cyrilzakka/clinical-trials huggingface dataset:
Comparison of Patient-Controlled Analgesia With Different Background Infusion

In this study, the investigators investigated the efficacy, usefulness and analgesic consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone without background infusion, bolus dose with low background infusion and bolus dose with high background infusion to evaluate postoperative analgesia for patients after laparoscopic colorectal surgery.

There have been many studies using patient-controlled analgesia (PCA) and opioids for postoperative analgesia.Patient-controlled analgesia with opioids is now widely used after surgery for the treatment of acute postoperative pain. This technique provides effective pain treatment, adjusts the dose according to personal need and keeps plasma analgesic levels at a constant level,but the incidence of opioid-induced side-effects still be reported frequently.A proper PCA programme may increase efficiency of analgesic and decrease incidence of analgesic-induced side-effects.

In this study, 90 patients who is undergoing elective laparoscopic colorectal surgery will be randomly allocated into three groups (no background infusion group(Group B0),low background infusion group(Group B1) and high background infusion group(Group B2)). Patients in all groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.The PCA programme of Group B0 is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 0ml/h, and a bolus of 4ml, with a lock-out of 15min. The PCA protocol of Group B1 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 1ml/h, and a bolus of 2ml, with a lock-out of 15min.The PCA protocol of Group B2 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing laparoscopic colorectal surgery
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18～30kg/m2

Exclusion Criteria:

1. Mental illness or cannot communicate.;
2. A second operation during the study;
3. Lung infection or sleep apnea syndrome;
4. Renal failure;
5. Alcohol or drug abuse;
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
7. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history .
Mind-body Medicine for Patients With Malignant Hematological Diseases

This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation
* Physical and mental ability to attent 8 of 11 group units

Exclusion Criteria:

* Chemotherapy, radiation, or rehabilitation programm during the study period
* Pregnancy
* Participation in other studies with behavioral interventions during the study period
High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope

To compare the effect of HFNC with standard apneic oxygenation on patient oxygenation and airway protection during foreign body removal by rigid bronchoscope.

This study is a prospective, randomized controlled trial, at Ain Shams University hospitals, Cardiovascular surgery hospital (Thoracic surgery unit), Cairo, Egypt. We will include 64 patients planned for foreign body removal by rigid bronchoscope. All patients will be ASA І with recent FB aspiration in the last 72hrs either by history or documented by radiopaque shadow in chest X ray or CT scan. After achievement of anesthesia and full muscle relaxation ventilation started by open mask technique. Then the patients will be divided into two groups according to the oxygenation technique:

Group (A) (32 patients) HFNC (Vapotherm) will be used during the bronchoscopy time flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃ .

Group (B) (32 patients) (control group) using the standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

Eligibility Criteria:
Inclusion Criteria:

* We will include 64 patients planned for foreign body removal by rigid bronchoscope.
* All patients will be ASA І
* Recent FB aspiration in the last 72hrs either by history or documented by radiopaque shadow in chest X ray or CT scan.

Exclusion Criteria:

* Patients age not more than 40 years old.
* Body weight less than 40 kg.
* Critically ill patients.
* Intubated patients.
* Inhalation of FB more than 72 hrs.
A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of ASC40 (Denifanstat) tablets compared to placebo in the treatment of patients with moderate to severe acne vulgaris. The proposed plan for this trial is to enroll subjects who are 18-40 years of age (including borderline values), with a diagnosis of moderate to severe acne vulgaris, and an Investigator's Global Assessment (IGA) graded as moderate (grade 3) or severe (grade 4). 480 subjects were planned to be enrolled in the trial and placebo groups, with all subjects randomly assigned in a 1:1 ratio to receive either ASC40 (denifanstat) tablets dose 1 or placebo, administered orally once daily (taken after dinner) for 12 weeks.

There will be a total of 6 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc..


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years (inclusive of threshold), gender is not limited.
* Subjects have an Investigator's Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe).
* Men of childbearing potential and women of childbearing potential willing to use effective contraception from the time of signing the informed consent until 3 months after the last dose of the investigational drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. Women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the investigational drug.
* Subjects are willing and able to complete the study, are able to understand and comply with the study requirements, adhere to the study required restrictions and related tutorials, use the investigational drug as prescribed, and are followed up according to the study plan.

Exclusion Criteria:

* Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to any of the excipients.
* Presence of cystic acne at screening.
* Patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne)
* Patients with other significant coexisting skin conditions that may affect the evaluation of facial acne efficacy or require co-treatment, such as solardermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc..
* Thicker facial hair, which has been assessed by researchers to impede accurate assessment of acne vulgaris grades or lesion counts
Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi

In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.

Exclusion Criteria:

* Severe infection
* Coagulation disorders
Clinical Assessment of an in-Patient Glucose Monitoring System (Accu-Chek Inform Cobas IT 1000)

The principal objective of this single-center 2-period study is to evaluate the glycemic control of in-patients in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care) as the rate of capillary blood glucose measurements within a pre-define target range, and to compare results during the period I (warning of the Accu-Check Inform glucose meter on glucose levels not activated) and period II (warning activated).

The study is a 6-month large scale assessment of an information system consisting in a glucose meter with multiple alerts (Accu-Chek Inform) associated with a data base (Cobas IT 1000) in order to share the results of glucose monitoring using the hospital information network.

The appraisal of the glycemic control was based on the rate of capillary blood glucose measurements within a pre-defined target range (3.9-8.5 mMol/l) during each study period.

Whether the system implementation can improve the outcome related to the management of in-patients with diabetes is assessed in 3 hospital departments (Diabetology, Cardiology and Pulmonary Care) as follows:

* principal objective, glycemic control of in-patients (Cardiology and Pulmonary Care) as the rate of capillary blood glucose (CBG) values within the pre-defined target range, and comparison of results observed during period I (meter warning not activated) and period II (warning of the meter on out-of-target glucose level activated).
* the impact on the performance of quality controls of CBG measurements with (period II) or without (period I) activation of a warning on the meter related to inappropriate quality control frequency (all departments).
* evaluate the traceability of CBG results and compare it with (period II) or without (period I) the activation of the automatic record of data ensured by the Accu-Chek Inform meter and Cobas IT 1000 data base (all departments).
* during a sub-period of period II, the impact on patient glycemic control of the intervention of a diabetologist, determined by the activation of a warning sent to the physician in case of out of target CBG results via the Cobas IT 1000 data base (Cardiology and Pulmonary Care).
* the impact of the above warning activation plus diabetologist intervention on the incidence of low CBG.

Eligibility Criteria:
Inclusion Criteria:

* In-patients,
* Age \> 18 years,
* Requiring a monitoring of capillary blood glucose levels

Exclusion Criteria:

* No glucose monitoring needed
Ziconotide Effectiveness and Safety Trial in Patients With Chronic Severe Pain

The purpose of this open-label study is to give chronic severe pain patients with existing intrathecal pump systems access to ziconotide.


Eligibility Criteria:
Inclusion Criteria:

* Each patient must have chronic severe pain of malignant or nonmalignant etiology with inadequate pain relief from or intolerance to conventional therapy.
* Each patient must have a predicted life expectancy of greater than or equal to 6 weeks relative to baseline.
* Each patient must be able to respond to the Visual Analog Scale of Pain Intensity (VASPI).
* Each patient must have an implanted programmable SynchroMed infusion device or a CADD-Micro external programmable infusion device and spinal catheter (hereafter "IT pump and spinal catheter") prior to enrollment into this trial. (If a patient has an external pump, the Investigator must ensure that the patient is at a low risk for infection and that the patient is capable of maintaining good personal hygiene. The Investigator must have demonstrated the ability to successfully manage patients with external pumps prior to enrolling a patient in this trial.)
* Each patient must be at least 18 years of age.
* Each patient must be competent to give written informed consent and has given written informed consent prior to performance of any study-related procedures. Reasonable accommodation of visually impaired patients will be allowed.
* Each patient is willing and able to comply with the protocol requirements.
* Each female patient of childbearing potential must agree to use adequate contraceptive methods while on PRIALT as determined by the Investigator.

Exclusion Criteria:

* Presence of pregnancy or lactation.
* Participation in another investigational drug or device trial within the preceding 30 days.
* Presence of known hypersensitivity to PRIALT or any of its components.
* Presence of any contraindication to continued IT therapy (for example, infection at the pump or catheter externalization site, uncontrolled bleeding diathesis, spinal canal obstruction that impairs cerebrospinal fluid \[CSF\] circulation, or patient and caregiver inability to manage and protect the IT pump and spinal catheter system and return for clinic follow up visits).
* Presence of any condition (for example, psychosis, severe depression or suicidal ideation, homicidality, somatization disorder, active substance abuse, cognitive deficits, dementia or other serious medical or psychiatric condition) that in the Investigator's opinion precludes the patient's ability to participate in this study.
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of rheumatoid arthritis
* Meets Class I, II or III of the ACR 1991 Revised Criteria
* RA seropositivity
* Stable dose of methotrexate
* Inadequate response to TNF inhibitors

Exclusion Criteria:

* Any prior treatment with lymphocyte depleting therapies
* History of active TB infection
* Known or screen test positive for specific viruses or indicators of viral infection
Cochlear-Vestibular Ganglion (CVG) in Newly Diagnosed Type 2 Diabetes Patients

The proposed study is an integrative scientific undertaking, reflecting the input of experts in the behavioral sciences, mHealth technology, computational biology, endocrinology, biochemistry, and nutrition. The project features a unique translational approach, connecting behavior and biology in an economical manner that provides mechanistic insights into the progression of type 2 diabetes (T2D) and the biologic consequences of behavior change. The project may have profound implications for the clinical management of early T2D.

T2D poses a significant public health problem. Hyperglycemia is associated with a variety of vascular complications, but clinical trials of medication regimes designed to achieve near-normal HbA1c have been mostly negative. The lack of benefit observed in these trials may be due to the fact that they targeted HbA1c rather than glucose variability, and were conducted in patients with established T2D that had already experienced complications of the disease. In early T2D, management of postprandial glycemia may be particularly important for minimization of metabolic memory effects and preservation of beta cell function. Postprandial glycemia in early T2D is largely driven by dietary intake, but research findings that guide clinicians regarding the best dietary approach to prescribe are mixed. Studies done, to-date, have used one-size-fits-all dietary regimes that do not take into consideration the person's unique glycemic response to food. The investigators know from decades of research that behavioral methods are required to engage patients in lifestyle behavior change. The investigators argue that tailoring the approach to the participant's glycemic response and gut microbiome will enhance self-efficacy in ways that cannot be achieved through standard behavioral methods alone and, in turn, reduce glycemic variability and metabolic memory effects.

Co-PI Segal et al. demonstrated that subjects have high between-subject variability in postprandial response to the same food, suggesting that universal dietary recommendations are of limited utility for controlling elevated postprandial glucose. The machine learning algorithm devised by the group integrates multidimensional data to accurately predict personalized postprandial glycemic responses. In a subsequent validation study in 100 participants, they showed that a personally-tailored intervention based on the predicted response resulted in significantly improved postprandial glycemic response, and were accompanied by beneficial changes in gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* 5 years or less since type 2 diabetes was diagnosed

Exclusion Criteria:

* more 5 years since type 2 diabetes was diagnosed
The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children

A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT.

Exclusion Criteria:

* Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression

The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar I Disorder, most recent episode depressed
* History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms

Exclusion Criteria:

* Current manic, hypomanic or mixed episode
* Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
* Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
* Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
* Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
* Axis II diagnosis likely to interfere with study compliance
* Serious suicidal or homicidal risk
* Sensitivity to any of the drug ingredients, including lactose
* Women who are pregnant, breast feeding or refuse to use adequate birth control
* Current seizure disorder
* Current episode of depression is longer than 1 year
CV-SQuISH-ED: Clinical Validation Study

This is a study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test as a diagnostic marker of sepsis in a population of patients presenting to the emergency department with signs or suspicion of infection compared to retrospective physician adjudication, per the sepsis 3 definition, of those patients.

This is a multi-site prospective study to evaluate the diagnostic performance of the investigational Cytovale System \& IntelliSep Test for patients presenting to the Emergency Department with signs or suspicion of infection. The IntelliSep Test is a microfluidic test that measures the biophysical properties of human leukocytes in conjunction with other laboratory findings and clinical assessments to aid in the early detection of sepsis with organ dysfunction occurring within the first three days after the blood sample collection.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
3. A 300µl blood sample originally collected in a K2 EDTA (hematology purple top) tube within 4 hours of the first recorded vital sign is available.
4. Sign or suspicion of infection, defined as meeting either of criterion A-1 and A-2 (based on temperature, WBC, heart rate, respiratory rate and/or culture order criteria):

Exclusion Criteria:

1. Patients in whom a palliative care or hospice course is expected during ED visit
2. Self-reported, documented or otherwise known to be actively enrolled on any experimental/investigational therapeutic medication prior to blood collection
3. Self-reported, documented, or known history of a hematologic malignancy (any leukemia, lymphoma, or myeloma), myelodysplastic syndrome, or myeloproliferative disorder
4. Self-reported, documented or otherwise known to receive a chemotherapeutic agent or other excluded medication in the past 3 months (Appendix C)
5. Self-reported, documented or otherwise known to have undergone a hematopoietic stem cell transplant or any solid organ transplant
6. Patients transferred to the Emergency Department from another acute care facility
7. Residents or patients of a hospital-based skilled nursing facility
A Pharmacokinetic/Pharmacodynamic (PK/PD) and Safety Evaluation of Oseltamivir [Tamiflu] in the Treatment of Infants 0 to <12 Months of Age With Confirmed Flu Infection

This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[Tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants.


Eligibility Criteria:
Inclusion Criteria:

* infants \</=12 months of age
* laboratory confirmed diagnosis of influenza within 96 hours prior to first dose
* influenza symptoms for \</=96 hours prior to first dose

Exclusion Criteria:

* preterm infants less than 40 weeks (corrected for gestational age)
* weight less than 5th percentile for age (corrected for gestational age)
* concurrent gastrointestinal conditions that preclude enteric absorption of the drug
* bronchopulmonary dysplasia/chronic lung disease on assisted ventilation at time of enrollment
* active or uncontrolled respiratory, cardiac, hepatic, CNS or renal disease at baseline
* symptomatic inborn errors of metabolism