cyrilzakka/clinical-trials huggingface dataset:
Temporomandibular Dysfunction and Cervical Posture

The aim of this research was to determine the existence of a correlation between the degree of temporomandibular dysfunction and cervical posture in different occlusal classes in adolescents. A cross-section, observational study was carried out, in which 296 adolescents took part. For the evaluation, the patients were divided into groups according to the presence and severity of the temporomandibular dysfunction, using a questionnaire and occlusal Angle classification. The posture analysis was carried out using photogrammetry and the software Alcimage® to measure the predefined angle based on the protuberances of the Spinous Process of the 7th Cervical Vertebra (C7), Manubrium of the sternum and Mentum Vertex.

The evaluation of signs and symptoms of TMD was obtained from a Questionnaire (15) which includes information regarding difficulties opening the mouth and movement of the mandible, pains in the head, nape of the neck, neck or joint regions, noise in the temporomandibular joints, and the habit of clenching or grinding the teeth. The questionnaire is comprised of 10 questions with possible answers of yes (10 points), sometimes (5 points) and no (0 points). For each question, only one answer can be checked. The total score is used to classify the severity of the TMD as severe (70 to 100 points), moderate (45 to 65), mild (20 to 40) and no dysfunction (0 to 15).

The clinical (visual) assessment of head posture was conducted using a postural grid. Each subject was asked to remain in his or her normal posture, in a standing position. The self balance position was used to standardize the posture of each subject, asking them to look straight ahead, parallel to the floor, keeping the gaze horizontal

Eligibility Criteria:
Inclusion Criteria:

* adolescents, aged between 10 and 20 years. As criteria for inclusion, age group and the presence of first permanent molar

Exclusion Criteria:

* Individuals undergoing orthodontic treatment, those with absent first molars and cases where it was impossible to clinically evaluate the occlusion were excluded.
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders

The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).


Eligibility Criteria:
Inclusion Criteria:

1. Participants with Progressive forms of Multiple Sclerosis including Primary Progressive and Secondary Progressive MS.
2. Participants must have discontinued disease modifying therapy (DMT) prior to signing the ICF and meet the following washout criteria prior to receiving lymphodepletion.

Exclusion Criteria:

1. History of malignancy that has not been in remission for at least 2 years.
2. Viral Screening

   1. Evidence of chronic active or history of hepatitis B virus (HBV).
   2. Seropositive for human immunodeficiency virus (HIV) antibody.
3. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
4. Prior treatment with adoptive T-cell therapy or any gene therapy product directed at any target (e.g. CAR T-cell therapy).

Note: Please note, other protocol specified Inclusion/Exclusion criteria may apply.
Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis

The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR).

Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.

Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups.

All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis \> 70 % and/or Fractional Flow Reserve \< 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), DEB or additional stent implantation.
* Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention.

Exclusion Criteria:

* Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
* Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).
Compare the Efficacy of Mepilex and Keramatrix in Second Degree Burn Wounds

The purpose of this study is to determine the extent to which Keramatrix dressing promotes the healing of second-degree burn wounds in pediatric patients.

Efficacy in promoting wound healing will be determined through comparison to Mepilex, an established burn wound dressing.

Eligibility Criteria:
Inclusion Criteria:

patient age 0-18 years old Flame or scald burn 10-30% total body surface area burned Partial-thickness second-degree burns Admission within 72 hours of burn injury Clean non-infected wound as diagnosed by the attending physician

Exclusion Criteria:

* Patient older than 18
* Causes other than flame or scald injuries (ie.chemical or frostbite)
* Wounds noted to be contaminated or infected
* Patients who have received previous treatment efforts (topical dressings or previous wound debridement)
* Pregnancy lactation
* Co-morbidity which may compromise healing: known history of AIDS, ARC, HIV, cancer, autoimmune diseases,cirrhosis, tuberculosis, chronic glucocorticoid therapy, diabetes mellitus, renal insufficiency, hepatic disease, congestive heart failure prior to burn injury, associated severe head injury requiring specific treatment
* known allergy to sheep's wool
Life Kinetic Training Enhances Physical and Cognitive Skills in Young Fencers

The purpose of this study was to examine whether Life Kinetic (LK) exercises could improve balance, agility, jumping performance, proprioception, and cognitive functions in recreationally active preadolescents participating in fencing. It specifically aimed to answer if LK training would lead to significant enhancements in these physical and cognitive attributes compared to a control group.

This study evaluated the effects of Life Kinetic (LK) training on balance, agility, jumping performance, proprioception, and cognitive functions in preadolescent recreational fencers. A total of 22 participants, aged 11.6 ± 1.2 years, were randomly assigned to either the experimental group, which performed LK exercises twice weekly for eight weeks, or the control group, which continued their regular fencing activities. The LK exercises combined physical and cognitive tasks to stimulate neuroplasticity and improve overall athletic and mental performance. Key metrics included agility, vertical jump, star balance, Stroop test, and proprioception assessments.

Eligibility Criteria:
Inclusion Criteria:

* Preadolescents aged between 10 and 12 years. Recreationally active in fencing and registered with the same athletic club. Healthy participants with no chronic illnesses, musculoskeletal injuries, or physical limitations in the last six months.

No use of medication within six months prior to the study. Written informed consent provided by the participants and their parents or guardians.

Exclusion Criteria:

* History of chronic illnesses or conditions that could interfere with physical activity (e.g., asthma, cardiovascular issues).

Any injury or physical limitation in the last six months that could impact performance.

Use of medication that could affect physical or cognitive performance within six months before the study.

Participants outside the specified age range (10-12 years). Lack of parental or participant consent.
Radiography Protocol in the Acute Phase After Proximal Femur Internal Fixation- Self Assessment and Recommendations

There is no standardized protocol regarding the post-operative radiographic follow up of patients that sustain pertrochanteric hip fractures and are treated with closed reduction and internal fixation. The policy in the investigator's institution as in other hospitals is to conduct a radiogram of the operated hip during the first days following operation after the patient bore weight on the fixated femur. The investigator's goal is to asses the added value of this policy and to offer recommendations regarding this specific followup component.

There is no consensus regarding the proper radiographic protocol following closed reduction and internal fixation of pertrochanteric femoral fractures. Despite its' questionable necessity and significant economic burden, many medical centers practice a policy of imaging internally fixated proximal femurs after the patients bore weight on them. The investigator's goal is to assess the added value of the postoperative imaging study described.

Materials and methods: We will conduct a prospective study. All patients who will be treated with closed reduction and internal fixation of AO31A fractures will be enrolled. Two sets of imaging studies will be assessed- the intra-operative AP and axial fluoroscopy studies and the radiograms that are taken following bearing weight on the operated hip. Three decision steps will take place regarding weight bearing limitations and a necessity for re-operation- (1) Immediately after the operation; (2) A day after the operation; (3) Following weight bearing according to a new radiogram. Objective measurements will be taken for each hip on both imaging modalities- neck-shaft angle, neck length and tip-apex distance.

Eligibility Criteria:
Inclusion Criteria:

* Pertrochanteric femur fracture, classified as AO-31-A
* Go through a closed reduction and internal fixation operation at the investigator's institution

Exclusion Criteria:

* patients that due to clinical findings or other necessities go through specific followup radiography imaging protocols
* Fluoroscopy imaging studies were not saved
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female participants 5 to \< 18 years of age at the time of randomization.
* Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:

  * Arthritis and psoriasis, OR
  * Arthritis with at least 2 of the following:
  * Dactylitis
  * Nail pitting or onycholysis
  * Psoriasis in a first-degree relative
* Active disease: at least 3 active joints (including distal interphalangeal joints).
* Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate \[MTX\] or biologic agents).

Exclusion Criteria:

* Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:

  * Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
  * Ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
  * History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
  * Presence of systemic juvenile idiopathic arthritis (JIA).
* Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
* Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Women

A study to explore whether different temperatures of warm water footbaths have different effects on the cardiovascular system, the autonomic nervous system and the general well-being of healthy women.

This is a blinded, four-arm randomized controlled trial with crossover design to explore the effects of warm water footbaths with different water temperatures on cardiovascular stress, reaction of the autonomic nervous system and a feeling of comfort and warmth in healthy female volunteers. Cardiovascular and ANS measurements are performed continuously throughout the interventions and the participants rate their feelings of warmth, general well-being and the footbath-related comfort with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 18 and 55 years

Exclusion Criteria:

* Male sex
* Chronic skin lesions at the lower legs or feet
* Varicose veins grade 3 and grade 4 (Marshall stage classification), chronic venous insufficiency
* Cardiac arrhythmia
* Cardiac pacemaker
* Asthma bronchiale
* Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
* Pregnancy
* Insufficient knowledge of the German language
Massive Iron Deposit Assessment

Iron overload is a severe complication of multiple blood transfusions. As the body has no physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to quantify excessive iron accumulation and to monitor response to iron chelation therapy. Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and R2\*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current R2\* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC \~ 15-25 mg Fe/g) and always for massive iron overloads (HIC \> 25 mg Fe/g) because R2\* is so high that the MR signal decays before it can be measured accurately.

Overall accrual: 200 patients

Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of people with large amounts of iron and compare the results with the same patient's liver bx. Estimated patient accrual is 150. It is estimated that 41 of these patients will have clinical indication for liver biopsy.

The MIDAS study is a prospective and non-therapeutic study that will test a new MRI technique for the assessment of iron overload in the liver: the newly developed ultra short echo time (UTE), R2\*-UTE. The R2\*-UTE technique, developed by St. Jude investigators from the Department of Radiological Sciences, will be first tested in healthy volunteers for feasibility and implementation of the technique. The technique will then be tested in research participants, who will have both the R2\*-GRE and the R2\*-UTE techniques performed, in addition to a liver biopsy for liver iron quantitation if clinically indicated. Quantitation of liver tissue iron will be done at Mayo Clinic Laboratory in Rochester, Minnesota.

Primary Objective:

* To test the association of hepatic iron content (HIC) measured with the newly developed 1.5T R2\*-UTE technique and HIC quantified by liver biopsy in subjects with iron overload.

Secondary Objectives:

* To explore the relationship between 1.5T R2\*-UTE and 1.5T R2\*-GRE measurements in subjects with iron overload.
* To explore the relationship between 1.5T R2\*-UTE measurements with iron studies (serum iron and transferrin saturation) in subjects with iron.

Eligibility Criteria:
Inclusion Criteria

* History of 12 or more lifetime erythrocyte transfusions, AND
* Need for liver iron content assessment (by MRI or liver biopsy)

Exclusion Criteria

* Presence of certain MR-unsafe foreign material in the body, or other conditions that make the research participant ineligible for an MRI scan per St. Jude policies.
* Any condition or chronic illness that in the opinion of the PIs makes participation on study ill-advised.
Efficacy of Aurosling in Frontalis Sling Suspension Surgery

To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis

Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery

Eligibility Criteria:
Inclusion Criteria:

* Congenital Ptosis
* Severe Ptosis (MRD\<0)
* Poor levator function (\<4mm by Berke's method)
* Myogenic Ptosis (Myasthenia gravis)
* Chronic progressive external ophthalmoplegia
* Neurogenic Ptosis (Third cranial palsy)
* Blepharospasm
* Ptosis caused by trauma

Exclusion Criteria:

* Acquired Ptosis
* Horners syndrome
* Blepharochalasis/Dermatochalasis
* Mechanical Ptosis
* Mild or Moderate Ptosis (MRD 1\>1)
* Good or fair levator function (\>4 mm by Berke's method)
* Previous Ptosis surgery
* Ptosis associated syndromes/Other anomalies including
* Marcus Gunn jaw winking syndrome
* Blepharophimosis syndrome
* Dry eye syndromes
* Corneal anesthesia
* Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia
* Nystagmus where adequate measurements could not be done
* Uncorrected vertical squint of any sort
A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.


Eligibility Criteria:
Inclusion Criteria.

* Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
* Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
* Prior treatment with at least 2 chemotherapy regimens:

  * At least 1 of these regimens must have been administered in the metastatic setting.
  * At least 1 of these regimens must have contained a taxane.
  * No more than 2 prior chemotherapy regimens in the metastatic setting.
* Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
* Have discontinued all previous therapies for cancer.
* Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

Exclusion Criteria:

* Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
* Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
* Have had major surgery within 14 days of the initial dose of study drug.
* Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
EUS-guided Ethanol Ablation of an Insulinoma

The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.

The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.

Eligibility Criteria:
Inclusion Criteria:

1. Adults: at least 18 years.
2. Patients with insulinomas which are evaluated by histopathology .
3. patients who have signed a written consent form.

Exclusion Criteria:

1. Patients whose condition is not suitable for the endoscopic procedure.
2. Patients who have blood coagulation dysfunction.
3. Patients who have mental disorders.
4. Patients who have mild or severe cardiorespiratory insufficiency.
5. Patients who have hypertension and could not be controlled to safe level.
6. Pregnant and lactating women.
7. Patients whose conditions are not suitable for the present study.
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.

This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age.
* Have a documented history of Dry Eye prior to Visit 1.
* Willing and able to follow protocol procedures and instructions.

Exclusion criteria:

* Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
* Recent or current evidence of infection or inflammation in either eye.
* Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
* Have used any investigational drug or device within 30 days prior to Visit 1.
* Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
* Have worn contact lenses 24 hours prior to Visit 1.
* Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.
* Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.