cyrilzakka/clinical-trials huggingface dataset:
Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.

Eligibility Criteria:
Inclusion Criteria:

* Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
* Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
* Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements

Exclusion Criteria:

* Anatomy unable to accommodate a 25 Fr delivery system
* Obstruction of the central veins
* Clinical or biological signs of infection including active endocarditis
* Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
* Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
* Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant
* A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
* Planned implantation of the Native Outflow Tract TPV in the left heart
* RVOT anatomy or morphology that is unfavorable for anchoring
* Known allergy to aspirin, heparin, or nickel
* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
* Pre-existing prosthetic heart valve or prosthetic ring in any position
* Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).

The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.

Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant females and aged more than 18 years;
2. Willing and able to adhere to visit schedules and all study requirements;
3. Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

1. Subject or his/her family is employed by the participated hospital;
2. Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
3. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
4. Personal or family history of Guillain-Barré Syndrome;
5. An acute febrile illness within 1 week prior to vaccination;
6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
7. Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
8. Female subjects who are pregnant during the study.
9. Patients who receive hemodialysis therapy less than 3 months.
10. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
11. Immunodeficiency, or under immunosuppressive treatment.
12. Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
13. Receipt of any blood products, including immunoglobulin in the prior 3 months;
14. Any severe illness needed to be hospitalization within three months.
15. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Mirror Therapy Education for Acute Stroke Patients

In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?


Eligibility Criteria:
Inclusion Criteria:

* Admitted with diagnosis of stroke with onset within two weeks
* Medically stable
* Able to follow directions
* No severe cognitive impairments that could interfere with patient participation
* Consent to treatment by patient
* Alpha-Functional Independence Measure (Alpha-FIM) score of \> 40

Exclusion Criteria:

* Medical instability
* Lack of motivation
* Recurrent/ chronic stroke
* Recent upper extremity musculoskeletal injuries with movement restrictions
* Receptive or global aphasia
* Delirium
* Unilateral neglect
* Visual field deficiency.
PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit

This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit \>48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit \<45% with a target of \<43%. Subjects may receive PTG-300 treatment for up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Known diagnosis of polycythemia vera.
2. Hematocrit \>48% before dosing.
3. Evidence of hematocrit \>48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients).
4. Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

Exclusion Criteria:

1. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening.
2. Active or chronic bleeding within 4 weeks of Screening.
3. Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
4. Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed.
5. Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study.
6. Known primary or secondary immunodeficiency.
7. Known positive for active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
8. Any surgical procedure requiring general anesthesia within 1 month prior to Screening or planned elective surgery during the study.
9. History of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer.
10. Current or recent history of alcohol dependence or illicit drug use within 1 year prior to Screening.
Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease

In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.

The aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease characterized by irreversible airway limitation. In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.It has been observed that balance systems, functional balance tests, posturography, posture assessment systems, force platform and inclinometer measurements are used in studies on postural control assessment in COPD patients.There are a limited number of studies in which devices that objectively present the degree of deviation in spinal curves are used in patients with COPD, and posture and lung volume and capacities are evaluated.

Therefore, the aim of this study is to investigate the changes in spine structure and mobility in COPD patients and to reveal their relationship with static and dynamic lung volumes and capacities.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study
* Be over 18 years old
* Being clinically stable
* Not having a COPD attack in the last 3 months at least

Exclusion Criteria:

* Refusing to participate in the research
* Having had spinal surgery Presence of back and shoulder pain
* Idiopathic scoliosis
* Ankylosing spondylitis
* Presence of respiratory disease other than COPD
* Difficulty understanding verbal commands
Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage

This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent before initiation of any study procedures
* Be a female outpatient, ≥ 18 years of age at the time of informed consent
* Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
* Eligible to allow embryos to develop through day 5 before implantation or freezing

Exclusion Criteria:

* Presence of ovarian endometriotic cyst
* Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
* Need for pre-implantation genetic diagnosis/screening of embryos
* Use of time-lapse embryo imaging
* Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center
Monitoring of Visual Axis Opacification Under Non-clinical Settings

The incidence rate of postoperative capsular opacification (PCO) in children after cataract surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term follow-up, timely diagnosis and treatment is important to improve patient's outcome.

The major and central part of lens is easy to be observed through a dilated pupil. Especially, opacification in the lens and/or lens capsule is distinctive showing as "white" on the "black" background. The characteristic features of the disease and advances in photographic technique with mobile phone make it possible for patients and/or their guardians to monitor the progress of cataract or PCO with mobile application in a "self-help" manner under non-clinical settings.

The incidence rate of postoperative capsular opacification (PCO) in children after cataract surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term follow-up, timely diagnosis and treatment is important to improve patient's outcome.

The major and central part of lens is easy to be observed through a dilated pupil. Especially, opacification in the lens and/or lens capsule is distinctive showing as "white" on the "black" background. The characteristic features of the disease and advances in photographic technique with mobile phone make it possible for patients and/or their guardians to monitor the progress of cataract or PCO with mobile application in a "self-help" manner under non-clinical settings. In this way, patients and/or guardians could adjust the time of return to clinical follow-up visit accordingly. Furthermore, standardized and analyzed pictures could be sent to clinicians for remote diagnosis when necessary.

The investigators developed a mobile phone application LenZOC. The investigators aimed to assess whether mobile phone application for parents of children with cataracts would improve their adherence with follow-up and increase rates of timely detection and management of treatable conditions such as posterior capsular opacification (PCO).

Eligibility Criteria:
Inclusion Criteria:

* Children after cataract surgery for more than 1 year without any postoperative complications
* Without other ocular abnormality
* Parents owned a smart mobile phone that meets the requirements for installation of the LenZOC
* Written informed consents provided

Exclusion Criteria:

* Intraocular pressure \>21 mmHg
* Pre-existing ocular diseases including but not restricted to:

Glucoma Micro-cornea Micro-ophthalmic Diseases of post-segment that might lead to VAO
Narrow Band Imaging in Diagnosis of Colorectal Polyps

Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.

Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for colonoscopy at NKC institute

Exclusion Criteria:

* Inflammatory bowel disease
* Polyposis syndrome
* Colorectal cancer
* Active gastrointestinal bleeding
* Pregnant woman
* Inadequate bowel preparation
* Contraindication for polyps removal
Self Screening Tool for Crohn's Perianal Fistula

This study aims to develop a self-screening tool for Crohn's perianal fistula.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease

Exclusion Criteria:

-
The Effects of Footwear on Balance and Confidence in Older Inpatients

The study aims to assess whether type of footwear worn changes the balance, mobility and confidence of older inpatients and consequently may affect their falls risk whilst in hospital. The investigators hope to identify which footwear type is most beneficial to patients in the ward environment.

Footwear is known to be one of many recognised significant risk factors for falls, presumably by affecting balance and gait pattern. However, little is known regarding the best footwear for hospital inpatients in whom approximately 40% of older persons fall during their hospital admission. Patients admitted to hospital without their own footwear (slippers or shoes) are routinely given foam slippers referred to as pillow paws (PPs). There are concerns that these PPs may contribute to falls as they are often ill fitting (come in a very limited size range) and or are flimsy offering little foot and ankle support. Hence Medicine for the Elderly consultant and registrars designed this study to gain information on differences in balance, mobility and confidence when patients are wearing different footwear types. As a secondary outcome, falls data will also be collected to see whether there is any association between footwear types and inpatient falls incidence.

The aim is to compare pillow paws (PPs) with sturdy outdoor footwear or sturdy slippers. In this way we hope to gain information on which footwear type is most beneficial to hospital inpatients. A recent similar study infers that sturdy outdoor footwear benefits outpatients, but it is not clear whether the same applies to a hospital inpatient population whom are often frailer with greater co-morbidities (physical and mental) and a higher falls risk.

Eligibility Criteria:
Inclusion Criteria:

* Appropriate footwear
* Over 65 years
* Able to stand independently
* Inpatient in an acute geriatric assessment or rehabilitation ward

Exclusion Criteria:

* Unable to stand independently
* Acutely unwell
* Terminally unwell
* Registered partially sighted or blind
* Using lower limb orthotic device
Trait Injustice, Social Exclusion, and Anger

Participants will be randomly allocated to one of two experimental conditions: social exclusion or social inclusion. Participants, but not experimenters will be blind to the assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in compensation for participating.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Signs the informed consent
* Can read and understand Spanish

Exclusion Criteria:

* Being younger than 18 years of age
* Does not sign the informed consent
* Cannot read or understand Spanish
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases

RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.

OBJECTIVES:

* Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases.
* Determine the antitumor immune response in patients treated with this regimen.
* Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients.
* Compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks.

OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). Patients are assigned to 1 of 2 treatment arms.

* Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5.
* Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12.

Patients with stable or responding disease may receive 1 subsequent course beginning on day 29.

Patients are followed at 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed solid malignancy

  * Surgically or medically incurable disease
  * No standard chemotherapy or radiotherapy exists for this disease
* Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin

  * Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC greater than 3,000/mm\^3
* Platelet count greater than 80,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL

Renal:

* Creatinine less than 2.0 mg/dL

Other:

* HIV negative
* No active infections requiring antibiotic, antiviral, or antifungal treatment
* No other active malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 1 month since prior immunotherapy
* No concurrent colony-stimulating factors

Chemotherapy:

* See Disease Characteristics
* At least 1 month since prior chemotherapy

Endocrine therapy:

* At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent)
* No concurrent steroids

Radiotherapy:

* See Disease Characteristics
* Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease

Surgery:

* See Disease Characteristics
* No prior organ allografts

Other:

* No other concurrent antineoplastic therapy
* No other concurrent investigational drugs
SEGATROM: Sensory and Gastrointestinal Impact of Taste Receptor Variants on Human Metabolism and Nutrition

We investigate the impact of taste receptors (sweet, bitter and umami) on human metabolism. There ist growing evidence, that components of the taste signalling system, including the taste receptor proteins , have important functions in the regulation of metabolic parameters in non-gustatory tissues.

We apply different sweet, bitter and umami taste compounds in a single dose in the human intervention. We use substances as for instance glucose, sucrose,saccharin and lactisol in the sweet part, and substances from cabbage, beer or red endive in the bitter part. For umami we take glutamate.

Blood samples are collected at baseline and 6 times thereafter up to 3hours, to analyse the incretins GLP-1(glucagon-like peptide 1) and GIP(gastrointestinal polypeptide) and other peptide hormones as insulin and PYY(peptide tyrosin trosin) in human beings.

Gastrointestinal mucosa is taken by gastroscopy from the lower duodenum from study subjects for analysis for the presence or absence of functional taste receptors in gastrointestinal tissues.

Eligibility Criteria:
Inclusion Criteria:

* Healthy persons

Exclusion Criteria:

* Tumor in history
* Pregnancy
* Severe illness in history
* Bodymass index below 18