cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.

The totally implanted Carina System is an active middle ear implant where all components are implanted under the skin. Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. Software is now available to enable non-intrusive microphone measurements in existing patients with the Carina device, through a wireless link to the implant. Detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes.

Subjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. No data monitoring committee will be used for this clinical investigation.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older at the time of enrolment in the study
* Current recipient of a Cochlear Carina System.

Exclusion Criteria:

- Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)

This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.


Eligibility Criteria:
Inclusion Criteria:

* Anti-tumor necrosis factor (anti-TNF) naive participants with a diagnosis of moderate-to-severe ulcerative colitis.
* Mayo clinic score \>= 6, including endoscopic subscore \>=2;
* Previous conventional therapy for a period of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to, or has contraindications to these treatments;
* Anti-TNF experienced participants with an established diagnosis of moderate-to-severe ulcerative colitis, either not responding or partially responding to treatment with Remicade (infliximab). The participant must also meet the following criteria prior to initiating first-line anti-TNF treatment: Mayo score ≥ 6, including an endoscopic subscore ≥ 2; and previous conventional therapy of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to or have medical contraindications for such therapies (should be documented);
* Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving study drug and for 6 months after the stop of study drug

Exclusion Criteria:

* Has a history of prior self-injection for any reason;
* Has concomitant use of other biologic agents;
* Has active tuberculosis (TB) within 12 months prior to the first injection or has suspected latent TB as indicated by a positive tuberculin skin test.
* Has an active clinical non-tuberculous mycobacterial infection or opportunistic infection within 6 months prior to the first injection;
* Has had an active infection and/or serious infection within 6 months prior to the first study drug administration;
* Has had a live viral or bacterial vaccination within 3 months prior to the first study injection or Bacillus Calmette-Guerin vaccination within 12 months prior to the first study drug injection;
* Has evidence of heart failure of New York Heart Association class 3-4;
* Has a history of demyelinating disease such as multiple sclerosis or optic neuritis;
* Has a history of systemic lupus erythematosus;
* Has a history of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the prior 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence;
* Has had an active hepatitis B infection;
* Has an allergy or sensitivity to golimumab or its excipients;
* Is pregnant or breast feeding;
* Is sensitive to latex.
Axillary Phonophoresis Versus Post Isometric Facilitation in the Treatment of Shoulder Adhesive Capsulitis

the aim of this study is to compare the effect of Axillary Phonophoresis versus Post isometric facilitation in subjects with Adhesive capsulitis

Adhesive Capsulitis is a common cause of shoulder pain and disability and also a condition involving glen humeral pain and loss of motion. It is characterized by significant restriction of both active and passive motion that occurs in the absence of a known intrinsic shoulder disorder. The intervention strategies for AC include a trial of conservative therapy followed by more invasive procedures.it may be primary-onset is generally idiopathic or Secondary- results from known cause. Clinically, patients may present with pain and mild restriction of movement which can lead to a gross loss of function predisposing factor or surgical event . it is most frequent in women, diabetic population and patient older than 40 years .It is described as having 3 stages. Stage Ⅰ involves pain (freezing or painful stage) and lasts from 3 to 9 months and is characterized by an acute synovitis of the glen humeral joint. Stage Ⅱ (frozen or transitional stage) includes pain and restricted movement and lasts from 4 to 12 months. Stage Ⅲ (thawing stage) involves painless restriction and lasts from 12 to 42 months. Contributing factors include diabetes mellitus, stroke, thyroid disorder, dupuytren disease, complex regional pain syndrome and metabolic syndrome.

Axillary Phonophoresis and Post isometric facilitation play a major role in the treatment of adhesive capsulitis so this trial was conducted to determine which one has superiority. this trial has three groups. two experimental and one control group. pain ,function, pressure pain threshold will be measured.

Eligibility Criteria:
Inclusion Criteria:

* The patient age will range from 30to 40years old from both sexes (male and female).
* All recruited subjects in the 2nd stage of adhesive capsulitis (transitional stage).
* The patient will be diagnosed and referred by orthopedist as Adhesive capsulitis.
* The diagnosis will be confirmed by shoulder MRI.
* The diagnosis will be confirmed by shrug test.
* The patient will be referred by anterior shoulder pain or anterolateral shoulder pain.
* Inclusion requirement include two or more of the following pain complaints: Grooming ones hair, Scratching your back and getting dressed, Overhead activities or Difficulty in the action of throwing the ball and giving a high -five.
* All patients will sign the informed consent before joining the study.

Exclusion Criteria:

* Previous fracture with or without internal fixation in the shoulder joint
* Any previous surgery in the shoulder joint and patient with tendon calcification
* Local corticosteroid injection to the affected shoulder within the last three months or recent ones (Michener et al, 2004).
* Neuromuscular disease
* Rotator cuff tear
* History of metastatic cancer or diagnosis of cancer within 12 months
* Unstable angina
Dynamic F-DOPA PET for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis

Contrast-enhanced magnetic resonance imaging is the most widely used examination for detecting the presence of brain metastasis. Functional sequences such as perfusion weighted imaging makes it possible to differentiate tumor recurrence from cerebral radionecrosis. However, this imaging technique may exhibit limitations, especially for brain lesions consisting of a mixture of necrotic tissue and tumor progression or depending on the location of the lesion in the brain. The use of 18F-DOPA PET is another option available to oncologists. Many studies on gliomas showed the superiority of this imaging technique over contrast-enhanced MRI. However, this imaging solution has been very poorly studied for brain metastases. The new PET technology equiped with silicon detectors makes it possible to obtain greater sensitivities than those of previous generations. It also make possible to obtain images in very short acquisition times. After injection, the hardware allows to obtain the perfusion kinetics of the lesion thanks to a very short temporal sampling (i.e. three seconds).

The main objective of this pilot study is to evaluate the association between early activity measurements (\< 4 minutes post-injection) of 18F-FDOPA in PET and the differential diagnosis between radionecrosis and recurrence of cerebral metastases treated by radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for cerebral 18F-FDOPA PET examination prescribed as part of his usual medical care for brain metastasis
* Age ≥ 18 years old
* Affiliation to a social security program
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age under 18
* Person under guardianship or curators
* Pregnant woman
Development of PHY606 as Adjunct Therapy for Anemia Patients

Many reasons can cause anemia, decreased RBC production or increased destruction of circulation RBC. The investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia.

Many reasons can cause anemia, decreased RBC production or increased destruction of circulating RBC. The reasons of the former are lake of nutrients, bone marrow disorder, low level tropic hormone, inflammation associated with infectious, inflammatory, or malignant disorders and the latter are intravascular hemolysis or blood loss. Anemia is characterized by the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes), fatigue, lightheadedness, and weakness associated with low hemoglobin.

Iron deficiency anemia (IDA) is mainly resulted from inadequate iron uptake of food, malabsorption of iron and blood loss. Adult female are easy to have IDA compared to male because of menstruation, pregnancy, lactation and low caloric uptake leading to iron deficiency. In Taiwan, cancer-related and chronic kidney disease also lead to insufficient secretion of erythropoietin (EPO). The cost of long-term use EPO and its derivative drugs is high. Besides, drug resistance, risk of tumor growth and cardiovascular disease are all important issues. However, ferrotherapy will induce GI upset, muscle pain and skin hives. Also, iron supplementation can lead to an increase in infectious disease morbidity in areas where bacterial infections or where malaria are common.

Based on the concept of dietetic invigoration, the investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomics and metabolomics in the healthy people and the patients with anemia. In the meantime, the investigators will explore whether PHY606 activates the immune function, improves anemia and reduces the side effects induced by anemia treatment. Furthermore, the novel metabolites from Angelicae Sinensis Radix and Astragali Radix will be tested from clinic back to the bench including immunological potentiation and hematopoietic function. According to the TCM theory, the investigators integrate with modern medicine and molecular biotechnology to investigate anemia and hope to provide the evidence base for clinical application.

Eligibility Criteria:
Inclusion Criteria:

* female: Hb\<11 g/dL; male: Hb\<13.5 g/dL
* has no allergic reaction to TCM

Exclusion Criteria:

* below 20 years old
* ever drug abuse or still in drug abuse
* pregnant or in breast-feeding women
* with psychotic disorders
* cardiac arrhythmia with pacemaker
* dyscoagulation or thrombocytopenia (platelet\< 15000/uL) or liver dysfunction (\> 2 fold normal range)
* with severe disease (cardiac arrest, heart failure, COPD, GI bleeding, etc.)
* under another clinical trials
Pilot of IMPACT Intervention at the University of New Mexico

Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.

In Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT), the investigators will pilot the feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT recipients' varied stability immediately post-transplant, and the need to individually monitor their post-transplant immunosuppression regimen, a critical component of IMPACT will be an individually-tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability. IMPACT will combine a personalized assessment of the patient's food preferences and access to exercise resources within their environment (based on a standard list of factors developed by the nutrition and rehabilitation experts) along with clinical specifications from the transplant team. The study is innovative because it addresses previous limitations, while adapting the intervention to meet the needs of the culturally-diverse ESKD population. The final innovation of the IMPACT Pilot is the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments, ensure adherence to the intervention, collect all questionnaire data, and enhance participant retention.

Eligibility Criteria:
Inclusion Criteria:

1. Received kidney transplant at UNMH
2. Greater than 18 years of age
3. Mentally competent

Exclusion Criteria:

1. Children under the age of 18
2. Incarcerated patients
3. Pregnant women
4. Active systemic infection
5. Non-skin malignancy or melanoma in the past 2 years
6. Known cognitive impairment
Evaluation of a Breast Biblock Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.

Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.

Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).

Currently in the investigators hospital in every day's practice, an association of the serratus block and the PIF block is made, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for analgesia of the lateral part of the breast.

This technique was previously described. The authors evoked the possibility of the association of serratus and PIF blocks and described this technique with a patient, but to the investigators knowledge no evaluation of the efficacy of this procedure was made.

The objective of the study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.

This is a purely observational study that assesses a current practice in this type of surgery.

Eligibility Criteria:
Inclusion Criteria:

* total mastectomy surgery with a complete axillary lymph nodes removal

Exclusion Criteria:

* age under 18
* contraindication to the surgery
* refusal of the protocol by the patient
Monotherapy Study of MP-513 in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 6.5% - 10.0%
* Patients who were not administered diabetes therapeutic drugs within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with serious diabetic complications.
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children

To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics presented with signs of septic hip .

Septic arthritis is a severe life and function threatening condition with a 1-year mortality rate of up to 10% and residual functional impairments in 30% to 50% of cases . Pediatric Septic Hip Arthritis is an intra-articular infection in children that peaks in the first few years of life. The incidence of septic arthritis is low, with about 4-5 per 100000 child annually with about 50% of cases occur in children younger than 2 years of age with gender affection in male \> female (2:1 ratio). The hip joint involved in about 35% of all cases of septic arthritis. Imaging studies contribute crucially to the optimal management of septic arthritis, thereby diminishing the risk of permanent functional loss .At present; magnetic resonance imaging (MRI) is the most informative method. Thus, MRI assesses the severity of the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess, and/or bone edema. MRI had 75% specificity and nearly 100% sensitivity for diagnosing concomitant abscess formation, cellulitis, or myositis . Disadvantages of MRI are high cost and limited availability on an emergency basis in some settings , Ultrasonography of the bone and joints has been developing at a fast pace in recent years. Ultrasonography is currently used in the management of septic arthritis to confirm the presence of a joint effusion and to guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the joint deep (e.g., hip). Ultrasonography has high sensitivity and specificity for joint effusions .The difficulty of applying hip MRI in pediatric age group patients especially neonates make challenge in the proper management of acute septic hip arthritis .the study aim to apply a new protocol in diagnosis of septic hip in children by doing extended hip ultrasound included psoas and quadriceps muscles.

Eligibility Criteria:
Inclusion Criteria:

* Neonates, infants and children presented with suspected septic hip arthritis.

Exclusion Criteria:

* DDH
Acquisition of 3D Facial Geometry of Patients' Scheduled for Radiotherapy Treatment

This study investigates the feasibility of using 3D-Printing to manufacture masks used to immobilize patients undergoing radiotherapy treatment for tumors affecting the head and neck.

The current types of masks that are used in radiotherapy treatment sessions for those patients who have head-and-neck cancer are 'made to measure' and the methods currently employed to make them are invasive and in some cases patients' have found this to be particularly unpleasant. Their experience motivates research into less invasive and potentially more accurate techniques for their manufacture.

To effectively develop an automatic manufacturing pipeline, and to assess the accuracy of the approach we need access to CT data from a cohort of patients for which we also have an accurate (ground truth) 3D facial model. Such a model can be acquired in a few minutes using a hand-held laser scanner.

Eligibility Criteria:
Inclusion Criteria:

* Have a Head-and-neck cancer
* Receiving radiotherapy treatments (CT images)

Exclusion Criteria:

* Children (age less than 18)
Improvement in Urine Collection Methods in Children

The population of children presenting to the Emergency Department (ED) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. Part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones.

Urinary tract infections in children are a common cause of death due to acute and chronic complications alike. Our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.

The study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. The innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.

Eligibility Criteria:
Inclusion Criteria:

1. Children incapable of giving urine voluntarily in the Emergency Department
2. Children requiring an urine test
3. Children whose parents have agreed to take part in the research and have signed a consent form

Exclusion Criteria:

1. Children who have an immediate medical condition which requires catheterization
2. Parents who have declined taking part in the research
3. Children who give urine voluntarily
4. Children who do not need an urine test for their continued treatment