cyrilzakka/clinical-trials huggingface dataset:
Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period

To evaluate the effects of preoperative oral carbohydrate on postoperative insulin resistance and tumor immunity in cervical cancer patients with neoadjuvant chemotherapy.

Fifty-one patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery(CHO group) or to fast on standard hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid)(FAST group).According to inclusion and exclusion standards, twenty-six patients undergoing the same surgery and standard fasting were selected as control group. Baseline and postoperative measurements of insulin sensitivity were assessed in term of fasting plasma glucose(FPG),fastingainsulin(FINS),HOMA-insulinaresistance(HOMA-IR),HOMA-insulin secretion function index(HOMA-IX) , HOMA-beta cell function index(HOMA-β),serum C-peptide and glucagon.Baseline and postoperative measurements of tumor immunity were evaluated using NK cell and T-cell dynamics.VAS score was introduced to assess preoperative comfort.

Eligibility Criteria:
Inclusion Criteria:

1. The patients aged from 18 to 60 years old were ASA level I to II, and the informed consent was signed by the patients, which was approved by the ethics committee of the hospital.
2. Cervical squamous cell carcinoma was confirmed by cervical biopsy before pathologic surgery. CT showed no distant metastasis. All patients underwent total hysterectomy, bilateral adnexectomy and pelvic lymph node dissection.
3. Fasting blood glucose was normal without diabetes, impaired glucose tolerance or other metabolic diseases.
4. no gastric emptying dysfunction.

Exclusion Criteria:

1. Dabetes
2. Patients with obstruction of gastric emptying, such as pyloric obstruction, gastroesophageal reflux, nausea and vomiting, etc
3. Obese (BMI \>32) or severely malnourished (BMI\<18.5)
4. Distant metastasis, multiple primary cancers and recurrent tumors
5. Patients with functional disorders of respiratory system, circulatory system, immune system, nervous system, urinary system and other organs
6. Received blood transfusion and nutritional support within 2 weeks before surgery
7. The supplement contains the sugar solution, the blood transfusion, the application glucocorticoid, the sympathetic blood vessel activity medicine in the operation.
The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients

The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.

Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective modalities. However,in fact, majority of CHF patients are complicated not only with CSA but with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV function. The present study is prospective randomised study to compare the effects of nocturnal oxygen therapy and Bipap® auto SV Advanced.

Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction\<50% confirmed by echocardiography
* Apnea hypopnea index(AHI)\>=20 confirmed by overnight polysomnography
* More than 15% of AHI is due to CSA

Exclusion Criteria:

* Changes of cardioactive drug prescriptions within 6 weeks
* Admission due to cardiovascular events within 6 weeks
* Ever used CPAP or ASV for sleep apnea
* Ever used nocturnal oxgen therapy
* Subjects with acute exacerbation of chronic heart failure
* Operation for upper airway within 90 days
* Renal dialysis
* History of stroke with neurological deficit
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or refractory multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with multiple myeloma that is refractory or has relapsed after treatment
* Measurable serum and/or urine M-protein
* Failed 1 or 2 prior therapies for multiple myeloma
* 18 years of age or older

Exclusion Criteria:

* Received more than 2 prior therapies for multiple myeloma.
* Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
* Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
* Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
* Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
* Subjects who received a stem cell transplant using cells from another individual
* Previously treated with bortezomib or mapatumumab
* Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection
* Infection requiring antibiotics or hospitalization within the last 2 weeks
* Major surgery within the last 4 weeks
* Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
* History of other cancers within the past 5 years
* Pregnant or breast-feeding women
Impact of Achilles Tendon Ruptures: Cross-Sectional Analysis

This project will assess the clinical outcomes of individuals completing rehabilitation for their Achilles tendon rupture at the University Hospitals of Leicester. Patients attending the Achilles tendon rupture clinic or rehabilitation classes will be asked to complete ultrasound imaging, strength testing and questionnaires. This will provide an insight into the rehabilitation outcomes of a broad range of patients at each rehabilitation timepoint.

This study will measure the recovery of participants following Achilles tendon rupture. Measurements will capture individual participants at each rehabilitation time point following Achilles tendon rupture. These time points include following rupture (week 0), after 8 weeks, 10 weeks, 4 months, 6 months and 1 year. The measurements include an ultrasound tissue characterisation scan, isometric (static) strength test and heel raise test. In addition questionnaires will be completed by participants at each time point. Questionnaires include the Achilles Tendon Rupture Score, Hospital Anxiety and Depression Scale, EQ5D (a health related quality of life measure), International Physical Activity Questionnaire, Tampa Scale for Kinesiophobia and the Pain Catastrophising Scale.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* 16 years of age or above

Exclusion Criteria:

* Inability to provide informed consent due to cognitive impairment
* Inability to provide informed consent as unable to understand sufficient English
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age and no more than 55 years of age.
* Must sign written informed consent.
* Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
* Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
* Must have visual acuity best correctable to 20/25+3 or better for each eye.
* Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
* The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.

Exclusion Criteria:

* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Any previous eye surgery involving the anterior segment.
* Pre-existing ocular disease that would preclude contact lens fitting.
* Abnormal lacrimal secretions.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial.
* Subject's habitual contact lens type is toric or multifocal.
* Require any concurrent ocular medication.
Using Practice Facilitation and Operationalizing Referral Information Technology to Increase DSMES Utilization

This is a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to diabetes self-management education and services (DSMES).

Diabetes self-management education and support (DSMES) is an evidence-based educational program that helps people with diabetes better control their blood sugar (improved hemoglobin A1c) and reduce diabetes-related complications and healthcare costs. DSMES is strikingly underutilized with fewer than 10% of eligible patients receiving this helpful service due to patient-, clinician-, and health system-level barriers that include low clinician awareness and lack of integrated referral processes between clinics and community-based DSMES programs.

In this study, we will conduct a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to DSMES. We have partnered with the Kentucky Department of Public Health (KDPH, statewide DSMES provider), the Kentucky Regional Extension Center (KY-REC, practice facilitation partner), and the Kentucky Health Information Exchange (health information technology (HIT) partner). We will recruit two healthcare systems in rural Kentucky to participate in the study. Within each healthcare organization, we will randomize control and intervention clusters at the clinic level. Clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation. The health information technology component provides the scaffolding for quality improvement efforts by automating patient identification and enabling bi-directional referral communication between providers and DSMES programs. Health information technology support will be available at all clinic sites within participating health care organizations, including the control clinics. The practice facilitation collaborative trains and supports clinical teams to use the Model for Improvement to make "breakthrough" improvements in diabetes care and DSMES utilization by recognizing barriers and changing clinical systems and care practices.

Eligibility Criteria:
Inclusion Criteria:

- Clinics are being recruited to participate in the intervention. All clinic staff at participating clinics are eligible for inclusion in the study.

Exclusion Criteria:

- There are no exclusion criteria beyond employment at a participating clinic.
Thoracic Mobility in Cystic Fibrosis Care

Cystic fibrosis (CF) is an inherited, genetic disease of the body's mucus-producing glands that primarily affects the lungs and gastrointestinal tract. There are no studies that have examined anatomical changes, the connection between structure and function in the ribcage and the effect of symptom-relieving manual treatment.

The purpose of the study is therefore to investigate chest mobility in people with CF.

Method The study is conducted in three parts; a / A retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of CF patients. Chest configuration will be measured standardized and blinded on computed tomography (CT) images and related to results from spirometry examinations.

b / A prospective, consecutive cross-sectional study of the same cohort. The aim is to investigate the extent of stiffness and pain that is examined standardized (number of pain-free / normal moving structures) and its relation to objective examination of respiratory movements, respiratory muscle strength and spirometry.

c / A randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms. The treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment. Evaluation will be done via the examination protocol in sub-study b / as well as objective measurements of respiratory movements (primary variable), respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention / control period.

Clinical significance When it comes to CF care, great medical advances have been made and for Swedish patients, the physiotherapeutic active treatment has proven to have very good effects. However, there are areas where care can be improved. The results from our study will provide additional breadth to strategies in CF care


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cystic fibrosis
* \>18 years of age

Exclusion Criteria:

* participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.
Intra-articular Dexmedetomidine Versus Neostigmine After Knee Arthroscopy (a Comparative Study)

Knee arthroscopy is a minimally invasive day case procedure which may be done for diagnosis, meniscectomy or debridement. Arthroscopic surgery is associated with a variable degree of postoperative pain, which is caused by an irritation of free nerve endings of the synovial tissue, anterior fat pad, and joint capsule due to surgical excision and resection

Many studies were done using different intra-articular agents as local anesthetics, opioids, ketamine and alfa2- adrenergic agonists for prevention and treatment of pain after knee surgeries.

Dexmedetomidine is a potent and highly selective alfa2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic and sympatholytic effects. Intra-articular dexmedetomidine was used in several studies to enhance postoperative analgesia after knee arthroscopy with an increased time to first analgesic request and a decreased need for postoperative analgesia Neostigmine is an anticholinesterase and also has antinociceptive effects when administered intrathecally or peripherally.

Eligibility Criteria:
Inclusion Criteria:

* patients aged above 18 years
* scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia

Exclusion Criteria:

* Absolute or relative contraindications for intrathecal anaesthesia,
* Allergy for the studied drugs.
* Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
* Patients receiving chronic pain treatment or hypertension treated with alfa methyldopa, clonidine or beta adrenergic blockers were excluded from the study.
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa

Hidradenitis suppurativa is a disease involving skin folds, causing swelling of the skin and surrounding tissues, pain, and foul-smelling discharges. Effective treatment options are lacking. Recently, clinical trials conducted in our lab found Brodalumab was an effective drug for this disease. Weekly dosing achieved superior therapeutic outcomes compared to a dosing given once in every other week. Brodalumab was safe in both regimens, but blood and tissue studies to better understand this response are still needed. By performing this small pilot study and collecting blood and tissue samples from participants treated with Brodalumab once weekly we would like to better characterize the molecular response to this treatment, identify blood and tissue markers reflecting disease severity, and better understand disease mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of Hidradenitis Suppurativa by the Principal Investigator
* Age 18 to 99 years old
* Moderate to severe Hidradenitis Suppurativa with draining tunnels (Hidradenitis Suppurativa Severity Score System/IHS4\>4)
* Must have medical insurance that is willing to pay for the study drug throughout the duration of the study

Exclusion Criteria:

* Inflammatory Bowel Disease
* HIV Positive
* Active Hepatitis B or C Infection
* Pregnant or Breastfeeding
* No concurrent use of any systemic antibiotics/retinoids/immunosuppressants/biologics (require washout period of \>5 half-lives)
* A Score of \>10 on the Beck's Depression Inventory (BDI) or on the Patient Health Questionnaire (PHQ)-9
* History of Keloid Scarring
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data
Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

What combination of ≤ 6 clinical variables will give the highest specificity for indicating significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?

Although shoulder trauma is a common injury, there is no clinical decision rule to determine the necessity for radiography for these traumas. With this trial the investigators aim to develop such a rule to reduce the amount of radiographs without missing any significant injuries.

The primary objective is to compose a set of clinical diagnostic criteria predictive of shoulder fractures or dislocations that would reduce the amount of radiographs without missing any significant injuries. A second objective is to determine if the clinical decision rule is applicable for triage use.

The CASH (Clavicle-AC-Joint-Sub-capital-Humerus) trial is designed as a cross sectional interobserver study. It will randomize between first examiner of the patient to determine applicability for triage use and use a list of 19 criteria to determine a clinical decision rule for significant shoulder injuries.

Method/intervention After admittance to the ED, all consecutive shoulder injury patients will be assessed for eligibility in the study. After informed consent is given, the patient will be randomized for first observer (ED physician or triage nurse) to be examined, which means they will be assessed in duplo.

The patient will be examined by means of a score form, which contains 19 different diagnostic criteria. The criteria are grouped: anamnesis, inspection, palpation and pain/range of motion(ROM). After completing the list, patients will get a full set of shoulder x-rays: shoulder AP- and axial-view, and clavicle AP and 30' cranio-caudal view.

The trial participation for the patient will be completed at this point and final diagnosis and treatment are provided by the ED physician according to his/her own findings and interpretation of the radiographs. For the study, the radiographs will be reassessed by one consultant radiologist specialized in skeletal trauma.

Eligibility Criteria:
Inclusion Criteria:

* Aged18-65 years
* Trauma \<48h

Exclusion Criteria:

* Any prior ipsilateral shoulder surgery.
* Any diseases of the bones potentially influencing fracturability (osteogenesis imperfecta, osteoporosis, achondroplasia, M. Kahler, chronic (\> 1yr) prednisone use \> 5mg)
* Any shoulder injury as part of a multi-trauma or high energy trauma (HET) with distractible injuries
* Any condition that will influence the perception of pain (e.g. alcohol intoxication, psychiatric problems, mental retardation)
Impact Evaluation of the Steps to Success Program

The evaluation will examine whether the Steps to Success enhanced home visits are more effective at delaying repeat pregnancies than are traditional Healthy Families home visits.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 14 to 21
* Pregnant, or have delivered a child in the last three months
Bispectral Index Throughout Esophageal Cancer Operation

The investigators try to conduct a study to assess the impact of changing patients' lateral decubitus position on BIS readings during esophageal cancer operation. Also, the investigators evaluate the effects of one-lung ventilation and total lung ventilation on BIS value with inhalation agent.

Bispectral index (BIS) was developed to monitor a patient's level of consciousness under general anesthesia. Several factors have been found to alter BIS readings without affecting the depth of anesthesia.Changing a patient's position (head up and head down) significantly affects the BIS values, which might affect the interpretation of anesthetic depth.

During esophageal cancer surgery, there were several factors which could affect to BIS values.First, the surgical positions are consisted with supine and lateral decubitus position more than 1 h. Thus, the investigators compare the BIS value of both side on supine and lateral decubitus position by both side approach. Second, the one lung ventilation was applied for surgical filed. It alters the oxygenation and the cerebral flow. Because of these effects, the BIS monitoring can differ by the period of surgery. Thus, in this study, the BIS value of both side monitor throughout the surgery.

Eligibility Criteria:
Inclusion Criteria:

the patients who are planned the esophageal cancer operation

Exclusion Criteria:

* patient who has dermatitis
* patient who refuse to participate in this study