cyrilzakka/clinical-trials huggingface dataset:
Intelligent Intensive Care Unit

Delirium, as a common complication of hospitalization, poses significant health problems in hospitalized patients. Though about a third of delirium cases can benefit from intervention, detecting and predicting delirium is still very limited in practice. A common characterization of delirium is change in activity level, causing patients to become hyperactive or hypoactive which is manifested in facial expressions and total body movements. This pilot study is designed to test the feasibility of a delirium detection system using movement data obtained from 3-axis wearable accelerometers and commercially available camera with facial recognition video system in conjunction with electronics medical record (EMR) data to analyze the relation of whole-body movement and facial expressions with delirium.

The aim of the study is to assess the potential of using motion and facial expression data to detect delirium in ICU patients by comparing motion and facial expression patterns in delirium and control groups. In this study, the investigators will use ActiGraph accelerometers to record each subject's movement patterns. Also, a processed video using a commercially available camera interfaces with a specialized program to identify patient facial expressions and movement patterns. A total of 60 participants will be enrolled with delirium, and 30 patients without delirium will be used as control group. Motion profiles will be compared in the motorically defined subgroups (hyperactive, hypoactive, normal) based on accelerometer and facial recognition data. Then, differences in facial expression, number of changes in postures, and percentage of time spent moving will be compared between motorically defined subgroups and in delirium and control groups. EMR data will also be used to assess the feasibility of detecting delirium by including additional information on related risk factors.

Eligibility Criteria:
Inclusion Criteria (ICU Patients):

* Intensive care unit patient
* 18 years of age or older

Exclusion Criteria (ICU Patients):

* Anticipated intensive care unit stay less than one day
* Less than 18 years of age
* Inability to wear a motion sensor watch (ActiGraph)

Inclusion Criteria (Healthy Controls):

* 18 years of age or older.
* sleeps in home environment

Exclusion Criteria (Healthy Controls):

* does not sleep in home environment
* Less than 18 years of age
* Inability to wear a motion sensor watch (ActiGraph)
AKITA Inhaled Steroid Suspension for Inhalation (AICS) in Subjects With Asthma

The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral corticosteroid dose and stability/improvement of clinical parameters related to asthma in the targeted subject population. Ultimately, the goal is to free subjects with severe asthma from the burden of chronic oral steroid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to the performance of any study-related procedures
* Age ≥ 18 and ≤ 65 year of age Diagnosis of asthma (ATS definition, either allergic or non-allergic) for ≥ 6 months
* Asthma treated for at least 3 months with inhaled (ICS) and oral corticosteroids (OCS). Exact baseline level will be measured during the screening period by subject diary entries
* FEV1 ≥ 40% or ≤ 79% predicted at the Screening or Baseline Visit
* Documented increase of FEV1 within 15-30 minutes after the use of inhaled Salbutamol at the Screening Visit or within 2 years prior to Screening
* Mandatory usage of long-acting β-agonists
* A negative pregnancy test must be available for any women of childbearing potential at screening and, in addition, a negative urine pregnancy test must be present at randomization (prior to randomization to one of the treatment groups!)
* Women of childbearing potential must agree to use a reliable method of contraception from the screening until 4 weeks after study completion or after study drug discontinuation in case study drug treatment is stopped prematurely. - In this study, hormone-based contraceptives alone are not considered as reliable method

Exclusion Criteria:

* History of allergy or adverse experience with Budesonide
* Pregnant women or nursing mothers
* Upper respiratory tract infection within 4 weeks of Screening
* Emergency room visit for treatment of asthma exacerbation within 4 weeks of Screening
* Hospitalization for asthma within 3 months of Screening
* Use of anti-IgE, methotrexate, oral gold, Dapsone, or i.v. gamma globulin within 3 months of Screening
* Treatment with other investigational asthma treatment within 30 days prior to Screening
* Evidence of chronic lung diseases other than asthma, including but not limited to: cystic fibrosis, allergic bronchopulmonary aspergillosis (ABPA), COPD, chronic bronchitis and emphysema
* History of medication noncompliance
* History of significant medical illness or condition that in the Investigator's opinion places the subject at undue risk by participating in the study
* Past episode of anaphylaxis with severe respiratory symptoms
* Oral corticosteroid average daily dose exceeding a maximum amount
* Currently smoking or history of smoking ≥ 10 pack years
* Taking oral or i.v. corticosteroids for any disease indication other than asthma
* Abnormal lab values for chemistry tests at Screening that may indicate impaired ability to metabolize and/or excrete Budesonide (AST, ALT \> 3 times upper limit of normal range, serum creatinine \> 1.5 times upper limit of normal range)
mil60 Versus Bevacizumab in Patients With Treatment-naïve Non-squamous Non-small Cell Lung Cancer

This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.

This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The primary objective of the study was to compare the Objective Response Rate according to RECIST 1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.

Eligibility Criteria:
Inclusion Criteria:

* signed inform consent form(ICF)
* Aged 18-75 years, male or female
* Histologically or cytologically documented inoperable, local advanced (stage IIIB), metastatic (stage IV), or recurrent non-squamous NSCLC
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for 6 months after receiving last study treatment

Exclusion Criteria:

* Mixed non-small cell lung cancer with squamous cell carcinoma component, or small cell carcinoma
* Patients with known Anaplastic Lymphoma Kinase（ALK） or C-Ros Oncogene 1 Receptor Tyrosine Kinase （ROS1）rearrangement
* History of hemoptysis within 3 months prior to screening with blood volume more than 2.5 mL
* Evidence of tumor invading major blood vessels on imaging
* Patients with brain metastasis, spinal cord compression or carcinomatous meningitis history
* Uncontrolled hypertension, prior history of hypertensive crisis and hypertensive encephalopathy
* Clinically significant cardiovascular disease but not limited to active infections; unstable angina; stroke or transient cerebral ischemia; myocardial infarction; congestive heart-failure; serious cardiac arrhythmia, hepatic, renal or metabolic disease requiring medication during the study
* History of radical radiotherapy to the thorax within 6 months
* Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 28 days prior to randomization or anticipation of need for major surgery during the course of the study
* Recent or current treatment with aspirin or other non-steroidal anti-inflammatory drugs (NSAID) known to inhibit platelet function within 10 days prior to first dose of study treatment
* Recent or current treatment with anticoagulants or thrombolytic agent within 10 days prior to first dose of study treatment
Dual Target CAR-T Cells in B-cell Lymphoma

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma .

Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma . Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD20 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the following criteria to participate in this study:

  1. 14-75 years old, no gender limit;
  2. Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
  3. ECOG behavior status score is 0-2 points;
  4. Expected survival time ≥ 3 months;
  5. No contraindications to peripheral apheresis;
  6. Flow cytometry/immunohistochemistry confirms that tumor cells express CD20;
  7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
  8. No serious heart, lung, liver or kidney disease;
  9. Ability to understand and willing to sign the informed consent form for this trial.

Exclusion Criteria:

* Patients with any of the following cannot be included in this study:

  1. Tumor cells do not express CD20;
  2. There is active infection;
  3. Abnormal liver function (total bilirubin\>1.5×ULN, glutamic-pyruvic transaminase\>2.5×ULN), abnormal renal function (serum creatinine\>1.5×ULN);
  4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
  5. HIV/AIDS patients;
  6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment;
  7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
  8. Known or suspected drug abuse or alcohol dependence;
  9. People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
  10. Those who have participated in other clinical trials within 30 days;
  11. Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
  12. The investigator judged that it is not suitable to participate in this trial.
Virtual Reality and Occupational Performance, Satisfaction, and Quality of Life of Older Adults

Older adult participants will complete eight immersive virtual reality (VR) sessions with the researcher, within five weeks (no more than two sessions per week may be scheduled). The screening process and assessment measures are not included in the five weeks of virtual reality. Sessions will consist of 30 minutes of use of the virtual reality goggles. During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues. Participants are expected to complete the session while seated with the VR set secured on their head.

Virtual reality (VR) may promote engagement in meaningful daily activities that is tailored to the individual's skill level, need, and significance to their individual context. There is limited research on measurable changes in perceived meaningful daily activities after utilizing immersive VR, specifically with a head mounted display. Only in recent years have head-mounted displays become less expensive and more commercially available for research and patron purchase. At the low cost of $250, the device is within the reach of many older adult community centers for leisure and recreational use. The researchers will measure changes in occupational performance, occupational satisfaction, and quality of life for the older adult members of a community center, after eight immersive VR sessions. Sessions will consist of 30 minutes of use of the virtual reality goggles. During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues. Participants are expected to complete the session while seated with the VR set secured on their head.

Eligibility Criteria:
Inclusion Criteria:

1. Older adults aged 55+ that attend Journey's Way
2. Members need to attend least twice a week

Exclusion Criteria:

1. Score of 17 or less on the MoCA
2. A self-report a history of any of the following: Seizures, epilepsy, dizziness, vertigo, or motion sickness, any current contagious skin and eye conditions, experience sensitivity to light, have or use hearing aids, and a pacemaker and/or a defibrillator.
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.


Eligibility Criteria:
Inclusion Criteria:

1. CD20-positive B-cell lymphoma.
2. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy
3. 18 years to 75 years
4. Signed an informed consent
5. Adequate organ function, including the following

   * Absolute neutrophil count (ANC) ≥ 1,500/uL; platelet count ≥ 75,000/uL; hemoglobin ≥ 8 g/dL
   * Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 times ULN
   * Serum creatinine ≤ 1.5 times the ULN
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Chemotherapy: must not have received within 8 weeks of entry onto this study
8. Radiotherapy: must not have received within 4 weeks of entry onto this study
9. Recovery (to baseline or to Grade 1 or less) from prior treatment-related toxicities except alopecia
10. Aagreement to practice contraception
11. More than 6 months life expectancy.

Exclusion Criteria:

1. Received any investigational drug within 28 days prior to study enrollment
2. Received blood transfusion or any therapies with erythropoietin (EPO), granulocyte-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study enrollment
3. Received previous immunotherapy
4. Received or plan to receive a live vaccine within 28 days of study enrollment
5. Major surgery within 28 days of study enrollment
6. Received systemic steroid therapy with 28 days of study enrollment
7. Received or plan to receive the hematopoietic cell transplant
8. History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment
9. Known allergic reactions against monoclonal antibody or rituximab.
10. Received rituximab or other anti-CD20 monoclonal antibody
11. Blood concentration of rituximab \> 10 ug/mL during screen visit
12. Human immunodeficiency virus (HIV) positive
13. Hepatitis C virus (HCV) antigen and antibody positive
14. Hepatitis B virus surface antigen (HBsAg) positive
15. Body Mass Index (MBI) ≥ 28 kg/m2
Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity

Rationale:

Effective and fast topical anesthesia of the nasal mucosa is of paramount importance for nasal instrumentation like nasal fiberoptic procedures, awake nasal fiberoptic intubation and placement of nasogastric tubes. Conventional topical anesthesia for the nasal mucosa is often patchy and not always effective. The investigators hypothesize that topical anesthesia of the nasal mucosa with the nasal atomizer adapter (NAA) provides good to excellent nasal topical anesthesia with high patient comfort.

Objective: In this study the NAA will be used for nasal topical anesthesia. The investigators will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of the NAA and the comfort level for the subjects.

Study design: Interventional study.

Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.

Intervention: Lidocaine 2% will be applied intranasally with the NAA before nasal instrumentation. On completion of the procedure the participant and the researcher will be asked to complete a feedback form.

Main study parameters/endpoints:

Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with successful awake nasal instrumentation with minimal discomfort for the subject.

Nature and extent of the burden and risks associated with participation:

Risk management on the nasal atomizer adapter (NAA) shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing topical anaesthesia of the nasal mucosa.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years
* Lean body weight \>= 50 kg
* ASA physical status 1

Exclusion Criteria:

* Inability to cooperate
* History of hepatic, renal and coagulation diseases,
* Respiratory tract pathology
* Obstruction of the nasal passage
* Chronic rhinitis
* Chronic sinusitis
* Pregnancy
* Allergy to amide type of local anaesthetics
* No written informed consent by subject
Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy

Transvaginal hybrid procedures are of interest as an available NOTES procedure for the clinical routine. The gynaecologists' experiences and the available studies report on low morbidity related to the transvaginal access. However, little is known about the vaginal and intraabdominal microbial contamination due to the transvaginal approach.

The aim of this cohort study is to evaluate the microbial colonisation and contamination in patients with transvaginal hybrid and conventional laparoscopic cholecystectomy.

Therefore, pre- and intraoperative microbiological evaluations will be performed in patients with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* indication for elective cholecystectomy
* informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy

Exclusion Criteria:

* cholecystitis
* intraabdominal infection
* existing antibiotic therapy
* adnexitis
* pelvic inflammatory disease
* infection (CRP \> 10 mg /l; Lc \> 11 G/l)
Hydroxychloroquine Dosing and Toxicity in Ophthalmology Clinics

This study assesses the ocular toxicity in patients on high dose hydroxychloroquine (HCQ) as per the latest guidelines of the American Academy of Ophthalmology (AAO).

Hydroxychloroquine (HCQ) is an anti-malarial drug that is used to treat a variety of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, juvenile idiopathic arthritis and Sjogren's syndrome. Hydroxychloroquine is a less toxic metabolite of chloroquine. There is an ongoing increase in the number of patients who are using HCQ for prolonged duration because of the expanding indications and the relatively safe systemic profile.

Hydroxychloroquine can cause variable ocular adverse effects including corneal deposits, posterior sub-capsular cataract, ciliary body dysfunction and toxic retinopathy. Toxic retinopathy caused by HCQ has been recognized for many years. Patients with toxic retinopathy usually complain of blurry vision. The classical clinical picture of HCQ toxic retinopathy is a bilateral bull's-eye maculopathy, which is caused by a ring of parafoveal RPE depigmentation that spares the fovea. The exact mechanism responsible for the development of this pattern is not fully understood, however, it is believed that the primary damage is in the photoreceptors and outer nuclear layer leading to secondary disruption of the RPE.

Eligibility Criteria:
Inclusion Criteria:

* Patients on hydroxychloroquine therapy who came for their ophthalmology screening appointment irrespective of the duration of use of the medication.

Exclusion Criteria:

* Patients who have stopped their hydroxychloroquine medication.
OSI-906 With Gemcitabine and Erlotinib for Metastatic Ductal Adenocarcinoma of the Pancreas

OSI-906 is a new drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies and information from those suggests that OSI-906 may help block cell receptors involved in tumor growth.

Gemcitabine and erlotinib are used as standard treatment for pancreatic cancer. In this research study, the investigators are looking for the highest dose of OSI-906 that can be given safely in combination with gemcitabine and erlotinib. This dose will then be given together with gemcitabine and erlotinib to a further group of patients with pancreatic cancer.

This study will be conducted in two parts: a phase I study and a phase II study. In both instances, a treatment cycle is 28 days (4 weeks). Subjects will take OSI-906 by mouth, twice a day, every day. Subjects will receive gemcitabine through an IV in clinic over 30 minutes on days 1, 8 and 15 of each 28-day cycle. Subjects will take erlotinib by mouth, once a day, every day.

At every visit subjects will have a physical exam and blood tests. An EKG will be done on days 1, 8 and 15 of cycle 1 and on day 1 of all subsequent cycles. A CT scan will be done every 2 cycles (8 weeks).

Subjects will complete a daily drug diary and perform glucose monitoring (finger stick) once daily at home.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic ductal adenocarcinoma
* Measurable disease
* Life expectancy \> 12 weeks
* Normal organ and marrow function
* Fasting blood glucose \</= 150 mg/dL
* Able to swallow pills

Exclusion Criteria:

* Prior chemotherapy or radiotherapy for treatment of pancreatic cancer
* Receiving any other experimental agent
* Known brain metastases
* History of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine, erlotinib, or OSI-906
* Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, or diarrhea)
* Use of enzyme-inducing anti-epileptic drugs
* Diabetes mellitus which requires the use of exogenous insulin for glucose control
* Major surgery within 4 weeks of the start of study treatment
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Use of strong or moderate CYP1A2 inhibitors/inducers
* Pregnant or breast feeding
* History of a different malignancy unless disease-free for at least 3 years
* HIV positive