cyrilzakka/clinical-trials huggingface dataset:
Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial

Maxillary canines are the second-most frequently impacted teeth in the dental arch after the third molars. The suspicion of a maxilary canine impaction raises with the absence of the permanent canine in the arch after the normal period of eruption, and has to be confirmed by a clinical evaluation of the patient and a radiographic assessment.

The approaches to the management of impacted canines are many, but the preferred approach typically involves surgical exposure and guided orthodontic eruption.

The initial mechanical eruption can be achieved in several ways, but an important distinction has to be done according to the anchorage method. The aim of this study is comparing Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the quantification of canines and molars displacement as the main parameter.

A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the need for it at large, and is subsequently removed after use.

The mini screw employed in this clinical trial will be an alloy type IV titanium screw with 1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between the first premolar and first molar, on the buccal or labial side according to the canine position and teeth position.

For the evaluation of the canines and molar displacement, two CBCT will be required: the first one before the beginning of the traction (T0), the second one after three months (T1). Both the CBCT will be imported in the MIMICS image processing software (Materialize Group, Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration, through the identification of 5 at least landmark points, will allow the overlap of the two masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment positions will be evident and the measurement of the displacement possible.


Eligibility Criteria:
Inclusion Criteria:

* presence of one or two impacted maxillary canine requiring surgical exposure and orthodontic treatment

Exclusion Criteria:

* permanent teeth extraction-based treatment
* current or previous orthodontic treatment in the last 12 months
* current systemic disease
* current antibiotic or antinflammatory therapy that can may compromise the result
Retrospective Study of Brachytherapy

Brachytherapy for gynecological cancers will be studied retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 female
* Underwent brachytherapy
* With gynecological cancer

Exclusion Criteria:

* Refusal to enter this trial
Corneal Epithelial Autograft for Pterygium

The purpose of the study is to explore whether femtosecond laser-assisted cornea epithelial autograft is more effective than limbal conjunctival autograft for ocular surface reconstruction after excision of pterygium.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 80 years old;
2. Primary pterygium, scheduled for elective surgical excision;
3. Pterygium encroaching from the nasal side onto the cornea, with less than 180° limbal involvement and without approaching the central visual axis (pupil area);
4. Morphologically intact palisades of Vogt in a given limbal region;
5. Absence of any one of the following structures in the limbal region underneath the pterygium: (1) epithelial basal cells with dark cytoplasm and reflective cell borders; (2) at least two prominent palisade ridge structures; (3) at least one circular and/or oval-shaped focal stromal projection;
6. Informed consent signed by patient or legal guardian; Having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

1. Limbal stem cell deficiency by ocular surface disorders other than pterygium;
2. Inability to determine whether the palisades of Vogt underneath the pterygium is absent or not using in vivo confocal microscopy;
3. High myopia with a spherical equivalent of -15.0 D or less;
4. Corneal or ocular surface infection within 30 days prior to study entry;
5. Ocular surface malignancy;
6. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
7. Renal failure with creatinine clearance\< 25ml/min;
8. Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L;
9. Platelet levels \< 150,000 or \> 450,000 per microliter;
10. Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female);
11. Prothrombin time \> 16s and activated partial thrombin time \> 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
12. Pregnancy (positive test) or lactation;
13. Participation in another simultaneous medical investigation or clinical trial;
14. Severe cicatricial eye disease;
15. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
16. Severe dry eye disease as determined by Schirmer's test \< 2mm at least in one eye;
17. Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
18. Signs of current infection, including fever and treatment with antibiotics;
19. Active immunological diseases;
20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.
Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 1

The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution (MPDS) compared to Biotrue™ Multipurpose Solution (MPS) in silicone hydrogel contact lens wearers.

In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist® Multi-Purpose Disinfecting Solution or Biotrue™ Multipurpose Solution in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least one month prior to Visit 1;
* Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on two days during the study;
* Must have habitually used a Biguanide preserved multi-purpose solution (other than Biotrue) for at least 30 days prior to Visit 1;
* Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
* Have access, capability and willingness to review and answer text messages;
* Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
* Willing to follow the study procedures and visit schedule;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Need to wear lenses on an extended wear (i.e. overnight) basis during the study;
* Known sensitivity or intolerance to Biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
* Monocular (only one eye with functional vision) or fit with only one lens;
* Wearing toric or multifocal contact lenses or fit with monovision;
* Use of additional lens care products other than a Biguanide preserved multipurpose solution such as daily or enzyme cleaners within the one week prior to Visit 1;
* Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
* Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
* Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
* Ocular surgery within the 12 months prior to Visit 1;
* Participation in any other clinical trial within 30 days of enrollment;
* Other protocol-defined exclusion criteria may apply.
Assessment of Neurodevelopmental Needs in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy is a genetic disease that causes progressive muscle weakness. There is now substantial evidence that boys with this disease do not demonstrate age-related gains in their cognitive skills.

The goals of this study are (i) to use a technology-enabled neurobehavioral assessment called National Institutes of Health Toolbox Cognition Battery (NIHTB-CB) to assess brain development over time; (ii) engage with key-stakeholders to understand how neurodevelopmental problems like attention-deficit hyperactivity, autism spectrum affects individuals (and/or) families, so that we can understand meaningful effects of a potential treatment at an individual level, and (iii) to investigate using brain magnetic resonance imaging (MRI) changes in brain connectivity.

Participants will be asked to do tasks such as solve puzzles, pay attention, and remember things through the NIHTB-CB administered using an IPad as well as complete questionnaires. The NIHTB-CB will be done four times (first visit, within 1 month after first visit, 12 months after first visit, and 18 months after first visit). NIHTB-CB takes about 20 to 35 minutes to complete.

Participants will also undergo brief assessment of the upper limbs; these tests will be administered by trained physical therapists and will take about 5 minutes.

Focus group: A focus group consisting of families and individuals affected by DMD will be invited to share their journey of cognitive and developmental needs. The focus group will be conducted online via the study team and is planned to last between 1 to 1.5 hours. This is optional for families.

A non-sedated brain MRI will be performed twice; scans will be separated by a one-year interval. (A child has to be age 8 or older to participate in a brain scan.) Brain imaging is optional for families.

Eligibility Criteria:
Inclusion Criteria:

* Boys with confirmed genetic mutation in the dystrophin gene
* Boys with clinical features of DMD and in whom muscle biopsy showed absence of dystrophin
* Boys with clinical features of DMD and in whom there is a family history of DMD
* Symptomatic carrier girls with DMD
* Ages 3 and above at time of study screening

Exclusion Criteria:

* Care-giver unable to give consent
* Any handicap that does not allow the ability to use an IPAD
* For MRI, braces or any metal implants.
Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

This clinical trial studies wide-field and high resolution in vivo imaging in visualizing lesions in patients with abnormal or uncontrolled oral cell growth (neoplasia) undergoing surgery. Diagnostic procedures, such as wide-field and high resolution in vivo imaging, are devices that let researchers look at a wide area of the lining of the mouth by shining different colors inside the mouth and taking pictures and this may help doctors to decide if a mouth lesion has a high risk of being pre-cancerous or cancerous.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility for assessing oral mucosa in vivo with wide-field and high resolution images obtained using new optical imaging devices composed of cameras and microscopes, and with a topically administered contrast agent.

II. To develop and evaluate algorithms to classify tissue as normal (including hyperkeratosis, hyperplasia, and inflammation) or abnormal (any grade of dysplasia or cancer) based on quantitative parameters extracted from the optical images.

SECONDARY OBJECTIVES:

I. To determine the percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye.

II. To identify qualitative and quantitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions.

OUTLINE:

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (high-resolution microendoscope \[HRME\]) at baseline, after induction of general anesthesia, and prior to surgery.

After completion of study, patients are followed up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head \& neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible
* Ability to understand and the willingness to sign a written informed consent document (ICD)

Exclusion Criteria:

* Known allergy to proflavine or acriflavine
* Pregnant or nursing females
* The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer

To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer;
* All sites of disease must be amenable to definitive radiotherapy;
* Age 18 years to 75 years;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
* Forced expiratory volume in 1 second(FEV1)\> 0.75L;
* No previous chest radiotherapy, immunotherapy or biotherapy;
* Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
* Patients and their family signed the informed consents;

Exclusion Criteria:

* Active infection;
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias);
* Malnutrition (loss of ≥ 20% of the original body weight);
* Performance status: 3-4;
* Sensor or motor neuropathy \> grade I;
* Second primary malignancy, except for non-melanoma skin cancer;
* Psychiatric illness or social situation that would preclude study compliance;
* Pregnant or lactating women.
Telephone Care as a Substitute for Routine Psychiatric Medication

The purpose of this study is to answer the following questions: (1) Does substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits reduce overall healthcare utilization? (2) Is substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits as effective as routine care?

Telemedicine uses communications technologies to provide health care when distance separates participants. Applied to general medical care practice, telemedicine is associated with improved continuity of care, cost-effectiveness, and improved service quality. To date, all evaluations of telepsychiatry have concentrated on video technology. The telephone is more readily available and less expensive communication technology that has not been evaluated as a method of health services delivery in the medication management of stable psychiatric outpatients. We will enroll 346 psychiatrically stable subjects, who carry a diagnosis of major depression, post-traumatic stress disorder (PTSD) or non-PTSD anxiety disorder. We will use a balanced randomization strategy to assign subjects to routine care or telephone care for a two-year period within each provider panel. Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval. Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinic visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval. At two years, we will use ten data sources to compare two primary outcomes (total VHA health services utilization and mental health component scores from the SF-12-V) as well as VHA costs, imputed non-VHA costs, patient and provider satisfaction, medication compliance and diagnosis specific outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for this study if they carry a diagnosis of major depression, Post-traumatic Stress Disorder (PTSD), or non-PTSD anxiety disorders.
* They must be psychiatrically stable subjects with a Global Assessment of Functioning scale score of \>50, no psychiatric hospitalizations in the previous six months, and no active substance abuse disorders.

Exclusion Criteria:

* Psychiatric hospitalization within 6 months prior to study entry.
* Visit interval \>1 year.
* Lack of telephone access.
* Inability to use a telephone.
* GAF\<50.
Retrospective Study of the Effects of Sub-pathologic Phenotypes of BP on Clinical Management and Prognosis

Bullous pemphigoid (BP) is a chronic autoimmune subepidermal blistering disease primarily affecting the elderly with a significant risk of mortality and morbidity. Various inflammatory cells such as eosinophils, lymphocytes, neutrophils and their granulopoiesis play an important role in the pathogenesis of BP. Infiltration of peripheral blood eosinophils, lymphocytes, and neutrophils into the skin is considered a major feature of BP, making it a heterogeneous disease with different histologic and clinical subtypes. This clinical study was conducted to further investigate the impact of different pathologic phenotypes of BP on the treatment and prognosis of the disease. A retrospective epidemiologic investigative approach was used，and case collection included demographic information, medical history, clinical manifestations, and histopathologic features. Including gender, age, duration of disease, number of days of hospitalization, mucosal involvement, clinical diagnosis before admission, histopathological diagnosis, laboratory tests, concomitant diseases, treatment and its changes in laboratory indexes before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients with Bullous Pemphigoid who were first hospitalized in the Department of Dermatology of Xijing Hospital
* (2) Age 0-100 years old, gender is not limited.
* (3) Diagnosis is confirmed by clinical, histopathologic, immunopathologic and/or anti-BP180 antibody tests.
* (4) Complete skin histopathology information

Exclusion Criteria:

* (1) Patients with Bullous Pemphigoid who were not first diagnosed in our hospital.
* (2) Those who have received systemic glucocorticoid, immunosuppressant, biologic, or other drug therapy within the past month.
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.


Eligibility Criteria:
Inclusion Criteria:

* age:≥18 years, male or female.
* Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
* Has not received any systematic anti-tumor drug treatment.
* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* ECOG 0-1.
* Adequate organ function.
* Life expectancy of greater than 12 weeks.
* Patient has given written informed consent.

Exclusion Criteria:

* Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
* Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
* Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
* Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
* Received a live vaccine within 4 weeks before the first dose of study medication.
* Pregnancy or breast feeding.
* Decision of unsuitableness by principal investigator or physician-in charge.
Intraoperative Navigation for Surgically Precise Resection of the Chest (INSPIRE)

While undergoing chest wall resection, a surgeon's major concern is obtaining an appropriate surgical margin. Difficulty or failure to do so can result in prolonged operative time, need for re-operation due to a positive resection margin, or need for complex chest wall reconstruction due to unnecessarily wide resection. Over the last decades, surgical navigation systems have been developed to improve operative precision in various surgical fields. This is achieved by integrating patient images with intraoperative findings.

Integration of CT imaging systems into the operating room now provide real-time 3D images of patient anatomy during surgery. This better adjusts for anatomical deformation and tissue excision compared to using preoperative images alone.

Twenty patients scheduled for chest wall resection will be enrolled over the study duration of 2 years. Patients will undergo imaging and surgery in the GTx-OR at Toronto General Hospital, as part of the GTx Program of the TECHNA Institute. All patients will be asked to consent to receiving their care in a research environment. They will also be asked to consent to having the intraoperative image acquired and used to generate a navigation view in the GTx-OR. Instead of resecting the chest wall lesion according to the preoperative images alone with intraoperative findings as per standard-care procedures, the navigation view will be used as an additional reference for surgeons during the operation.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent
2. Scheduled to undergo surgical resection of a chest wall lesion
3. At least 18 years of age
4. Must sign and be given a copy of the written informed consent form

Exclusion Criteria:

1. Unresectable lesions or unstable patient condition, for which surgery is not recommended
2. Participants with metallic implantation, such as ribs fixations, a pacemaker, or pedicle screws, which may affect the accuracy of CBCT
3. Excluded at the discretion of the clinical investigator/surgeon, if they are enrolled in other studies that will result in combined radiation exposure exceeding standard of care
4. Pregnant, lactating, or planning to become pregnant during the period of the evaluation