cyrilzakka/clinical-trials huggingface dataset:
Clostridium Difficile Virulence Mechanism Study (CDVM Study)

This study is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI) to investigate the virulence mechanisms of C. difficile ribotypes in Hong Kong, mainly ribotype 002. No intervention is involved.

This is an observational study to collect stool samples from patients with Clostridium difficile infection (CDI), aims to (1) to investigate the virulence mechanisms of C. difficile ribotype 002, by analysing its growth, cytotoxicity, and metabolite production in vitro and in vivo. The investigators also aim (2) to compare these virulence mechanisms with other common ribotypes in Asia, and (3) to correlate these with important clinical outcomes. The results of this study will have a major significance to the medical and scientific community. The results of this study will have a major significance to the medical and scientific community. The mechanistic data will point to important molecular pathways that can be targeted for novel therapies; whereas the phenotypic data will inform the investigators of its virulence and therefore will be useful for disease surveillance and public health interventions. The identified toxin(s) and metabolite(s) may be useful as prognostic biomarkers to stratify patients with different outcomes, as patients with a worse outcome may require more aggressive therapy. Given the prevalence and severity of this ribotype, the results will be useful for gastroenterologists, microbiologists, infectious diseases physicians and public health specialists in the Asia Pacific region.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of CDI, as documented by diarrheal symptoms and positive stool test result for C. difficile toxin or toxigenic C. difficile, or colonoscopic findings of pseudomembranous colitis (PMC).
* Patients aged over or equal to 18 years old.
* Patients able and willing to provide informed consent.

Exclusion Criteria:

* Patients with concomitant infection by other microbes such as Salmonella, Campylobacter, Vibrio, Shigella, and Escherichia coli.
* Patients under 18 years old.
* Patients who cannot give consent.
To Study the Impact of Radiation Treatment After Surgery in Patient With Locally Advanced Thyroid Cancer.

This trial deals with cancers of the thyroid gland which are advanced at the local site of thyroid. These cancers are treated with surgery and complete removal of the thyroid gland. But due to advanced nature, there is risk of re-occurrence. Radiotherapy can be used to prevent this re-occurrence. This study attempt to see the effect of radiotherapy in preventing re-occurrence and its side effects in advanced thyroid cancer.

Surgery, when possible offers the best chance of cure for cancer of the thyroid gland. Surgery for thyroid cancer involves removal of the thyroid gland along with removal of the lymph nodes which drain the gland. After surgery most patients will receive radio-iodine treatment to diagnose and treat any spread of the cancer in the body. Most thyroid cancers will have good outcomes with the above mentioned treatment. However, in advanced thyroid cancer there is a higher chance of recurrence even with surgery and radio iodine. Surgery for recurrence of these cancers is very morbid This may entail surgeries which may also involve removing portions of the voice box and food pipe. You may therefore develop and discomfort or inability to eat or speak.

Radiation therapy can be given to the neck along with radio-iodine therapy to decrease these re occurrences of the cancer. A number of studies have shown a benefit with the use of radiation therapy in advanced cases of thyroid cancer. However, the side effects of radiation, if any, have not been well documented. This study is being done to assess the impact of radiation on the outcome of cancer and the exact side effects of radiation therapy. If the side effects are not too many, then radiation therapy can be used to decrease the chances of recurrence in the neck after thyroid.

In this study, patients undergoing total thyroidectomy for thyroid cancer will be assessed for high risk features on the histopathology report and the intra operative findings. Those with advanced thyroid cancer as per the eligibility criteria will be counselled and consented for the study. Those patients willing to participate in the study will be randomised to either receive only surgery and radio-iodine or surgery, radio-iodine and external beam radiation.

Eligibility Criteria:
Inclusion Criteria:

A) All patients of differentiated thyroid cancer (papillary/follicular/poorly differentiated/) who have undergone total/completion thyroidectomy at our institute and having at least two of the following features (listed below) intra-operatively and/or on histopathology

1. Gross extrathyroidal spread into soft tissues of the neck, trachea, esophagus, recurrent laryngeal nerve (constituting stage T4a)
2. R1/ shave resections (minimal residual disease)
3. R2 resections (gross residual disease)
4. Multiple lymph nodes positive(\>2) with perinodal extension at level VI B) Normal baseline haematological and biochemical parameters.

Exclusion Criteria:

1. Anaplastic or medullary thyroid cancer
2. Previous history of radiation
3. Pregnancy
4. \< 18 years Patient unwilling to participate in the study.
Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma

Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively.

Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively. We used 1.0 ml of 40 mg/ml nonbuffered gentamicin in three intratympanic installations over 2 days, 2 months preoperatively in 10 patients. Reduction of vestibular function was measured by the head impulse test and the caloric test. Reduction of vestibular function was found in all gentamicin patient groups. After gentamicin vestibular ablation, patients underwent home vestibular exercising for two months. The control group consisted of 10 patients who underwent only home vestibular training two months preoperatively. Postoperative rate of recovery and vertigo in both groups were evaluated with the Glasgow Benefit Inventory (GBI), the Glasgow Health Status Inventory (GHSI) and the Dizziness Handicap Inventory questionnaires, as well as survey of visual symptoms by specific questionnaire developed by us.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of vestibular schwannoma
* hearing loss on affected side
* preserved vestibular reactivity of labyrinths on the affected side

Exclusion Criteria:

* allergy to gentamicin
* vestibular areflexia on the affected side
Surveillance of Patients With Precancerous Lesions of the Stomach

The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered and performed endoscopic surveillance.

Gastric cancer is still an important healthcare problem with significant mortality rates. Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less effective.

Ideally, gastric cancer could be prevented by detecting gastric precancerous conditions/lesions and identifying those individuals at high-risk of progressing to cancer to the follow-up.

Population based endoscopic screening for gastric cancer is not recommended for the early detection of gastric cancer generally deemed not to be cost-effective.

However, in the absence of screening, patients present with advanced disease, and prognosis is poor.

Targeted endoscopic surveillance strategies for gastric cancer should be introduced following the principles of the recent European guidelines: Management of precancerous conditions and lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).

The project will aim to identify and determine subgroups of patients with different risks of progression to gastric cancer and to assess appropriate follow-up intervals. Implementing risk stratification only high risk individuals will be offered endoscopic surveillance.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing upper endoscopy Motivation to participate in the study Signed consent

Exclusion Criteria:

Known gastric cancer Unwillingness or inability to co-operate
Development of Magnetic Resonance (MR) Simulation for Treatment Planning

Retrospectively have access to MR images of patients to develop software that:

1. segment images
2. convert MR values to electron density and then
3. entered into a dose calculation system

The project involves software development of data that is already available. No intervention is made at this point.


Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years of age and older
Emission Patterns of Respiratory Pathogens

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) isolation and barrier precautions such as face masks, and 3) decontamination of the exposed areas and surfaces. A lack of understanding how these pathogens are transmitted hampers the ability to develop effective prevention measures. This study will be used to collect preliminary data of the emission patterns of respiratory pathogens.

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. The study team have been investigating bacterial and viral transmission routes and barrier precautions. In a recent clinical study, it was observed that Measles virus RNA was detected from a patient for at least up to 10 feet. In addition, the group has been studying barrier precautions (facemasks) for their ability to prevent the spread of aerosolized viruses. Finally, in a controlled lab setting the investigators have assessed the impact of environmental conditions (temperature, humidity) on pathogen transmission and the effect of UV-C light to prevent the spread of influenza. The purpose of this observational study is to describe the human aerosolization patterns of respiratory pathogens. The study team hypothesizes that the emission patterns of specific airborne pathogens varies between individual patients.

Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years of age admitted to the ED or an inpatient care unit of Wake Forest Baptist Medical Center (WFBMC)
* Positive

Exclusion Criteria:

* positive respiratory pathogen tests
MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo


Eligibility Criteria:
Inclusion Criteria:

* subject who aged 20 to less than 65 years
* subject with benign masseteric hypertrophy

Exclusion Criteria:

* subject not appropriate for participating in this study according to the investigator's opinion
* subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product
A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)

This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years.

There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.

Eligibility Criteria:
Inclusion Criteria:

* Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.
* Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met.

Exclusion Criteria:

* Medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to the use of LUM-201
* Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.
NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis

The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.


Eligibility Criteria:
Inclusion Criteria:

* Male patients 18 years or older
* Voluntary written consent
* Histologically proven adenocarcinoma of the prostate
* Evidence of radiographic bone metastases
* May have received prior chemotherapy for metastatic disease, but prior chemotherapy is not a requirement for eligibility
* Eastern Cooperative Oncology Group performance status 0-2
* Serum testosterone level is less than or equal to 50 ng/dL
* Has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone (GnRH) analogue therapy
* Adequate organ function as measured by screening laboratory values specified in the protocol
* Must agree to use appropriate contraceptives prior to study procedures, during duration of study participation and for 4 months after last dose of TAK 700
* Must be able to lie flat for greater than or equal to 30 minutes during PET/CT imaging
* Screening calculated ejection fraction of greater than or equal to 50% by multigated radionuclide angiography (MUGA) scan or Echocardiogram

Exclusion Criteria:

* Received Strontium-89, Samarium-153, or other radioisotope within 3 months of registration
* history of allergic reactions attributed to compounds similar to sodium fluoride F-18 (NaF)
* history of seizure disorder
* Known history of brain metastases
* Concurrent treatment with any herbal products within 7 days of study entry
* Received radiotherapy less than or equal to 4 weeks prior to registration
* Known hypersensitivity to TAK-700 or related compounds
* Prior therapy for treatment of metastatic castrate resistant prostate cancer with any androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as: enzalutamide (MDV-3100), abiraterone, ketoconazole, or aminoglutethimide
* Current bladder neck outlet obstruction
* Current spinal cord compression
* Current bilateral hydronephrosis
* History of adrenal insufficiency
* History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias (over grade 2), thromboembolic events, or any other cardiac condition within 6 months prior to first dose of study drug.
* Uncontrolled high blood pressure
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
* Major surgery less than or equal to 4 weeks before the first dose of study drug
* Serious infection less than or equal to 2 weeks before the first dose of study drug
* Known gastrointestinal (GI) disease or GI procedure that could interfere with oral absorption or tolerance of TAK-700, including difficulty swallowing capsules
LEONIDaS Caregivers Study

Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections.

Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers.

The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the study
* Aged 18 years or above
* Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
* Able to access the internet

Exclusion Criteria:

* Inability to provide informed written consent
* Another caregiver of the same individual with Dravet is already enrolled in the study
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)

The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients in sinus rhythm
* with or without previous paroxysmal AF
* with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT)
* capable of atrial activity monitoring were included in the study

Exclusion Criteria:

-Previous documented atrial fibrillation
Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants

The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).


Eligibility Criteria:
Inclusion Criteria:

* Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant

Exclusion Criteria:

* Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover
Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy

The study investigates the safety, tolerability and efficacy of a single intravenous infusion of two doses of mesenchymal precursor cells versus placebo in subjects with diabetic nephropathy and type 2 diabetes.

This study is taking place in Melbourne, Australia.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are ≥ 50 and ≤ 85 years old
* Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening
* Subjects with diabetic nephropathy and CKD stage 3b-4
* Albumin-to-creatinine ratio (ACR) from a spot urine sample \>30 and \< 3000 mg/g at Screening
* Subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) for at least 12 weeks prior to Screening.
* HbA1c \< 10.0% at Screening

Exclusion Criteria:

* Prior participation in any stem cell study
* Women of childbearing potential
* Potentially unreliable subjects and those judged by the Investigator to be unsuitable for the study
* History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of \>3 alcoholic beverages (i.e. \> 21 alcoholic beverages per week)
* Body weight \>150 kg
* Subjects with non-diabetic renal disease e.g. known polycystic kidney disease
* Subjects with a history of a renal transplant or who have had prior dialysis within 3 months of Screening and/or have not maintained a stable level of kidney function within 3 months of Screening
* Current or history within 6 months of Screening of NYHA Class III or IV heart failure
* Myocardial infarction or stroke within 6 months prior to Screening
* Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the Investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study