cyrilzakka/clinical-trials huggingface dataset:
Study of Aldurazyme® Replacement Therapy in Patients With Mucopolysaccharidosis I (MPS I) Disease

This is a multi-center, open label, study conducted to evaluate the safety of laronidase administered by intravenous drip infusion in Japanese patients with MPS I disease.

Following baseline evaluation, patients will receive weekly infusions of JC0498 at an intravenous dose of 100 units/kg. Patient safety will be monitored continuously throughout the trial. In addition, the effects of JC0498 treatment in this patient population will be assessed by periodically evaluating aspects of MPS I disease in patients at scheduled intervals over the duration of the trial.

Since patients may be eligible for the trial if they have received JC0498, a portion of the data may be captured retrospectively and recorded onto the case report forms (CRFs).

This study represents the first good clinical practice (GCP) effort to characterize MPS I in the Japanese population and evaluate the effects of JC0498 on disease manifestations.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent of the patient or written informed consent of the parent(s) or the legal guardian(s), depending on the age of the patient, is required prior to any protocol-related procedures being performed; this includes information regarding hematopoietic stem cell transplantation (HSCT) in order to assure that the guardian(s) is fully informed regarding the risks and benefits of this alternative treatment for patients eligible for the trial and who have severe manifestations of MPS I with neurodegeneration.
* Have a clinical diagnosis of MPS, confirmed by measurable clinical signs and symptoms of MPS I.
* Have confirmed iduronidase deficiency with a leukocyte alpha-L-iduronidase enzyme activity level of less than 10.0% of the lower limit of the normal range of the measuring laboratory (SRL)

Exclusion Criteria:

* The patient is under consideration for or has previously undergone hematopoietic stem cell transplantation.
* The patient has acute hydrocephalus at the time of enrollment.
* The patient has a clinically significant organic disease (with the exception of symptoms relating to MPS I) including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival.
* The patient has received any investigational product within 30 days prior to trial enrollment (exception: JC0498).
* The patient has known severe hypersensitivity to JC0498 or components of the delivery solution.
Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

OBJECTIVES:

Primary

* To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM
* To characterize the biodistribution and radiation dosimetry of Cotara®

OUTLINE:

This is an open-label, dose escalation study of Cotara®.

All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent GBM
* Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
* Patients of 18 years of age or older
* Karnofsky Performance Status ≥ 60 at screening
* Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry

Exclusion Criteria:

* Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
* Patients with diffuse disease
* Patients with known or suspected allergy to study medication or iodine
* Patients who received investigational agents within 30 days prior to baseline
* Patients who received surgical resection within 4 weeks from baseline
* Patients with known HIV or evidence of active hepatitis
* Patients who cannot undergo MRI
Heterologous Effect of Diptheria, Tetanus, Acellular Pertussis Vaccination on Influenza Challenge in the Elderly

Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (\>65 years of age) and healthy adult control subjects (30-50 years).

This prospective randomised study aims to investigate the heterologous immunological effects of DTP and seasonal influenza (Flu) vaccination in an elderly Tasmanian population and healthy adults. The study will assess whether prior or concurrent administration of DTP with seasonal Flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. It will also analyse for effects of DTP on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). Volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks.

The study is exploratory and will investigate vaccine effects on multiple immune parameters.

Eligibility Criteria:
Inclusion Criteria:

* Two study groups 30-50 years old \>65 years old

Exclusion Criteria:

* Unwell on day of vaccination
* Temperature \>38°C
* Active cancer
* Active autoimmune disease
* Diabetes mellitus
* Taking immunosuppressive drugs including steroids
* Any vaccination in last 3 months
* DT or DTaP vaccination in the last year
* Known allergy or contraindication to influenza or DTaP vaccination
* Pregnant or breastfeeding
Assessment of Pulmonary Specialty Physicians' Approach to Advanced Care Planning in Patients With Chronic Pulmonary Diseases

To understand current practices of pulmonary physicians in relation to Advanced Care Planning (ACP) in order to develop future disease-specific tools that will improve patient-physician communication about ACP.

The study will be a retrospective, observational study and analysis of charts of patients with Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis treated as outpatients at the Ohio State University Wexner Medical Center Lung Center. Using pre-existing data, we will determine if advanced care planning has been discussed with these patients and record this information. For all patients, we will gather data about specific demographic and clinical characteristics that may have contributed to the presence or absence of these discussions. The study is descriptive in nature and is not powered to detect a difference between the two groups. Instead, we aim to describe the characteristics most frequently associated with advanced care planning discussion in these two particular groups.

Potential subjects will be identified with assistance from the Information Warehouse. After identification, data will be abstracted from pre-existing data in the electronic medical record and collected in a coded fashion for each subject. Each subject will be assigned an anonymous subject identification number and all links to identifying information will be destroyed prior to analysis. All study data will be stored on a secure password protected data base to which only study personnel will have access.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are between 18 and 88 years of age who have been diagnosed with a physician diagnosis of COPD based on at least one of the following:

   * clinical history - a documented history of COPD, emphysema, or chronic bronchitis.
   * pulmonary function results - defined as an forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) less than 0.7
2. Patients who are between 18 and 88 years of age and have been diagnosed with pulmonary fibrosis based on the following:

   * Subpleural, basal predominance of parenchymal abnormality on high resolution computed tomography (HRCT)
   * Reticular abnormality on HRCT
   * Honeycombing without traction bronchiectasis on HRCT
   * Absence of features that are inconsistent with usual interstitial pneumonia (UIP) pattern OR
   * UIP based on surgical lung biopsy

Exclusion Criteria:

* Age \< 18 years or \> 88 years
* Prisoners
* Pregnant patients
Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI

The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.


Eligibility Criteria:
Inclusion Criteria:

* Prior PVI ablation procedure for paroxysmal AF within past 2 years
* Recurrent symptomatic paroxysmal AF despite prior PVI
* History of essential hypertension requiring at least 2 chronic antihypertensive medications

Exclusion Criteria:

* Persistent AF after prior ablation
* Congestive heart failure (NYHA III-IV functional class)
* Left ventricle ejection fraction \< 35%
* Left atrial diameter \>55 mm
* An estimated glomerular filtration rate (eGFR) \< 45mL/min/1.73m2, using the MDRD calculation
* Renal arteries unsuitable for RDN:

  1. Inability to access renal vasculature
  2. Main renal arteries \< 4 mm in diameter or \< 20 mm in length.
  3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
  4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
  5. Multiple main renal arteries to either kidney
* Unwillingness to participate
The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults

Bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which may be accompanied by recurrent exacerbations.It has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. However,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.This study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.

Bronchiectasis is a chronic airway disease characterised by a vicious cycle of persistent bacterial colonization,inflammation and progressive tissue destruction.Patients with bronchiectasis frequently developed acute exacerbations characterised by acute worsening requiring changes in concomitant use of medication,with attendant adverse effects on their morbidity and health-related quality of life. The detailed pathogenesis of exacerbations of bronchiectasis, however, remains poorly understood.

Recent data suggested that airway infection and inflammation are important drivers of exacerbations,therefore the imbalance between chronic bacterial infection and host immune response may result in bronchiectasis exacerbations. Viral infection may be an important factor that leads to this events.It has been established that respiratory viruses are mainly responsible for the exacerbations of other chronic respiratory diseases, i.e. asthma, COPD and cystic fibosis. However, the data regarding prospective studies that sought to investigate the roles of viruses in acute exacerbation of bronchiectasis are lacking. Furthermore,the associations between viruses and bacteria during exacerbation need to be assessed. This study targets at indentifying the frenquency of common viral infections in adults with non-cystic fibrosis bronchiectasis and may shed light on the effects they have on clinical parameters,i.e. the length of exacerbated symptom to recovery,lung function, pulmonary inflammation, bacterial load and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HRCT-diagnosed Bronchiectasis
* Capable of providing written informed consent

Exclusion Criteria:

* Patient judged to have poor compliance
* Cystic fibrosis bronchiectasis
Health-Related Quality of Life in Gay Men With Localized Prostate Cancer

RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from gay men with prostate cancer may help doctors plan the best treatment.

PURPOSE: This clinical trial is collecting information about health-related quality of life from gay men with localized prostate cancer.

OBJECTIVES:

* To enroll 200 gay men with localized prostate cancer in a cross-sectional study of prostate cancer outcomes.
* To complete an R01 application using pilot data collected from these patients.
* To complete manuscripts describing the factors that influence quality of life and treatment satisfaction in these patients.

OUTLINE: Patients complete a web-based survey about their disease (biopsy Gleason score, PSA at diagnosis, and T-stage), treatment (treatment type, time since treatment, and use of healthcare services \[e.g., oral medications for erectile dysfunction\]), symptom distress, and psychosocial factors (ethnicity, health literacy, level of social support, communication with provider, relationship status, and communication with partner) that affect their health-related quality of life. The data will be used to provide the information necessary to tailor an existing prostate cancer survivorship intervention to address the specific needs of gay men with prostate cancer.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of localized prostate cancer

  * No advanced disease
* Self-identified as gay

PATIENT CHARACTERISTICS:

* Able to complete an online questionnaire
* Able to speak and understand English

PRIOR CONCURRENT THERAPY:

* Not specified
Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database

The primary purpose of the proposed study is to validate our previously developed predictive model for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended definition of outcomes of interest.

The TOH sleep database was created as a part of the project: "Validation of provincial health administrative data algorithms to identify patients with obstructive sleep apnea (OSA): Feasibility project". Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to be used for future clinical, research, educational and quality improvement purposes.

The primary purpose of the proposed study is to validate the previously developed predictive model by the investigators for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended definition of outcomes of interest.

From clinical and quality improvement perspective the TOH database will be used for description, evaluation, monitoring and/or educational purposes. For example, using this database the investigators will be able (i) to describe characteristics of individuals who underwent a diagnostic sleep study at the TOH between 2015 and 2017 to understand better clinical and health care utilization needs as well as to educate sleep fellows and technologists; and (ii) to evaluate the quality of the triaging process in the sleep clinic. This database will be used to: (i) examine risk factors for long-term adverse health consequences (e.g. cardio-vascular diseases, diabetes, depression, dementia, depression and cancer) among individuals referred for diagnostic sleep testing in order to identify high risk groups that are potential targets for education and treatment, (ii) develop health interventions in order to improve the quality of care and management strategies available for adults with chronic diseases that are comorbid with obstructive airway diseases and sleep-related disorders, (iii) evaluate the cost-effectiveness of the developed health interventions, e.g. screening for obstructive sleep apnea (OSA), evaluation of home versus laboratory-based diagnosis of OSA, and education strategies, (iv) develop key messages for different stakeholder groups (health care providers, patients and their relatives, provincial sleep and lung associations, public health managers, the respiratory vendor among others) related to diagnosis, education and treatment of patients with respiratory and sleep-related problems.

Eligibility Criteria:
Inclusion criteria:

• All adults who underwent a diagnostic sleep study in the TOH Sleep Center from Apr 2015 to April 2017

Exclusion criteria:

* Uninsured individuals
* Individuals who did not agree for their data to be linked to the ICES
* Individuals who underwent split-night sleep studies
Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease

This study aims to develop an effective, brief, family-based intervention targeting quality of life and school functioning for youth with sickle cell disease. Utilizing a randomized, delayed control group intervention methodology, the present study will systematically document the effectiveness of a family-based, one-day intervention plus booster phone calls to improve quality of life and increase school functioning for children with sickle cell disease transitioning to school and their families.

Families Taking Control-School-age Intervention (FTC) will provide education and problem solving training for disease management and school functioning. In 4 sessions offered over the course of one day, families (patient, caregivers, and school-age siblings) will work together and individually to learn and apply the problem solving skills training model to relevant examples and family-specific problems, culminating in an outline of family goals to target after the intervention. The three booster phone calls will provide support to families in implementing the problem-solving model by addressing and refining goals and trouble-shooting barriers to implementation. Children and caregivers completed measures at baseline (prior to intervention participation) and 6 months later.

Eligibility Criteria:
Inclusion Criteria: English speaking, treated at one of two participating Sickle Cell Centers -

Exclusion Criteria: severe developmental delay or children/caregivers with severe psychopathology that would adversely affect their ability to participate

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Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)

Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.

This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.

Chronic fatigue syndrome (CFS, which is also sometimes called ME, Myalgic Encephalomyelitis) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. They often function at a substantially lower level of activity than they were capable of before they became ill. Besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. Often, CFS can persist for many years. Researchers have not yet identified what causes CFS, and there are no specific tests to diagnose CFS. The prevalence has been suggested to be around 1-2 %.

All humans are exposed to small amounts of mercury every day from the environment. It is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. It is also known that the sensitivity to the toxic effects by mercury differs greatly between people. Thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. Therefore, the question arises if a reduction of the mercury content in the body of CFS patients can improve their symptoms and problems in daily life.

This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.

This is a double blind placebo controlled parallel group study.

Patient population: 40 patients diagnosed with CFS will participate.

Eligibility Criteria:
Inclusion Criteria:

* Chronic fatigue syndrome
* 35-60 years old
* Male
* Female (not pregnant or breastfeeding, using adequate highly effective contraception consistently and correctly or \>1 year post-menopausal or surgically sterile).

Exclusion Criteria:

* Iodine allergy
* abnormal thyroid function or other thyroid disease such as goiter
* severely reduced kidney function (Cystatin C \> 1.5 mg/L)
* alcohol/drug abuse
* severe depression
* severe fibromyalgia
* severe cardio-vascular disease
* other severe disease, according to the clinical investigator
* participation in another ongoing clinical trial
* participation in drug trial the preceding 3 months
A Study of Management of Tarceva - Induced Rash in Patients With Non-Small Cell Lung Cancer.

This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* confirmed non-small cell lung cancer;
* failure after first line chemotherapy for advanced disease, and scheduled for second line therapy with Tarceva.

Exclusion Criteria:

* rash of any etiology at study entry;
* history of significant heart disease;
* any other malignancies (other than adequately treated squamous cell skin cancer, or in situ cancer of the cervix);
* history of allergic reactions to tetracyclines.