cyrilzakka/clinical-trials huggingface dataset:
Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index for Fluid Responsiveness

Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.

Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily agreed and signed the written informed consent form before participating in the study
* Adults aged 19 years or older
* American Society of Anesthesiologists physical class (ASA) 1-3
* Patients scheduled for elective hepatectomy under general anesthesia
* Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation
* Non-smokers with normal pulmonary function

Exclusion Criteria:

* Patients with abnormal findings on electrocardiogram before surgery
* Patients who cannot undergo peripheral venous puncture
Clinical Trial to Evaluate the Efficacy and Safety of CKD-386

Clinical Trial to Evaluate the Efficacy and Safety of CKD-386


Eligibility Criteria:
Inclusion Criteria:

1. Subjects are diagnosed with Dyslipidemia Patients with Hypertension or are being administered anti-hypertension and anti-hypertension drugs after diagnosis.
2. Subjects who agreed to participate in this clinical trial voluntarily.

Exclusion Criteria:

1. Subjects who were satisfied specific blood pressure levels that measured at screening period.
2. Subjects who were satisfied specific lipid levels that measured at screening period.
3. Subjects who cannot participate in a clinical trial based on the PI's judgment.
Child to Adult Neurodevelopment in Gene Expanded Huntington's Disease

Huntington's Disease (HD) is an autosomal dominant disease manifested in a triad of cognitive, psychiatric, and motor signs and symptoms. HD is caused by a triplet repeat (CAG)expansion in the gene Huntingtin (HTT). This disease has classically been conceptualized as a neurodegenerative disease. However, recent evidence suggests that abnormal brain development may play an important role in the etiology of HD. Huntingtin (HTT)is expressed during development and through life. In animal studies, the HTT gene has been shown to be vital for brain development. This suggests that a mutant form of HTT (gene-expanded or CAG repeats of 40 and above) would affect normal brain development. In addition, studies in adults who are gene-expanded for HD, but have not yet manifested the illness, (pre-HD subjects) have significant changes in the structure of their brain, even up to 20 years before onset of clinical diagnosis. How far back these changes are evident is unknown. One possibility is that these brain changes are present throughout life, due to changes in brain development,though initially associated with only subtle functional abnormalities.

In an effort to better understand the developmental aspects of this brain disease, the current study proposes to evaluate brain structure and function in children, adolescents, and young adults (ages 6-30) who are at risk for developing HD - those who have a parent or grandparent with HD. Brain structure will be evaluating using Magnetic Resonance Imaging (MRI) with quantitative measures of the entire brain, cerebral cortex, as well as white matter integrity via Diffusion Tensor Imaging. Brain function will be assessed by cognitive tests, behavioral assessment, and physical and neurologic evaluation. Subjects that are gene-expanded (GE) will be compared to subjects who are gene non-expanded (GNE). Changes in brain structure and/or function in the GE group compared to the GNE group would lend support to the notion that this disease has an important developmental component.


Eligibility Criteria:
Inclusion Criteria:

* Family history of Huntington's Disease
* Age 6-30 years
* Age-appropriate knowledge of HD and personal risk

Exclusion Criteria:

* Metal in body, including braces
* History of head trauma, brain tumor, seizures, epilepsy
* History of major surgery and/or significant ongoing medical issue(s)
Prospective Cohort of HIV/HBV-coinfected Patients in Europe

The overall aim of the project is to establish an international multi-cohort research platform of HIV/HBV-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes.

Hepatitis B virus (HBV) infection is a major cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected individuals and the progression of liver disease is accelerated in this population compared to HBV-monoinfected individuals. Tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) as part of antiretroviral therapy (ART) suppresses HBV viral load in most patients. However, risk factors of suboptimal virological response to TDF/TAF and predictors of hepatitis B surface antigen (HBsAg) loss remain unclear. While novel drugs for HBV therapy are being developed, a more thorough understanding of the factors associated with optimal outcomes is urgent. Euro-B considers all HIV/HBV-coinfected participants from EuroSIDA, the Swiss HIV cohort study and French, Spanish and German HIV-HBV cohorts treated with TDF/TAF for inclusion.

The overall aim of the project is to establish an international prospective multi-cohort research platform of HIV/HBV-coinfected individuals to improve our understanding of the determinants of treatment outcomes, including functional cure of HBV infection. Specifically, we aim to:

1. evaluate HBV virological suppression, hepatitis B e antigen (HBeAg) and HBsAg loss as well as the course of quantitative HBsAg (qHBsAg) levels during TDF/TAF-containing antiretroviral therapy
2. evaluate predictors of HBsAg loss and its correlation with Hepatitis B core-related antigen (HBcrAg) and pre-genomic RNA (pgRNA) levels
3. explore risk factors for low-level HBV replication after 2 years of therapy
4. describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to HBV therapy outcome
5. assess rates and reasons of treatment interruptions or changes.

Eligibility Criteria:
Inclusion Criteria:

* Study participant from contributing cohort
* 2 positive HBsAg tests more than 6 months apart
* At least 2 data points (baseline and 2 years after TDF/TAF start either as available data or stored sample

Exclusion Criteria:

* None
A Study Comparing the Safety and Efficacy of Risankizumab to Methotrexate in Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to compare the safety and efficacy of risankizumab to methotrexate in participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque psoriasis (with or without concurrent psoriatic arthritis) for at least 6 months before the first administration of study drug
* Have stable moderate to severe plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline Visits
* Be a candidate for systemic therapy for plaque psoriasis as assessed by the investigator
* Be a candidate for treatment with methotrexate (MTX) according to local label

Exclusion Criteria:

* Subjects with non-plaque forms of psoriasis, current drug-induced psoriasis, or active ongoing inflammatory diseases other than psoriasis that might confound study evaluations according to investigator's judgment
* Previous exposure to risankizumab
* Previous exposure to MTX
* Use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
* Subject has a history of clinically significant hematologic, renal, or liver disease
Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial

The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy compared with later removal of drain.

This study is to analyze the association between the time of removal of drain after pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal infection and pancreatic leakage. We design a prospective randomized study. Patients with pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000 U/L on postoperative day (POD) 1. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 4 or beyond. The primary outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications, and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Age: \>18yr, \<75yr
* Patients with pancreatic diseases (including tumor and inflammatory disease) or non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP)
* The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3.

Exclusion Criteria:

* Reconstruction of the pancreatic remnant by pancreaticogastrostomy
* Intra-abdominal hemorrhage within 72 hours after operation
* Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72 hours after operation
* Chylous leakage (milky water) within 72 hours after operation
* The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after operation.
Right Apical Versus Septal Pacing Trial

The purpose of this study is to examine whether RV (right ventricular)septal pacing has any effect on LV ( left ventricular) function than RV apical pacing in patients who require ventricular pacing.

The primary objective of this study is to compare the effect of RV pacing site on LV systolic function as measured by LVEF (left ventricular ejection fraction).

Secondary objectives of this trial include:

1. to compare the effect of RVSeptal(RVS) versus RVApical(RVA)pacing on other indices of systolic and diastolic LV function
2. to compare the rate of heart failure-related hospitalization between RVS versus RVA pacing
3. to compare new-onset atrial fibrillation and stroke rates between RVS versus RVA pacing
4. to assess the effect of RVA versus RVS pacing on quality of life and functional capacity
5. to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of RVS versus RVA pacing

Eligibility Criteria:
Inclusion Criteria:

1. a)Fixed (third degree) AV block b) Atrial Fibrillation with average Ventricular rate on ECG \</= 40bpm or mean heart rate on Holter monitor \</= 60bpm c) Sinus node Dysfunction with PR interval \>/= 300msec d) Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation e) 2°AV Block with ≥3:1 block
2. the subject is 18 years of age or older
3. the subject has provided written consent -

Exclusion Criteria:

1. Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
2. Presence of Hypertrophic Obstructive Cardiomyopathy
3. Recent cardiac surgery (\</= 30 days)
4. Recent myocardial infarction (\</= 30 days)
5. Presence of mechanical prosthetic tricuspid valve
6. Patient inability or unwillingness to comply with study protocol and required study visit schedule
7. Concomitant research study whose protocol would conflict or affect the outcome of this study
8. Patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A

This study is to describe the safety and efficacy of Xyntha® during the usual care setting.

non probability sample

Eligibility Criteria:
Inclusion Criteria:

* Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
* Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha.

Exclusion Criteria:

* Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product.
* Patients with a known history of hypersensitivity to hamster protein.
* Patients participating in an interventional trial of any investigational drug or device.
A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
* Heterosexual relationship for more than 6 months
* Partner willing to complete the TSS

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
* Other exclusion criteria apply according to the Summary of Product Characteristics
Plasma-based Colorectal Cancer Screening Research & Development

The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.

The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.

Eligibility Criteria:
Inclusion Criteria: Group 1

* Willing and able to sign an Informed Consent and adhere to study requirements.
* Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality).
* Colonoscopy diagnosis of colorectal cancer (CRC).\*
* Blood sampling a minimum of 7 days after colonoscopy and before resection surgery.

  * = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report.

Inclusion Criteria: Group 2

* Willing and able to sign an Informed Consent and adhere to study requirements.
* Eligible for colorectal cancer screening colonoscopy.
* 45 - 84 years of age at blood sampling.
* Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy.

Exclusion Criteria: Group 1

* Subject with curative biopsy during colonoscopy.
* Current neoadjuvant treatment.
* Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
* Known infection with HIV, HBV or HCV.

Exclusion Criteria: Group 2

* Previous personal history of CRC, adenomatous polyps \>10mm or sessile serrated adenomas (polyps).
* Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP).
* History of inflammatory bowel disease.
* Current neoadjuvant treatment.
* Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer.
* infection with HIV, HBV or HCV.
Arthroscopic Rotator Cuff Repair With Synovectomy

The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

- Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair

Exclusion Criteria:

* History of shoulder surgery
* Acute trauma on affected shoulder
* Chronic dislocation
* Pyogenic infection
* Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
* Isolated subscapularis tear
* Psychiatric problems that precluded informed consent
* An inability to read or write
* Other serious issues that precluded participation in the study
* Open surgery
* Rotator cuff tear with worker's compensation claim
* Refuse to participate in the study
* LOM that need brisement force
* Partial-thickness tear with focal full-thickness extension
* Irrepairable rotator cuff tear
* Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator
Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.

To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.


Eligibility Criteria:
Inclusion criteria

1. Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
2. Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
3. Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

1. Chronic intestinal disease.
2. Current immunodeficiency or immunosuppressive treatment.
3. Chronic or acute diarrhoeal disease.
4. Use of laxatives the week before inclusion in the study.
5. Antibiotic treatment for the last four weeks before inclusion in the study.
6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo \[potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture\].
7. Intake of any probiotic products for the last two weeks before inclusion in the study.
8. Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis

To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.


Eligibility Criteria:
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
PET-CT in Determining the Radioembolization Dose Delivered to Patients With Liver Metastasis, Primary Liver Cancer, or Biliary Cancer

This clinical trial studies positron emission tomography (PET)-computed tomography (CT) in determining the radiation dose delivered with radioactive spheres to patients with liver metastasis or primary liver or biliary cancer. Comparing results of diagnostic procedures dose before and after delivery of radioactive spheres to the liver may help determine radioembolization dose and plan the best treatment for liver metastasis or primary liver or biliary cancer.

PRIMARY OBJECTIVES:

I. To determine the relationship between radiation dose to 70% of the tumor volume as determined by post-treatment positron emission tomography (PET)-computed tomography (CT) and local control at 6 months.

SECONDARY OBJECTIVES:

I. To evaluate the ability of PET-CT to reproducibly determine dose to tumor, normal liver, and other surrounding organs.

II. To determine the stability of microsphere location by examining the changes in dose in a subset of patients with PET-CT scans performed on day 0 and day 1.

III. To determine the relationship of dose predicted by technetium-99m (Tc-99m) labeled Macro-aggregated albumin (MAA) imaged using single-photon emission computed tomography (SPECT) versus post-treatment dosimetry.

IV. To determine the effect of dose delivered on local control and normal tissue complications.

V. To measure the perfusion of the tumor for correlation with dose deposition, based on arterial phase CT measurements.

OUTLINE:

Patients undergo PET-CT scan before and after standard radioembolization on day 0. A subset of patients undergo PET-CT scan on day 1, 24 hours after the day 0 post-treatment PET-CT.

After completion of study treatment, patients are followed up at 1 week, 1 and 3 months, every 3 months for 1 year, every 6 months for 1 year and then annually for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have liver-dominant or liver-only metastatic disease from any primary histology; patients with primary hepatocellular or biliary cancer are also eligible
* Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver
* Women of child bearing potential must have a negative serum pregnancy test no more than 72 hours prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
* Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of medical information
* Complete blood count (CBC) and chemistry panel (CMP) no greater than 4 weeks prior to visit 1
* Diagnostic imaging of the abdomen utilizing either CT with contrast, magnetic resonance imaging (MRI), or PET/CT no greater than 4 weeks prior to visit 1

Exclusion Criteria:

* Patients not undergoing radioembolization to the liver
* Women of childbearing potential (WOCBP) and men who refuse to comply with appropriate contraception
* Women who are either pregnant or breast feeding