cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating The Safety Of Xyntha In Usual Care Settings

The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF.

The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Male patients 12 years of age and older.
* Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products.
* Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit.
* Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy.

Exclusion Criteria:

* Bleeding disorder other than hemophilia A.
* Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy.
* Immunomodulatory therapy during screening period.
* Known hypersensitivity to hamster protein.
Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy

The purpose of the study is to investigate the effect of four different follow-up strategies on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions. Furthermore the investigators aim to examine associations between preoperative thresholds for pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain after benign hysterectomy.

Contact sponsor if detailed information is requested.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 60 years of age.
* Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia).
* Women who understand and speak Swedish fluently.
* Women who gives signed informed consent to participate in the study.
* Women who have access to a telephone and/or internet.

Exclusion Criteria:

* Women where the hysterectomy is carried out in association with surgery for genital prolapse
* Women with genital malignancies (does not include cervical dysplasia).
* Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant.
* Women with previous bilateral salpingooophorectomy.
* Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual.
* Women who are mentally disabled to a degree so she cannot complete the forms in the study or understand the tenor of the participation or it is considered doubtful from an ethical point of view to participate.
* Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable.
* Women with current drug or alcohol abuse.
Genomic Changes in Childhood Acute Lymphoblastic Leukemia

To study the genomics with cell cycle and lymphocyte differentiation in disease, remission and relapse of childhood acute lymphoblastic leukemia. Then correlate these data with age, white cell count, cytogenetic changes, response to the chemotherapy and prognosis.

In order to know the genomic evolution of childhood acute lymphoblastic leukemia, we will collect bone marrow (10c.c.) at diagnosis, remission and relapse. We will do the following genes in addition to gene-chip including IKZF1,ETV6, EBF1, NR3C1, RAG1/G2, TCF3, BTLA, PAX5,LEF1, ERG and VPREB1.We will study the gene dosages and degree of methylation. The estimated patients numbers will be 300-400. Then we will correlate these data with patients'age, white blood cell count at diagnosis, cytogenetic abnormalities, response to the chemotherapy and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed as acute lymphoblastic leukemia
2. age less than or equal to 18 years old
3. signed informed consent

Exclusion Criteria:

1. who is not acute lymphoblastic leukemia
2. who did not sign informed consent
Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.

In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype in the circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this study we will determine the change in ratio of M2 (type II, alternatively activated) versus M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1), which is critical for the activation of M1 myeloid cells. We will assess correlates with changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya on myeloid lineage cells.


Eligibility Criteria:
Inclusion Criteria:

* Patients must qualify to receive treatment with Gilenya, according to the University of Southern California, Department of Neurology, MS Group, Gilenya Prescribing Process.
* Clinically definite Multiple Sclerosis defined by the revised McDonald criteria (Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
* Ability to understand and sign this study-specific institutional review board-approved informed consent form.
* Willing to donate \~50mls of blood for immunological testing on up to five occasions.

Exclusion Criteria:

* Patient does not qualify to receive treatment with Gilenya, according to the USC, Department of Neurology, MS Group, Gilenya Prescribing Process.
* Inability to understand nature of the study.
* Treatment with any of the following within 30 days of commencing treatment with Gilenya: Avonex, Betaseron, Rebif, Copaxone, Natalizumab, Rituximab, Mitoxantrone, Cyclophosphamide, Cyclosporine, Azathioprine, Methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids

The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.

Hearing aids constantly undergo incremental improvements from already marketed devices. The new devices are expected to perform as well or better than the previous ITE devices.

The aim of the testing is to grant quality control prior to product launch according to Bernafon development requirements.

The current study will evaluate a new ITE hearing aid hardware. The firmware driving the hearing aid has already been sold on the market using the BTE hardware for almost one year and will now be launched using the ITE custom hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the two hardware styles regarding the benefit received from different microphone locations.

As human subjects are involved the validation falls under the definition of a clinical investigation. The validation will address the performance of the new chip using the ITE hardware, and ensure that there is no reduction in speech understanding between using the BTE and ITE hardware styles. Evaluating the overall performance of the Mermaid 9 ITE devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. All features available in Mermaid 9 have been validated and are currently used on the market in Mermaid 9 BTE devices.

Eligibility Criteria:
Inclusion Criteria:

* All classifications of hearing loss (sensorineural, conductive, mixed)
* If the hearing loss is conductive or mixed it must be approved for amplification by a physician
* All shapes of hearing loss (flat, sloping, reverse slope, notch)
* Severity ranging from mild to severe
* German speaking
* Current hearing aid users
* Both genders
* Ages 18 and older
* Ability and willingness to sign the consent form

Exclusion Criteria:

* Contraindications for amplification
* Active ear disease
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
* A reduced mobility making them unable to attend weekly study appointments
* Uncooperative so that it is not possible to record a valid pure tone audiogram
* A strongly reduced dexterity
* Central hearing disorders
* Bernafon employees
* Family members of Bernafon employees
Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars

The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown.

the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient within the age group of 3-8 years old.
* Healthy children free of any systemic disease.
* Pulpotomized or pulpectomized (endodontically treated) lower second primary molars.
* Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.

Exclusion Criteria:

* • Patient younger than 3 years old or older than 8 years old.

  * non-Healthy children or have any systemic disease.
  * primary molars with no pulpal treatment
  * Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.
Virtual Reality-Based Relaxation Program on Pain Intensity, Anxiety Level in Patients to be Applied With Endoscopy

This study was conducted to evaluate the effect of relaxation exercise with VR (Virtual Reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy.

Beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the Cardboard Super Flex Binoculars Glasses.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Ability to communicate adequately
* Absence of psychiatric problems
* Volunteering to participate in the research

Exclusion Criteria:

Those who have communication problems

* Those with psychiatric problems
* Being unconscious
Analgesic Efficacy of Duloxetine in Patients Undergoing Lumbar Discectomy

Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine for patients undergoing lumbar discectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar discectomy

Exclusion Criteria:

* Patients on regular opioid therapy
* Uncontrolled hypertensive patients
* Patients with ischemic heart disease
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart

This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition, daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid deposition in the brain. Participants will be randomly assigned to receive insulin aspart or placebo during a 12-week treatment period.

A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.

This trial will consist of a randomized double-blind, placebo-controlled parallel group trial in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day for 12 weeks. All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug. All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration. Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period. Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's cerebral spinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment
* Ability to communicate in English

Exclusion Criteria:

* Preexisting diabetes
* Clinically significant elevations in liver function test
* Clinically significant elevations in lipid profile
* Prior lumbar lumbar surgeries or other medical conditions that render lumbar punctures unsafe
* Hemoglobin \<8 g/dl
* Significant neurologic disease that might affect cognition, other than Alzheimer's disease, including stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury (within the last year) with loss of consciousness \>30 minutes or with permanent neurologic sequelae
* Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
* Current use of antipsychotic, anticonvulsant, anxiolytic, anticoagulant or sedative medications
* Current or previous use of glucose-lowering agents or insulin;
* Chronic use (≥ 3 times per week) of nasal sprays of any type for any indication
* Premenopausal status (defined as having had a period within the last year).
TDCs to Treat Drug-resistant Epilepsy

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. It encompass a wide spectrum of conditions, intensities and seizure types; therefor, several drugs have proven to treat different types of seizures. However, around 22.5 % of patients are unable to attain control regardless of the drug used or even a combination of several of them. TDCs offers a non-invasive approach with a focal effect for those patients. The focus of this study is to define the role for tDCS in the treatment of drug-resistant epilepsy on children.

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. There are between 16 and 51 new cases per 100 000 people every year. A community-based study conducted in France concluded that up to 22.5 % of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial disfunction and a reduced quality of life. The International League against Epilepsy defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients are the drive to develop different approaches in order to offer alternatives for control. In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarisation shifts, an enhanced probability of high-frequent and hypersyncronous activity of small neuronal networks and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal conections. Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repidetly, it generates long-lasting cortical excitability alterations and thus, has the potential to treat epilepsy targeting to the specific brain region where the cortical excitability is alterated. The aim of this study is to define the role for tDCS on the treatment of drug resistant epilepsy on children.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 montths
* Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
* At least 2-3 seizure per month documented with EEG, not only clinically.
* In good health except epilepsy.
* Patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

* Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
* Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
* sleep-related breathing disorders
Middle Ear Pressure Disregulation After Tympanostomy Tube Insertion

This study will determine if the investigators can use certain tests (eustachian tube function tests and gas exchange tests) to predict whether or not a child who had tubes surgically placed in their eardrum because of middle-ear disease will redevelop the disease again after the tubes quit working.

This study will enroll children 3-6 years of age with tympanostomy tubes inserted for otitis media with effusion (OME)and measure middle ear gas demand, middle ear volume and eustachian tube function longitudinally between the time of tube insertion and extrusion/nonfunctioning. The data will be used to test the hypotheses that: gas transfer across the middle ear mucosa decreases in phase with resolution of middle ear inflammation and effusion; gas transfer across the middle ear mucosa is increased by an episode of otorrhea; eustachian tube function is unaffected by tympanostomy tube insertion, and measurement of eustachian tube function and trans-middle ear mucosa gas transfer predicts disease recurrence and presentation after tube extrusion/nonfunctioning. The results of these studies will be used to support or refute tested components of existing models of middle ear pressure-regulation and to develop test protocols for risk assignments with respect to disease recurrence in individual ears after tympanostomy tube extrusion/nonfunctioning.

Eligibility Criteria:
Inclusion Criteria:

* 3-6 years old
* History of chronic otitis media with effusion(OME)
* Scheduled or within 6 weeks of tube insertion
* OME at entry or surgery
* Generally good health

Exclusion Criteria:

* Cleft palate or other syndromes predisposing to OM
* History of recurrent acute otitis media only
* History of complications of OM or its treatment
* Unable to cooperate for testing
Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy

Nasogastric decompression is standard practice after esophageal resection in most centers because it is expected to reduce the incidence of esophagogastric anastomotic leakage by preventing overdistension of the gastric conduit. Most esophageal surgeons have been reluctant to move away from this tradition because of the considerable morbidity of anastomotic leaks after esophagectomy. However, a contrarian view is that the use of prolonged NGD may increase the incidence of postoperative pulmonary complications by promoting aspiration. Considering the numerous complications caused by using the tube and the uncertainty about its usefulness and the scarcity of studies conducted on the subject, particularly in patients with esophageal cancer, the necessity of using the tube in these types of cases is investigated in the present study.

Methods In this clinical trial, patients with esophageal cancer were randomized into groups with NG tube and without NG tube after surgery. Sequence generation was performed using a computer-generated sequence of random numbers with permuted blocks. Standard postoperative management protocols were followed in both groups to avoid potential bias, which including preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery was performed by laparotomy, gastric tube reconstruction was performed using linear staplers, and the conduit was brought up to the neck through the posterior mediastinal route. A cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All patients were mobilized early, began early enteral feeding through jejunostomy tubes. Randomization was performed during the surgery. The group without NG tube after surgery will discharge the NG tube during the surgery. While the control group(group with NG tube after surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each patient included pulmonary complications, wound complications, anastomosis leak as well as the duration of postoperative hospitalization and the need for placing replacing the NG tube.

Eligibility Criteria:
Inclusion Criteria:

Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction.

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Exclusion Criteria:

1. Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b).
2. Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
3. Patients with unstable situation after surgery (eg, need ventilation and ICU treatment)
4. Patients medically unfit for surgical resection.
5. Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
6. Mentally disabled.
7. Expected life duration of less than 3 months.
8. Patients undergoing colonic reconstruction.