cyrilzakka/clinical-trials huggingface dataset:
Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

The main purpose of this observational cohort study is to assess routine emergency management of acute stroke patients with AF under different anticoagulation schemes before the index stroke.

The investigators will address the following aims and objectives:

1. Describing emergency management of stroke patients (IS and ICH) with AF in clinical routine including early diagnostic, therapeutic and preventive procedures and assessing variations in emergency management of patients with AF by anticoagulation schemes pre stroke.
2. Identifying variations in risk of early complications (e.g. symptomatic secondary intracerebral haemorrhage in ischemic stroke patients) with AF by different anticoagulation schemes pre stroke.
3. Determining factors influencing outcome of stroke patients with AF at three months and clarifying the potential influence of different anticoagulation schemes pre stroke.

The registry consists of 2 separate substudies that cover two different patient cohorts: ischemic stroke and intracerebral hemorrhage.

The study will collect information from prospectively enrolling Neurology departments with certified stroke units across Germany.

The principal investigator, Prof. Dr. med. Roland Veltkamp, is affiliated with Imperial College London, UK, and Heidelberg University Hospital, Germany.

Eligibility Criteria:
Ischemic stroke substudy:

Inclusion Criteria:

* Age \>= 18 years
* Informed consent
* Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging

  * Anticoagulation with NOAC
  * Anticoagulation with VKA
  * No anticoagulation
* Previous/present atrial fibrillation

Exclusion Criteria:

* No informed consent
* Symptom-onset \> 24 h

Hemorrhagic stroke substudy:

Inclusion Criteria:

* Age \>= 18 years
* Acute primary intracerebral hemorrhage
* - a) Anticoagulation with NOAC
* - b) Anticoagulation with VKA
* - c) No anticoagulation
* Previous/present atrial fibrillation

Exclusion Criteria:

* No informed consent
* Symptom-onset \> 24 h
DIT After RYGB - A Prospective Study

Bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese patients. This loss is a result of several factors that go beyond the simple anatomical abnormality of the gastrointestinal tract and may be the product of post-op energy expenditure changes. The respiratory quotient (RQ) and diet-induced thermogenesis (DIT) are important components of energy expenditure and possible changes in them can perform an important role in weight loss after Roux-en-Y Gastric Bypass (RYGB). Previously, we conducted a cross-sectional study where we measured the RQ and DIT in pre and post-op RYGB patients, which was published in the Surgery of Obesity and Related Diseases (SOARD) journal. The objective of this study is to perform a prospective analysis of these same variables (RQ and DIT), evaluating them in the same patients, when pre and postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Pre-op: Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with associated co-morbidities. Age \> 18 years
* Post-op: Patients who underwent surgery ≥ 12 months by the Head Surgeon of the Gastrocirurgia de Brasilia Clinic;

Exclusion Criteria:

* Patients aged \> 65 years. Severe heart and/or respiratory problems; Pregnant women.
White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

The aim of this study is to evaluate the effectiveness of calcium fluoride nanoparticles containing orthodontic primer in preventing or decreasing the incidence WSLs over a period of 6 months in patients with fixed orthodontic appliances.

This study proposed to be double blinded, split mouth, randomized clinical trial, with equal randomization (1:1 allocation ratio).

The sample was selected and recruited from patients attending two centres (Orthodontic Department at Karbala Governmental Specialized Dental Center and Almina Dental Private Clinics/Karbala), but the bonding and follow up sessions were done in Almina Dental Private Clinics/Karbala. Patient recruitment was done according to specified inclusion and exclusion criteria.

Intervention procedure planned to be by bonding fixed orthodontic appliances to all patients. The four quadrants of the mouth will be divided into two groups (Group 1 and 2), with one group, the upper right and lower left quadrants bonded with nCaF2 resin, while the upper left and lower right quadrants bonded with control resin. For the other group, the reverse will be carried out. Then, by the use of a computer random number generator, the two groups will be randomly allocated, and each number in the random table will be given a study number in order to create the final Allocation Table for the participants in the study (which contained the study number and allocation group). the primary planned to be measured by DIAGNOdent Pen 2190 device to measure enamel demineralization objectively, while the secondary objective planned to be quantitative detection of Streptococcus mutans bacteria by using real-time PCR

Eligibility Criteria:
Inclusion Criteria:

* Patients have

  1. Fully erupted permanent teeth (regardless the third molar),
  2. Indication to have orthodontic treatment without extraction
  3. Fair or good oral hygiene before or after oral hygiene instruction

Exclusion Criteria:

* Patients will be excluded if they had

  1. Previous orthodontic treatment or extractions
  2. Missing teeth
  3. Active enamel caries determined by clinical examination
  4. Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation
  5. Labial restorations
  6. Severe periodontal diseases determined according to PDI index by Sigurd P. Ramfjord (Ramfjord, 1967)
  7. Craniofacial syndromes such as clefts
  8. Xerostomia determined from clinical history of the patient
  9. Severely rotated teeth (limiting the appearance of buccal surfaces)
  10. Heavy smokers determined by accounting the number of cigarettes per day and time to the first cigarette of the day (Heatherton et al., 1989) .
The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis

This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).

1. Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
2. To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of FSGS.
* Patients with a proteinuria ≥ 3.5g/24h,and blood albumin \<30g/L,and Scr\< 2.3 mg/dl and eGFR\>30ml/min per 1.73m2.
* Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.

Exclusion Criteria:

* Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
* Patients who are known to be allergic to a macrolide.
* Patients who have active hepatitis.
* Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
* Patients with blood leukocyte \< 3000/ul.
* Patients with kidney disease family history
* Patients with 2 type diabetes.
* Patients with obesity whose BMI\>28kg/m2.
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma or Observation After Radical Resection

The goal of this study is to determine the feasibility and safety of treating patients with a brain tumor known as craniopharyngioma with limited surgery and a 5mm clinical target volume margin in combination with proton therapy. Proton therapy will be indicated for patients with diagnosed craniopharyngioma who are not treated with radical surgery (gross-total resection). Irradiated patients will undergo a series of evaluations designed to evaluate the effects of proton therapy. Similar evaluations will be performed on patients treated with radical surgery. Proton therapy will include 30 treatment fractions administered 5 days per week. Weekly imaging will be a requirement to monitor for cyst expansion and target volume deformation.

The primary objectives of this study :

To estimate the progression-free and overall survival distributions for children and young adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm clinical target volume margin while monitoring for excessive central nervous system necrosis.

The Secondary Objectives of this study:

* To estimate the cumulative incidence of cystic intervention and the event-free survival distribution for children and young adults with craniopharyngioma treated with limited surgery and proton therapy using a 5mm clinical target volume margin; and compare the distributions of progression-free, event-free and overall survival with the distributions for the St. Jude Children's Research Hospital cohort of 93 patients on which the design of this trial is based.
* To estimate the distributions of progression-free survival and overall survival for children and young adults with craniopharyngioma treated only with primary surgical resection and to compare these distributions with the distributions observed for patients treated with limited surgery and proton therapy.

Eligibility Criteria:
Inclusion Criteria:

* Craniopharyngioma diagnosed by histology, cytology or neuroimaging.
* Patients ages 0-21 years at the time of diagnosis.

Exclusion Criteria

* Prior history of fractionated radiation therapy.
* Prior treatment with intracystic P-32, intracystic bleomycin or radiosurgery.
* Pregnant females are excluded. Radiation has teratogenic or abortifacient effects.
Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

Coronavirus disease (COVID-19) is a pandemic of unprecedented proportions with an exponential increase in incidence. Airway epithelium infection caused by coronavirus (SARS-CoV-2) triggers a cascade of difficult-to-control reactions, a so-called "cytokine storm". In contrast to the previously used method of external beam radiation therapy for patients at high risk of a cytokine storm, in present study a different dose delivery mechanism through inhalation of 99mTc-labeled carbon ultrafine aerosol obtained from a TechnegasPlus generator is used. By utilizing anthropometric phantoms the dosimetric characteristics of the applied technique and obtained the coefficients of the transition from the count rate over the area of interest to the activity contained in this area (in kBq) were studied. By observing a group of healthy volunteers after inhalation of 99mTc-labeled carbon ultrafine aerosol, the accumulated dose in the human lungs under internal irradiation of 99mTc was determined. A novel technique has been developed and the possibility of using inhaled low-dose radionuclide therapy in the complex treatment of patients with COVID-19 - associated pneumonia has been studied. As a result, a significant improvement of hematological parameters in the group of patients after inhalation of 99mTc-labeled carbon ultrafine aerosol as compared to the control group is expected.


Eligibility Criteria:
Inclusion Criteria:

1. Positive SARS-Cov-2 polymerase chain reaction (PCR)
2. CT confirmed pneumonia
3. Men and non-pregnant women ≥ 18 y/o with early laboratory signs of cytokine storm
4. Men and non-pregnant women \<65 y/o and/or with early laboratory signs of cytokine storm
5. Informed consent obtained for participation

Exclusion Criteria:

1. Age ≤ 18
2. Severe course of COVID-19
3. Pregnant or breast-feeding females
4. Severe concomitant pathology
5. Previous and/or present treatment of oncology disease (e.g. immunotherapy)
6. Autoimmune diseases, severe cardiac disease, bone marrow and/or visceral transplantation
7. Surgical treatment and/or radiotherapy of chest pathology
8. Treatment with specific antiviral and anticytokine agents a day before inhalation procedure
9. Absence of informed consent obtained for participation
Microdosing ICG for Serial Colonic Perfusion Study During Surgery

using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery

Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment

Eligibility Criteria:
Inclusion Criteria:

* all patient undergoing intestinal resection surgery

Exclusion Criteria:

* pregnancy, renal insufficiency
China Registry for Genetic / Metabolic Liver Diseases

CR-GMLD registry started on June 13, 2015 to collect cases of genetic/metabolic liver diseases from tertiary or secondary hospitals in mainland China. Demographics, diagnosis, laboratory test results, family history and prescriptions were recorded. Patients' whole blood and serum were collected for genetic testing and future researches. These patients will be followed-up every six to twelve months.

This web-based database was launched on June 13, 2015 and consists of tertiary or secondary hospitals with special interest and expertise on managing genetic/metabolic liver diseases patients across mainland China. The main inclusion criteria for this registration are patients who were diagnosed or possibly diagnosed with Wilson's disease, hereditary hemochromatosis, hereditary hyperbilirubinemias, inherited cholestatic liver disease or other genetic/metabolic liver diseases. At the first time of data entry, demographics, medical history, biochemistry and hematology results, radiology reports, diagnosis and treatment information were recorded. Patients' whole blood and serum were collected for molecular genetic testing and future researches. Then the registered patients will receive standard of care and be followed-up every 6 to 12 months. On each visit, biochemical, radiological reports, as well as clinical progress were recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients who were diagnosed or possibly diagnosed with Wilson's disease, hereditary hemochromatosis, hereditary hyperbilirubinemias, inherited cholestatic liver disease or other genetic/metabolic liver diseases.

Exclusion Criteria:

Patients who are unable or unwilling to provide informed consent.
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.

Compare the effects of Colesevelam versus the placebo on diabetic subjects with chronic diarrhea. In this study, diabetic subjects will get either the Colesevelam or the placebo, not both.

The plan is to have about 30 subjects complete this study at Mayo Clinic.

Eligibility Criteria:
Inclusion Criteria:

* Females and males age 18 -75.
* An IBS diagnosis based on the Rome III criteria for at least 3 months, with onset at least 6 months previously, of recurrent abdominal pain or discomfort.
* Biomarkers serum alpha C4 ≥ 40 ng/mL or FGF19 ≤ 80 pg/mL or fecal bile acid \>2000 micromoles/48h

Exclusion Criteria:

* IBS patients with known clinically-relevant inflammation.
* IBS patient with known bleeding diathesis
* History of abdominal surgery

Patients participating will not take any of the following disallowed medications for at least 7 days prior to and during the remainder of the study:

* Any treatment specifically taken for IBS-D, including loperamide, cholestyramine, alosetron
* Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors
* All narcotics
* Anti-cholinergic agents
* Tramadol
* Oral anticoagulants
* Antimuscarinics
* Peppermint oil
* Systemic antibiotics, as well as antibiotics directed at colonic flora such as rifaximin and metronidazole

Gastrointestinal preparations:

* Anti-nausea agents
* Osmotic laxative agents
* Prokinetic agents
* 5-HT3 antagonists
Ioflupane I123 (DaTSCAN) and Positron Emission Tomography-computed Tomography Fludeoxyglucose (PET-CT FDG) to Assess Brain Function of Parkinson Patients With Different Genetic Characteristics

Parkinson disease is one of the most common neurodegenerative illnesses. The disease is characterized by decrease in dopamine levels and decrease in the number of dopaminergic neurons and dopamine receptors. There are gene mutations that increase the risk for the disease. Two of those mutations are on the LRRK2 gene and on GBA gene. It is yet unknown if there is a difference between the metabolic brain function of Parkinson patients that carry one of the two mutations to Parkinson patients with no known mutation.

Participants: diagnosed Parkinson patients that carry a gene mutation in either LRRK2 or GBA genes, Parkinson patients with no known mutation and healthy volunteers as a control group.

The participants will go through both examinations DAT SCAN and PET CT SCAN at the Tel Aviv Sourasky Medical Center Nuclear Medicine Institute.

The examination results will be given to the participants by a doctor from the neurology department.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed Parkinson patients with known genetic characteristics

Exclusion Criteria:

* patients unable to understand and sign an informed consent
* minors
* patients in medical condition that does not allow them to stay still during the examination
cliNIcal sCEnarios and Pathophysiology of Atrial Fibrillation

Atrial fibrillation (AF) remains the most common sustained cardiac arrhythmia with prevalence and incidence continuously increasing worldwide. Current guidelines propose an etiological, symptom-based classification of the arrhythmia and mainly focused on its duration with consequent rhythm or rate-control strategies. Moreover, risk scores for atherothrombotic systemic or hemorrhagic events related to atrial fibrillation are principally based on patients cardiovascular history and risk factors.

This approach do not consider relevant pathophysiological aspects that may play a pivotal role in triggering or perpetuating the arrhythmia, especially at its first occurrence. At this point, a crucial step would be deeply investigating AF clinical and pathophysiological features to guide a tailored diagnostical and therapeutic approach. Indeed, early recognition and proper characterization of triggers, substrates, autonomic system imbalance and modulating factors (drugs, electrolytes, etc) are of the utmost importance for AF care and management.

Therefore, this large scale prospective observational study aims to evaluate clinical and pathophysiological features of patients with symptomatic and asymptomatic atrial fibrillation in different scenarios to understand possible distinctive characteristics warranting a personalized approach to the arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with electrocardiographic diagnosis of Atrial Fibrillation (New Onset, Paroxysmal, Persistent, Long Standing Persistent and Permanent) admitted to the Emergency Room and/or Cardiology Department /ambulatory care center of our Hospital
* Age \>18 years old
* Patients who can give their written informed consent.

Exclusion Criteria:

* Age \<18 years old
* Patients who cannot give their written informed consent.
Understanding Fabry Disease Therapy Choices Through the Eyes of the Patients

The objective of this study is to increase the understanding surrounding the choices presented to patients and families impacted by Fabry disease.

This will be a cross-sectional study conducted in approximately 130 individuals (or representative parents/caregivers of patients) living with Fabry disease. All study participants will complete the RSVP followed by a structured interview conducted by trained interviewers. It is estimated that each respondent will need up to 60 minutes for the entire process; 10 minutes to complete the RSVP including uploading the proof of Fabry disease diagnosis or verifying membership with Fabry groups, including but not limited to: Fabry Support and Information Group, National Fabry Disease Foundation, MPS Society UK, Morbus Fabry Selbsthilfergruppe, Fabry International Network, or others, and approximately 50 minutes to complete the interview.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be a person with Fabry disease who is 18 years or older or the parent/legal guardian of a living person with Fabry disease who is under the age of 18 years or who are 18 years and older who are unable to answer for themselves.
* Confirmed diagnosis of Fabry disease with written proof of disease provided
* Must have a genetic mutation that is amenable to oral therapy
* Resident of Germany, the U.K or the U.S.
* Able to read, write and communicate in German, or English.
* Able to grant informed consent
* Willing to participate in a 50 to 60-minute telephone interview, including follow up questions (if necessary) and information regarding adverse events (if necessary).

Exclusion Criteria:

* Inability to meet any of the inclusion criteria
A Comparison of Computerised Versus Interviewer-administered Approach for Assessing Health-related Quality of Life

The aim of this study is to compare a multimedia, computerised approach vs. interviewer administration of health-related quality of life (HRQoL) instruments.

There are no drug treatments involved in this study. The administration of health-related quality of life questionnaires is the intervention being studied. Health-related quality of life questionnaires measure the physical, mental and social well-being of an individual, are recognised as important patient-reported outcomes and are increasingly being used in clinical trials and routine clinical practice. By asking study participants to complete a questionnaire assessing their physical, mental and social well-being, we are increasing their awareness of these aspects of their health and may directly or indirectly prompt them to take actions and/ or have thoughts that may improve or worsen their health status. Hence, we have considered this an interventional study. This survey will be conducted in Chinese.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 and above
* Singaporean citizens or permanent residents
* Speaks Mandarin

Exclusion Criteria:

* Patients who are mentally incapable of completing a questionnaire