cyrilzakka/clinical-trials huggingface dataset:
Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy

This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.

PRIMARY OBJECTIVE:

I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.

GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.

After completion of study intervention, patients are followed up 1-2 days post-colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ages 45-75
* Patients must be at average risk for colorectal cancer (CRC)
* Patients must have scheduled their first-time screening colonoscopy as an outpatient at Ohio State University (OSU) at least 14 days in advance
* Patients must be able to speak and read English
* Patients must have daily access to a working telephone, email address, and internet connection
* Patients must provide consent

Exclusion Criteria:

* Previous colonoscopy
* Colonoscopy for diagnostic purposes
* Auditory or visual impairment that prevents internet use
* Previous cancer diagnosis (other than skin cancer)
* Previous diagnosis of a mental health disorder
* Current mental health treatment
* Family history of CRC
* Personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Confirmed or suspected hereditary CRC syndrome, such as familial adenomatous polyposis or Lynch syndrome
Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

Approximately 60% of males and 40% of females do not meet current fluid intake recommendations, which is associated with adverse health consequences such as obesity, diabetes, and chronic kidney disease. Newer technologies have been designed to promote fluid intake. "Smart Water Bottles" use mHealth technology to capture fluid intake behaviors automatically and provide cues to encourage fluid consumption. Studies using Smart Water Bottles have helped some individuals increase fluid intake to help reduce kidney stone formation. However, limited research has assessed the efficacy of this technology on improving fluid intake in college students. College is a time with the potential to form healthy habits that carry into adulthood. Previous work has also identified daily changes in morning urine color, thirst perception, and body mass, as simple, inexpensive indicators of daily fluctuations in water balance. Tracking changes in these metrics has the potential to provide participants with evidence of adequate or inadequate fluid consumption. Thus, the combination of prompting from a smart water bottle, as well as daily self-monitoring changes in hydration status, may encourage college students to increase daily fluid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Participants must report currently drinking less than the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (\<2.5 L per day for males; \<2.0 L per day for females).
* Has access to a cell phone which can download the app associated with the Smart Water Bottle.

Exclusion Criteria:

* Currently trying to gain or lose weight
* Have had surgery of the digestive tract
* Currently taking diuretics (e.g., Thiazide, Loop diuretics or potassium-sparing diuretics)
* Currently taking centrally-acting medications (e.g., anesthetics, anticonvulsants, central nervous system stimulants/amphetamines, muscle relaxants)
* Report currently consuming at least the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (\>= 2.5 L per day for males, \>=2.0 L per day for females).
* Currently pregnant (females)
The Accuracy of Home Monitoring for Acute Macular Degeneration (AMD) Disease Activity

Currently the best treatment for "wet" macular degeneration involves regular injections of Ranibizumab (Lucentis). In the initial clinical trials, the drug was injected into the eye every month. Since then a number of studies have found similar benefits when the drug is given with a fixed number of injections initially and then with further injections only when needed. This approach has been adopted in the UK, following recommendation by the National Institute for Clinical Excellence (NICE).

Although this approach reduces the expense and risk of un-necessary treatment, it does require regular hospital assessment of disease activity to determine if a repeat injection is required or can be deferred. The hospital assessment is time-consuming, inconvenient and the large number of assessments can cause delays in hospital follow-up.

Using three different assessment criteria to monitor disease activity at home, the investigators plan to see if home monitoring is as good as hospital assessment. The investigators have already identified that many patients dislike the lengthy hospital assessment visit and would welcome the opportunity to do some of the monitoring of disease activity at home. The investigators have also shown that they understand and can complete each of the home assessment tests. In this pilot project, the investigators aim to get an idea of how reliable home monitoring can be in a small sample of just over 30 patients. The data that the pilot project generates will be used to influence and to help plan a subsequent, larger, national study to be submitted for funding to the National Institute for Health Research.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 60 years with a clinical diagnosis of neovascular age-related macular degeneration (ARMD), receiving treatment with intra-vitreal ranibizumab in accordance with current UK practice
* At least 6 months of prior treatment beyond the loading phase of three fixed injections
* At least 2 injections during the prior 6 months of the maintenance phase of treatment
* Early Treatment for Diabetic Retinopathy Study (ETDRS) chart letter score at 2m of between 30 and 70 letters at the start of the study

Exclusion Criteria:

* Patients with chronic intra-retinal cycts or sub-retinal fluid in the study eye on Optical coherence tomography (OCT) examination despite prior treatment and judged to be stable without the need for further treatment
* Significant hearing impairment, felt likely to interfere with training and the telephone calls prior to the home monitoring
* Lack of informed consent
Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Experimental Trial

Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition to that, studies have reported that delays to provide medication is associated to worst survival rate for very sick children. To minimize delays and error, the investigators recently published a resuscitation handbook who provides drug dosages for each weight for children thus eliminating the need for dosage calculation. Once the weight of the patient is known, the physicians only have to open the book at the page corresponding to the weight and all the medications with their calculated dosage are provided. The primary goal of this study is to evaluate the number of dosage error during simulated pediatric resuscitation comparing residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This will be an experimental crossover trial among 40 residents performing four simulated case-scenarios in a high-fidelity simulation lab.


Eligibility Criteria:
Inclusion Criteria:

* Residents doing a rotation in pediatrics emergency medicine

Exclusion Criteria:

* Resident who participated in a previous month
Sensory-Targeted Ankle Rehabilitation Strategies (STARS)

The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. The investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.

The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. If a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. The participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. After completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. Upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. Upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. Then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18-45 years of age
2. History of ankle sprain with at least two episodes of "giving way" within the past six months
3. Score of ≥ 5 on the Ankle Instability Instrument (AII)
4. Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
5. Score of ≤ 80% on the FAAM-Sport Subscale.

Exclusion Criteria:

1. Younger than 18 or older than 45 years
2. No history of ankle sprain or episodes of "giving way" in the past six months
3. Score of ≤ 5 on the Ankle Instability Instrument (AII)
4. Score of ≥ 90% on the FAAM-ADL
5. Score of ≥ 80% on the FAAM-S.
6. An acute ankle sprain within the past 6 weeks.
7. Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
8. Lower extremity injury within the past 6 months (other than ankle sprains)
9. Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.
OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437®, using the EyeGate® II Drug Delivery System (EGDS) in patients having undergone cataract surgery with implantation of a posterior chamber intraocular lens (IOL)

This will be a Phase 1b/2a, open-label, multi-site study, in which a total of up to 20 eyes of up to 20 patients will be enrolled. Patients having undergone unilateral cataract surgery with implantation of a posterior chamber monofocal intraocular lens (IOL) who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include best corrected visual acuity (BCVA), slit lamp examination, conjunctival injection, and intraocular pressure (IOP) by tonometry will be used to determine eligibility just prior to cataract surgery on Day 0. Eligible subjects will undergo iontophoresis treatment immediately post-cataract surgery on Day 0 and Day 7, and will return to the clinic for examination on Days 1, 14, and 28.

Eligibility Criteria:
Inclusion Criteria:

1. Have undergone unilateral cataract extraction and implantation of a monofocal IOL at the time of enrollment
2. Age 18 to 85 years
3. Receive, understand, and sign a copy of the written informed consent form
4. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

-
Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes

Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical mediated damage to cellular macromolecules either by chelating divalent cations or scavenging hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to affect the structure of proteins and nucleic acids.

To the best of our knowledge, no previous study assessed the role of carnosine in diabetes associated complications in particular diabetic nephropathy and there is insufficient evidence to recommend its supplementation in those patients. Therefore, this study was undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic nephropathy in children and adolescents with type 1 diabetes and assess its relation to microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 diabetes.
* have diabetic nephropathy (≤18 years with at least 5 years disease duration )

Exclusion Criteria:

* any clinical evidence of infection, renal impairment due to causes other than diabetes, elevated liver enzymes, hypertension, neoplasm, hypersensitivity to carnosine, and taking any vitamins or food supplements one month before study or participation in a previous investigational drug study within the 30 days preceding screening.
Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatitis C infection
* Clinical diagnosis of herpes simplex type 2 infection

Exclusion Criteria:

* HIV infection
* Other forms of chronic liver disease
* Chronic medical conditions
* On immunosuppressive medications
Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman
PDS Versus Prolene as Suture Material for Vaginal Sacrospinous Hysteropexy

Introduction: Pelvic organ prolapse is a common gynecological disease, which about 50% of women develop in the course of their lives. There are many different options for surgical care, e.g. the uterus-preserving sacrospinal fixation (= sacrospinal hysteropexy = SSHP). This technique has been increasingly used in recent years. However, there is still no data on whether the fixation sutures should be performed with absorbable or non-absorbable threads. Internationally, both types of threads are routinely used and both types of threads are described in publications. So far, there is no comparative data on the effectiveness and subjective results. The aim of this study is to compare subjective symptom improvement Materials \& Methods: This is a randomized, single-center superiority study. The sacrospinal fixation is performed according to a standardized method and two different types of threads (absorbable PDS sutures vs. non-absorbable Prolene sutures) are used for the fixation suture. Patients are randomized to either the absorbable PDS sutures group or the non-absorbable Prolene sutures group. The primary outcome of interest is the subjective symptom improvement 12 months after surgery (evaluated using the German version of the pelvic floor questionnaire). Secondary outcome variables are anatomical outcomes, condition-specific quality of life, and adverse events. 52 patients will be included in the study.

The results of the study will be published in peer-reviewed journals and the results will be presented at scientific meetings.


Eligibility Criteria:
Inclusion Criteria:

* Anterior vaginal wall prolapse beyond the hymen (POP-Q-point Aa or Ba \>0) with central defect
* Prolapse of the apical vaginal vault beyond the hymen (POP-Q point C \>0) with central defect
* Symptoms of a vaginal bulge
* A primary reconstructive operation using sacrospinous hysteropexy is planned

Exclusion Criteria:

* Recurrent prolapse
* History of hysterectomy
* A primary reconstructive operation with mesh or obliterative surgery is planned
* An operation with hysterectomy is planned
* Known pelvic malignancy
* Known inflammatory disease
* Current systemic treatment with glucocorticoids or immunosuppressants
* The subject cannot or does not want to participate
NICE Guideline 'Red Flags' to Predict Serious Outcome After Transient Loss of Consciousness

This study is designed to evaluate the accuracy of the National Institute for Health and Clinical Excellence (NICE) guideline 'red flags' to identify patients at high risk of short term serious outcome when presenting in the emergency department (ED) with Transient Loss of Consciousness (TLoC). Red flags were defined as ECG abnormality, history or physical signs of heart failure, TLoC during exercise, family history of sudden cardiac death at an age \< 40 years and/or an inherited cardiac condition, new or unexplained breathlessness, heart murmur, absence of prodromal symptoms in any patient aged \> 65 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>= 16 years) with a complaint of TLoC

Exclusion Criteria:

* Patients needing immediate treatment, with trauma related or drug or alcohol related TLoC were excluded, as well as patient with persistent altered level of consciousness, simple fall and drop attack
Procalcitonin Level and Kinetics in Children With Bacterial Infections

The purposes of this study are:

1. To determine whether procalcitonin level at admission of pediatric patients with bacterial infections can be used as a marker for prediction of defervescence and hospitalization length
2. To examine the kinetics of procalcitonin in pediatric patients with bacterial infections and persistent fever


Eligibility Criteria:
Inclusion Criteria:

* Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture
* Cellulitis, lobar pneumonia, osteomyelitis,
Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

Measure trimethylamine oxide in the breath.

Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.

The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* patients with kidney disease under the care of Royal Free Hospital

Exclusion Criteria:

* patients unable to provide informed consent
* patients unable to exhale into breath analyser
Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics

In pediatric patients, the accuracy of body temperature measured with an esophageal temperature probe placed through the gastric lumen of the supraglottic airway device is investigated.

Pediatric patients using a supraglottic airway device during general anesthesia are targeted. When the patient enters the operating room, standard monitoring is performed, general anesthesia is induced, a supraglottic airway device is installed, and an anesthesiologist inserts an esophageal thermometer through the gastric lumen. We recorded the body temperature measured in the esophagus, tympanic membrane, temporal artery, and rectum every 10 minutes from 10 minutes after insertion.

Eligibility Criteria:
Inclusion Criteria:

* Pediatrics patients under six years old with ASA PS 1-3
* Patients undergoing general anesthesia using the Supraglottic airway device
* Patient's weight: 10-30kg

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients with tumors in the esophagus or esophageal varices
* Patients with a monitoring device inserted through the esophagus during surgery
* Patients with ear inflammation
* Patients with congenital anomaly in the rectum
* Patients judged unfit to participate in the study by medical staff for other reasons