cyrilzakka/clinical-trials huggingface dataset:
Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery

This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.

PRIMARY OBJECTIVE:

I. To improve is pre-operative patient anxiety in surgical settings.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients listen to 10 minutes of guided meditation prior to surgery.

ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery.

After completion of study intervention, patients are followed up for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be recruited among patients who are scheduled for cancer-directed surgery
* Participants must be 18 years or older

Exclusion Criteria:

* Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
* Currently incarcerated
* Have a diagnosis of dementia
* Are admitted to the intensive care unit (ICU)
* Have a hearing impairment that would make them unable to hear the recorded meditation
VCRC Patient Contact Registry Patient-Reported Data Validation Study

The purpose of this study is to provide validation of patient-reported data in the VCRC Patient Contact Registry by comparing patient-reported data with data provided by the physician who is the primary provider caring for the patient's vasculitis. Patients enrolled in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), and Takayasu's arteritis (TAK) were invited via email to participate in this study.

Via email, consent was obtained from at least 20 randomly selected patients with the seven forms of vasculitis detailed above in the VCRC Patient Contact Registry who have completed the Diagnostic Questionnaire. The form was sent in PDF format to the patient, who either printed out or emailed the form to his or her primary vasculitis provider to complete. This form included the same questions in the patient questionnaire, with minor reformatting and a few expanded details to verify the patient-provided data (please see appendix B). If the 20 questionnaires are not returned one month after the initial recruitment email to the Patient Contact Registry participants, 20 additional participants with the seven forms of vasculitis will be selected randomly and will be asked to participate in this study. The survey data is stored by the Rare Diseases Clinical Research Network's (RDCRN) Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to Dr. Kathleen McKinnon. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.

Eligibility Criteria:
Inclusion Criteria:

* At least 20 patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN, and TAK who have completed the online questionnaires.

Exclusion Criteria:

* Inability to provide informed consent and complete survey
* Patients whose diagnosis of vasculitis was not confirmed by a physician
* Patients who did not complete the initial questionnaire in its entirety
The Effects of Anesthesia Depth Monitoring on Postoperative Recovery and Cognitive Functions in the Geriatric Patient Population

This study will be conducted on patients aged 65 and older scheduled for surgery due to lumbar or cervical disc herniation. General anesthesia is routinely used for these types of surgeries in the hospital. In patients receiving general anesthesia, anesthesia depth monitoring is performed.

As part of the study, a preoperative anesthesia evaluation will be conducted, which will include age, weight, height, comorbidities, regularly used medications, previous surgical or anesthesia experiences, nutritional habits, mental status, and daily activity levels.

On the day of surgery, upon arrival in the operating room, the following will be measured and recorded:

* Blood pressure using a non-invasive blood pressure monitor
* Heart rate and rhythm via electrocardiogram (ECG)
* Blood oxygen level with a pulse oximeter
* Anesthesia depth using a forehead-applied sensor

All monitoring procedures are non-invasive and painless. Following the placement of these monitoring devices and initial measurements, anesthesia induction and surgery will commence. Throughout surgery, blood pressure, heart rate, and brain activity will be continuously recorded. After the surgical procedure, anesthesia emergence and mental status will be assessed. Preoperative evaluation data and intraoperative recordings will be used solely for research purposes, with patient identity information remaining confidential.

Perioperative cognitive decline and delirium occur more frequently in the geriatric population undergoing surgery. International guidelines recommend monitoring anesthesia depth to reduce the risk of postoperative cognitive dysfunction. Anesthesia depth is commonly measured using non-invasive electroencephalography (EEG)-based methods, such as the Bispectral Index (BIS).

Previous studies have predominantly utilized processed EEG monitors that generate numerical values for tracking anesthesia depth. However, in this study, anesthesia depth will be monitored using both the standard numerical BIS index and the Density Spectral Array (DSA) mode, an advanced feature of the BIS device. To date, no studies have simultaneously examined BIS and DSA modes in relation to cognitive function and the recovery process.

The use of advanced monitoring techniques may serve as a valuable resource for future research, particularly in optimizing anesthetic management for geriatric patients with reduced cognitive reserve. This study aims to evaluate the effects of different intraoperative anesthesia depth monitoring approaches, including hemodynamic monitoring, numerical BIS values, and DSA functions. The primary objective is to determine the optimal anesthesia monitoring strategy that minimizes intraoperative hypotension, burst suppression, and postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Elective spinal surgeries
* ASA status I-III

Exclusion Criteria:

* Emergent surgeries
* ASA status IV-V
* Prediagnosed delirium and or dementia
* Inability to give consent
Improving Patient Understanding of Preeclampsia

Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.


Eligibility Criteria:
Inclusion Criteria:

* 12-40 weeks pregnant
* No significant hearing or vision impairment
* English speaking

Exclusion Criteria:

* Active diagnosis of preeclampsia
* Significant hearing or vision impairment
* Non-English speaking
PROne POsition and Volumetric CAPnography

Beneficial effect of prone position in ARDS on mortality is not linked to increase in PF ratio. It is probably due to improvement in ventilation-perfusion ratio (V/Q). Volumetric capnography allows assessment of dead space and homogeneity of V/Q. All prone positionned patients will be included in the study with usual monitoring (i.e. respiratory system basic mechanics, volumetric capnography, blood gas samples). Epidemiologic and monitoring data will be collected during all prone position sessions.


Eligibility Criteria:
Inclusion Criteria:

* all prone positioned patients

Exclusion Criteria:

* age below 18 y, dependant patients, participation reject
POLlinosis and Exhaled Breath Temperature

The purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. Sublingual Immunotherapy with respective allergens suppresses the seasonal increase of EBT. During the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.

Patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. Their selection will be done in accordance with the criteria listed in Chapter 9 of the World Allergy Organization Position Paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice.

Proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients.

Suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage.

Statistical analysis: On the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level \<0.05. However, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. By all means this study will identify trends to be used for sample size calculations in future studies. During the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.

Eligibility Criteria:
Inclusion Criteria:

* 60 randomized patients from either sex
* age range 5-55 years
* included patients should have a proven grass pollen sensitization

Exclusion Criteria:

* age under or above the stated
* lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen
Hydroxypropyl-methylcellulose and GlicoPro® Eyedrops in the Treatment of Dry Eye Disease: Clinical Study

The goal of this clinical trial is to learn if Hydroxypropyl-methylcellulose and GlicoPro® eyedrops work to treat mild-to-moderate dry eye disease in adult patients. The main questions it aims to answer are:

Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops reduce patients' symptoms? Do Hydroxypropyl-methylcellulose and GlicoPro® eyedrops increase patients' tear film stability? Researchers will compare Hydroxypropyl-methylcellulose and GlicoPro® eyedrops to Hydroxypropyl-methylcellulose without GlicoPro® eyedrops to see if Hydroxypropyl-methylcellulose and GlicoPro® formulation works better to treat dry eye..

Participants will

* Take Hydroxypropyl-methylcellulose and GlicoPro® eyedrops or Hydroxypropyl-methylcellulose eyedrops every day for 3 months
* Visit the clinic 3 times in 3 months for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Ocular Surface Disease Index (OSDI) \>12 AND \<65
* Fluorescein breakup time (FBUT) \<10 seconds OR (Oxford staining Score \>1 AND \<4).

Exclusion Criteria:

* Systemic or ocular diseases with known effect on tear film and ocular surface
* Systemic or ocular medications with known effect on tear film and ocular surface
* Contact lens wearing,
* Ocular surgery in the 12 months before enrollment
* Known allergy or poor tolerance to any ingredient of the study products
* Presumed poor compliance to study procedures.
Dairy Product Consumption and Impact on Nutritional Adequacy, Environment and Diet Cost

This is a secondary analysis of dietary, demographic and health parameter data collected in the 2008/09-2011/12 National Diet and Nutrition Survey (NDNS), UK to determine the roles of dairy products in sustainable diets by modelling nutritional adequacy, financial cost and environmental impact of UK diets containing varying amounts of dairy products.


Eligibility Criteria:
Inclusion Criteria:

* Eligible respondents were adults aged 19-64 years.

Exclusion Criteria:

* Younger than age 18 or older than age 65
Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections

Acinetobacter species have emerged as agents of serious nosocomial infections in critically ill patients. Only a few effective antibiotics are currently available for the treatment of this pathogen and, therefore, sulbactam is being considered as an alternative treatment option. The aims of this study were to i) reveal the population pharmacokinetics and ii) assess the probability of target attainment (PTA) of sulbactam in septic critically ill patients caused by Acinetobacter spp. infections.

The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the probability of attaining a specific pharmacodynamic target.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patients who had diagnosed an Acinetobacter infections that sensitive to sulbactam and colistin
* Infected at sterile site
* Pneumonia was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent sputum, temperature\>38.3°C or \<36°C, a leukocyte count\>10,000 cell per mm3, heart rate of \>90 beats per min and respiratory rate \>20 breaths per min
* Urinary tract infection: Acinetobacter spp ≥ 100,000 cfu/mm3

Exclusion Criteria:

* Patients who are pregnant.
* Patients who have documented hypersensitivity to sulbactam and colistin
* Patients who are chronic renal disease
* Patients who are shock
Low Exhaled NO and ICS in Suspected Asthma

The purpose of this study is to determine whether a low exhaled nitric oxide reading (\<27ppb) is a good predictor of a negative response to inhaled steroid treatment for patients with symptoms suggestive of asthma.

At the first visit, which will take place at either at the GP surgery or the Nottingham Respiratory Research Unit (NRRU) informed written consent for the study will be obtained. The patients will then have an exhaled NO measurement, spirometry, venepuncture (for Full Blood Count and research blood - if consent obtained) taken and complete an Asthma Control Questionnaire (ACQ), Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire (LCQ). All procedures will be carried out by the NRRU research nurse.

The investigators may use the NRRU existing database of research volunteers to recruit as necessary and also the respiratory clinics held at the NUH. If patients from clinics are recruited they will be initially approached by their usual care doctor and an information sheet will be sent / given to them accordingly.

If all the inclusion criteria are met and none of the exclusion criteria, the patients will be randomised to receive either a placebo inhaler, to be taken one puff twice daily, or a low dose inhaled steroid treatment, Budesonide 200mcgs via Turbuhaler one puff twice daily, for 3 months. Dr Tim Harrison will be prescribing the inhalers and they will be dispensed from the Nottingham City Hospital Clinical Trials Pharmacy and delivered/given to the patient by the research nurses.

Participants will be asked to return for follow up visits at 4 weeks, 8 weeks and 12 weeks following randomisation. At these follow up visits, exhaled NO, spirometry and the 3 questionnaires will be repeated.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over.
2. Asthma suspected by GP/Practice Nurse
3. Must be able to give informed consent
4. Exhaled Nitric Oxide reading \<27ppb
5. FEV1 \>70% predicted

Exclusion Criteria:

1. Patients requiring oral steroid treatment on visit to GP/Practice nurse
2. Use of oral prednisolone or antibiotics within last 4 weeks
3. Already using an inhaled corticosteroid
4. Any other clinically significant co-morbidity.
5. Expectant or breast feeding mothers.
Cryocompression to Reduce Chemotherapy-induced Peripheral Neuropathy in Gynecologic Cancer - COHORT 2

The investigators aim to determine the effect of cryotherapy wraps plus compression therapy (henceforth referred to as cryocompression) versus cryotherapy wraps alone on the incidence and degree of chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer using a noninferiority design. The investigators also aim to determine the effect of cryocompression versus cryotherapy on patient tolerability and patient and staff satisfaction.

Participants will be randomized by patient to receive cryotherapy wraps plus compression therapy (cryocompression) versus cryotherapy wraps alone applied to the bilateral hands and feet. Participants will receive cryotherapy (+/- compression) for the duration of their taxane infusions. Participants will be asked to complete the FACT-NTX survey and a PNQ neuropathy surveys at each infusion visit to evaluate symptoms related to neuropathy. Participants will also complete a brief acceptability and tolerability survey at each visit. Lastly, a staff satisfaction survey will be administered at each visit as well. The investigators will test the hypothesis that the average final visit FACT-NTX11 scores in the cryotherapy group are noninferior to the cryocompression group with a noninferiority margin of 2.5 points. The investigators will routinely monitor for the following adverse events: frost bite, (unexpected) hospitalizations, and death.

Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
* Plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at the Duke Cancer Center or Macon Pond or at the Carilion Clinic in Roanoke, VA. Patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

Exclusion Criteria:

* Treated with prior neurotoxic chemotherapeutic agents
* Baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or conditions including but not limited to fibromyalgia, cryoglobulinemia and Raynaud's disease.
Validation of the French Version of the Fremantle Back Awareness Questionnaire (FreBAQ) in Patients With Chronic Low Back Pain

In patients with chronic low back pain, the Fremantle Back Awareness Questionnaire (FreBAQ) measures the duration and intensity of pain and functional limitations. The FreBAQ is a simple tool created to assess disturbances in the body representation of the back, and the only one existing in chronic low back pain. It is a 9-item self-questionnaire in which each item is measured on a 5-point Likert scale ranging from "Never (score of 0)" to "Always (score of 4)". It assesses neglect, perceived body image of the back, accuracy in proprioceptive perception of back movements.

The psychometric properties of the FreBAQ in English, Japanese, Dutch, Turkish and German are validated and acceptable; however, they have never been studied in French and no validated version of this questionnaire in French exists.

The study investigators hypothesize that the French version of the FreBAQ has good psychometric qualities, allowing it to be used in the French chronic low back pain population.


Eligibility Criteria:
Inclusion Criteria:

* Subject with no history of chronic low back pain and with a lumbar VAS \<2 for more than 3 months.
* Patient with chronic low back pain: pain localized between the edge of the last lower ribs and the intergluteal groove (17) for more than 3 months.
* Patient with a lumbar VAS \> 2 for more than 3 months.
* Patient whose low back pain is of common origin (no underlying organic etiology).
* In case of lumbar-radicular pain, patient with a VAS (lumbar) \> VAS (leg)
* Patient who speaks and understands French
* Patient with no history of arthrodesis or lumbar disc prosthesis
* Subject affiliated or beneficiary of a health insurance plan.
* The patient must have given their free and informed consent and signed the consent form

Exclusion Criteria:

* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant, parturient or breastfeeding
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer

Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

1. Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
2. Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
3. Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
4. To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Metastasis colorectal cancer confirmed by histologically and radiography
2. Receive target therapy over half a year
3. Have a measurable lesions

Exclusion Criteria:

1. A history of other malignant tumors in five years
Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer

The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable non small cell lung cancer Stage III
* Adequate hematological parameters
* Adequate Lung function reserve

Exclusion Criteria:

* Previous chemotherapy and thoracic radiation for non small cell lung cancer
* Presence of distant metastases