cyrilzakka/clinical-trials huggingface dataset:
The Relationship Between Aortic Pulse Wave, Aortic Calcification and Peripheral Artery Occlusion Disease in Peritoneal Dialysis Patients

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. As compared with HD or pre-dialysis patients, uremic patients treated with PD have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in PD patients, are needed for future management and preventions of CV related morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Patients at National Taiwan University Hospital (NTUH)
2. Patients who have received PD more than 3 months
3. Patients who sign the informed consents

Exclusion Criteria:

1. Patients who refuse to sign informed consents
2. Patients who refuse to draw additional blood for research
Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy.

The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.

Some authors have investigated, in a retrospective fashion, the use of routine shave margins, where surgeons routinely take additional margins at the time of the initial partial mastectomy as a means of obtaining negative margins. While these retrospective studies have found that positive margin rates declined using this technique, opponents to this technique wonder if this truly results in a higher negative margin rate without compromising cosmesis or increasing tissue volume removed. As these studies were retrospective, it was possible that the initial resection was smaller than what those who do not routinely take shave margins would resect. No one had evaluated the impact of further resection on operative time, nor in a blinded fashion, evaluated cosmesis. Further, there had yet to be a prospective study to evaluate the impact of this on local recurrence rates. Hence, the investigators performed a prospective randomized controlled trial of this technique at Yale. The data from this study, published in the New England Journal of Medicine, found that the technique cut positive margin and re-excision rates in half. Some wondered, however, about the external generalizability of these findings, particularly in non-academic settings. Hence, a multicenter trial to validate these findings is warranted.

Eligibility Criteria:
Inclusion Criteria

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same
2. Women ≥ 18 years of age
3. Ability to understand and the willingness to sign a written informed consent document.

Exlusion Criteria

1. Total mastectomy
2. Known metastatic disease
3. Bilateral synchronous breast cancer
4. Multicentric cancers requiring double lumpectomy
5. Previous history of breast cancer (even in the other breast)
6. Patients receiving Intraoperative radiation therapy (IORT)
7. Patients who had excisional biopsy for diagnosis of their cancer (I.e., instead of a core biopsy)
Polymorphism of ITGA4 Gene in Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.

The aim of the study:

is to investigate ITGA4 gene expression pattern in CLL.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed CLL.

Exclusion Criteria:

* ▪ Patients previously diagnosed as CLL and received treatment before.

  * Patients with other solid tumors.
INVESTIGATION OF THE EFFICACY OF FISTULA OBLITERATION BY STEAM ABLATION IN PERİANAL FISTULAS

Perianal fistula(PF) is one of the most frequent disease in anorectal disease.The incidence of PF is 8,6 -10 / 100 000 . The first surgical treatment is defined by Hippocrates in PF .This surgical treatment which found by Hippocrates , involves seton insertion into the tract of fistula . Today most of surgeon still use the same technic but PF is really hard disease to treat. Recurrence rate of PF is really high and there are lots of complication about this disease. The most scary complication during the surgery or postoperatively is anal disfunction. ın PF surgical technics involves ;fistulectomy (coring out), lay open (fistulotomy), Ligation of Intersphincteric Fistula Tract, advancement flap and laser ablation of the fistula tract . The popularity of laser ablation of the fistula tract is increasing day by day.This surgical procedure is applied with the laser device which use in varicose vain ablation in vascular surgery.In this study the investigator are trying to find out the effect of steam ablation in PF on rats.

Perianal fistula(PF) is one of the most frequent disease in anorectal disease..This surgical treatment which found by Hippocrates , involves seton insertion into the tract of fistula . Todaymost of surgeon still use the same technic but PF is really hard disease to treat. Recurrence rate of PF is really high and there are lots of complication about this disease.

The most scary complication during the surgery or postoperatively is anal disfunction. ın PF surgical technics involves ;fistulectomy (coring out), lay open (fistulotomy), Ligation of Intersphincteric Fistula Tract), advancement flap and laser ablation of the fistula tract . The popularity of laser ablation of the fistula tract is increasing day by day.This surgical procedure is applied with the laser device which use in varicose vain ablation in vascular surgery.In this study the investigator are trying to find out the effect of steam ablation in PF on rats.This new procedure has to be tried on rat firstly and the studies is very important which tried on rats.

Our research includes 32 rats and Firstly the investigator created perianal fistula tract with 2.0 silk suture material on 3 o'clock in perianal region.1 month will wait for the maturation of fistula tract. After that the suture materials removed from the fistula tract and one fistula tract will treat with steam ablation device (3 o'clock )in 16 rats and the other 16 rats will be the control group .1 month will be wait for the examination of treatment of fistula tract in steam ablation group.Evaluation of fistula tract will define with microscopic examination after the excision.End of the study the investigator will be find out the effect of steam ablation on perianal fistula .

Eligibility Criteria:
Inclusion Criteria:

* All rats which have iatrogenic perianal fistula tract.

Exclusion Criteria:

* Death of rat
Personality and Drug Use (PDU)

The study aims to assess whether the use of drugs relates to personality ratings. Specifically, we plan to investigate if people with different histories of substance use differentiate on personality assessments (current and past).

The study aims to assess the association between the use of various substances (including psychedelic and non-psychedelic drugs) and personality profiles. Specifically, the association between past drug usage and personality profiles will be investigated. As psychedelics were found to influence changes in personality over time, the present study aims to measure both the current personality profile (via the Big Five Inventory-44 (BFI)) and perceived retrospective changes in personality (via a self-constructed Retrospective Personality Scale (RPS)). To our knowledge, no study has explored the diversity of substance use histories in relation to individual current and retrospective personality traits and aggregate personality profiles.

This project aims to survey a large number of participants from all around the world, using a mobile app-based survey. The remote character of the study will increase its accessibility and diversity, which are common shortcomings in the psychedelic line of research. Additionally, a remote, anonymous study setup with no face-to-face interactions might help overcome any potential concerns participants may have regarding the sharing of sensitive information (e.g., reports on illicit substance use).

To increase scientific transparency and for educational purposes, the study team plans to share results summaries (comparisons of personalized results with the aggregated ones among participants sharing similar characteristics e.g., age, substance use history), which might be an additional motivating factor for study completion. Lastly, given that drug use in the natural environment (excluding laboratory/experimental setting) is characterized by large substance diversity and poly-drug use, we aim for a large sample size (with a minimum of 36 subjects per substance(s) category) to perform subgroup analyses. Therefore, this large-scale, low-budget, naturalistic, retrospective, observational study aims to shed light on the aforementioned gap in the literature and to lay a foundation of evidence for further (observational and experimental) research within the field.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* full legal and mental capacity
* access to a smartphone (iOS and Android) with internet

Exclusion Criteria:

* not fluent in English
* not able to read
CLAM Chemotherapy With PBSC Support for Relapsed Patients After Allogeneic Stem Cell Transplantation

For acute leukemia patients with early relapse after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we evaluate the treatment outcome and safety of chemotherapy with Cladribine, cytarabine and mitoxantrone followed by peripheral stem cell support from the original donor.

For acute leukemia patients experienced relapse 6 months or less after allogeneic stem cell transplantation, the overall outcome is poor. In this study, we design a treatment protocol aiming to achieve complete remission for this high-risk group of patients with chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days followed by infusion of mobilized peripheral stem cell from the original donor. For patients who failed to achieved remission,a second cycles will be given. For patients who achieved remission, the post-remission therapy is open depend on patient's intent: consolidation with one more cycle, second allo-HSCT with different donor or continuous DLI.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute leukemia relapsed within 6 months after previous allo-HSCT
* no active GVHD
* mobilized PBSC from the original donor available

Exclusion Criteria:

* ECOG \>=3
* liver function/renal function damage (over 2 X upper normal range)
* active infection including CMV and EBV
TaKeTiNa in the Treatment of Depression: a Pilot Study.

The goal of this clinical study's to analyse the impact of TaKeTiNa music therapy in depressed patients.

The main question\[s\] it aims to answer are:

. Can TaKeTiNa result in a significant pre-to-post intervention decline of depression severity 2. Can TaKeTiNa result in a significantly lower post-intervention depression severity in the T1/T2 group than in the W1/W2 group.

Participants will

* be randomly assigned to the two groups, intervention vs. waitlist
* receive either an eight week TaKeTiNa music therapy or waitlist
* be analysed using questionaires, blood taking, cortisol saliva analysis, measured heart rate variability

Researchers will compare a waitlist to see if TakeTiNa is superior to waitlist

One third of the depressed patients do not respond adequately to conventional treatment. This seems to be associated with increased production of proinflammatory cytokines such as TNF-a and IL-1, as well as dysregulation of cortisol levels. This project aims to investigate Investigate the effectiveness of TaKeTiNa music therapy in the treatment of patients with clinical diagnosis of moderate to severe depression Investigate the physiological and pathophysiological effects of TaKeTiNa using novel blood based biomarkers of depression, especially LDL cholesterol as well as on immune system function in order to establish immune system based biomarkers for better diagnosis and therapy monitoring of major depressive disorder.

Eligibility Criteria:
Inclusion Criteria:

Major depressive disorder Ability to walk, speak, and clap

Exclusion Criteria:

* psychotic symptoms
* acute suicidality
* prior intolerance to body therapeutic methods
Study of Efficacy and Safety of Voretigene Neparvovec in Japanese Patients With Biallelic RPE65 Mutation-associated Retinal Dystrophy

The purpose of this study is to provide safety and efficacy data for voretigene neparvovec, administered as subretinal injection, in Japanese patients with biallelic RPE65 mutation-associated retinal dystrophy.

This is an open-label, single-arm study to evaluate the safety and efficacy of bilateral subretinal administration of voretigene neparvovec in Japanese patients with biallelic RPE65 mutation-associated retinal dystrophy. Assessments will include full-field light sensitivity threshold testing, visual fields, visual acuity, vector shedding, immunogenicity and adverse events. Participants will be monitored for 5 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Japanese participants with biallelic RPE65 mutation-associated retinal dystrophy; molecular diagnosis of RPE65 mutation must be confirmed by a Novartis designated laboratory in Japan.
* Age four years or older.
* Visual acuity worse than 20/60 (both eyes) and/or visual field less than 20 degrees in any meridian as measured by a III4e isopter or equivalent (both eyes).
* Sufficient viable retinal cells as determined by non-invasive means, such as optical coherence tomography (OCT) and/ or ophthalmoscopy. Must have either:

  * An area of retina within the posterior pole of \> 100 µm thickness shown on OCT, or
  * ≥ 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole, or
  * Remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent

Exclusion Criteria:

* Any prior participation in a study in which a gene therapy vector was administered.
* Participation in a clinical study with an investigational drug in the past 6 months from screening visit.
* Known hypersensitivity to any of the study treatments including excipients or to medications planned for use in the peri-operative period.
* Unable to reliably perform the FST assessment.
* Use of retinoid compounds or precursors that could potentially interact with the biochemical activity of the RPE65 enzyme in the past 6 months from screening visit.
* Prior intraocular surgery within 6 months from screening visit.
* Prior use of any medicines that, in the opinion of the investigator, may have caused retinal damage (e.g., sildenafil or related compounds, hydroxychloroquine, chloroquine, thioridazine, any other retino-toxic compounds)
* Pre-existing eye conditions or complicating systemic diseases that would preclude the planned surgery or interfere with the interpretation of study. Complicating systemic diseases would include those in which the disease itself, or the treatment for the disease, can alter ocular function.
Gentle Jogger and Oxygen Consumption

This is a non randomized study to determine the effects of Gentle Jogger(GJ), a passive jogging device on oxygen consumption in 2 postures supine and seated. Oxygen consumption measurements will be performed via indirect calorimetry in duplicate at rest ( supine and seated posture) , and repeated in duplicate during GJ (in supine and seated posture)

The Gentle Jogger (GJ) is a patented non-FDA regulated wellness device in which GJ; 1) as part of a healthy lifestyle may help prevent certain chronic diseases or conditions such as heart disease, high blood pressure, and type 2 diabetes and 2) may help living well with certain chronic diseases or conditions such as heart disease, high blood pressure and type 2 diabetes. GJ is a passive simulated jogging device which moves the feet up and down passively, simulating jogging. GJ addresses the major health problem of physical inactivity.

This is a non randomized study of adult subjects on the effects of Gentle Jogger (GJ) on resting oxygen consumption (VO2).

This study will determine whether or not the use of GJ in either sitting or supine postures changes resting oxygen consumption, measured using indirect calorimetry method.

Potential study subjects will be invited to participate, and informed consent obtained from each subject.

Each subject will me asked to lie in supine posture for 20 mins followed by duplicate measurements of VO2. The GJ will be started in supine posture for 20 min followed by duplicate measurements of VO2. The subject will then be asked to sit in a chair for 20 min, followed by duplicate measurement of VO2, The GJ will be started for 20 min in seated posture followed by duplicate measurements of VO2.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects \> 25 yrs old

Exclusion Criteria:

* Unable to provide informed consent
* Inability to follow command
* Physically unable to move feet up and down on a gentle jogger
Effectiveness of Vancomycin Loading Therapy

The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.

The Study drug

* Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus

Study design : Randomized controlled trials

Study Drug Administration

* If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
* Patients with SIRS (systemic inflammatory response syndrome)
* Intravenous vancomycin therapy deemed necessary

Exclusion Criteria:

* Age less than 20 years
* Age more than 75 years
* Current renal insufficiency defined as estimated Glomerular filtration rate \< 50mg/min/1.73 m2 by MDRD equation
* History of adverse events to vancomycin 5. Pregnant woman
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.

The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years old
* elective liver resection of liver tumor
* in females: pregnancy test negative
* Subjects willing and able to give fully informed written consent

Exclusion Criteria:

* subjects with contra-indications to Moxifloxacin
* subjects under therapy with Moxifloxacin within 2 weeks before recruitment
Tailored Messages to Increase Eye Examination Behavior

The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.

Studies have shown that people are not getting their eyes examined on a regular basis, even though dilated eye exams can detect eye diseases like glaucoma and diabetic retinopathy early, before significant vision loss has developed. Early detection can lead to earlier treatment, which can save sight by preventing or slowing the progression of these eye diseases. In this project we designed, implemented, and are now evaluating tailored and targeted print health messages to increase eye examination behavior in an African-American population 65 years of age and older, a group at increased risk of glaucoma and diabetes.

Eligibility Criteria:
Inclusion Criteria:

* African-American
* 65 years of age or older
* no dilated fundus exam in past 2 years

Exclusion Criteria:

* appointment for dilated fundus exam scheduled
* no access to phone