cyrilzakka/clinical-trials huggingface dataset:
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation

The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.

We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
* ASA 1 \& 2

Exclusion Criteria:

* Known allergy or hypersensitivity reaction to dexmedetomidine
* Organ dysfunction (renal/hepatic failure or leukemia)
* Cardiac disease (congenital or acquired)
* Airway or thoracic malformation
* Cerebral palsy
* Hypotonia
* Need for premedication
* Current/recent upper respiratory infection (within four weeks prior to the surgery)
* Asthma
* Allergy or intolerance to clonidine
* Non-English speaking parents/patients.
A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects with Chronic HCV

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
* Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
* Females must have a negative pregnancy test at Screening and at Day 1 prior to dosing
* Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
* Documented medical history compatible with chronic HCV
* Liver disease staging assessment as follows:

  * Absence of cirrhosis (F0 to F3)
  * Compensated cirrhosis (F4)

Exclusion Criteria:

* Female subject is pregnant or breastfeeding
* Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen \[HBsAg\]) and/or human immunodeficiency virus (HIV)
* Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
* Prior exposure to any HCV DAA
* Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
* Subject with known allergy to the study medications or any of their components
* History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
* Cirrhotic and has a Child-Pugh score \>6, corresponding to a Child-Pugh Class B or C
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
* Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting

The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration \[AMD\]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).


Eligibility Criteria:
Key Inclusion Criteria for Patients with nAMD:

1. Any patient aged at least 50 years at the time of enrollment
2. Diagnosis of nAMD (per physician)
3. Previously treated patient cohort, patients that had treatment with any ocular intervention for nAMD in the study eye at any time before starting aflibercept 8 mg, as defined in the protocol
4. For treatment-naïve patient cohort, patients never receiving previous treatment in the study eye for nAMD, as defined in the protocol
5. Initiating treatment with aflibercept 8 mg for nAMD

Key Inclusion Criteria for Patients with DME:

1. Any patient aged at least 18 years at the time of enrollment
2. Macular edema associated with DME (per physician)
3. Diagnosis of diabetes mellitus type 1 or type 2
4. For previously treated patient cohort, treatment with another intravitreal (IVT) anti-VEGF agent(s) or IVT steroids, or surgery/laser for DME in the study eye at any time before starting aflibercept 8 mg, as described in the protocol
5. For treatment-naïve patient cohort, patients never previously treated with IVT agents or surgery/laser in the study eye for DME
6. Initiating treatment with aflibercept 8 mg for DME

Key Exclusion Criteria for Patients with nAMD

1. Macular edema/hemorrhage/choroidal neovascularization due to any other cause besides nAMD
2. Any systemic or ocular condition that would prevent any improvement of VA in the study eye (eg, permanent visual impairment or blindness from any cause)
3. Any patients that have been treated with photodynamic therapy
4. Treatment with aflibercept 8 mg prior to baseline

Key Exclusion Criteria for Patients with DME:

1. Macular edema due to any other cause besides DME
2. Any systemic or ocular condition that would prevent any improvement of visual acuity in the study eye (eg, permanent visual impairment or blindness from any cause)
3. Treatment with aflibercept 8 mg prior to baseline

NOTE: Other Protocol-Defined Inclusion / Exclusion Criteria Apply
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma

To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
* At the expanded cohort, part 2 of the study, subjects must have one of the following:
* Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
* Diffuse large B-cell lymphoma
* Age 18 years or older

Exclusion Criteria:

* Candidate for potentially curative therapies in the opinion of the investigator
* Chronic lymphocytic leukemia
* Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy

This observational study will evaluate the efficacy, safety and patient reported quality of life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally, information on selection criteria of breast cancer patients treated first-line with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data will be collected from eligible patients for up to 20 months of treatment and 24 months of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Female adult patients, \>/= 18 years of age
* HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) relapsing after completed adjuvant Herceptin therapy
* Indication for first-line treatment with Perjeta in combination with Herceptin and chemotherapy according to the Summary of Product Characteristics
* Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a potentially curable setting); additional upfront neoadjuvant Herceptin therapy is allowed
* No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally recurrent, inoperable) HER2-positive breast cancer

Exclusion Criteria:

* Pregnant or breastfeeding women
* Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the Summary of Product Characteristics
* No Herceptin treatment for early breast cancer in the adjuvant setting
Postoperative Pain Assessment After Using Different Kinematics

The aim of this study is to evaluate postoperative pain after endodontic instrumentation using rotation, reciprocation and adaptive motion.

Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS) questionnaires were handed out to the patients and they were asked to assign a number correlating to their post-treatment pain, with 0 representing no pain and 10 representing the most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h following endodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Medically free patients with good health.
2. Patient's age between 18_50
3. Mandibular first molars teeth diagnosed clinically and radiographically as acute irreversible pulpitis with no evidence of apical pathosis
4. Positive patient's acceptance for participation in the study

Exclusion Criteria:

* Root resorption
* Non restorable teeth.
* Pregnancy.
* Systematic disease as hypertension ,diabetes .
* Psychologically disturbance.
* Need for prophylactic antibiotics
A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease

Graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (ATD), radioiodine (RAI) and surgery. For ATD, it has been the first-line treatment over decades. Despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with RAI or thyroidectomy. However, RAI is not preferable in patients with Graves' ophthalmopathy as it could further worsen eye symptoms. RAI may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. As for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. Due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. With the evolution of thermal ablative strategies, high-intensity focused ultrasound (HIFU) and radiofrequency ablation (RFA) have been reported as feasible treatment options for relapsed Graves' disease. There has also been increasing reports in the use of microwave ablation (MWA) in the treatment of benign thyroid nodules. MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (USG) guidance. The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. As compared to RFA, MWA is not affected by heat sink effect and may require a shorter treatment time. Similar to other thermal ablative approaches, MWA has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.


Eligibility Criteria:
Inclusion Criteria:

* (a) age older than 18 years,
* (b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more
* (c) absence of vocal cord immobility

Exclusion Criteria:

* (a) patients who prefer or are indicated for surgery,
* (b) presence of head and/or neck disease preventing hyperextension of the neck,
* (c) history of thyroid cancer or other malignant tumours in the neck region,
* (d) history of neck irradiation,
* (e) severe Graves' ophthalmopathy,
* (f) large compressive goitre,
* (g) pregnancy or lactation, and
* (h) any contraindication to intravenous sedation.
Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients.

Anemia in patients on hemodialysis (HD ) is common and although usually responds well to treatment with Erythropoiesis Stimulating Agents (ESAs ) , this dosage , based on different clinical protocols , often ignores the high variability inter- and intra -individual in patient response . The result leads to swings in the objective by different dosage range that is associated with multiple risks and side effects. There are artificial intelligence-based optimization methods that predict treatment with ESAs in maintaining patient hemoglobin target range . So far the model has been validated for the long half-life of EPO ( darbepoetin ) with promising results.

HYPOTHESIS: Maintaining patients in Hb levels ESAs range using short half-life , avoid the one hand , the need for transfusions and, secondly , the levels exceeding the upper range ( overshooting ), preventing the onset of a increased cardiovascular risk events.

RELEVANCE:The results allow us to validate the model with short half-life ESAs optimizing the management of anemia and improving comorbidity associated with overdosage.

SUMMARY:

Prospective observational study of paired data. Data obtained from the data base Euclid . Data will be collected by clinical teams according to standard clinical practice. Informed at the time of admission to the clinic consent will be obtained . All patient data including to november 15th 2014 and who have completed the study period to 30 april 2015. The results will be compared with those prior to the patient's inclusion in the study were processed.

To detect a difference of 10% in the percentage of patients in the hemoglobin target range after intervention (from 70% to 80%) we will need a minimum sample size of 268 patients assuming an alpha error of 0.05, a beta error of 0.2 and a correlation between both observations of 0.1.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 Years
* \> 3 Months on HD / OLHDF
* Treated with ESAs( epoBeta ) from\> 3 Months

Exclusion Criteria:

* Chronic inflammatory diseases
* Liver Cirrhosis
* Active Neoplasms
* Immunosuppression or other antiinflammatory medication
* Patients who do not require treatment with ESAs
Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease

* To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients
* To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment
* To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)

Study Design:

Eligibility Criteria:
Inclusion criteria:

1. Idiopathic Parkinsons disease with or without fluctuations
2. Indication for treatment with Sifrol®
3. Male or female patients of age
4. Presence of at least mild depressive symptoms (as judged by the treating physician)
5. Ability to reliably complete a self-rating scale (HADS)

Exclusion criteria:

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Sifrol®.
Clinical Predictors of Short Term Outcomes of Ablation of Idiopathic Monomorphic PVCs

Clinical predictors of successful Pvcs ablation

Clinical predictors of short term outcomes of ablation of idiopathic monomorphic pre mature ventricular contractions

Eligibility Criteria:
Inclusion Criteria:

* patients with idiopathic monomorphic PVCs

Exclusion Criteria:

* patients with heart failure
Effects of Herbst Appliance Therapy to Improve Airway Dimension

Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. Since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used to treat SDB children. Previously no study compared the effects of Herbst appliance therapy with removable functional appliance on airway dimension, so it still remains unclear which kinds of functional appliance is more suitable for improving airway dimension. This study will assess the effect of Herbst appliance on airway dimension and compare the effects with those of twin block appliance (a popular 24 hours used removable functional appliance, and also commonly used to treat adult sleep apnea).

Sleep disordered breathing (SDB) is an important paediatric problem. It is estimated that 3.2% to 12.1% of children have habitual snoring and 0.7% to 10.3% have obstructive sleep apnea syndrome (OSAS). Children OSAS is associated with a series of daytime and nighttime signs and symptoms. Nighttime symptoms include heavy snoring, restless sleep, heavy seating and enuresis, etc. Daytime symptoms include excessive daytime sleepiness and abnormal behavior such as aggressiveness and hyperactivity, etc. Untreated OSAS was reported to result in serious morbidity, such as failure to thrive, poor learning, attention deficit and hyperactivity disorder, etc.

There is an increasing concern related to sleep disordered breathing(SDB) of children by orthodontists. Since not only the tonsilar and adenoid hypertrophy is the main cause of paediatric OSA, but also craniofacial anomalies such as retrognathic mandible, narrow maxillary palatal arch and increased lower facial height can also contribute to it, orthopedic treatment such as rapid maxillary expansion (RME) and mandibular advancement device (MAD) may potentially permanently cure the children OSA. RME which is used to widen maxilla, thus increasing the nasal cavity and improving the nasal flow, has been thoroughly researched. However, only a few previous studies focused on the treatment effect of MAD for treating OSA children. These studies showed sorts of MAD such as jaw-positioning appliance, mono-block, and Herbst appliance were effective to OSA children, but it remains unclear how to choose a functional appliance, and if there is any treatment difference between removable functional appliance and fixed functional appliance for improving airway dimension.

Eligibility Criteria:
Inclusion Criteria:

1. Class II malocclusion

Exclusion Criteria:

1. Cleft lip and palate
2. Craniofacial syndrome
Determination of New Biomarkers of Septic Arthritis by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF)

Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic therapy).

This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new biomarkers of a septic origin.

Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of admission.


Eligibility Criteria:
Inclusion Criteria:

* acute arthritis (onset not more than 7 days ago)
* joint fluid leukocyte count : more than 2000/mm3, more than 50% polymorphonuclear

Exclusion Criteria:

* none (apart from unability to accept inclusion)
Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement

The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:

Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?

Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.


Eligibility Criteria:
Inclusion Criteria:

* Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
* Distal Third (\<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
* Insolated Radial Shaft Fracture (diaphyseal)
* Radial and Ulna Shaft Fracture (diaphyseal)

Exclusion Criteria:

* Initial presentation \>7 days from the time of injury
* Pathologic fracture
* Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
* Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
* If operative treatment is required at initial presentation