cyrilzakka/clinical-trials huggingface dataset:
To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers

A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers

A Phase 1, open-labeled, single-dose, one-sequence, one-period, 3-part study to investigate the absorption, metabolism, excretion, absolute bioavailability, and immunogenicity of GX-I7 in healthy volunteers To show ABA and Mass balance of GX-I7

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to give informed consent after listening character of the clinical trial
2. Must be 19-45 years of age, inclusive
3. Weight 50-100kg, BMI 18-30kg/m2
4. Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
5. No clinical abnormality from ECG test
6. Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test)

Exclusion Criteria:

1. Suspected or confirmed malignancy, or has malignancy history
2. Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases
3. Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab
4. Are considering or scheduled to undergo any surgical or dental procedure during the study
5. Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 6 months
6. Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases
7. Positive from urine drug screen or respiratory alcohol screen at medical screening
8. History of alcohol, drug, or substance abuse in the past 12 months
9. A heavy alchol consumer (\>21 units/week, 1 unit = 10 g of pure alcohol) or Consumption of alcohol within 48 hours prior to hospitalization
10. Medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
11. Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration
12. Do not have veins suitable for cannulation or multiple venipunctures
13. Previously donate whole blood within 60 days or component blood within 14 days
14. Excessive consumption of foods containing grapefruits
15. Any other factor that the Investigator thinks will increase subject risk with participation
Use of 3-D Blood Pool Scintigraphy to Guide Left Ventricular Pacing Lead Placement in Patients Requiring Cardiac Resynchronization Therapy

The purpose of this study is to determine whether multiple gated acquisition (MUGA) guided lead placement improves clinical outcomes for patients needing cardiac resynchronization therapy (CRT) compared to traditional posterolateral left ventricular lead placement.

Heart failure (HF) has a prevalence of five million individuals in the United States. Approximately 25-30% of patients with HF due to left ventricular (LV) systolic dysfunction have prolonged QRS. Prolonged QRS duration (\>120ms) on ECG in HF patients is associated with increased morbidity and mortality.

Delayed electrical activation of the LV translates to temporal delay in ventricular contraction. This is referred to as mechanical dyssynchrony. Patients with advanced HF, low ejection fraction (EF) of less than 35% and QRS of more than 120ms are indicated for cardiac resynchronization therapy (CRT). While most patients undergoing CRT implantation show dramatic improvement in HF symptoms, 30-40% of the HF patients undergoing CRT placement do not show a clinical response. The site of placement of the LV lead has been shown to be an important determinant of the effects of CRT.

Measurement of left ventricular ejection fraction (LVEF) is performed using non-invasive measures such as the MUGA. By using the available information on left ventricular systolic function the investigators plan on investigating the effects of MUGA-guided versus traditional LV lead placement for CRT.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* Must have an approved indication for CRT implantation
* Must have ischemic or nonischemic dilated cardiomyopathy
* Must have symptomatic HF with a New York Association (NYHA) Classification of III or IV
* Must be on optimal pharmacological therapy (this should include at the minimum, ACE inhibitor and beta-blocker therapy as tolerated.
* Must have left ventricular ejection fraction (LVEF) of ≤35%
* Must have ventricular conduction delay manifested as a QRS duration of \>120msec
* Must be able to provide informed consent for study participation and be willing to comply with follow-up tests and scheduled visits

Exclusion Criteria:

* HF diagnosis for less than 3 months
* Physical limitations to ambulation
* Life expectancy of less than six months
* Pregnant or planning for pregnancy in the next 6 months (must have a negative pregnancy test 7 days prior to enrollment)
Chronic Resveratrol Supplementation in Healthy Humans

The effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. It is hypothesised that the effects will be different to those seen in acute supplementation. This study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. It is hypothesized that these measures will be affected differently by acute and chronic supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Between 18-35
* At least enrolled on undergraduate degree programme
* Native English speaker

Exclusion Criteria:

* Smoking
* Taking other medication/ supplements
* Pregnant/ breast feeding
* High caffeine consumers
* Migraine sufferers
Pulmonary Rehabilitation for Rural Patients With COPD

The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria

* 40 years of age or older
* Physician-diagnosed COPD
* Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10
* mMRC score\>=1
* English Speaking

Exclusion Criteria

* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)
* Cognitive impairment or inability to understand and follow instructions.
* Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.
* Traditional center-based PR was completed within 3 months of initial study recruitment.
* Transition to hospice or end-of-life care at the time of screening.
* Acute exacerbation at the time of screening.
Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL

To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PCNSL
* Patients who have not received treatment for PCNSL in the past
* Patients with ECOG Performance Status 0-2
* Patients expected to survive for 6 months or more

Exclusion Criteria:

* Patients with intraocular PCNSL without brain lesions
* Patients are unable to swallow oral medications
Hospital Interns Psychological State During the COVID-19

The mental health of the French population in response to covid-19 pandemic is of concern.

Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.


Eligibility Criteria:
Inclusion criteria:

* Being a DES intern (Occitanie-Est)
* Being on internship as of November 1, 2020

Exclusion criteria:

- Refusal to participate
Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.

The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.

To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.

Patients requiring EAT will be randomly assigned to:

* intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers.
* control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years
* Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI)
* With an expected ICU length of stay of at least 6 days after EAT initiation
* Informed written consent

Exclusion Criteria:

* Neutropenia (neutrophil count \<500 cells /µL)
* Active malignant hemopathy
* Bone marrow transplantation in the last 6 months
* Polyvalent immunoglobulins in the past months
* Documented ICI in the past 3 months
* Pregnancy or breastfeeding
Virtual Reality for Generalized Anxiety Disorders

The goal of this clinical trial is to apply Virtual Reality as an adjunct treatment for Generalized Anxiety Disorder. The main question it aims to answer are:

* Determination of the efficacy of VR modules as an adjunct therapy in improving GAD-7 scores
* Assessment of the acceptability of VR modules as an adjunct therapy to the standard of care

Participants will randomized into two arms:

* Control Arm: Standard of Care only
* Intervention Arm: Standard of Care + VR Modules


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-59
2. The primary diagnosis is a generalized anxiety disorder
3. Agree to participate and consented as per study protocol.
4. There is no change in the standard of care within the past two months prior to enrollment into the study. If a patient is on any psychotherapy, then there is no change in the type of current psychotherapy intervention.
5. GAD- 7 more than or equal to 5.
6. Able to come for the session as per scheduled.

Exclusion Criteria:

1. Documented or known case of permanent hearing/visual impairment e.g., vestibular abnormalities that represent significant contraindications for the use of VR or visual impairment e.g., cataract.
2. Documented Disorder as listed:

   * A. Psychosis
   * B. Psychosis disorder - previous case, known case of
   * C. Claustrophobia
   * D. Substance use
   * E. Personality disorder
   * F. Visual impairment that might hinder usage of virtual reality equipment
   * G. Intellectual disabilities
   * H. All types of seizures including febrile seizure
3. The patient is under more than 1 center during follow up (e.g., patient is also receiving treatment from a private hospital for GAD).
Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases

Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented.

The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.

The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.

MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.

Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent obtained from subject to participate in the study.

Exclusion Criteria:

* Age \<18 years
* ASA health class status IV-V
* Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
* Medical contraindication to perform exercise
* Inability to obtain informed consent
The Effect of Circadian Rhytm on Postoperative Pain Undergoing Pediatric Surgery

These circadian rhythms are self-sustained, endogenous oscillations generated by circadian clocks that persist with a period of around 24 -h under constant conditions. Multiple clinical and foundational science studies report that circadian rhythm disruption can directly alter pain thresholds. Altered circadian pain rhythms manifest inconsistently in various disease states. circadian differences exist in tolerability of administration as well as in effectiveness of analgesia during surgical, obstetric, and dental procedures, with the majority of studies demonstrating highest pain sensitivity during the overnight or early morning hours. Although the relationship between pain states and circadian rhythm has been studied in various surgical procedures and chronic pain syndromes, there is little literature examining the relationship between postoperative pain and circadian rhythm in pediatric surgical procedures. Therefore, it was aimed to evaluate the relationship between postoperative pain and circadian rhythm after pediatric acute appendicitis surgery.

This study will be conducted with the data to be obtained from the Anesthesiology Surgery Form and Pediatric Surgery Service Forms in 200 patients aged 6-18 years, after the approval of the Faculty Local Ethics Committee in the Department of Anesthesiology, Faculty of Medicine, Selcuk University. According to the time the patients were taken into the operation, Group 1; 01:01-07:00, Group 2; 07:01-13:00, Group 3; 13:01-20:00 and Group 4; 20:01-01:00, It will be divided into four groups between. The files of the patients will be examined and demographic data such as age (year), body weight (kg), height (cm), gender, ASA scores (I-III), anesthesia and surgery time, anesthesia and surgery time will be recorded. Intraoperative vital signs; systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), heart rate (HR) oxygen saturation (SpO2) Endtidal CO2 and temperature before operation (control) and 5, 10, 15, 20, 25 and 30 minutes (min) and at the end of the process (end) data will also be saved. Perioperative side effects such as nausea-vomiting, hypotension, bradycardia, tremor, respiratory distress, sore throat, headache, and dizziness symptoms will be noted if they occur. The routinely applied analgesic protocol and vital signs in the postoperative pediatric surgery service, the total amount of analgesic administered, the time to first analgesia requirement and VAS scores at 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24th hours will also be recorded. There will be no interference with the routinely applied analgesic protocol.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical condition I-II,
* Undergoing acute appendicitis,
* Patients aged 6-18 years

Exclusion Criteria:

* ASA ≥ III,
* Uncontrolled chronic, metabolic disease,
* Opioid or analgesic use in the last 10 days,
* Acute peritonitis or sepsis
* History of abnormal operation or recovery from anesthesia,
* Patients with parents who are unwilling to give informed consent
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m\^2 iv, and gemcitabine 200 mg/m\^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, ≥ 18 years of age.
* Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
* HER-2 negative disease.
* Candidates for chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

* Previous chemotherapy for metastatic or locally advanced breast cancer.
* Previous radiotherapy for treatment of metastatic breast cancer.
* Any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment.
* Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
Treatment Options for Acute Distal Radioulnar Joint Instability

This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.

This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated at Orlando Regional Medical Center,
2. 18 years or older,
3. Have an acute (less than 4 week old) injury with instability of the DRUJ.

Exclusion Criteria:

1. Younger than 18 years old,
2. Patients with an injury over 4 weeks old,
3. Previous history of ipsilateral upper extremity trauma,
4. Functional deficit,
5. Those who are unable to complete postoperative assessments. -
A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed squamous NSCLC
* Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
* Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
* Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments

Exclusion Criteria:

* Nonsquamous NSCLC
* Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
* Previous chemotherapy for NSCLC
* Major surgery or received any investigational therapy in the 4 weeks prior to randomization
* Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
* Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)