cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension

The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure vessels sealing system) in esophagogastric decongestion and splenectomy in patients with portal hypertension.

Bleeding from esophageal and gastric cardia varices is the major life threatening complication in patients with portal hypertension. Patients with portal hypertension have a mortality rate of 30%-50% at the first episode of esophagogastric variceal rupture. The associated 1-year mortality rate is reported to be 75%. The ideal treatment for gastric varices should effectively control bleeding and improve the liver function to optimum levels. Although endoscopic treatments have showed great promise for esophageal varices, there is still controversy regarding the treatment of gastric varices. Hepatic encephalopathy remain a dominant problems after transjugular intrahepatic portosystemic shunt placement (TIPS) and surgical shunts. A meta-analysis has shown that the incidence of hepatic encephalopathy and mortality was increased significantly either in nonselective or selective shunt operations.

Esophagogastric decongestion and splenectomy with or without esophageal transaction were the fundamental operation performed in our department for patients with portal hypertension. Patients under the azygoportal devascularization methods revealed reduction of the encephalopathy as well as diminished rebleeding rates. The crucial point of the procedure is prevention of the brisk bleeding from the dilated vessels like enlarged azygoportal collaterals. Conventional hand-tied ligatures can become dislodged and represent a foreign body, and more important, it is tedious and time-consuming. The LigaSure vessel sealing system (Valleylab, Boulder, Colorado) is a bipolar electrosurgical device, sealing vessels up to 7 mm in diameter, by denaturing collagen and elastin within vessel wall and surrounding connective tissue. This device was tested, with excellent results, in different fields of surgery (gastrointestinal, hepatopancreatobiliary, urologic, gynecologic, laparoscopic, etc), as demonstrated by several recently published studies. Shamiyeh et al confirmed the reliability of LigaSure for the closure of the veins in laparoscopic azygoportal disconnection procedure on the portal hypertension porcine model in 2005, there was no intra- or post-operative bleeding and no conversion to open surgery, and when more than 2 mm far from the thermal energy source, no collateral damage of the solid tissue such as stomach could be detected.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy

Exclusion Criteria:

* Liver function as Child-Pugh C
* Hemoglobin \< 9 g/dL
* Ascites
* Abnormal coagulation
Post-COVID-Health Study: Multidimensional Health Status of COVID-19 Survivors One Year After a SARS-CoV-2 Infection

This study assesses the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.

Rationale: Within the Netherlands, more than 1 million people have been infected with SARS-CoV-2, also known as COVID-19. Although the mortality rate is considerable, the vast majority of COVID-19 patients survive the infection. Preliminary findings show that a majority of COVID-19 survivors still experience health problems 3 months after the infection, including reduced lung diffusion capacity, low exercise capacity, muscle weakness, mental problems and reduced cognitive function resulting in a generally poor health status. Whether these health consequences persist on the long-term is unknown.

Objective: To assess the multidimensional health status of COVID-19 survivors one-year post-infection using validated subjective and objective measures.

Study design: A multicenter prospective observational study performed within the MUMC+ and VieCuri Medical Center.

Study population: 200 COVID-19 survivors of the MUMC+, VieCuri Medical Center or Zuyderland Medical Center, both hospitalized (ICU and non-ICU admitted) as well as non-hospitalized patients.

Main study parameters/endpoints: Outcome parameters include objectively and subjectively measured multidimensional health outcomes including physiological and metabolic health, physical capability, cognitive function, psychosocial well-being, social well-being, patient reported outcomes as well as potential determinants of these multidimensional health outcomes (e.g. treatment during/after SARS-CoV-2 infection, vaccination, comorbidities, medication use etc.). Outcomes will be measured during a one-day study visit.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will benefit from participating within this study, because their general health will be evaluated in detail and from a multidimensional perspective. Furthermore, subjects will be informed on their multidimensional health outcomes and will receive a lifestyle advice tailored to their health status. Risks and inconveniences are limited to the time investment associated with the completion of the questionnaires and the study visit. During the study visit various non-invasive measurements as well as minor invasive blood sampling will be performed.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive based on:

  * Confirmed RT-PCR;
  * Proven serology for SARS-COV-2 with clearly associated complaints for a SARS-COV-2 infection;
  * CO-RADS score of 4 or more with a proven serology for SARS-CoV-2 afterwards.
* Age of ≥18 years;
* Able to provide informed consent;
* Understanding of Dutch language.

Exclusion Criteria:

* Patients not willing to participate;
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
Endostar Combined With Concurrent Chemoradiotherapy For Locally Advanced Cervical Carcinoma

A total of 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. Patients were randomly divided into two groups, with 60 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. The short term efficacy and the toxic of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. The investigators data may provide an alternative option for the treatment of Locally advanced cervical carcinoma with high efficacy and low toxicity.

This study was a multicenter, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed Locally advanced cervical carcinoma were enrolled. These patients were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 45-50Gy, DDP 40mg/m2, per week for 5cycles, Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles) and concurrent chemoradiotherapy group ( IMRT 45-50Gy, DDP 40mg/m2, per week, for 5cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients of either gender and aged from 18 to 65 years old.
* patients with histologically confirmed cervical carcinoma.
* patients at stage Ib, IIa2, IIb-IVa by FIGO 2009 staging.
* KPS ≥ 70 (Appendix I)
* patients with available MRI or CT data of cervical and measurable tumor lesions.
* patients did not receive any treatment before enrollment.
* patients with expected survival longer than 6 months.
* biochemical indexes: WBC \> 4,000/mm3, and blood platelet ≥ 100,000 mm3; PT≤UNL; levels of indicators for hepatic and renal function was 1.5 folds of the upper limit of normal value.
* the informed content was obtained from every patient.
* patients with effective follow-up.

Exclusion Criteria:

* those with malignant tumors other than cervical carcinoma.
* those received treatments before enrollmment.
* lactating women and Pregnant woman.
* those who were undergoing other drug trials.
* those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
* those who were treated with tumor targeting drugs.
* those who could not subject to MRI or CT examination.
* those who could not meet the requirements of the prescribed dose.
Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma

This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.

The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
2. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
3. Age ≥21 years
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
5. Adequate organ and marrow function
6. Signed Informed Consent Form
7. For women of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

1. Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
2. Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
3. Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
4. Subjects with Grade \>2 peripheral neuropathy
5. Subjects with clinically significant ascites
6. Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
7. Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
8. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
9. Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
10. Pregnant women or nursing women
11. Subjects with known HIV infection
12. Known bleeding disorder or coagulopathy
A Study of Seltorexant in Participants With Probable Alzheimer's Disease

The purpose of this study is to investigate the effect of seltorexant versus placebo on the sum of Agitation and Aggression domain scores (A plus A) of the Neuropsychiatric Inventory-Clinician rating (NPI-C) in participants with probable Alzheimer's Disease (AD) with clinically significant agitation/aggression.


Eligibility Criteria:
Inclusion Criteria:

* Participant has received a diagnosis of probable Alzheimer Disease (AD) (Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\]) with the following characteristics at screening: Clinical Dementia Rating (CDR) global score greater than or equal to (\>=) 1; Mini-Mental State Examination (MMSE) total score of 10 to 24 (inclusive)
* Participant meets the criteria of a syndrome diagnosis of agitation based on International Psychogeriatric Association (IPA) consensus clinical and research definition of agitation in cognitive disorders for at least 2 weeks before screening
* Participant meets the criteria of Neuropsychiatric Inventory (NPI-12) Agitation/Aggression (A/A) domain score \>= 4 with frequency score \>= 2 at screening and baseline with no more than 35 percent (%) of improvement in NPI-12 A/A domain score from the screening to baseline assessments
* Female participants must be postmenopausal before study entry (amenorrhea for at least 12 months)
* Body Mass Index (BMI) within the range 18-40 kilograms per square meter (kg/m\^2) (inclusive)

Exclusion Criteria:

* Participant fulfils diagnostic criteria for non-Alzheimer's Dementia: example, Frontotemporal Dementia (FTD), Diffuse Lewy Body Dementia (DLBD), and post-stroke dementia, based on clinical history. (Participants may be included with mixed AD/vascular dementia)
* Participant has a clinically significant acute illness within 7 days prior to study intervention administration
* Participants with a history of delirium within 30 days prior to or during screening
* Participant with a cause of agitation that is not secondary to dementia (such as pain) or significant history of aggression prior to dementia based on investigator judgment
* Participants who are not stable on concomitant medications or take prohibited medications
Decompression and Drainage Seton in the Treatment of High Complex Anal Fistula

This study aimed to compare the efficacy of the decompression and drainage seton (DADS) and cutting seton (CS) in the treatment of high complex anal fistula.


Eligibility Criteria:
Inclusion Criteria:

* high trans-sphincteric cryptoglandular anal fistulas (involving \>30% of the EAS muscles evaluated through magnetic resonance imaging (MRI) scan, endoanal ultrasonography)
* suprasphincteric fistulas were enrolled

Exclusion Criteria:

* Low anal fistula; -Non-glandular anal fistulas, such as tuberculous anal fistula and Crohn's anal fistula; -
* Patients with symptoms of fecal incontinence;
* A previous history of anal fistula surgical treatment;
* Patients with malignant tumors or mental illness or other reasons unable to cooperate with the treatment.
Cross Sectional Area of Umbilical Cord Versus Hadlock's Formula in Prediction of Neonatal Birth Weight

Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.

Umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate pregnancy outcomes. In the past, sonographic investigations of the umbilical cord were limited to identification of the number of vessels and Doppler evaluation of the blood flow. Various formulas have developed to calculate Estimated Fetal Weight (EFW) using fetal biometry. While it is being accurate to a degree, they are associated with error especially with extreme birth weight. In this study using the ultrasound to look for a relation between the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and readily available, comparing the estimated birth weight obtained by this method with that of Hadlock's formula measures at term gestation. Trying to prove that the umbilical cord area formula might gave advocacy for future usage for birth weight prediction.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with:

  * Age: 18-35 years.
  * Singleton living fetus.
  * Term gestation (37wks_ 41wks+6days). (Spong , 2013).
  * Admitted at labor room or prepared for caesarean section

Exclusion Criteria:

* o Intrauterine Dead fetus (IUFD).

  * Structurally malformed fetus or umbilical cord (single umbilical artery; SUA).
  * Multiple pregnancies.
  * Oligohydraminos (AFI \< 5cm or DVP \<2 cm) or polyhydraminos (AFI \> 25 cm or DVP \> 8 cm) (Morteza et al., 2018).
  * Uterine fibroid.
  * Abnormal Doppler flowmetry of umbilical artery.
  * Maternal diseases (Diabetes mellitus, Hypertensive disorders, renal diseases, Ischemic heart diseases), history of drug intake (Antihypertensive, antiepileptic, oral hypoglycemic drugs).
Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans

Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.

Significant public health efforts have been made towards salt reduction but most have met with failure. Dietary factors such high sodium/low potassium diets contribute to the development of cardiovascular diseases (CVDs) such as atherosclerosis and high blood pressure (BP). This is important as CVD is the number one killer in the U.S. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation, is an important non-traditional risk factor for atherosclerosis. Evidence supporting potassium's beneficial role on vascular health remains unclear although it may be more effective in the presence of a high sodium diet. A purported mechanism responsible for sodium-induced vascular dysfunction is overproduction of reactive oxygen species (ROS) resulting in reduced nitric oxide (NO) production/bioavailability. Additionally, high sodium diets have been shown to stiffen the endothelium. This investigation will evaluate the vascular effects of dietary potassium during a high salt diet including its impact on sodium-induced oxidative stress and endothelial cell stiffness.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* normal blood pressure
* normal resting ECG

Exclusion Criteria:

* hypertension
* history of heart disease
* diabetes
* kidney disease
* obese (BMI ≥30)
* significant weight changes in the last 6 months
* use of tobacco products
* pregnant
* on a special diet (gluten free; vegan)
* take any medications for the above conditions
* endurance trained athletes
Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa

OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents with epidermolysis bullosa.

II. Determine patterns of body composition in these patients. III. Determine the energy requirements of these patients by measuring resting energy expenditure.

IV. Assess protein nutrition by measuring lean body mass.

PROTOCOL OUTLINE:

Data collected from a 5-day food diary are analyzed for protein, nutrient, and calorie intake. Nutritional, metabolic, and body composition are evaluated by indirect calorimetry, total body electrical conductivity, total body potassium, and lean body mass.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Epidermolysis bullosa
* Patient age: 2 months to 18 years
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction

The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.

In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* 1) Pathological examination confirmation the adenocarcinoma of stomach before surgery
* 2) Physical conditions compliance with the requirements for curative gastrectomy
* 3) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
* 4) Comply with the protocol during the whole study period
* 5) No neoadjuvant therapy administration
* 6) Sign informed consent and permission of withdraw in the whole study period
* 7) Consent to provide the tissue specimens after surgery for this study
* 8) Estimation the overall survival after surgery no less than 6 months
* 9) No anesthesia or operation contraindication disease
* 10) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
* 11) Negative cytological detection in operation
* 12) No seriously concomitance's diseases
* 13) Karnofsky Performance Scores (KPS) more than 60
* 14) Examined lymph node count no less than 16

Exclusion Criteria:

* 1) Women during pregnant stage and breast-feed stage
* 2) Women of childbearing age without any contraceptive measures
* 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
* 4) Immunosuppressive therapists for organ transplantation
* 5) Seriously uncontrolled recurrent infection
* 6) other malignant tumors
* 7) No abilities of self-knowledge or mental disorders
* 8) Participating in other clinical trials
* 9) Siewert I and II esophagogastric junction tumors
* 10) Serious internal diseases obstruction surgery