cyrilzakka/clinical-trials huggingface dataset:
Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis

The purpose of this study is to determine the safety and efficacy of anticoagulation in the treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.

Portal vein thrombosis is a common complication of liver cirrhosis, especially at the decompensated or advanced stage. The reported prevalence was 10-25% by ultrasound. The effect of PVT on the natural history of liver cirrhosis is not clear, especially the non-occlusive PVT. According to a recent large prospective study (n=1243), the development of PVT and the progression of liver disease are two separate consequences of a common mechanism. It was hypothesized that the activation of coagulation factors in the cirrhotic liver or the portal venous system is the common mechanism for the progression of liver disease, on the one hand, and the development of PVT on the other. A recent randomized clinical trial has shown that enoxaparin therapy for 48 weeks can prevent disease progression and PVT in patients with Child class B-C cirrhosis. Besides, emerging evidences have shown that 30-50% of patients with cirrhosis and partial PVT can achieve this spontaneous recanalization. So what the role of anticoagulation played in the management of PVT in liver cirrhosis is still contraversal. Anticoagulation therapy was also shown very effective with a high recanalization rate of 42-100%. But this data was mostly derived from retrospective, non-randomized study and no well-designed randomized controlled trial has been conducted to evaluate the safety and efficacy of anticoagulation for non-occlusive PVT.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent was obtained
* liver cirrhosis
* Non-occlusive portal vein thrombosis
* No history of variceal bleeding or receive endoscopy or β-blocker for the prevention of patients with G3 or G2 with red marks within 3 months before enrollment
* No plan for liver transplantation
* Age between 18 and 70
* Child-Pugh score ≤ 11

Exclusion Criteria:

* Acute PVT
* Fibrotic cord of PV
* Isolated splenic vein thrombosis or isolated superior mesenteric vein thrombosis
* Extensive superior mesenteric vein thrombosis involving the distal part
* Known coagulation disorder besides liver cirrhosis
* HCC or other malignant tumor
* Patients with G2 varices with red mark or G3 but did not underwent any preventive endoscopy or β-blockers
* Platelet count \< 10×109/L
* Receive contraceptive, anticoagulation or antiplatelet drug
* Receiving thrombolysis treatment
* Receiving TIPS or shunting surgery
* Bleeding tendency
* Recent gastrointestinal bleeding like digestive ulcer or hemorrhagic stroke
* Severe portal hypertension，for example, refractory ascite or acute variceal bleeidng
* Spontaneous bacterial peritonitis
* Severe cardiovascular disorder, endocrine disorder, or mental disease
* Major surgery within 6 months
* History of organ transplantation
* Pregnancy or breast-feeding
* History of HIV
* Poor compliance
The Use of Tidal Volume Challenge of Dynamic Parameters During Laparoscopic Surgery

Laparoscopy is increasingly used for major abdominal and pelvic surgery. As this approach is also recommended in elderly patients with serious comorbidities, optimal fluid therapy guidance during this procedure is important.

Many studies have reported that less invasive dynamic indices such as pulse pressure variation (PPV) and stroke volume variation (SVV), which are derived from the arterial pressure waveform, are superior to static indices to predict fluid responsiveness. PPV and SVV are based on the heart-lung interaction and reflect cyclic changes in stroke volume induced by mechanical ventilation in the closed-chest condition. Therefore, their ability to predict fluid responsiveness can be affected by factors that influence the arterial tone or the compliance of the respiratory system.

Laparoscopic surgery for the abdominal visceral organs requires pneumoperitoneum and the Trendelenburg position to optimize surgical conditions, and can reduce cardiac output and respiratory compliance. Accordingly, the usefulness of PPV and SVV in predicting fluid responsiveness during laparoscopic surgery under these conditions may be questioned.

It has been clearly shown that the values of dynamic parameters are significantly correlated with the magnitude of VT. Min et al. reported that augmentation of PPV and SVV via a temporary increase in VT from 8 to 12 ml/kg improved their predictive power in the inconclusive zone with respect to fluid responsiveness (PPV values of 9% and 13%, respectively). Another recent study reported that on increasing VT from 6 to 8 ml/kg, augmented PPV and SVV, as well as their absolute changes, predicted fluid responsiveness with high sensitivity and specificity, even in critically ill patients receiving low VT.

Therefore, the aim of the current study was to investigate whether increasing VT from 6 to 8 ml/kg would improve the predictive power of PPV and SVV in patients undergoing robot-assisted laparoscopic surgery in the Trendelenburg position under lung-protective ventilation. We also assessed the ability of absolute changes in PPV and SVV values induced by a temporary increase in VT from 6 to 8 ml/kg to predict fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who performed robot assisted laparoscopic surgery under Trendelenburg position

Exclusion Criteria:

* preoperative arrhythmia
* Severe bradycardia
* Moderate to severe valvular disease
* left ventricular ejection fraction \< 50%
* Poorly controlled hypertension (systolic BP \> 160 mmHg)
* Patients with renal insufficiency (creatinine \> 1.5 mg/dL)
* Moderate to severe liver disease
* BMI \>.30 or \< 15 kg/ m2
* preexisting pulmonary disease
* FEV1 \< 60% of predicted value
* contraindications to oesophageal Doppler (OED) monitoring probe insertion (i.e. oesophageal stent, carcinoma of the oesophagus or pharynx, previous oesophageal surgery, oesophageal stricture, oesophageal varices, pharyngeal pouch, and severe coagulopathy)
HbA1c Prediction Model in Patients With Type 2 Diabetes

Patients with type 2 diabetes who have poor blood glucose control are enrolled to evaluate the efficacy and safety of the HbA1c prediction model for adjust the hypoglycemic treatment regimen, compared with the conventional treatment using self-monitoring blood glucose or glycated albumin.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Diagnosed with type 2 diabetes mellitus, and the hypoglycemic treatment was not limited; The study physicians judged that the hypoglycemic treatment regimen was stable in nearly 8 weeks;
* Have HbA1c results within 4 weeks, and the range was 7.5-11%;
* Willing and able to conduct self-glucose monitoring;
* Have not participated in any other research program in the past 4 weeks.

Exclusion Criteria:

* Type 1 diabetes mellitus;
* Severe hypoglycemia ≥1 time or fasting C-peptide ≤0.80 ng/mL in the past 6 months;
* Diabetic ketosis in the last 1 week;
* Oral or inhaled corticosteroids for more than 14 days within the last 8 weeks;
* Anemia, recent blood transfusion, hemoglobinopathy (hemoglobinosis and thalassemia), use of erythropoietic drugs, undergoing dialysis;
* Pregnancy or breastfeeding;
* Receiving chemotherapy or radiation therapy;
* Have a severe mental illness and cannot complete the trial.
Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）

This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will be included.The pathological results, adverse events and other information of eligible patients will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80, male or female；
* Cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)；
* There was at least one radiographically measurable lesion according to the solid tumor response Evaluation Criteria (RECIST version 1.1)；
* Patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma；

Exclusion Criteria:

* Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)；
* Currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing；
* Evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；
Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients

This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.

After fully informing and consent, patients recruited would be randomized 1:1 to intradermal injection group and subcutaneous injection group. Investigators aimed to find out the difference in sentinel lymph nodes detected rate, blue lymphatic detected rate and complication incidence between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* who sign the informed consent form
* pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
* did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
* without breast and axillary surgery history
* Ejection fraction score in normal range accord to cardiac doppler
* Eastern Cooperative Oncology Group score ≤0-2
* axillary lymph node clinical negative

Exclusion Criteria:

* pregnancy
* any history of malignant tumor within five years
* diagnosis of multi-center, multi-focal or bilateral breast cancer
* history of breast tumor incision biopsy or vacuum-assisted biopsy
* methylene blue allergic
* appear with severe systematic disease or disfunction of any organ
Multicentric Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Patients With Stage II-IV Follicular Lymphoma

The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:

R-CVP vs R-CHOP vs R-FM.

Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Histological DIAGNOSIS of B cell follicular lymphoma
2. ECOG performance status 0-2
3. Age range 18-75
4. Ann Arbor Stage: II-IV
5. Assessment of pathology with diagnostics biopsy
6. Presence of one of these criteria:

   * B Sistemic symptoms B
   * Extranodale pathology
   * Cytopenia
   * Splenomegaly
   * Leukemia
   * Serous effusion
   * Ves \> 20 mm/h
   * Ldh \> normal value
   * Nodale or extranodal mass \> 7 cm
   * 3 or more nodal sites \> 3 cm
   * Adenopatic syndrome
7. LVEF \> 50%
8. Normal hepatic (bilirubin \< 1.5 mg/dl) and renal functionality (creatinin \< 2 mg/dl). If there is a lymphoma it's allow values of bilirubin \> 1.5 mg/dl and of creatinin \> 2mg/dl
9. No previous treatment for follicolar lymphoma unless RT-IF
10. Lifetime \> 6 mounth
11. Absence of HbsAg, HCV e HIV
12. Negative Coombs Test
13. Negative pregnant test
14. Cotracceptive method during the treatment and the follow three months
15. Formal written consent
16. Ability to follow the patients after the treatment for follow up

Exclusion Criteria:

1. Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
2. Stage I of Ann Arbor scale
3. Central Nervous system involvement
4. HIV, HBV OR HCV Positivity
5. Cardiac Pathology
6. Positive Coombs Test
7. Previous chemotherapeutic treatment
8. Hypersensitivity to antibodyes or other murine proteins
9. Previous cancer pathology unless in situ cervix and epithelial carcinomas
10. Other type of infections
11. Pregnant and nursing woman
Informational Tool for Smoking Cessation in COPD Patients

Chronic obstructive pulmonary disease (COPD) is a lung disease that affects nearly 8% of the adult population and causes 18,000 deaths per year in France. The most frequent cause of this pathology is smoking. COPD patients who stop smoking have a better quality of life, a marked a significant slowdown in disease progression and an increased life expectancy. Investigators propose to carry out a quantitative study among patients smokers suffering from COPD, by setting up a tool in the form of an motivational intervention specific to this population.

implementing a tool in the form of an informational intervention with a specific motivational intervention

Eligibility Criteria:
Inclusion Criteria:

* People suffering from chronic obstructive pulmonary disease (COPD) stage 2/3
* People treated at HNFC
* Smokers

Exclusion Criteria:

* People with cognitive disorders compromising comprehension and completion of the study
LGCP (Laparoscopic Greater Curvature Plication)

The aim of this study is to find out the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP) procedure. This study procedure is an alternative restrictive weight loss surgery that has the potential to reduce the complications associated with gastric banding and sleeve gastrectomy by creating a small sized stomach without the use of an implant and without cutting stomach.

STUDY OBJECTIVES: To demonstrate the safety and efficacy of Laparoscopic Greater Curvature Plication (LGCP)

DESIGN: Prospective, open-label, and single center

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age at the time of enrollment into the study;
* Have a BMI of at least 30;
* Subject is willing to give consent and comply with protocol evaluation and treatment schedules;
* Subject agrees to refrain from any type of weight-loss drug (prescription or OCT) or elective procedure that affect body weight for the duration of the trial; and
* HbA1C\<11%

Exclusion Criteria:

* History of previous malabsorptive bariatric procedures;
* Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
* Any condition which precludes compliance with the study;
* History or presence of pre-existing autoimmune connective tissue disease; and
* Use of prescription or over the counter weight reduction medications or supplements within 30 days of the screening visit or the duration of study participation.

This study is a local study (NY, within 50 miles). This study is not a sponsored trial. Therefore, the procedure is not free.
Penicillin De-labeling in the Pediatric Primary Care Setting

While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.


Eligibility Criteria:
Inclusion Criteria:

* Children from ages 2-18 years with a history of parent-reported penicillin allergy.

Exclusion Criteria:

* Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded
Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease

To compare clinical safety \& efficacy of fixed-high potent statin therapy (according to 2013 ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL\<70mg/dL) for secondary prevention. Total 4400 patients with coronary artery disease patients requiring statin treatment were categorized fixed high-potent statin group and targeted LDL-C group. The investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2. Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism, 4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic intervention or operation, 6. ESRD with renal replacement therapy).


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Patients clinically diagnosed with coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
* Patients with signed informed consent

Exclusion Criteria:

* Pregnant women or women with potential childbearing
* Patients severe adverse events or hypersensitive to statin or patients with multi-drug allergy.
* Who had received drug that have a drug interaction with statin (strong inhibitor of cytochrome p-450 3A4 or 2C9)
* Patients with risk factors for myopathy with hereditary muscle disorder, hypothyroidism, alcohol use disorder, severe hepatic dysfunction (3 times normal reference values) or rhabdomyolysis
* Life expectancy \< 3 years
* Patient with who can not be followed up for more than 1 year
* Patients who cannot understand or read the consent form
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients

The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;

Exclusion Criteria:

- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
SSAT 054: Non Genetic Factors in the Pathogenesis of IBD in Twins

This study aims to investigate the role of non-genetic factors in the pathogenesis of inflammatory bowel disease.An exploratory study to investigate differences between the epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel disease.

Background: The inflammatory bowel diseases (IBD), Crohn's Disease (CD) and Ulcerative Colitis (UC), are debilitating conditions with a complex aetiology. The biggest risk factor for developing IBD is having an affected first degree relative. However when an identical twin is diagnosed with IBD, the other twin goes on to develop the condition in only 20-55% of cases.

Recent research suggests the microbiota the ecosystem of bacteria within the gut may trigger disease in susceptible individuals. Another important research area is the epigenome changes to the structure and regulation of our genome which occur throughout our life. It is known that siblings of Crohn's Disease sufferers have a changes to the immune system characteristic of Crohn';s. However it is not known whether these changes are due to genetic similarity or shared environment. Comparison between mono and dizygotic twins elucidates the relative importance of genetic and environmental factors.

Primary Objective: An exploratory study to investigate differences between the epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel disease.

Study Design: Multicentre basic science study involving human participants

Planned sample size: 200 data subjects (100 twin pairs)

Methodology:

A) Identification of twin pairs where one or both have inflammatory bowel disease via:

1. IBD Nixon Twin and Multiplex Registry.
2. Advertising for twin pairs via BSG website and newsletters/patient support groups/social media sites/clinic posters.
3. Identification by study sites B) Obtaining formal written consent C) Collection of blood, stool and urine.

D) The following analysis will be carried out:

* Epigenetics (blood) DNA extraction and subsequent methylation analysis and bisulphate conversion with 450 Illumina beadchip assay
* Functional immunology (blood) - flow cytometry of CD3, CD4 and CD8 cells. (London Twin pairs discordant for Crohn's Disease)
* 16S rRNA gene sequencing (stool) - of bacterial DNA
* Metabolomic profiling (Urine and stool) - using Nuclear Magnetic Resonance (NMR) and mass spectrometry E) Collection of dietary history information for the previous 72hr period Study Duration: 2 years (single visit).

Eligibility Criteria:
Inclusion Criteria:

* Monozygotic twins discordant for IBD
* Monozygotic twins concordant for IBD
* Dizygotic twins discordant for IBD
* Dizygotic twins concordant for IBD
* Healthy controls

Exclusion Criteria:

* \<18 years old
* Antibiotics within past 3 months of sample collection
* Unable to give informed consent