cyrilzakka/clinical-trials huggingface dataset:
Cerebral Embolization During Pulmonary Vein Isolation

The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.

Pulmonary vein isolation (PVI) is a well-established interventional treatment of patients with atrial fibrillation. Previous studies have shown that catheter-based treatments such as PVI may lead to cerebral ischemia. Cerebral ischemia related to PVI may present with new neurological deficits but may also occur as "silent brain infarction". However, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. To date, it remains unclear which procedural steps of PVI are associated with an increased risk of cerebral ischemia.

Cerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (TCD). TCD has been used in clinical routine for many years and is known to be safe in stroke patients. By performing continuous TCD monitoring for microembolic signals during PVI, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. In addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 W (QMODE) and very high power with a maximum of up tp 90 W (QMODE +)

Eligibility Criteria:
Inclusion Criteria:

* patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin
* age 18 years or older

Exclusion Criteria:

* pregnancy
* patient unable to provide written informed consent
Phase II Study of Arginine Butyrate With or Without Epoetin Alfa in Patients With Thalassemia Intermedia

OBJECTIVES: I. Determine whether arginine butyrate with or without epoetin alfa can stimulate gamma-globin chain production to a degree that decreases anemia and results in hematologic improvement in patients with thalassemia intermedia.

II. Determine whether a proportional increase in gamma-globin synthesis and mRNA and an improvement in nonalfa and alfaglobin chain imbalance by at least 10% over baseline correlate with improved hematologic response in these patients when treated with this regimen.

III. Determine whether a decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels correlates with improved hematologic response in these patients when treated with this regimen.

IV. Determine whether any particular genotypes are more responsive than others to this therapy in these patients.

V. Determine whether baseline epoetin alfa levels, gender, and/or baseline reticulocyte counts (or percent circulating nucleated erythroblasts) correlate with improved hematologic response in these patients when treated with this regimen.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive arginine butyrate IV over 6-14 hours on days 1-5 of weeks 1-4 and 7-10. Patients then receive maintenance arginine butyrate IV over 6-14 hours on days 1-4 of weeks 13, 15, 17, 19, 21, 23, and 25.

Patients who have no medical contraindications (e.g., paraspinal extramedullary hematopoiesis, hypertension, or poorly controlled congestive heart failure) may continue therapy. Patients receive arginine butyrate IV over 6-14 hours on days 1-4 of weeks 27, 29, 31, 33, 35, 37, and 39 and epoetin alfa intramuscularly (IM) or subcutaneously (SC) three times weekly on weeks 27-40.

Patients may continue to receive epoetin alfa IM or SC alone three times weekly on weeks 41-52. Patients with severe anemia (hemoglobin less than 7 g/dL) may receive epoetin alfa alone on weeks 1-12 before arginine butyrate induction therapy.

Patients who complete therapy at week 26 are followed every 2 weeks for 2 months. Patients who complete therapy at week 40 are followed monthly for 2 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of thalassemia intermedia with hemoglobin no greater than 10 g/dL Two beta thalassemia mutations
* Must have undergone prior splenectomy or have no palpable spleen

--Prior/Concurrent Therapy--

* At least 3 months since prior red blood cell transfusion

--Patient Characteristics--

* Performance status: SWOG 0-2
* Hematopoietic: No severe iron overload or ferritin greater than 5,000 ng/mL
* Hepatic: Normal hepatic function No active hepatitis
* Renal: Normal renal function
* Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be willing to have vascular access placed No viral disease No contraindication to study compliance
Cryoablation Therapy or Radiotherapy Therapy for Stage III Prostate Cancer

This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or cryoablation.

OBJECTIVES:

* To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
* To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (\> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma, T3aN0M0, T3bN0M0
* Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
* Survival ≥ 12 months
* WHO performance status 0-2
* white blood cell ≥ 3.5 ×10\*9/L
* Platelets ≥ 5×10\*9/L
* Hemoglobin ≥ 10 g/dL

Exclusion Criteria:

* History of malignant disease
* History of coronary artery disease
* Uncontrolled infection
* Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
* Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
Molecular Analysis of Microbial DNA in Infected Necrotizing Pancreatitis

Necrotizing pancreatitis is a severe form of inflammation of the pancreas with subsequent destruction of the pancreas (necrosis). Often, this condition manifests in patients as an overwhelming systemic inflammatory response and multisystem organ failure. Many times the pancreas can become superinfected with bacteria and other organisms as a result of this process. Clinicians may decide to sample fluid from the pancreas or pancreatic tissue to determine the presence of infection. This can be done through surgery with a concurrent debridement and drainage of the pancreas or by a radiologist using an ultrasound or CT guided method to sample the pancreatic fluid. These samples are then sent for culture in the microbiology laboratory. Culture results often reveal 1-2 types of infecting bacteria that originate from the gastrointestinal tract. The investigators hypothesize that in actuality, many different kinds of bacteria may infect the pancreas. This project uses molecular DNA techniques to help identify bacteria present in the pancreas of patients with severe necrotizing pancreatitis.

In this study, patients with severe necrotizing pancreatitis will be followed prospectively throughout their hospital course (anticipated duration of hospitalization ranging between 4-8 weeks). If patients are suspected to have infection of pancreatic necrosis, they will be consented for enrollment. Patients will be determined by their attending physician to require either operative intervention or radiologic guided drainage of pancreatic necrosis and infected peripancreatic fluid. At the time of drainage procedure or intervention, one sample of peripancreatic fluid will be sent to the hospital's microbiology department for standard gram stain and bacterial culture identification and a second sample will be frozen for bacterial DNA analysis. Patients will be followed for the duration of their hospitalization for in hospital outcomes, mortality and final microbiology culture results. Samples will then be processed at six months and one year following sample collection for bacterial DNA deep sequencing analysis and will be compared to bacteria identified using standard culture technique.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Severe necrotizing pancreatitis as evidenced by clinical examination, biochemical analysis, and/or imaging studies demonstrating pancreatitis and pancreatic necrosis

Exclusion Criteria:

* Age less than 18 years old
* Participation in another device or drug study
Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.

The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.


Eligibility Criteria:
Inclusion Criteria:

* To be caregivers
* Have been in employment between March 15 and May 15, 2020

Exclusion Criteria:

* None
Treatment of Cutaneous Leishmaniasis With a Combination of Miltefosine and Antimony

Cutaneous leishmaniasis is endemic in the New World and, until recently, the standard treatment was pentavalent antimony. The cure rate for L panamensis in Colombia is 91%-93% and the cure rate in Bolivia is also 90%. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.

The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia (91 and 92% respectively). Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.

Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.

In the present protocol, the combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.


Eligibility Criteria:
Inclusion Criteria:

* Parasitological confirmation
* at least 1 lesion must be ulcerative
* No specific antileishmanial therapy during the previous six months

Exclusion Criteria:

* Concomitant diseases such as Tuberculosis, HIV, diabetes, renal failure, liver disease
* abnormalities CTC 2 in blood, liver, kidney test or EKG
Identification of Critical Thermal Environments for Aged Adults

This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.

The earth's climate is warming well above historical averages, and there is an increased frequency, duration, and severity of heat waves. At the same time, the world's population is rapidly aging. Aging is associated with reductions in thermoregulatory capacity due to reductions in sweating and skin blood flow. For this reason, people ≥65 years exhibit exponentially larger increases in morbidity and mortality during heat waves than younger individuals, with the large majority of excess deaths during heat waves occurring in the elderly.

Compounding the physiological effects of primary aging, co-morbidities and common classes of drugs taken by older adults can further compromise their thermoregulatory function. One such class of medications is cyclooxygenase inhibitors, including aspirin (ASA) and other platelet inhibitors. Provocative data published by our lab indicate that platelet inhibitors including ASA increase the rate of heat storage during passive heat stress by \~25%. Following current clinical guidelines, nearly 40% of US adults over the age of 50 engage in an aspirin therapy regiment for the primary or secondary prevention of cardiovascular disease.

Although there is compelling evidence that aging is associated with decreased heat dissipation and elevated risk of heat illness in hot ambient conditions, the significant question remains: In what specific environments does this age disparity begin to occur? The goal of the current study is to identify and model ambient conditions that are unsafe for older adults. A second aim of the study is to determine the effects of the commonly used platelet inhibitor, acetylsalicylic acid (ASA), on age-specific critical environmental limits.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older (those 40+ years of age must be cleared by collaborating physician)
* All premenopausal women will be eumenorrheic (by survey)
* Asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription

Exclusion Criteria:

* Medications that affect thermoregulatory or cardiovascular responses to exercise
* Any contraindications to low intensity physical activity on the Physical Activity Readiness Questionnaire
* Any mobility restrictions that interfere with low intensity physical activity
* Pregnant or planning to become pregnant in the next 12 months
* Prior diagnosis of cancer, cardiovascular disease, diabetes, or metabolic syndrome
* Illegal/recreational drug use
* History of Chron's disease, diverticulitis, or similar gastrointestinal disease
* Abnormal resting or exercise electrocardiogram (ECG)
Albiglutide Glucose Clamp Study in Subjects With Type 2 Diabetes

This is a stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given prior to a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner.

This is a Phase II, single-site, randomized, double-blind, parallel-group, placebo-controlled, stepped glucose clamp study designed to investigate the effect of treatment with albiglutide on counter-regulatory hormone responses and recovery from hypoglycemia in subjects with Type 2 diabetes mellitus. A single dose of albiglutide or placebo will be given 3 days before employing a stepped hyper- and hypoglycemic clamp. The goal of this study is to demonstrate that albiglutide increases insulin secretion and decreases glucagon levels in a glucose-dependent manner. In particular, this study is being conducted to ensure that albiglutide does not impair counter-regulatory responses during hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Historical diagnosis of type 2 diabetes mellitus for at least 6 months and less than 10 years before Screening
* HbA1c \<10% at Screening for subjects who do not require washout of existing OAD or \<9% at Screening for subjects who do require washout from existing OAD
* Body mass index in range 28 kg/m2 to40 kg/m2

Exclusion Criteria:

* History of pancreatitis or current ongoing symptomatic biliary disease or pancreatitis
* History of significant gastrointestinal surgery,
* History of significant cardiovascular disease
* History of a seizure disorder
* Documented hypertension or hypotension
* Use of oral antidiabetic agents, except for metformin, within 14 days before investigational product administration.
* Current hepatic disease or abnormal liver function tests
* Positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 1 or 2
* History of regular alcohol consumption (exceeding 7 drinks/week for women or 14 drinks/week for men)
* Female subject is pregnant (confirmed by laboratory testing), lactating, or less than 6 weeks postpartum
* Known allergy to any GLP-1 analog or excipients of albiglutide, Baker's yeast, or insulin
* History of type 1 diabetes,
* Prior exposure to GLP-1 agents, including albiglutide
* Blood donation over 500 mL within 8 weeks before Screening
Comparing Intensive and Standard Training for Human Insulin Inhalation Powder (HIIP)

The purpose of this study is to compare intensive and standard training for human insulin inhalation powder in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Age 18 or older.
* Taking at least 1 oral antihyperglycemic medication.
* Have an HbA1C between 7.5 and 12.
* Be a nonsmoker

Exclusion Criteria:

* Body Mass Index (BMI) greater than 40.
* Have frequent episodes of severe hypoglycemia.
* Have advanced autonomic neuropathy.
* Have history of asthma.
* Have chronic obstructive pulmonary disease (COPD).
Effects of Wearing Progressive Addition Lens on Working Distance and Refractive Status in Adult Computer Users

With the increasing reliance on tablet computers and smartphones in daily life, it is important to determine whether and how the prolonged usage of these handheld digital devices influences the working habits and refractive status. This study aimed to determine the effects of wearing conventional single-vision lenses vs. new progressive addition lenses on the working distance and refractive status while playing interactive video game in Chinese pre-presbyopic adult computer users.

Chinese adult computer users were recruited from two age cohorts. They were prescribed, in random order, with conventional single-vision lenses and progressive addition lenses designed for handheld digital display devices (iPad). Basic ocular parameters were measured through a comprehensive eye examination at the baseline visit. Working distance and refractive shift were measured immediately after delivering the lenses and after one month of lens wear. Working distance were recorded with an automatic ultrasound sensor while the participants were playing a 30-minute video game. Refractive-error shift before and after playing the video game were measured with an open-field autorefractor in both eyes and averaged.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese
* Computer users (computer usage \>2hours/day)
* Spherical-equivalent refractive errors between plano and -9.00D and cylindrical power ≤2.50D

Exclusion Criteria:

* Anyone with visual acuity worse than 0 logMAR, anisometropia more than 2.00D, abnormal accommodative function, wearing rigid contact lens, and a history of ocular surgery and pathology
Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF（Tumor Necrosis Factor）Therapy

A case-control study to evaluate the immunoinflammatory effect of prior exposure to anti-TNF therapy in patients with ulcerative colitis starting vedolizumab therapy

Inflammatory bowel disease (IBD)- ulcerative colitis (UC) and Crohn's disease (CD)- are chronic conditions of the gastrointestinal tract. Treatment generally consists of immunosuppression to modify the dysregulated immune responses. Vedolizumab, an inhibitor of α4β7, is a highly effective therapy for treating IBD, that minimized adverse effects through its gut selective inhibition of lymphocyte trafficking. However, the mechanism of action remains incompletely characterized especially in those previously treated to other biologics and why some patients are either vedolizumab non-responders or fail to respond over time. We would like to address the question whether anti-TNF non-responders as well as those that either do not respond or fail overtime to respond to vedolizumab identifies a specific population with difficult to treat disease that have alternate trafficking patterns and whether prior exposure to anti-TNF alters the mucosal immune responses, and/or trafficking patterns when compared to anti-TNF naive patients that may help explain impaired response to vedolizumab induction therapy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>18 years old)
* clinical diagnosis of inflammatory bowel disease (Ulcerative Colitis)
* clinical indication for biologic therapy
* naive or failed anti-TNF therapy previously

Exclusion Criteria:

* patients allergic or intolerant to vedolizumab,
* past use of vedolizumab;
* patient unable to give consent to enter the study
The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.


Eligibility Criteria:
Inclusion Criteria:

* Every patient with non union in the site of long bone fracture
* Age more than 18 and under 60 years old
* Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
* No infection in site of surgery
* Be able and willing to participate in the study
* Written informed consent

Exclusion Criteria:

* Evidence of malignancy
* Pregnancy or breastfeeding
* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing