cyrilzakka/clinical-trials huggingface dataset:
Study of Pazopanib and Pemetrexed in Advanced Non-small Cell Lung Cancer

The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* At least 18 years old
* Histologically- or cytologically-confirmed diagnosis of predominantly nonsquamous cell Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC
* No prior systemic first-line therapy for advanced NSCLC
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 12 weeks
* Able to swallow and retain oral medication
* Adequate organ system function (hematological, hepatic, and renal)
* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception. A male with a female partner of childbearing potential is eligible if he uses a barrier method of contraception or abstinence during the study

Exclusion Criteria:

* Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC
* Central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
* Clinically significant gastrointestinal abnormalities
* Prolongation of corrected QT interval (QTc) \> 480 msecs
* History of any one or more cardiovascular conditions within the past 6 months prior to randomization
* Poorly controlled hypertension
* History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
* Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
* Evidence of active bleeding or bleeding diathesis
* Recent hemoptysis
* Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
* Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Use of any prohibited medication
* Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
* Ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity except alopecia
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, pemetrexed, and/or cisplatin
* Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs during the study
* Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
* Clinically significant third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study start
* Recent or concurrent yellow fever vaccination
The Effects of Endotracheal Suctioning on Pain and Serum Markers

The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress.

The main questions this study aims to answer are:

Does ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress.

Participants will:

Have pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning.

Provide demographic information (like age, gender, and diagnosis) from medical records.

This research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 years and older)
* Current diagnosis of flu, pneumonia, COVID, or sepsis
* Intubated and receiving mechanical ventilation.
* Have arterial lines placed
* Require endotracheal suctioning as part of their care

Exclusion Criteria:

* Patients receiving neuromuscular blocking agents
* Contraindications for blood draws (hemoglobin levels below 8.0 g/dL; Jehovah's Witness)
Quality of Sleep in Patients With Rheumatoid Arthritis

As one of the characteristic clinical features of the patients with rheumatoid arthritis, the unique character of the patients, somewhat difficult to be persuaded but theoretical, has long been pointed out. The investigators hypothesized that this unique character might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. The investigators test (1) the sleep quality of the patients and draw some characteristic features, and (2) investigated the connection between unique biochemical changes such as the increase of c-fos or wee-1.

Under the hypothesis the unique character of patients might be due to the sleep disturbance in the patients possibly due to severe pain of arthritis or unique biochemical disease activities. We do following studies; The study of sleep quality of the patients; The number of patients expected to be included in the study is 1,000. Inclusion criteria is the ACR criteria, and exclusion criteria is any defined disease conditions of sleep disorders in ICSD. The method includes questionnaire using the Pittsburgh Sleep Quality Index (PSQI) scoring and Epworth scoring, and actigraphy measurement for more than 3 days. In a portion of the patients, we measure clinical arthritis activities in conjunction with western blot for c-fos and wee-1 as well as routine clinical laboratory tests. Also in a portion of the patients, we do the polysomnography study; expected number of participants would be 100. We also plan to test the effect of good sloop on arthritis in a portion of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the American College of Rheumatology criteria of rheumatoid arthritis

Exclusion Criteria:

* Any defined sleep disorders of International Classification of Sleep Disorders (ICSD)
Human Milk Fortifier - Growth Evaluation

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.


Eligibility Criteria:
Inclusion Criteria:

* Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
* Male or female
* Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
* Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
* Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria:

* Infants with current systemic disease
* Infants with a history of systemic disease
* Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
* Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
* Infants diagnosed with any inherent metabolic disease.
* Infants diagnosed with any chromosomic disease.
* Receiving any commercial formula supplementation to breast milk.
* Receiving steroids at the time of enrollment.
* Participation in another nutritional clinical trial that may affect outcomes of this study.
MRS and Medication Response: A Pilot Study

We hope to demonstrate that magnetic resonance spectroscopy can detect brain concentration levels of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) in depressed patients.

The primary objective of this study is to demonstrate that it is feasible to image paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) brain concentrations using MRS technology in depressed patients.

The longer-term goal is to determine the relationship between clinically administered doses of paroxetine (Paxil) or citalopram (Celexa) or escitalopram (Lexapro) (antidepressants), the amount of drug in the body via blood level, the concentrations of the drug achieved in brain measured via MRS, and genetics.

It has been previously reported that individuals taking 20mg of paroxetine daily had brain paroxetine \[(Paxil) levels via MRS ranging from 2-13 micromolar. Similar or slightly higher ranges of brain drug concentrations have been reported for fluoxetine and fluvoxamine.

Since not all depressed patients respond to medications, one reason may be the amount of medication that crosses the blood-brain barrier. This may be influenced by genetic information. We want to examine these issues on a larger scale, but first we need to demonstrate that we can indeed determine paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\] levels via MRS.

Intended results analysis could not be conducted because a reliably sensitive spectroscopic method could not be developed.

Eligibility Criteria:
Major depressive disorder:

Inclusion Criteria:

1. DSM diagnosis of Major Depressive Disorder
2. Taking paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\]for at least 6 weeks
3. Between 21 - 75 years of age.
4. Taking a stable dose of paroxetine \[(Paxil) or citalopram (Celexa) or escitalopram (Lexapro)\] for at least the 2 weeks prior to the imaging session

Healthy controls:

1. Between 21 - 75 years of age.
2. Have a 21-item HAM-D score of less than or equal to 5.
3. No current, or history of any Axis I disorder.

Identify exclusion criteria.

Exclusion criteria are as follows:

1. Contraindications for an MRI exam. These includes biomedical devices such as pacemakers, aneurysm clips, prostheses, and other metallic objects embedded in the body such as bullets, buckshot, shrapnel, and any metal fragments from working around metal.
2. Current pregnancy or lactation.
3. Patients with claustrophobia.
4. History, or current Axis I or Axis II disorders
5. Active unstable medical problems, as confirmed by screening procedures
6. Diagnosed with any autoimmune disease, (e.g., rheumatoid arthritis, Lupus, MLS).
7. Chronic use of steroids or opiates.
8. Positive urine toxicology screen for illicit substances of abuse.
The TRAMPOLINE VT Study

This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will identify sites of interest for focussed activation mapping. The investigators hypothesise that the examination of these data will identify critical target sites for ablation. Intra-procedural diagnostic performance of the Octaray and Optrell catheters will be assessed as the primary outcome, and will be compared with the standard of care. Secondary, clinical outcomes - primarily the need for ICD therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.


Eligibility Criteria:
Inclusion Criteria:

* ICD in situ
* Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs
* Ischaemic or non-ischaemic heart disease

Exclusion Criteria:

* Valvular heart disease precluding LV access
* Cardiotomy within previous 3 months
* Acute coronary syndrome within 6 weeks
* Dialysis patients
* Coagulopathy/Thrombocytopaenia
* Pregnancy/breastfeeding women
* CMR contraindicated
* Prognosis \<12 months
* Unable to provide informed consent
Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

Phase II, multi-centric, randomized, double-blinded, placebo-controlled, parallel design clinical trial to evaluate the safety, tolerability and efficacy of Donepezil in patients with Mild Cognitive Impairment in Parkinson's Disease (PD-MCI). A total of 120 patients with PD-MCI will be randomized to 12 months of oral Donepezil 10mg or matching placebo (1:1).

Primary and co-primary efficacy endpoints are cognitive and functional cognitive scales: PD-CRS and PD-CFRS. Secondary efficacy endpoints include: cognitive tests evaluating attention, executive functions, language, memory and visuospatial domain; mood, anxiety, and apathy scales; questionnaires to evaluate quality of life; and subjective impression scales. Serum Neurofilament light chain, genetic screening of GBA, ApoE and MAPT, and Magnetic Resonance Imaging will be performed in a subset of these patients.

The study will be conducted in 20 different centers around Spain. The Movement Disorders Unit of the Neurology Department at Sant Pau Hospital (Barcelona, Spain) will be the coordinating center.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80
* PD diagnosis according to MDS criteria
* Hoehn and Yahr stage I-III
* Persistent subjective cognitive complaints for at least 6 months
* MDS PD-MCI Level I and Level II criteria
* Persistent PD-MCI for at least 3 months
* Stable dopaminergic treatment for at least 1 month

Exclusion Criteria:

* PD dementia criteria
* Severe motor complications
* DBS or any brain condition that may be contributing to cognitive impairment
* Active psychosis, major hallucinations, HADS ≥11, active impulse control disorder, or other active severe behavioral disorders.
* Treatment under anticholinergics, cholinergic enhancers, or neuroleptics.
* History of symptomatic arterial hypotension.
* Hypersensitivity or intolerance to donepezil or any of the excipients
* Pregnancy
* Unstable medical or surgical condition
* Any other significant observation that, in the investigator's opinion, would contraindicate participation in the study.
A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure.

Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part.

The name of the study drug involved in this study is: RLS-0071.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 based on positive SARS-CoV-2 viral RNA PCR or antigen test.
* Hypoxemia.
* Radiographic evidence of opacification consistent with viral-related pneumonia.
* Weight less than 150 kg.
* Provide written informed consent.

Exclusion Criteria:

* Endotracheal intubation and mechanical ventilation.
* Noninvasive positive pressure ventilation without endotracheal intubation.
* Requires chronic oxygen therapy.
* Treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents for ≥ 4 weeks duration within 3 months prior to the Screening visit.
* Use of oral corticosteroids in a dose higher than prednisone 15 mg or equivalent per day for ≥ 4 weeks duration within 3 months prior to the Screening visit.
* Systemic autoimmune disease.
* Participation in any clinical research study evaluating an investigational product or therapy within 3 months prior to the Screening visit,
* Presence of any of the following abnormal laboratory values at Screening: absolute neutrophil count \< 2,000/mm3, aspartate aminotransferase or alanine aminotransferase \> 5 × upper limit of normal (ULN), platelets \< 50,000/mm3.
* D-dimer \> 2 × ULN at Screening, as evidence of potential disseminated intravascular coagulation (DIC).
* Has confounding medical conditions, including poorly controlled diabetes, uncontrolled New York Heart Association Class III congestive heart failure, clinically significant arrhythmias not controlled by medication, idiopathic pulmonary fibrosis, interstitial lung disease, or chronic obstructive pulmonary disease.
* Has bacterial sepsis currently or suspicion thereof.
* Has cancer currently and is receiving active treatment (including radiation therapy or chemotherapy) or malignancy within the last 5 years, with the exception of curable cancer (eg, basal or squamous cell skin cancer, cervical cancer in situ, nonmedullary thyroid carcinoma) that has been adequately treated (eg, excision).
* Prior history of myocardial infarction or angina, stroke or transient ischemic attack (TIA), pulmonary embolism or deep vein thrombosis.
* Is moribund and not expected to survive 48 hours following Screening or for whom no further aggressive treatment such as mechanical ventilation is planned.
Supervised Versus Home Based Exercises Neck and Low Back Pain Among Students Due to Quarantine During COVID-19

This study investigates whether or not the stretching and strengthening exercises are effective both at home and under supervision for people suffering from neck pain from using equipment for online courses due to quarantine during COVID-19.

The aim of this study is to investigate which regime is best to follow a recommendation, be it under the supervision of the therapist or at home with stretching and strengthening exercises. There was no study that could explain the effect of stretching and strengthening exercises as a comparison between a supervised and a home treatment plan for neck pain in students during quarantine due to Covid-19.This study examines whether or not the recommendations given are effective both at home and under supervision.

Eligibility Criteria:
Inclusion Criteria

* Participants using gadget like computer, mobile or laptop for online education during quarantine
* Participants having musculoskeletal pain during COVID-19 quarantine
* Prolonged sitting and low physical activity during quarantine
* Prolonged exposure of screen more than 6 hours per day due online classes during the quarantine

Exclusion Criteria:

* Participants having musculoskeletal pain before the quarantine
* Participants doing any type of physical activity during quarantine
* Participants taking online classes or any online educational program before quarantine
* Participants with known congenital, inflammatory and infectious conditions of spine
* Participants following any ergonomic recommendations or any postural awareness during and after quarantine
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss

The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a smartphone application developed to facilitate weight loss, assessing its feasibility and acceptability. Overweight and obese adults will be recruited from large employers within the local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision based on randomizing 45 people to each arm. Participants will be randomized to one of three groups. The researchers have developed a smartphone application for weight loss called "My Meal Mate" (MMM) which incorporates a large branded food and drink database. MMM was developed using focus group data collected from potential system users and by benchmarking with similar commercially available diet tracking applications. One group will receive a smartphone with the MMM app downloaded on it, one group will receive access to an online food diary and one group will be given a paper food diary. Participants will be asked to set a goal for weight loss and self-monitor their food intake and activity using their allocated study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and at 6 months. Feasibility and acceptability outcomes will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* BMI equal to or greater than 27 kg/m2
* Willing to commit the necessary time and effort to the study,
* Employed by a large employer in Leeds (and expects to continue to be employed there for the next 12 months),
* Able to read and write in English,
* Able to access the internet,
* Willing to be randomised to one of three groups.

Exclusion Criteria:

* Pregnant, planning a pregnancy within next 12 months, lactating
* Has had surgery for weight loss
* Taking the medication sertraline (due to associations with weight gain)
* Taking anti-obesity medications or medications for diabetes
Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion

Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.

A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications

B. Patient evaluation and assessment:

The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :

1. Kidney functions (Serum creatinine, blood urea nitrogen)
2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)
3. Complete blood count
4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
6. APACHE II Variables

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-74 years
* Expected ICU stay more than 24 hours

Exclusion Criteria:

* Allergy or potential allergy to the study medications

  * Pregnancy
  * Patients with CrCl\< 20 ml/min or on dialysis
  * Cancer patients