cyrilzakka/clinical-trials huggingface dataset:
Rituximab-induced Pulmonary Function Changes

Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

The objective of this study is to investigate whether rituximab (RTX), a drug commonly prescribed in patients with rheumatoid arthritis (RA) or inflammatory myositis, is associated with subclinical interstitial lung disease (ILD). Surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (FVC) and/or the diffusing capacity of the lung for carbon monoxide (DLCO). However, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with RTX according to the principles of "good clinical practice". We will perform pulmonary function testing (spirometry) including measurement of the DLCO in patients with RA, who are going to be treated with RTX. A baseline lung function measurement will be performed immediately before RTX therapy is started. Follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of RTX therapy. A reduction in forced vital capacity (FVC) of \>10% or a fall of \>15% in DLCO will be defined as indicative for ILD.

Eligibility Criteria:
Inclusion criteria: - Patients with established diagnosis of RA or inflammatory myositis, in whom a de novo RTX treatment is indicated

* Age \>18 y
* Informed consent of patient

Exclusion criteria: - Acute infection

* Pre-existing interstitial pulmonary disease
* Patients with impaired forced vital capacity (FVC) on spirometry (\<80% predicted) or with impaired DLCO (\<75% predicted).
* Pregnancy
Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics

Immune checkpoint inhibitors (ICIs) are an important breakthrough in cancer therapy and have been increasingly used.However, ICIs can cause a unique spectrum of side effects termed immune-related adverse events (irAEs),which can affect any organ systems and in some cases are fulminant or even fatal.In clinical practice, irAEs and clinical efficacy maybe various for patients with same standard treatment, and some studies have shown that gene and metabolic differences in cancer patients may be an important factor. In this project, peripheral blood samples from cancer patients will be collected prospectively at baseline, and at regular intervals (2 cycles, about 6 weeks) for about 30 weeks, then these blood samples will be analyzed using the technique of genomics, metabonomics.

The investigators aim to find biomarkers associated with irAE or clinical efficacy. When the sample size and data is big enough, the investigators plan to establish a prediction model using machine learning to access the safety and efficacy of ICIs for cancer patients. Our study have important clinical implications in the prediction and early management of severe, potentially life-threatening immune-related toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant tumor, no relative contraindications for immunotherapy, in line with the standards of immunotherapy
* Receive immune checkpoint inhibitors (ICIs) for the first time or have received ICIs but no immune-related adverse reactions have occurred
* Have provided informed consent, are willing to participate in study and routine follow-up
* At least one measurable lesion according to Guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST)

Exclusion Criteria:

* Active, known, suspected or a documented history of autoimmune disease
* Eastern Cooperative Oncology Group(ECOG) performance status 3-4
* Long-term hormone therapy，corticosteroids (\>10mg/day prednisone curative dose)
* Subjects with human immunodeficiency virus (HIV)
* Subjects with other tumors
* Myocardial infarction, poorly control led arrhythmia, New York Heart Association (NYHA) standard III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF)\<50% in the last 6 month
* Active tuberculosis
* Active or a documented history of interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function
* Common Terminology Criteria for Adverse Events (CTCAE) peripheral neuropathy grade≥2
* History of alcohol abuse
Digital Subtraction Radiography Evaluation of SMART Restoration With Partial Caries Removal in Primary Teeth

The objective of this study was to analyze the radiographic density of digital subtraction radiographs after SMART restoration with partial caries removal in primary molars at 6 and 12 months.

In management of deep caries in primary teeth, the partial caries removal approach favored the arrest of dentin carious lesions, reduced cariogenic micro-organisms and the risk of pulp exposure. The carious tissue at the lateral walls of the cavity at the enamel dentin junction (EDJ) was removed by a spoon excavator without carious tissue removal at the pulpal site. After caries removal, restoration using glass ionomer cement (GIC)(GC Fuji IX™GP extra) was completed. Such an approach is called SMART restoration. The serial radiographs of each restoration consisted of three radiographs; immediately after restoration, at the 6-month follow-up and at the 12-month follow-ups. Digital subtraction radiography(DSR) was used to evaluate dentin remineralization following partial caries removal. Image-Pro Plus software was used to evaluate DSR. For evaluating the changes in DSR, areas with increase density show higher radiopacity, whereas areas with decreased density show higher radiolucency. The 6-month and 12-month follow-up radiographs were subtracted from the baseline radiograph.

Eligibility Criteria:
Inclusion Criteria:

* Presence of teeth with dentinal caries limited to the occlusal and proximal surfaces without clinical signs and symptoms of irreversible pulpitis (spontaneous pain, sinus opening, or abnormal tooth mobility
* The radiographic examination showing dental caries involving not less than half of the dentin without any pathologic findings (external root resorption, internal root resorption, abnormality of root resorption, or radiolucency area at furcation /periapical regions).

Exclusion Criteria:

* Teeth with caries exposure to pulp
Decreasing Environmental Impact and Costs of Using Inhalational Anesthetic With a Carbon Dioxide Membrane Filter System

Efficient inhalational anesthetic delivery requires the use of low-flow air and oxygen to reduce drug waste and minimize workspace contamination and environmental pollution. Currently, excess anesthetic gas is scavenged and removed from the operating room via the hospital ventilation system, where it is released into the atmosphere. CO2 is removed from the anesthesia circuit by the use of CO2 removal systems to prevent re-breathing and potential hypercarbia.

Carbon dioxide is currently removed using chemical granulate absorbers (CGAs), which trap CO2 in the granules that are later disposed of when absorption capacity is reached. They require replacement approximately every other day when used in moderate to high volume surgical centres, placing a costly burden on the healthcare system and environment (landfill).

One of the more concerning downfalls of using CGAs is the potential for the inhalational anesthetics to react with the granules and potentially produce toxic byproducts known as compounds A-E that are nephrotoxic and neurotoxic and require excess amounts of anesthetic gas to dilute.

This excess use of anesthetics gases places a financial burden on the healthcare system and has a detrimental impact on the environment. The vast majority of the gases used are eventually released into the environment with little to no degradation where they accumulate in the troposphere and act as greenhouse gases.

DMF Medical has created Memsorb, a new CO2 filtration membrane. Memsorb can remove CO2 from the anesthesia circuit without the use of CGAs, thereby eliminating the potential for toxic byproducts and allowing for significantly lower air and oxygen flow to be used, resulting in less use of inhalational anesthetics. Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system, while maintaining the inhalational anesthetic in the circuit.

The lifespan of Memsorb is at least 12 months, resulting in less particulate waste and a decreased cost to the healthcare system.

We wish to evaluate the ability and efficacy of Memsorb in removing CO2 from the anesthesia circuit while maintaining physiologic minute volume ventilation, as compared to the traditional CGAs in a variety of surgical procedures, patient populations, and anesthesia gas flows.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - III
* Elective surgical procedure
* Laparoscopic surgery for study aim III

Exclusion Criteria:

* ASA \> IV
* Emergency surgery
* Severe respiratory disease (eg Asthma)
* Raised intracranial pressure
* Regional anesthesia
* Absence of arterial line for study aim III
* Self-reported pregnancy
Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders

Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Functional Movement Disorders (Espay and Lang, 2015)
* Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study.
* Patients should be able to attend the one-month ambulatory regime and follow-up visits.

Exclusion Criteria:

* Any condition that avoid the patient from giving free consent to participate in the study.
* Any non-controlled psychiatric disorders
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 to ≤ 65 years of age
* Weight ≤ 110 kg
* Negative qualitative urine drug/alcohol test
* Female volunteers must be of non-childbearing potential
* Male volunteers must agree to use a medically acceptable contraceptive
* Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document

Exclusion Criteria:

Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)

* Tendency to bleed easily
* History of recent trauma or surgery
* History of gout or renal stones

Clinically significant abnormal lab parameters for the following:

* PT INR \> 1.4
* aPTT \> reference laboratory values
* Serum creatinine \> 1.3 mg/dL
* Platelet count of ≤ 100,000/mm3
* ALT/AST \> 2 times ULN
* WBC ≤ 3000 x 109/L
* Hemoglobin \< 11 g/dL
* Total bilirubin \> 1.2 mg/dL
* CBT \> 15 min
Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors

A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with PD-L1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer;
2. measurable tumors by RECIST1.1 standard;
3. patients are 18 to 70 years old;
4. life expectancy \> 3months;
5. KPS ≥70;
6. satisfactory major organ functions: adequate heart function with LVEF≥50%; no obvious abnormities in ECG; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl ;
7. Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10\^9/L, PLT ≥ 50×10\^9/L;
8. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.

Exclusion Criteria:

1. patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
2. active infection.
3. HIV positive.
4. active hepatitis B virus infection or hepatitis C virus infection.
5. currently enrolled in other study.
6. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
7. patients with allergic disease, or are allergic to T cell products or other biological agents used in the study.
8. patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain.
9. patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.
Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion Criteria:

* Potassium \> 5.2 mmol/l; estimated glomerular filtration rate \< 30 ml/min/1.73 m2; systolic blood pressure \<100 mmHg or \> 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo

Light Emitting Diode (LED) therapy has been investigated in burns and skin ulcers, as it has a bactericidal effect and promotes tissue repair. This study aims to evaluate LED therapy at different wavelengths in the healing process of graft donor area in adult burn victims.

It is a blinded and controlled clinical trial in which burned adult patients will be selected, who will be irradiated with red (630 nm) and infrared (940 nm) LEDs at 4J / cm2 fluency, in the donor area of until complete reepithelialization. Patients included will be the donor scalp area, with withdrawal of 0.2 mm. For application of the LEDs, the device will be calibrated for wavelength parameters, beam divergence, nominal power and fluency in the photobiophysical laboratory of the University of Ribeirão Preto - SP. Three groups will be divided: GS = Sham group (will not receive LED irradiation), will only receive routine hospital care, GT-V = treatment group with red led, and GT-IV = treatment group with infrared led. Patients will be randomized for group distribution. The donor areas will be evaluated by infrared thermography, computerized bioimpedance, infrared plethysmography, and Vancouver healing scale at two times, the first within a period of up to 24 hours after graft surgery, and the second after release of the primary dressing. The evaluations will be carried out by an expert evaluator, blind to the groups. For the analysis of the results will be applied statistical tests intra and intergroup (p \<0.05). This research aims to contribute with a new therapeutic method in the control of infections commonly found in cutaneous lesions, as well as in the healing process of the skin.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the Burn Unit of the HCFMRP-USP - Emergency Unit, who agree to participate in the study and are over 18 years of age, guided and without diagnosis of psychiatric diseases, who have undergone graft surgery for a maximum of 24 hours, with a body mass index greater than 16 kg / m² and without infection (sepsis), and that do not present any factor that could interfere in healing such as diabetes or the use of corticosteroids.

Exclusion Criteria: patients who develop infection, are not adherent to treatment or are willing to not continue to participate in the research are excluded.
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study

This study will use the caring chatbot developed by the Taipei University of Technology team to provide care for participants and use robots to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the physical and mental health of the elderly.

The prevalence of anxiety and depression in middle-aged and elderly people is quite high. Among the risk factors for illness, "loneliness" is closely related to the physical and mental health of the elderly: the higher the loneliness of the elderly, the more likely to develop unhealthy lifestyle habits and emotional symptoms such as depression and anxiety. Depression and anxiety are often comorbid, and the diagnoses of the two groups have many symptoms that overlap each other. Emotional symptoms that have not been effectively treated have a great impact on the quality of life, and the drug treatment of emotional disorders in the elderly is more difficult. In addition to medication, maintaining a healthy lifestyle is also conducive to the control of emotional disorders.

Information technology has been used in supplementary medical care and maintenance of physical and mental health for decades. However, reviewing the literature, there is less research on applications developed in cooperation between the information field and the field of psychiatric medical care, and there are no applications developed for the mental health of middle-aged and elderly people.

This study will use the caring chatbot developed by the National Taipei University of Technology team to provide care for the participants enrolled from the psychiatric outpatient department, and use the chatbot to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the mental health of the elderly.

This research anticipates the following goals:

1. With the chatbot developed, it provides care for subjects every day and collects their daily changes in mood, sleep, and activities.
2. Analyze the relationship between robot interaction and emotional changes, and evaluate the impact of chatbot intervention on the health behavior of the case.

Eligibility Criteria:
Inclusion Criteria:

* with the diagnosis of persistent depressive disorder, major depressive disorder, general anxiety disorder, panic disorder, or agoraphobia
* the condition of their disease is relatively stable (defined as no thought of death and no medication adjustment in the recent 3 months).
* Have a personal mobile phone or communicator that can connect to the Internet

Exclusion Criteria:

* Those who are unwilling to participate in this research
* Those who have poor assessment ability by clinicians and cannot understand the content of the questionnaire; or those who cannot continue to complete the test due to their physical condition
* Comorbid schizophrenia or bipolar disorder
* Patients with dementia, brain injury, substance abuse, and stroke
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment

A single centre, placebo controlled, blinded (participant, investigator, outcome assessor) trial to evaluate the effects of COX-2 inhibition with celecoxib on endothelial function in healthy male volunteers.

Primary Objective: To perform a systemic analysis of how COX-2 inhibition by celecoxib affects vascular function and 'omic biomarkers including those associated with the COX-2/prostacyclin/ADMA axis in healthy male volunteers

Secondary Objective: To investigate how this is altered by L-arginine supplementation

Methods: A single centre, double blind, placebo controlled trial will be carried out in healthy male volunteers between 18 and 40 years of age. In phase 1, participants will be blinded and randomised to receive either Celecoxib 200mgBD for 7 days or placebo. The primary endpoint is endothelial function measured by EndoPAT. In Phase 2, the same participants will receive either Celecoxib 200mgBD for 7 days + 10g L-arginine supplementation or placebo + 10g L-arginine supplementation to see if L-arginine can reverse any endothelial dysfunction caused by Celecoxib. Secondary outcomes will include measurement of 'omic biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* No abnormal findings on medical history, screening physical examination, hematology, biochemistry, urinalysis (including specific gravity), and vital signs (sitting blood pressure, sitting pulse rate, sitting respiratory rate and body temperature) within 2 weeks of commencement of the study.
* Normal fasting lipid profile
* Non-smoking
* Clear venous access in upper limbs
* BMI: 18-30
* No history or signs of drug abuse
* No other medication 4 weeks before or during the study
* Informed written consent

Exclusion Criteria:

* Any history of allergy to NSAIDS or arginine
* Significant medical conditions
* Pulse rate \<50 bpm
* Sitting systolic blood pressure \<80 or \>160 mmHg
* Sitting diastolic pressure \<60 or \>100 mmHg
* Baseline endothelial dysfunction (as defined by EndoPAT; LnRHI \<0.51)
* Participation in other clinical study 8 weeks before or during the study
* Donation of blood 8 weeks before or during the study
* Those on medication that cannot be discontinued
Changes in Anatomical Landmark Locations

This study was performed to ultrasonographically demonstrate the changes in relationship between the right internal jugular vein (IJV) and an anatomical landmark in two different head positions: neutral and rotational.

Background: This study was performed to ultrasonographically demonstrate the changes in relationship between the right IJV and an anatomical landmark in two different head positions: neutral and rotational.

Methods: One hundred patients scheduled for elective surgery under general anesthesia with endotracheal intubation were enrolled in this study. The patients were placed in the supine position with a neutral head position and without a pillow. The apex of the triangle formed by the sternal and clavicular heads of the sternocleidomastoid muscle and clavicle was marked (anatomical landmark point: AL point). The ultrasonography of the neck anatomy was performed, and a mark was placed at the central point of the IJV to the skin (ultrasonography point: US point). The other investigator measured the distances from the AL point to the US point (AL-US distance). The patient's head was then turned 30° to the left; the same procedure was repeated and the AL-US distance was again measured. The changes in AL-US distance were calculated.

Eligibility Criteria:
Inclusion Criteria:

* 100 patients weighing 40 - 100 kg and with heights of 140 - 190 cm

Exclusion Criteria:

* a history of neck surgery or trauma involving the neck, previous IJV-related interventions (e.g., venous catheterization), limitation of neck movement, and a body mass index ≥ 30.