cyrilzakka/clinical-trials huggingface dataset:
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries.

We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (ASA Physical Status 2)
* Age \>18 years old
* Non-obese (BMI \<40 kg/m2)
* Age \>18 years
* Term (\>37 week)
* Non-laboring parturient
* Single gestation
* Scheduled for a cesarean delivery and NPO

Exclusion Criteria:

* Systemic disease such as diabetes mellitus (type 1 or 2)
* Multiple gestation
* Abnormality of upper GI tract
* History of GI tract related surgical procedures
* Use of gastric motility medications
* Active labor
* Renal impairment (creatinine \>2)
* Non-English speaking
* Cognitively impaired
* History of QT prolongation
* Use of general anesthesia
Cryotherapy & Oxaliplatin

The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.

Peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. Everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. Select chemotherapy agents are known to cause significant peripheral neuropathy. Studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. These studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. There are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years
* Willingness to participate in research
* Diagnosed with stage III colon cancer
* Chemotherapy naïve
* Planning to initiate Capecitabine + Oxaliplatin (CAPOX) chemotherapy regimen as part of standard of care.

Exclusion Criteria:

* Pre-existing peripheral neuropathy
* Pre-existing diabetes
* Raynaud's disease
* Metabolic syndrome, including: Hypertension; Hypercholesterolemia; and Obesity (BSA \> 2)
* Upper extremity amputees
* Specific autoimmune diseases: Guillain-Barre; Lupus; Rheumatoid arthritis; and Sjogren's syndrome
Feel Breathe, Restriction Device Ventilatory Nasal (COPD)

FEELBREATHE®, a nasal ventilatory restriction device, used during an exercise test in treadmill produces changes on breathing efficiency in patients with Chronic Obstructive Pulmonary Disease (COPD). 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Rationale: A device called FeelBreahte (FB)® has been designed, developed and patented for inspiratory muscle training in dynamic situations.

Objetive: To examine the effects of FB on lung ventilation, gas exchange and heart rate during exercise in patients with COPD.

Methods: 20 men with COPD with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. In the first visit to the laboratory, baseline static maximum inspiratory pressure and spirometry were performed previous to the exercise. Then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. During the second day, each participant conducted two tests with 30 min of rest between them. Exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of VO2peak. Each test was performed randomnly in two different conditions: 1) oronasal breathing (ONB); and 2) nasal breathing through the FB.

Results: Lung ventilation and gas exchange during exercise in COPD patients was modified during exercise using FB. Our results showed a positive effects of FB vs ONB on dynamic hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and inspiratory time and higher perceived effort. Despite these differences, blood oxygen saturation percentage, oxygen uptake and heart rate showed similar response between both conditions.

Conclusions: The new device FB used during exercise in COPD patients influenced ventilatory responses to an efficiency breathing compared to oronasal mode.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed of Chronic Obstructive Pulmonary Disease (COPD) at least 6 months before, with a forced expiratory volume in the first second (FEV1) between 70 and 30% of predicted value

Exclusion Criteria:

* Suffer other illness.
* Unwillingness to complete the study requirements.
* Cardiovascular diseases (resting electrocardiogram and during exercise).
* Elevated resting blood pressure (\>130/85 mmHg). All inclusion and exclusion criteria were assessed by a detailed medical history and, where noted, by specific measurements.
MRE for Diagnosis of Pancreatic Masses

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.

The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.

High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Eligibility Criteria:
Inclusion Criteria:

1. granting of written informed consent
2. age ≥18 years
3. no history of extrapancreatic malignancy
4. no preoperative biliary drainage
5. definitive histologic evidence of PDAC in excisional biopsy
6. with no less than three months of postoperative mortality or six months of follow- up

Exclusion Criteria:

1. inability to re-review of tissue specimens
2. unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
3. tumor diameters \<1.0 cm
4. withdrawal/dropout during follow-up
Long-term Safety and Tolerability of AFFITOPE AD01

The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
* Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
* Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.

Exclusion Criteria:

* Patients having received no vaccination with AFFITOPE AD01
* Contraindication for MRI imaging
* History of questionable compliance to visit schedule, patients not expected to complete the clinical trial
Clinical Research on the Efficacy of Acupuncture Treatment in Chronic Low Back Pain

This research is planned to build a basis about effect of acupuncture for chronic low back pain with economical efficacy.

It is consisted with two sub research. First,clinical research to know the effect of acupuncture for chronic low back pain will be processed with acclate, randomized, patient, outcome-assessor masking. 130 subjects would be collected and devided into two groups(Experimental and placebo). Experimental group will undergo with real acupunture treatment twice a week, for 6 weeks and acupuncture spots would be selected for each person by clinical specialist. Placebo group will undergo with Park-sham needle and same 8 acupuncture spots would be used for all subjects also twice a week, for 6 weeks. The effect will be accessed by VAS, x-ray, ODI, SF-36, EQ-5D, BDI before and the last treatments.

Second is qualitative research to make a basis through the economic evaluation and satisfaction of acupuncture treatment for chronic low back pain. 15 persons who have been treated at oriental medical hospital for chronic low back pain and 15 in experimental group and 15 in placebo group who participate the clinical research will be collected and through the personal interview, satisfaction about the treatment and economic efficacy will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The person who have been undergo chronic low back pain for chief complain over 3 months.
* The person whose age is from 18 to 65.
* The person who are normal in neurology examination.
* The person whose bothersomeness for the last week before the participation of the treatment is over VAS 5.
* The person who are diagnosed as nonspecific loe back pain.

Exclusion Criteria:

* The person who have radicular pain.
* The person who are diagnosed as specific disease which cause low back pain such as metastatic cancer, vertebral fracture, spinal infection, inflammatory spondylitis.
* The person who are diagnosed as other chronic disease which could affect the result such as caediovascular disease, diabetic neurophaty, active hepatitis, fibromyalagia, rheumatic arthritis, dementia, hemorrhagic disease, epilepsy.
* The person who have had or would have spinal surgery.
* The person who have other skeletomuscular pain as chief complain.
* The person who have been treated acupuncture treatment for low back pain last 1 month.
* The person who is taking corticosteroids, narcotics, muscle relaxant,anticoagulant drug, herb-med for low back pain, or other non-propal drugs.
Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.

EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.

Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head \& neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.

The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.

In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.

Eligibility Criteria:
Inclusion Criteria:

* aged between 3 and 5 years
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* American Society of Anesthesiologists physical status over III,
* any disease that could affect mental status
* pre-existing forehead wound
Cytokine Profiles in Children With Obstructive Sleep Apnea

The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.

We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.

Eligibility Criteria:
Inclusion Criteria:

* OSA documented by polysomnography and clinical symptoms.
* Patients with no symptoms of OSA and negative sleep questionnaire.

Exclusion Criteria:

* Significant systemic disease except mild asthma
Reducing Dose and Irradiated Volume in Cervical Prophylactic Irradiation for Nasopharyngeal Cancer

The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.

Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
2. No distant metastatic;
3. Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
5. Signing informed consent;
6. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Disease progression during IMRT;
2. Previous malignancy or other concomitant malignant diseases;
3. The evaluation information of tumor efficacy can not be obtained;
4. Receive blind treatment in other clinical research;
5. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
7. Active systemic infection;
8. No or limited capacity for civil conduct;
9. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
10. Pregnancy or lactation period;
Study of Children's Activity and Nutrition (SCAN)--Extended Analyses

To continue analysis of data from a longitudinal study of 246 urban Black preschool children and their families in order to identify the long-term effects of social and environmental influences on nutrition and activity and the consequences of these influences for the children's cardiovascular disease (CVD) risk status.

BACKGROUND:

This study contributed to understanding the development of patterns of eating and exercise, focusing on environmental influences that promoted healthful life styles and prevented risk behaviors for CVD.

DESIGN NARRATIVE:

The data set included additional measures of activity and nutrition of the preschool child as well as measures of the activity of an older sibling and mother. The data were gathered in the homes and schools of the children and included both self-report and direct measurement of activity and nutrition. Additional assessments of activity, lipid fractions and apolipoproteins, and Type A Behavior Patterns and Life Stress in the preschool child, i.e., target child , an older sibling and the children's mother added considerably to the complexity and value of the data set permitting additional questions regarding the development of activity, the influences of siblings and parents on this development, and the relationship to CVD risk status and Type A Behavior Patterns.

Hypotheses addressed included 1. Activity levels and the activities selected showed increasing stability with age in preschool and older Black children. 2. The influence of parental prompts and family environment on activity increased asymptotically with age: The effects increased during early childhood; the effects did not increase significantly in older children. 3. Older sibling's influence on the target child's behavior increased with age. The target child's CVD risk status became more like the older sibling's with age. 4. Perceptions of recent Life Stress and ratings of Type A Behavior Patterns for target child, the older sibling, and mother were predisposing variables that were positively related to the target child's activity. 5. Long-term patterns of physical activity were associated with HDL and apo A-1 in the target child and the older sibling; the effect was stronger for the older sibling. Long-term patterns of the target child's nutrient intake were associated with his/her lipid levels.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer

a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

1. non small cell lung cancer (non squamous carcinoma)
2. ECOG 0-1
3. from 18-75 years old

Eligibility Criteria:
Inclusion Criteria:

* non squamous cell non small cell lung cancer
* with measurable disease
* ECOG 0-1

Exclusion Criteria:

- patients received surgery in recent 4 weeks
Topical Gentamicin Cream Versus Alternating Gentamicin and Mupirocin Cream in Peritoneal Dialysis

Catheter-related infection, namely exit site infection and peritonitis, is the commonest complication of peritoneal dialysis. This complication causes significant morbidity and mortality in patients requiring peritoneal dialysis. Topical application of mupirocin 2% cream was first proven to be effective in reduction of staphylococcus-related catheter infection in 1990s. Subsequent randomized trial published in 2005 showed that gentamicin cream was superior to mupirocin 2% cream in reducing both Gram's positive and Gram's negative related catheter infection. However, a retrospective report published in 2007 puts the use of prophylactic antibiotic cream into a question. It reported an emergency of non-tuberculous mycobacterial infection in a dialysis center in Hong Kong after practising prophylactic application of gentamicin cream at the catheter exit site. The following prospective, randomized and open-label study aims to find out an optimal regimen of topical antibiotic prophylaxis in patients requiring peritoneal dialysis.

Topical antibiotics therapy is a well-recognized prophylactic therapy towards the catheter exit site infection in peritoneal dialysis patient. Previous data has shown the superiority of gentamicin cream over the mupirocin cream in this aspect. However, the efficacy of the combination therapy using gentamicin cream alternating with mupirocin cream has not been tested. There is a potention benefit of reducing drug resistant strain in the combination group theoretically.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 years old or above
2. Patient has Tenckhoff catheter inserted
3. Patient is expected to continue his or her dialysis in our center in the subsequent 3 years

Exclusion Criteria:

1. Patient fails to sign the written consent
2. Patient known to have allergy to either gentamicin or mupirocin
3. Patient has suffered from peritonitis or exit site infection 30 days before the enrollment.
4. Patient, suffering from terminal illness, has life-expectancy of less than one year
5. Patient expected to undergo peritoneal dialysis for less than one year, such as patients planning for elective renal transplantation or suffering from acute renal failure necessitating dialysis while waiting for the kidney to recover.
6. Pregnant patient
7. Patient known to be non-compliant
8. Patient bound by another clinical study