cyrilzakka/clinical-trials huggingface dataset:
The Use of Virtual Reality Glasses to Reduce Anxiety in Fixed Orthodontic Treatments in Children Aged 10-15 Years

This study aims to manage anxiety and fear experienced by young patients during orthodontic treatments through the use of virtual reality glasses, ensuring a more comfortable procedural experience.

The study included twenty-six patients who visited the faculty of dentistry. Thirteen patients in the study group were shown animation through virtual reality glasses during the procedure. The 13 patients in the control group underwent standard treatment procedures without virtual reality glasses. Both groups were asked questions from the CASI and Trait Anxiety Inventory at the beginning of the procedure, State Anxiety Inventory at the beginning and at the end of the procedure, and pulse rate, saturation and VAS values were recorded.

The implementation of virtual reality glasses in orthodontic treatments has been shown to effectively manage anxiety by distracting patients from what is actually happening.

This study shows that virtual reality goggles reduce the anxiety experienced by patients during orthodontic treatment. These results offer a different treatment process that can increase treatment comfort in clinical practice.

Orthodontic treatments are treatments that have less knowledge and experience among patients compared to other dental procedures, and therefore have a more uncertain process for patients. The tools and materials used in orthodontic treatments also differ from the materials that patients are familiar with using in other dental procedures. Patients aged 10-15 years were identified as an age group in which fixed orthodontic treatment could be started for the age range of our study group, who had less experience in dental treatments compared to adults, and therefore the level of anxiety was mostly higher. In addition, it has been observed that the bracket placement session, which is the first session of fixed orthodontic treatment, is longer than the sessions in which other orthodontic procedures are performed, and during this period, patients in the age group we have chosen tend to question the remaining time and want to check their mobile phones, and it is believed that virtual reality (VR) glasses can be utilized to enhance the comfort of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Children who needed and accepted fixed orthodontic treatment,
* Children who had not received orthodontic treatment before
* Children who did not have any psychiatric or systemic disorders

Exclusion Criteria:

* Children who had previously undergone orthodontic treatment
* Children with psychiatric or systemic disorders.
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury

Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin \&Lip Sensation Post Inferior Alveolar Nerve Injury


Eligibility Criteria:
Inclusion Criteria:

* Patients with hemimandiblectomy
* Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months
* Age group : from 15 to 60 years old
* No sex predilection
* Patients with no contraindications to surgical intervention

Exclusion Criteria:

* • Patients with systemic condition counteracting with the surgical procedure.
MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer

This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.

There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.

Eligibility Criteria:
Inclusion Criteria:

1. Underwent primary rectal adenocarcinoma resection
2. Received MRI scan before surgery
3. Willing and able to provide written informed consent for participation in this study.
4. Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge).
5. Clinical stage of T3Nx or T1-3N+ at initial diagnosis
6. Non-complicated primary tumor (complete obstruction, perforation, bleeding).
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

1. Treated with transanal local excision
2. with distant metastases at the time of initial diagnosis
3. Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
4. Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).
Arrhythmia Genetics in the NEtherlandS

The AGNES case-control set consists of individuals with a first acute ST-elevation myocardial infarction. AGNES cases have ECG- registered ventricular fibrillation occurring before reperfusion therapy for an acute and first ST-elevation myocardial infarction. AGNES controls are individuals with a first acute ST-elevation myocardial infarction but without ventricular fibrillation. All cases and controls are recruited at seven heart centers in The Netherlands. The investigators' exclude individuals with an actual non-ST-elevation myocardial infarction, prior myocardial infarction, congenital heart defects, known structural heart disease, severe comorbidity, electrolyte disturbances, trauma at presentation, recent surgery, previous coronary artery bypass graft or use of class I and III antiarrhythmic drugs. Individuals who develop ventricular fibrillation during or after percutaneous coronary intervention are not eligible. Furthermore, because early reperfusion limits the opportunity of developing ventricular fibrillation, potential control subjects undergoing percutaneous coronary intervention within 2 h after onset of myocardial ischemia symptoms were not included. This time interval is based on the observation that \>90% of cases develop ventricular fibrillation within 2 h after onset of the complaint of symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. First ST elevation myocardial infarction (STEMI)
2. Between 18 and 80 years old

Exclusion Criteria:

1. A grandparent from non-European descent
2. Inborn errors; congenital heart defects.
3. Prior myocardial infarction (either STEMI or non-STEMI)
4. Previous CABG (coronary artery bypass graft)
5. Use of anti-arrhythmic drugs with the exception of beta-blockers, Ca2+-antagonists and lanoxin.
6. Severe current co morbidity (electrolyte disturbances, K+\>5.5, K+\<3.0 mmol/L, anaemia, trauma, surgery).
Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration

The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.

In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.


Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
* At least one exacerbation in the previous year with systemic glucocorticoids
* Uncontrolled/Partially Controlled Asthma by GINA guidelines

Exclusion Criteria:

* Allergy to salmeterol/fluticasone
* Patients Controlled by GINA guidelines
Follow up of Autoantibodies in Active Tuberculosis

We have previoulsy shown that patients with active Tuberculosis develop a wide array of autoantibodies including rheumatoid factor, anti-CCP, Antinuclear facyor and anti Sm antibodies. The purpose of this study is to evaluate whether the level of autoantibodies decrease after treatment aganist tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Active Tuberculosis treated

Exclusion Criteria:

* None
A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Had axial LBP with or without radiation present for at least 3 months as defined as:

  * Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below
  * Chronic axial LBP with radiation: pain that radiates to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component \<50%
* Had daily moderate to severe LBP as the primary source of pain
* Had a normal neurological examination, including:

  * Motor strength
  * Sensory exam in lower extremities
  * Deep tendon reflexes
* Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
* Had discontinued use of all analgesic medications (including over-the-counter \[OTC\] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).
* Had a daily average pain intensity rating of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as "no pain" and 10 was defined as "pain as bad as ever imagined" as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary

Key Exclusion Criteria:

* Had spinal stenosis with \> 50% leg pain component
* Had elective surgery scheduled to occur during the 14-week study
* Had a history of one or more back surgeries within 1 year of study entry
* Had severe renal insufficiency (creatinine clearance of \<30mL/min)
* Had moderate or greater hepatic impairment
* Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
* Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period
* Had received an epidural steroid/local anesthesia injection within 4 weeks prior to study entry
* Had received trigger point injections within 2 weeks prior to study entry
* Had received Botulinum Toxin (Botox) Injections for LBP within 6 months prior to study entry
* Were using a lidocaine-containing product that could not be discontinued during the study
* Were using any topical medication applied to the low back region
* Had previously failed treatment with Lidoderm analgesic patch for LBP
* Were taking class 1 anti-arrhythmic drugs (e.g. mexiletine, tocainide)
* Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers

Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy males
* Age range from 21 to 50 years
* Body mass index (BMI) be within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

* Erythema, exanthema and comparable skin alterations
E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer

This trial studies how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.

PRIMARY OBJECTIVE:

I. To examine the impact of an e-health support program on patient reported outcomes.

SECONDARY OBJECTIVES:

I. To evaluate the effect of e-health support program in comparison with standard of care support services, on the symptom experience of patients receiving chemotherapy in the ambulatory setting.

II. To evaluate the effect of e-health support program in comparison with standard of care support services, on the satisfaction of patients receiving chemotherapy in the ambulatory setting.

III. To evaluate the effect of e-health support program, in comparison with standard of care support services, on the frequency of emergency room visits and hospital admissions for patients receiving chemotherapy in the ambulatory setting.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in the PACK Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application, as well as weekly interaction with a health coach over 3 months. Patients also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.

GROUP II: Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.

Eligibility Criteria:
Inclusion Criteria:

* English speaking.
* Newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time.
* All chemotherapy treatment to be completed at the study institution.
* Access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails.

Exclusion Criteria:

* Patients who have received previous chemotherapy treatment for cancer.
* Patients who are unable to verbalize (e.g. due to tracheostomy).
* Patients enrolled on Protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.
More Frequent Dialysis (>3 Treatments Per Week)

The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
* 18 years of age.
* History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
* Plan to continue care and follow-up at the investigational site.
* Able to sign the informed consent and other relevant documents.

Exclusion Criteria:

* History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
* Pregnancy.
* Intravenous drug abuser.
* Expects to receive a transplant or transfer to another facility within six months of entering the study.
Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.

Compare the Effect of Different Physical Programs on the Body Composition of Adult Women and Men With a Total Body Fat Percentage ≥ 30 % at the Beginning of the Test or BMI ≥25

Weight loss by exercise can be frequently deceptive. The focus continues to be centred around total body weight and body mass index (BMI), despite the fact that body fat and fat-free mass are the indicators that represent the greatest risk in the comorbidity associated with obesity. Body weight per se cannot be considered to be reliable; however, its quality can be justified, when measured together with the loss in body fat and the maintenance or increase in fat-free mass.

The purpose of the study is compare the effect of different physical programs (FA) on the body composition (BC) of adult women with a total body fat percentage ≥ 30 % and adult men with a BMI ≥25 at the beginning of the test.

Participants (n=220, women = 110, men = 110) will be recruited through outpatient from private clinics in Cádiz, Andalucía, Spain, as well as through community presentations. Overweight or obese and sedentary women and men will be randomly assigned into three groups according to different levels of AF. 21 of the participants will be assigned to the sedentary control group (METs \<2.9), 20 in a group of moderate AF (METs 3-5.9), and 19 will be assigned to the group of intense AF (METs \>6).

For 6 months, all of the women shall follow the same diet with an identical distribution of macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass for all of them.

Eligibility Criteria:
Inclusion Criteria:

* Having a body fat percentage \>30
* Having a BMI \>25
* Being sedentary and
* Have not been submitted to a restrictive diet in the 6 months preceding this study.

Exclusion Criteria:

* Suffered from type 2 diabetes or renal conditions
* Being pregnancy or attempt at pregnancy,
* Being in a maternal lactation period,
* Being underage
* Undergoing antidepressant pharmacological treatment
Water Filter Study in Ciudad Victoria

This study measures effects of water filters and filter types on household health in Ciudad Victoria, Mexico.

A project to assess the water quality in Ciudad Victoria, Mexico and the effectiveness of different Sawyer PointOne Filter types (Bucket, Tap, Squeeze) . The project is designed to 1) assess the impact of filters on health and well-being of families, 2) assess the impact of filters on the economic status of families and 3) compare different filter formats for use/adoption on the above metrics. The project will provide information about how well the different filters are working in urban households in a middle-income Latin American country, make recommendations for future deployment of filter types in similar settings, and determine the potential for scaling the use of filter systems to provide clean drinking water for people in need in future projects.

Eligibility Criteria:
Inclusion Criteria:

* Recruiting will occur in Ciudad Victoria, Mexico at any household in the areas surveyed

Exclusion Criteria:

* None, except those who decline the survey and/or filter