in monitoring the outcome of drug abortion during the control visit.

This is a monocentric observational study.


Eligibility Criteria:
* Inclusion Criteria:

  * Women ≥18 years of age
  * Undergoing drug abortion in Orthogenic Departement, Croix-Rousse Hospital, Lyon
  * Intrauterine pregnancy, single or multiple, until 8 weeks of amenorrhea
  * Agreeing to participate in the study after receiving information note
  * Affiliated to a social security system
  * Not subject to a measure of legal protection
* Exclusion Criteria:

  * Women \<18 years
  * Ineligible patient to drug abortion
  * Patient practicing a surgical abortion
Tofacitnib for the Treatment of Alopecia Areata and Variants

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old
* Diagnosis of alopecia areata with \>50% scalp involvement, alopecia totalis, or alopecia universalis
* Hair loss present for at least 6 months
* No treatment for alopecia areata in past 2 months
* No evidence of hair regrowth
* Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication

Exclusion Criteria:

* Age \<18 years old
* Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
* Patients known to be HIV or hepatitis B or C positive
* Patients with positive tuberculin skin test or positive QuantiFERON TB test
* Patients with leukopenia or anemia
* Patients with renal or hepatic impairment
* Patients with peptic ulcer disease
* Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
* Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
* Women who are pregnant or nursing
Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation

Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has emerged as the gold standard for paroxysmal AF with excellent success rates, however, individuals with persistent AF procedural efficacy from pulmonary vein isolation is not optimal. Therefore, improved ablation strategies for these individuals are needed.

This randomized controlled trial will compare two radiofrequency ablation strategies, PVI alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in individuals with persistent AF. Both strategies are currently used to treat persistent AF, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious.

Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for AF. For group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall.

All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for AF, and then two-week ambulatory monitors at 3 months and one year post ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
2. Refractory to at least one antiarrhythmic agent.
3. Undergoing ablation for the first time.

Exclusion Criteria:

1. Paroxysmal AF
2. Sustained atrial fibrillation lasting more than 3 years
3. Left atrial diameter of 60 mm or greater
Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection

stanford type A aortic dissection is the most common cause of death caused by aortic disease in Chinese mainland. Patients who are hospitalized need immediate surgical treatment.Emergency aortic arch replacement is difficult and risky. Different surgical methods have different effects on postoperative prognosis. Aortic arch replacement is divided into total-arch replacement (Sun's operation) and hemi-arch replacement. In this study, and the learning Curve of Aortic Arch Replacement Surgery was evaluated with cumulative cum curve.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years who underwent surgery for stanford type A aorta dissection without concurrent cardiac Surgery

Exclusion Criteria:

* data miss greater than 10%
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma

The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV


Eligibility Criteria:
Inclusion Criteria:

* osteosarcoma
* eligible to receive 2 sequential cycles of HDMTX-LV

Exclusion Criteria:

* prior administration of glucarpidase
* progression of disease while on previous MTX treatment
The Role of Leptin Receptors in NASH

NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD.

Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective bariatric surgery, ages 18-65.

Exclusion Criteria:

* non-obese patients, ages less than 18 and over 65. Pregnant patients.
Clinical Characteristics and Prognostic Factors of Patients With COVID-19 (Coronavirus Disease 2019)

This is a multicenter, non-interventional, retrospective study using data captured in the EHRs (Electronic Health Records) of the participating hospital sites to determine factors that predict disease prognosis and outcomes in COVID-19 patients, specifically: Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanical ventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/ hospital discharge, in-hospital death)

Data captured in the EHRs will be collected from all available departments, including inpatient hospital, outpatient hospital, emergency room, etc. for virtually all types of provided services in each participating site. The study period will be from January 1, 2020 to the most recent data available.

* Primary objective To determine factors that predict disease prognosis and outcomes in COVID-19 patients, specifically: Hospitalization/Off-site monitoring, transfer to ICU and/or need for medical mechanical ventilation (both invasive and non- invasive), length of ICU stay, and outcome (cure/ hospital discharge, in-hospital death)
* Secondary objectives

  * To describe the demographic and clinical characteristics of COVID-19 patients
  * To describe the patient management (treatment and procedures) in the target population
  * To describe the outcomes of COVID-19 (discharge, hospitalization, transfer to ICU/ mechanical medical ventilation, in-hospital death) in relation to patients' clinical and demographic characteristics, and treatment received
  * To determine whether the factors that predict COVID-19 prognosis and outcome also apply to other types of pneumonia.
* Exploratory objectives One of the goals of this study is to configure the Big Data system to unravel any hidden variable/s (and their associations) that may offer novel clinical insights into COVID-19 management.

Eligibility Criteria:
Inclusion Criteria:

* All patients with suspected COVID-19 infection, as captured in the patients' EHRs of the participating sites.

Exclusion Criteria:

* Not suspected COVID-10 infection
Nurse Promotion of IV to PO Antimicrobial Conversion

This is a prospective, quasi-experimental, historically controlled study to evaluate if a behavioural change intervention informed by the COM-B model of behaviour change can improve nurses' self-perceived capability, opportunity, and motivation to engage in the assessment of patients who may be appropriate for IV to PO antimicrobial conversion. This study also seeks to determine if this translates into an increase in IV to PO antimicrobial conversion rates in the acute care setting.

Current antimicrobial stewardship guidelines recommend appropriate and timely IV to PO antimicrobial conversion in hospitalized patients. Published rates of IV to PO antimicrobial conversion are consistently below 50% in eligible inpatients. Studies have suggested that nurses may be well positioned to provide a positive influence on prescriber behavior related to antimicrobial IV to PO conversion, however, no published research has evaluated the impact of nurses on antimicrobial IV to PO conversion rates. Published research has described the barriers and enablers to nurse participation in promoting antimicrobial IV to PO conversion using the COM-B model of behaviour change. This quasi-experimental study will evaluate whether determinants of nurse behaviour and their actual behaviour can be changed to increase antimicrobial IV to PO conversion rates in hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* Nineteen years of age or older
* Employed as a RN or LPN at KGH in any capacity (full-time, part-time or casual employee)
* Practicing on a medicine/thoracic surgery ward (4A) or medicine/oncology/respiratory ward (4B)

Exclusion Criteria:

* RNs or LPNs on orientation shifts/training
* RNs or LPNs not engaged in patient care
* Student nurses/nurses in training