cyrilzakka/clinical-trials huggingface dataset:
ILD: Health Outcomes in Remote Digital Monitoring Versus Usual Care

Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness.

This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months.

Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight.

Health outcomes will be described and compared between the two groups.

This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibrotic interstitial lung disease
* Aged at least 18 years
* Owns a smartphone or tablet device
* Has a mobile telephone number, email address and access to the internet at home
* In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
* Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
* Willing to allow home monitoring of their health including spirometry and pulse oximetry data
* Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email)
* Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period
* Fluent in English language
* Written or electronic informed consent

Exclusion Criteria:

* Unable to fulfil all inclusion criteria
* Cognitive impairment
* History of difficulties performing spirometry at previous clinic testing
* Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)
* Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.
* Current or recent (within the last 6 weeks before baseline) participation in another research project
Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant

A prospective, multisite study to evaluate the Impact of Measles, Mumps, Rubella and Varicella ProQuad® vaccination in pediatric patients 6-24 months of age who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney)

Primary Aim:

To measure the antibody response to ProQuad® vaccination given earlier than the current recommended age in patients from the age of 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five years. These subjects would not reach the recommended ages to receive the vaccine before the transplant.

Hypothesis:

The Investigator proposes the hypothesis that the proposed study population will mount a clinically significant response to two (2) doses of the ProQuad® vaccine.

Primary Endpoint:

With respect to expected outcomes, the work proposed is expected to provide tools for optimizing the ProQuad® vaccination strategy in this population.

Secondary Aim:

To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).

Hypothesis :

The Investigator proposes the hypothesis that the study population will have similar safety profiles compared to children who receive the vaccine at the recommended ages.

Secondary Endpoint:

The secondary outcome measure is represented by the children in the study having either no adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination report card that the parents/legal guardians of the participants in the study will complete for their child for 7 days after he/she receives each dose of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

1. Parent and/or legal guardian willing and able to give informed consent.
2. Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:

   * to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
   * to participate in the three (3) antibody titer blood draws.

Exclusion Criteria:

1. History of allergy to any vaccine component, bleeding disorder, exposure to measles, mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.
2. Receipt of any blood product or immunoglobulin received in the previous 180 days prior to vaccination.
3. Previously received any measles, mumps, rubella and/or varicella vaccine either alone or in combination prior to vaccination.
4. Any condition which causes the investigator to determine that the subject is not appropriate to enroll.
Cervical Radiculopathy Trial

The primary aim of the present project is to compare the effectiveness of surgery and nonsurgical treatment in patients with cervical radiculopathy caused by either disc herniation or spondylosis. Secondary aims are to evaluate cost-effectiveness and predicting factors of success of the two treatments, and to explore the terms success rate and expectations by asking the patients to fill in their expected primary outcome score at baseline.

Cervical radiculopathy is usually caused by disc herniation or spondylosis. Prognosis is expected to be good in most patients but there is limited scientific evidence about the indication for non-surgical and surgical treatment.

Two randomised controlled trials comparing cervical decompression and non-operative treatment with cost-effectiveness analysis and assessment of expectations and predictors of outcome. The main research question will be evaluated at one-year follow-up.

1. To test the hypothesis that the effectiveness of surgery as measured by the change in Neck Disability Index (NDI) at 1-year follow-up in patients with cervical radiculopathy is not different from non-surgical treatment in:

   1. Study 1: one level disc herniation (C5/6 or C6/7)
   2. Study 2: one or two level spondylosis (C5/6 and/or C6/7)
2. To test the hypothesis that surgery is more effective in patients with more clinical finding (dermatomal sensory loss, myotonal weakness and reflex disturbance) at baseline when adjusted for other possible predictors such as age, gender, baseline pain, duration, radiological findings, expectations, and psychological factors).
3. To estimate cost-effectiveness for health care costs and societal costs (including sickness absence) in surgical versus non-surgical patients.
4. To assess radiological (MRI and CT) measurements of foraminal area and nerve compression and if changes can predict clinical changes (NDI and arm pain) at 1-year .
5. To evaluate treatment outcome expectations at baseline asking the patients to fill in their expected improvement.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 65 years.
* Study 1: Neck and arm pain for at least 3 months with a corresponding herniation involving one cervical nerve root (C6 or C7) Study 2: Neck and arm pain for at least 3 months with a corresponding spondylosis involving C6 and/or C7) .
* Pain intensity of arm pain of at least 4 on a scale from 0 (no pain) to 10 (worst possible pain)
* Willing to accept either of the treatment alternatives
* NDI \> 30

Exclusion Criteria:

* Patients with any previous cervical fractures or cervical spine surgery;
* Signs of myelopathy;
* Rapidly progressive paresis or paresis \< grade 4;
* Pregnancy;
* Arthritis involving the cervical spine;
* Infection or active cancer;
* Generalised pain syndrome;
* Serious psychiatric or somatic disease that exclude one of the treatment alternatives;
* Concomitant shoulder disorders that may interfere with outcome;
* Abuse of medication/narcotics,
* Not able to understand written Norwegian,
* Not willing to accept one of the treatment alternatives.
E4D Compare Adapted to Preclinical Endodontics

Based on pilot study's promising results, we decided to further investigate the impact of adapting Planmeca Romexis Compare software to evaluate pulpal access preparations on second-year dental students' technical performance, self-evaluation skills and opinions. No educational records, grades, coursework, or any other assignments that are completed as part of the regular class will be analyzed as part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Second-year dental students enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
* Students who have completed fixed prosthodontics preclinical course
* Students attending the endodontics preclinical course.

Exclusion Criteria:

* First, third and fourth-year dental students at Texas A\&M School of Dentistry
* Second-year dental students NOT enrolled in DDDS 719 Integrated Practice of Dentistry Lab II during 2022-2023 at Texas A\&M School of Dentistry
* Students who are not interested in participating.
Accuracy and Reliability of Fetal Heart Rate and Uterine Contraction Monitoring Method

Clinical Investigation Protocol for a study designed to determine the equivalence of the Monica AN24 monitor to Philips 50XM for fetal heart rate (FHR) and uterine contraction (UC) monitoring during labor. The study will be carried out on subjects in the first and second stages of labor.

The study is a prospective, randomized, single-center observational study designed to compare the Fetal Heart Rate (FHR) and Uterine Activity (UA) output data obtained by the Monica AN24 monitor during the first and second stages of labor to those generated by existing FDA-approved devices.Patients were enrolled at the facility but the patient details were removed from the results in order that the data could be randomized for the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, age 15-40
* Term gestation (\>36 completed weeks)
* Singleton fetus
* Active labor
* Vertex presentation
* Requiring internal monitoring

Exclusion Criteria:

* Clinical contraindication for Intra Uterine Pressure Catheter
* Major fetal malformation
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla

The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.

This randomized clinical study included 20 patients with a horizontally deficient ridge in the esthetic region. Two groups were divided according to the type of intercortical bone graft used after ridge splitting: 10 patients for each. (The intervention group) had grafting with autogenous bone wedges harvested from the chin, and (the control group) had mixed (autogenic and xenogenic) bone particles.

Eligibility Criteria:
Inclusion Criteria:

1. All patients possessed partially edentulous anterior maxillary ridge with the following criteria

   1. The anterior maxillary vertical dimension was more than ten mm measured from the alveolar crest to the basal bone of the maxilla.
   2. The horizontal alveolar dimension varies from 3-5 mm at the crest and 6-8 mm at the basal part of the ridge measured from the labial cortex to the lingual cortex.
2. All patients were free from any medical conditions that may affect bone healing .
3. No local pathosis that may interfere with bone healing.
4. No previous grafting procedures at the indicated edentulous ridge.

   -

   Exclusion Criteria:

1- Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.

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MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer

The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.

Sentinel lymph node (SLN) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (VSCC) in the absence of clinical signs of lymph node metastasis. The gold standard technique for identifying SLN utilizes Technetium (Tc99m) lymphoscintigraphy and blue dye. An alternative method has emerged using superparamagnetic iron-oxide (SPIO) and magnetic resonance imaging (MRI).

This study aims to enroll 20 VSCC patients scheduled for the SLN procedure. Determination of the minimal dosage of SPIO required to avoid excessive MRI artifacts while still identifying the SLN. Intraoperative SLN detection with a magnetometer will be compared with the gold standard gamma probe.

As secondary objective, in addition to determining the SNL, MRI analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.

Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed primary VSCC \<4 cm, candidates for surgery with SLNB Age above 18

Signed and dated written consent before the start of specific protocol procedures.

ECOG performance status 0-2

Exclusion Criteria:

Contraindications for MRI such as electronic implants or severe claustrophobia

Hip replacement

Iron overload disease 4. Known hypersensitivity to iron or dextran compounds

Inability to understand given information and give informed consent or undergo study procedure
Does Oxytocin Alter Tolerance to or Motivation for Alcohol

This pilot study is intended to demonstrate feasibility and acquire preliminary data. If successful, this data could support a future project studying the effect of oxytocin on tolerance and alcohol seeking in humans.

This pilot study is designed to demonstrate feasibility and provide preliminary data supporting use of intranasal oxytocin in treatment of alcohol use disorders. Specifically, experiments are planned to test the ability of oxytocin to reverse tolerance and alcohol seeking in humans by employing state-of-the-art computer-assisted intravenous alcohol administration. Two separate experiments will be run. In the first, tolerance will be assessed using sensitive tests of subjective response and cognitive function during an intravenous infusion that maintains a steady breath and therefore brain exposure to alcohol. In the second, an intravenous alcohol self-administration paradigm that requires increasing effort for each additional infusion will be used to assess change in motivation for alcohol. Demonstrating that oxytocin (compared to placebo) worsens test performances in alcohol-dependent individuals and/or reduces the compulsive drive to self-administer alcohol would be strong evidence for its potential to treat alcohol use disorders.

Eligibility Criteria:
Inclusion Criteria:

* Heavy alcohol drinkers.
* Able to understand/complete questionnaires and procedures in English.
* Have venous access sufficient to allow blood sampling.

Exclusion Criteria:

* Latex allergy.
* Nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin
* Pregnant or breast-feeding women.
* Desire to be treated for any substance use disorder or court ordered to not drink alcohol
* Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety.
* Positive urine drug screen for amphetamines/ methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine if determined by the PI to adversely affect participant safety or data integrity.
* Medications (past 30 days) that could influence participant safety or data integrity (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by the PI.
* DSM 5 Disorders (other than alcohol) or current/history of neurological disease of cerebral origin, or head injury with \> 20 min loss of consciousness, if determined by the PI to affect participant safety or data integrity.
* Positive breath alcohol reading at beginning of the experimental session.
* Actively suicidal (for example, any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the PI.
* Any condition for which the PI and investigative team determine it is unsafe or not prudent to enroll a participant.
Multifocal Lens Centration and Its Effect on Visual Performance in a Presbyopic Population

The purpose of this study is to use a corneal topographer, a device that is readily available in most optometric practices, in order to determine the position of the multifocal (MF) contact lens (CL) optics in relation to the optics of the eye. The specific purpose of this study is to evaluate if there is a relationship between the positioning of the optics of the study lenses and the objective and subjective visual performance as well as participant satisfaction. The MF CL lenses will be fitted to two groups of participants (previously unsuccessful vs. currently successful MF CL wearers).

HYPOTHESES

* The measurement of the power distribution acquired from the Medmont E300 corneal topographer is effective in determining MF CL lens centration and is a predictor of MF CL success.
* There is a difference in MF CL centration, determined by corneal topography, between successful and unsuccessful MF CL wearers.
* MF CL centration, determined by corneal topography, is correlated with visual performance, determined by ocular aberrometry, measures of visual acuity and subjective satisfaction.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 42 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Has previous experience with wearing MF CLs;
5. Is able to be successfully fitted with all study lenses;
6. Has a vertex-corrected spherical distance prescription of +6.00 to 8.00D (inclusive) in both eyes;
7. Has a spectacle cylinder ≤0.75D in both eyes;
8. Requires a reading addition of ≥+1.00D;

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has monocular best-corrected VA of worse than 20/30 in each eye;
10. Has amblyopia or strabismus;
11. Has anisometropia \>2D between both eyes

    * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
The Character of Perfusion Parameters Derived From MDCT Between Adenocarcinoma and Squamous Cell Carcinoma of Lung in the Treatment Course of Radiation Therapy

Lung cancer is one of the leading causes of cancer-related death in Taiwan. Recently, there are more treatment methods available which result in increased patient survival. Although adenocarcinoma and squamous cell carcinoma were both categorized as non-small cell lung cancer (NSCLC), the recent advancement of target therapy implied that these two histologies behave differently (Shah NT, et al. 2005; Sandler A, et al. 2006). Radiation therapy is an important method for locally advanced non-resectable non-small cell lung cancer (NSCLC). Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed evaluation of tissue and organ perfusion with excellent resolution. Using this new technique with image post processing, excellent spatial resolution and functional perfusion information can be obtained simultaneously. Therefore, the purpose of this study is to explore not only the longitudinal change of lung cancer eligible for radiation therapy (including concurrent, sequential chemoradiotherapy and high-dose radiation therapy) but also comparison of adenocarcinoma and squamous cell lung cancers using perfusion MDCT. Total twenty patients with histopathologically proved adenocarcinoma or squamous cell carcinoma will be enrolled in this study and receive longitudinal study for perfusion MDCT evaluation before, during radiation therapy and in early and late phases after complete radiation therapy. Dynamic perfusion will be used for processing the image data, and quantitative parameters such as tumor blood volume and permeability etc will be derived. From this study, we expect to understand the change of tumor vascularity after radiation therapy and characters of treatment response of adenocarcinoma and squamous cell carcinoma in addition to the change of tumor size.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and up
* Males and females

Exclusion Criteria:

* Pregnancy