cyrilzakka/clinical-trials huggingface dataset:
An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

For epidemiological part of the study:

* Adult patients \>/= 18 years of age
* Positive HBsAg for at least 6 months

For the non-interventional section of the study

* Adult patients, \>/= 18 years of age
* Positive HBsAg for at least 6 months
* Positive anti-delta and positive HDV RNA by PCR
* Elevated serum ALT \>/= 2x ULN

Exclusion Criteria:

Patients with any of the following will not be eligible for treatment with Pegasys:

* History of neurological disease
* History of severe psychiatric disease
* Decompensated diabetes
* History of immunologically mediated disease
* History of severe cardiac disease
* History or other evidence of severe chronic pulmonary disease
* Inadequate hematologic function
Transcranial Magnetic Stimulation for Bipolar Depression

This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder.

In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. No anaesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe.

Most of the published studies to date have focused on unipolar depression. There is limited data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson B, George MS.in 2003, which was negative.

The investigators wish to assess this in a sham-controlled study of adults. The investigators hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population.

Inpatients and outpatients with major depressive episodes as part of either bipolar I or II illness will be eligible. In the event that patients (in any arm) have no significant response after a defined period, they will shift to an open phase where they will receive left prefrontal 10Hz stimulation. Thus all participants will have the opportunity to receive active treatment.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depressive Episode of no more than 3 years.
* Diagnosis of bipolar I or II disorder
* Montgomery-Asberg Depression Rating Scale score of 20 or more.
* Aged over 18
* May or may not be taking antidepressant medication.

Exclusion Criteria:

* Patient not able to give informed consent.
* Failure to respond to ECT in current episode of depression.
* Significant other Axis I psychiatric disorders e.g. schizophrenia.
* In imminent physical or psychological danger, or needs rapid clinical response due to inanition, psychosis or high suicide risk.
* Comorbid substance abuse or dependence
* History of neurological illness e.g. epilepsy; neurosurgical procedure
* Metal in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device.
* Women of child-bearing age in whom pregnancy cannot be ruled out.
* Patients with a history of mood 'switching' in response to other treatments.
Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer

The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.

The patients on this study will receive treatment in 3 stages of therapy.

The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.

The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by pemetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.

The last stage of treatment is Maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB
* Measurable or evaluable disease
* Be up and about and able to care for self
* Adequate kidney, liver and bone marrow function
* No prior treatment for this disease
* Must be able to give written informed consent
* Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
* Age 18 years or older

Exclusion Criteria:

* Stage IV or IIIB patients with pleural or pericardial effusions
* Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
* Squamous cell predominant tumors
* Pregnant or lactating women
* Patients with active infections
* History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
* History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
* Symptoms of peripheral vascular disease
* History of neurological disease
* Recent history of blood in the sputum or vomitus
* Non-healing wounds, ulcer or long bone fractures
* History of bleeding problems or coagulation problems
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
* History of uncontrolled hypertension
* Chronic use of non-steroidal anti-inflammatory medication not allowed on this study

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Dose Ranging Study of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study is to determine how well a range of different doses of fermagate are tolerated by the subjects in the trial.

High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease.

Current guidelines indicate that blood phosphorus levels should be maintained between 1.13 to 1.78 mmol/L in patients who receive hemodialysis.

The purpose of this study is to determine the range of dosages which are tolerated by patients with hyperphosphatemia, undergoing haemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures
* Written informed consent given
* On a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period
* On a stable dose of phosphate binder for at least 1 month prior to screening
* Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium- or iron-containing products and preparations, other than the study medication
* Willing to avoid any intentional changes in diet such as fasting, dieting or overeating
* On a dialysate magnesium ion concentration of ≤1.0 mmol/L for at least 1 month prior to screening

Exclusion Criteria:

* Received a cardiac transplant
* Heart failure according to New York Heart Association (NYHA) Functional IV Classification
* Participation in any other clinical trial using an investigational product or device within the previous 4 weeks
* A significant history of alcohol, drug or solvent abuse in the opinion of the investigator
* Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn
* Clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator
* Any history of recent clinically significant malignancy
* A significant illness (excluding renal disease) in the 4 weeks before screening
* A history of poorly controlled epilepsy
* Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device
* Allergy to magnesium iron hydroxycarbonate or sevelamer or any component of the formulations
* Any condition that affects the reliability of measuring QT interval, for example, an irregular heart rhythm such as atrial fibrillation or frequent ectopic activity
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients

The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations.

The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Eligibility Criteria:
Inclusion Criteria:

* De novo kidney transplantation patients, aged 13-65 years,have aminotransferase concentrations within 2 times the upper limit of normal.

Exclusion Criteria:

* pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis.
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.

Secondary objectives were:

* To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.
* To investigate the pharmacokinetic and pharmacodynamic relationships.

The total duration of the study period per participants was 46 weeks comprising 3 periods:

* a 4-week screening period,
* a 36-week double-blind treatment period,
* a 6-week post-treatment follow-up period.

Participants who successfully completed the double-blind treatment phase were offered the possibility to continue study treatment in the extension study LTS6048 - NCT00228163.

Eligibility Criteria:
Inclusion Criteria:

* Clinically confirmed multiple sclerosis \[MS\];
* Expanded Disability Status Scale \[EDSS\] score less or equal to 6;
* Two documented relapses in the previous 3 years, and one clinical relapse during the preceding year;
* Screening magnetic resonance imaging \[MRI\] scan fulfilling the criteria for a diagnosis of MS.

Exclusion Criteria:

* Clinically relevant cardiovascular, hepatic, hematologic, neurological, endocrine or other major systemic disease;
* Pregnant or nursing woman;
* Wish to parent children during the trial or following the trial (men and women were required to practice effective contraception during the trial and for 24 months after drug discontinuation);
* Prior treatment with interferon \[IFN\], gamma-globulin, glatiramer acetate, or other noncorticosteroid immunomodulatory therapies in the 4 months prior to the trial;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Proton Radiation Therapy for Gliomas

In this research study the investigators are looking at a type of radiation called proton radiation. Proton radiation has been shown to deliver virtually no radiation beyond the area of the tumor, sparing surrounding normal tissue from exposure. This may reduce side effects that patients would normally experience with conventional radiation therapy.

In this research study the investigators are looking to determine if proton radiation with a reduced field size will be as effective in controlling tumor growth as photon therapy, while reducing the treatment-related side effects observed in patients with brain tumors.

Proton radiation will be delivered daily for approximately 6 weeks. Subjects will be assessed weekly for side effects. Each visit will take about 15 minutes.

Subjects will have follow-up visits at 3, 6, 12, 24, 36, 48, 60, 72, and 84 months after their last proton radiation treatment. They will receive a physical exam, MRI, have blood tests (about 4 teaspoons) and answer questionnaires regarding medical history, quality of life, and emotional well-being. Subjects will also receive a neurocognitive exam annually.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed low-grade gliomas OR Grade III anaplastic glioma with either or both IDH1 mutation or 1p/19q codeletion
* Subject must be indicated for radiation therapy
* Life expectancy greater than 5 years
* Willing to participate in rigorous neurocognitive evaluations at baseline and serially following treatment
* Able to speak and comprehend English
* Recovered from adverse events due to agents administered more than 4 weeks before entering study
* Able to undergo MRI scans

Exclusion Criteria:

* Prior cranial radiation therapy
* Chemotherapy within 4 weeks prior to entering study
* Pregnant or breastfeeding
* Known brain metastases
* Baseline neurocognitive or emotional disorders
* Uncontrolled intercurrent illness
* History of a different malignancy unless disease-free for at least 5 years
* HIV positive on antiretroviral therapy
Exploratory Study of 3D Printed Biodegradable Cervical Interbody Fusion Cage

A small sample, single center, non-randomized, noninferiority clinical trial to evaluate the safety and effectiveness of 3D printed biodegradable cervical interbody fusion cage in anterior cervical discectomy and fusion (ACDF) for treating patients with a symptomatic degenerative cervical disc disease at one level from C2/C4 to C7/T1.

The study will evaluate if 3D printed biodegradable cervical interbody fusion cage is non-inferior to poly-ether-ether-ketone (PEEK) cage in single-level ACDF with the use of local autologous bone. 3D printed biodegradable cervical interbody fusion cage is a restorable cervical interbody cage for the treatment of fusion, following discectomy, of the cervical spine from C2/C4 disc space to the C7/T1 disc space. The material used to prepare the implant is a mixture of polycaprolactone (PCL) and tricalcium phosphate (TCP), which is called PCL-TCP. The implant has proper strength and connective porosity. The PCL-TCP cage is intended to be used with a supplemental fixation system.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature patients aged between 25 and 85 years (inclusive);
2. Symptomatic cervical disc disease (SCDD) in the vertebral level between C2/C3 to C7/T1, correlated with radiculopathy or myelopathy;
3. Radiographic confirmation (by CT, MRI, x-ray, etc.) of any of the following: herniated nucleus pulposus, spondylosis or loss of disc height;
4. Requires only one cervical vertebral level to be surgically treated;
5. Failed at least 12 weeks of conservative treatment;
6. Patient must understand and sign the Informed Consent document that has been approved by the Ethics committee;
7. No significant restrictions showed by the pre-surgical routine test and examination.

Exclusion Criteria:

1. Skeletally immature patients;
2. Prior radiation history at anterior cervical area;
3. Prior surgery at the level to be treated;
4. More than one vertebral level requiring treatment, confirmed radiologically by X-ray, CT, or MRI
5. Complication of ossification of the ligamentum flavum, and Ossification of the posterior longitudinal ligament;
6. Clinically compromised vertebral bodies at the affected level(s) due to trauma or tuberculosis
7. Severe osteoporosis;
8. Active systemic or local infection;
9. Participation in other investigational device or drug clinical trials within 3 months of surgery;
10. Other patients whom the investigator believe not appropriate.
Treating Growing Patients With Mandibular Prognathism and Maxillary Constriction

This randomized controlled trial intends to test the efficacy of two treatment protocols in the correction of Class III malocclusion with maxillary constriction. We have to options, either to modify the growth using inter-maxillary traction based on an upper fixed appliance that is used in the same time for rapid maxillary expansion or to inhibit mandibular growth by a removable mandibular retractor (RMR) supplied with an expansion screw.


Eligibility Criteria:
Inclusion Criteria:

1. growing male and female patients aged between 12 and 15 years
2. Angle's class III malocclusion
3. skeletal class III relationship judged clinically and confirmed radiographically (-4 \< ANB \< + 1)
4. An anterior crossbite involving two or more teeth or an edge-to-edge incisor relationship with or without an anterior shift of the lower jaw upon closure
5. normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
6. maxillary constriction requiring expansion judged clinically and confirmed radiographically
7. permanent dentition
8. no previous orthodontic treatment

Exclusion Criteria:

1. skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA\<78° with a normal SNB angle)
2. severe skeletal class III presenting mainly due to mandibular protrusion (ANB \< - 4° with no functional shift on closure)
3. contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
4. a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
5. facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
6. MM angle \>35° or SN-MP angle \> 40°
7. The existence of cleft lip or craniofacial syndromes and/or palate abnormalities and
8. The existence of supernumerary teeth or missing ones except for the third molars.
Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.


Eligibility Criteria:
Inclusion Criteria:

* patients under the age of 16 referred to GOSH for management of empyema

Exclusion Criteria:

-
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer

This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients

The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been studied in a phase \[I\]/\[II\], with favourable profile of toxicity in pretreated patients with anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).

In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin Oncol 19: Abstract 420, 2000)

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* Age 18-75 years
* Bidimensionally measurable or evaluable disease
* Performance status (PS) 0-2 (ECOG)
* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment
* Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the UNL in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
* At least three weeks from completion of irradiation
* Life expectancy ≥ 12 weeks
* Patients able to take oral medication
* written informed consent

Exclusion Criteria:

* Active infection
* Brain metastases
* History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Malnutrition (loss of ≥ 20% of the original body weight)
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
Biomarker Analysis of Stress

Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Wadsworth Center with Sepsis