cyrilzakka/clinical-trials huggingface dataset:
Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)

A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score with a predicted 10-year risk of local recurrence ≤10%, these women will be enrolled and followed as part of the study.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. A two-step registration/enrollment process will be implemented.

Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient \> 45 years of age with DCIS without microinvasion.
2. Tumour size ≤ 2.5cm.
3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*

   \* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion Criteria:

1. Multifocal DCIS.
2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
3. Synchronous or previous invasive or non-invasive breast cancer.
4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
5. ECOG performance status ≥3.
6. Life expectancy \<10 years.
7. Geographic inaccessibility for follow-up.
Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program

The investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting Spanish-speaking Latina caregivers of children 2 and under.

Participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. They will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions.

Objectives are

1. Evaluate the subjective and objective usability of the touchscreen computer.
2. Determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.


Eligibility Criteria:
Inclusion Criteria:

* 1. Have a child 2 and under in their care 2. Consider themselves Latina 3. Are Spanish-speaking

Exclusion Criteria:

Exclude if child has major medical issues interfering with feeding
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with one chronic keratitis/corneal ulcer
* Patients who signed and dated informed consent

Exclusion Criteria:

* Patient under 18 years
* Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.
Clinical and Genetic Study of Neurodegenerative Disorders with Cognitive Impairment

Patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. A blood sample will be proposed in the field of this research project, and the biological material will be stored at the DNA and Cell Bank of Institut de Fédératif Recherche (IFR) of Neurosciences (Pitié-Salpêtrière Hospital, Paris). The clinical research network is already set up for Alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol.

Among these disorders, a monogenic sub-group has been identified. In Alzheimer's disease, it is associated with the APP, PSEN1 and PSEN2 genes, which account only for 75% of the familial forms with early onset. In frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. The identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. The familial forms are also useful for identifying the modifier genes.

In the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. The strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (SNPs) spread out in the whole genome. Meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment.

Finally, correlations will be performed with seric markers according to each kind of dementia.

Specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with a neurodegenerative disorder with cognitive impairment controls (without signs of the disease), matched with sex and age with the patients
* Relatives for the familial cases

Exclusion Criteria:

* Pregnant women
* Minors
* Persons refusing to sign the informed consent
Exercise in Air Pollution and Lung Health in Asthmatics

When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Greater doses of air pollutants reach deeper areas in the lungs where they can trigger asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen even more, allowing the air pollutants to reach even deeper areas of the lung. With this study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and lung health in physically active asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
* men and non-pregnant women

Exclusion Criteria:

* any history of uncontrolled respiratory or cardiac disease
* pregnancy
* allergic reactions to lidocaine and salbutamol
* any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
* claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
* English as a second language (ESL) - participants who are not able to understand the risk that may be associated with the participation in this study due to language difficulties after following the University of British Clinical Research Ethics Board Guidance Notes 13.2.1. (ESL participants will be given a consent form in the most appropriate language or an appropriate translator will be present during the initial consent process).
Clinical Effects of Lumbal Stabilization Exercises and Connective Tissue Massage on Neuropathic Pain, Functional Capacity and Quality of Life

The aim of the study is to investigate the efficacy of connective tissue massage and lumbar stabilization exercise treatment on pain severity, functional capacity and quality of life in those who have experienced peripheral neuropathy

The patients diagnosed with fine fiber neuropathy by the neurology department of hacettepe university will be included and the patients referred to physical therapy will be included.

Patients meeting the inclusion criteria will be randomly divided into 3 groups by simple randomization. The first group consisted of lumbal stabilization exercises, the second group with connective tissue massage and the third group with only medical treatment. All patients will be evaluated 2 times before and after 6 weeks. The treatment will be 2 days per week for 6 weeks. Exercise programs of the patients will be performed under the supervision of physiotherapist. In the first group, lumbal stabilization exercises will be applied for 6 weeks and the second group will be given connective tissue massage.

Statistical analysis of the study will be done using SPSS 21 statistical program.

In the statistical analysis to be carried out within the scope of the study, p value will be selected as 0.05 and p \<0.05 will be considered significant. Mean ± standard deviation, number, percentage, minimum and maximum values will be used as descriptive statistics. Wilcoxon test is used to compare the pre- and post-treatment values of the groups in the variables and the Kruskal-Wallis test will be used to compare the groups with each other.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed small fiber neuropathy
* Score-4 and over from the -DN4 score
* 18-65 years old adults
* Volunteers to participate in the study.

Exclusion Criteria:

* Pain from different etiologies
* Other neurological disorders involved in neuropathy evaluation
* Cognitive or reading disorders to prevent the questionnaires from being filled
* People with musculoskeletal or orthopedic disorders that affect exercise will not be included.
Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.


Eligibility Criteria:
Inclusion Criteria:

- Patients which participated in double blind study

Exclusion Criteria:

* Patients with intolerable toxicity.
* Patients which confirmed progressive disease during double blind study.
* Patients which have received concurrent anti-cancer therapy during double blind study.
Evaluation of the Effect of Self-Assembling Peptide P11-4

Dental caries is a biofilm-mediated, sugar-driven, multifactorial, dynamic disease that results in the phasic demineralization and remineralization of dental hard tissues.

These tissues have poor regeneration capability because of the lack of both regenerative cells and vascularization.

In the complex caries progression process involving dietary sugars, bacterial metabolism and demineralization, the collagenous organic matrix becomes exposed and destroyed by resident and bacterial proteases, allowing the lesion to expand

It is possible to find numerous noninvasive or minimally invasive therapies for caries such as hygiene education, fluorides, Phosphopeptide compounds, xylitol and infiltrative resins.

However, when caries progresses to the point of breaking down the dental tissues, composite restorations are imperative to preserve the tooth functionality.

During the execution of routine dental restorations, the hybrid structure formed by the dental bonding procedure occurs through the interaction and subsequent polymerization of monomers around the demineralized collagen matrix.

The oral cavity is a severe environment for the resin-dental bond to survive for a reasonable length of time, with thermomechanical changes, chemical attacks by acids and enzymes and other factors posing routine daily challenges. Therefore to achieve effective and stable bonding, the preservation of dentin collagen is critical, since collagen represents the major organic component of the dentin matrix.

Based on today's understanding of the dental biomineralization process, new efforts have been made to develop synthetic analogues of non-collagenous proteins (NCPs), which are involved in the events of nucleation and growth of hydroxyapatite crystals in hard tissues Such analogues have been designed mirroring the amphiphilic characteristics of NCPs, with polar groups complexing inorganic ions and non-polar side chains governing the matrix-matrix interactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the study will be required to present at least one permanent molar with an active deep carious lesion without pulpal involvement.
* Age of patient: 18 -30 years
* Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures

Exclusion Criteria:

* Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
* Developmental disorders and adjacent soft tissue lesions
* Patients with systemic illness will be excluded
The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions

Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients with lumbar degenerative conditions with the aim of improving pain relief and quality of life. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons choose to use braces mainly based on their experience and training.

The aim of this study is to investigate whether wearing a brace after PSIF can improve pain relief and quality of life (QOL) 6 weeks and 3 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease);
* Patients scheduled for an elective posterior spinal fusion.

Exclusion Criteria:

* Patients with obesity (BMI \> 35kg/m2).
VR-PAT During Home Burn Dressings - Multisite

This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.

Eligibility Criteria:
Inclusion Criteria:

* Being treated for acute burn injury
* Age 6-17 years, inclusive
* Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit
* Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient)
* Patient and family caregivers can communicate (read and write) using English or Spanish
* Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change.

Exclusion Criteria:

* Any wounds that may interfere with study procedures
* Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
* History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
* Minors in foster care, prisoners, or currently pregnant
* Suspected child abuse
* Families who do not have access to a VR compatible smartphone.
Effect of Prazosin on Neurophysiology and Cognition in Post-Traumatic Stress Disorder (PTSD)

In this study, the investigators are looking at how PTSD affects things such as memory, attention, reaction to sounds, eye movements, and heart rate. The investigators are also studying whether a medication called prazosin has an effect on these things.

Converging lines of evidence suggest that central nor adrenergic function is perturbed in PTSD. Placebo-controlled trials demonstrate that the centrally acting alpha-1 antagonist prazosin is clinically effective for several core symptoms of PTSD in combat veterans. However, no detailed assessment of the impact of prazosin on human neurophysiology and cognition have been conducted. Our hypotheses are based on studies that demonstrate (1) the importance of central adrenergic receptors in regulating fundamental neurophysiologic and cognitive functions, (2) the alteration of these functions in PTSD, and (3) the efficacy of prazosin in improving the clinical symptoms of PTSD. The primary objective of this study is to measure the subtle neurocognitive and neurophysiologic effects on prazosin in combat veterans with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Exposure to one or more life-threatening war zone trauma events;
* DSM-IV diagnosis of PTSD derived from the Clinician-Administered PTSD Scale (CAPS), CAPS total score greater than or equal to 50;
* CAPS recurrent distressing dreams item score greater than or equal to 5 (of a maximum score of 8), with a frequency rating greater than or equal to 2 (of 4);
* stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
* good general medical health;
* female participants must agree to use a reliable form of birth control throughout study.

Exclusion Criteria:

* Acute or unstable chronic medical illness;
* diagnosis of current schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder, delirium, or cognitive disorder;
* severe psychiatric instability or severe situational life crises;
* substance dependence disorder currently or in past 3 months;
* current cocaine or stimulant abuse or evidence of acute intoxication on alcohol or nonprescribed medication;
* allergy or previous adverse reaction to prazosin or other alpha-1 adrenergic antagonists;
* serious head injury with loss of consciousness of greater than 30 minutes;
* current diagnosis of seizure disorder;
* current use of prazosin or other alpha-1 adrenergic antagonists;
* current use of atypical antipsychotic medication;
* stimulants or alternative medications with stimulant properties (e.g. ephedra), certain exposure therapies must be completed at least 4 weeks before baseline;
* certain medications (trazodone, erectile disfunction medications) are not allowed or are restricted during the study;
* women must not be pregnant or nursing during the study.
Magnesphere for Autonomic Alteration

To evaluate the physiologic effects of an electromagnetic resonator(EMF) on autonomic nervous system tone modulation through measurement of heart rate variability(HRV).

Null Hypothesis: An EMF Resonator will not change autonomic nervous system tone and no demonstrable difference in physiological parameters will recorded.

Alternative Hypothesis: Using an EMF Resonator will enhance parasympathetic activty as supported by HRV.

During the initial encounter, participants will be randomized to either therapy or sham. The randomization scheme will be blinded to all investigators, will be devoid of patient information, and will be programmed by a non·investigator third party. All patients will receive the same total duration of therapy, and all patients will receive a sham and a treatment session.

Participants will wear head phones to reduce effects of any outside noises and will lay supine in a chair at approximately 40 degrees which is inside the FDA approved Resonator® EMF field. The active treatment session will be A160 which is a narrow range but variable magnetic field. This ranged from 3.1 x10·8 to 3.2 x 10-8 amplitude with a frequency of 0.857-0.859.

Eligible participants will arrive for testing in the morning and will be randomized to either treatment sequence. Randomization will be predetermined. Mobile phones and pagers will be placed into airplane mode during the study on a table in the room. The patient will be connected to HRV measurement systems. A BP reading will be taken in each arm. Patients will then lay supine in a standardized relaxation chair at approximately 40 degrees at which time the headphones will be placed. Ambient room light will remain powered on during therapy and will remain unchanged regardless of randomization. The researcher will then start either arm A or B (based on randomization). During the session, each participant will be given a short novel/magazine to read to reduce the chance of sleeping.

All HRV monitors will be disconnect and the subject's electronics will be returned.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients more than 18 years old with LVEF of \< 40%(N=20)
2. Healthy age matched controls (N=20)
3. Ability to lay in a reclining chair for at least 60 minutes

Exclusion Criteria:

* 1. Inability to provide consent 2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 3. Recent (\<6 months) stroke or myocardial infarction 4. Severe heart failure (NYHA IV) 5. Hemodialysis 6. Recurrent vaso-vagal syncopal episodes 7. Unilateral or bilateral vagotomy 8. Pregnancy or breast feeding
Planned Semi-Elective Lung Transplantation Using 10C Cold Static Preservation

This is a prospective, single-arm study to demonstrate the proof-of-concept of semi-elective lung transplantation. We plan to evaluate 15 patients that receive lung(s) delayed for transplantation under our study criteria.


Eligibility Criteria:
Inclusion Criteria:

* Recipient is ≥ 18 years old
* Recipient, or their Legally Authorized Representative is able and willing to sign informed consent
* Recipient meets standard listing criteria for lung transplantation

Exclusion Criteria:

* Donor lungs meet criteria for transplantation with ex vivo lung perfusion (EVLP)
* Recipient is \< 18 years old
* Recipient, or their Legally Authorized Representative is unable to sign informed consent for re-transplantation
* Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study