cyrilzakka/clinical-trials huggingface dataset:
Maternal Antiviral Treatment and Infants Immunoprophylaxis in the Prevention of Mother-to-child Transmission

The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.

From 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis B infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. The investigators recommended those pregnant women with HBV DNA \> 2\*10\^6 IU/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. Patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high HBV DNA level. Meanwhile, those pregnant women with HBV DNA \< 2\*10\^6 IU/ml was assigned as the control group with low HBV DNA level. All infants would be instructed to receive hepatitis B vaccine and hepatitis B virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. Umbilical cord blood were collected to determine the HBV serological markers and HBV DNA level. Children were followed every three to four years until December 2018.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy

Exclusion Criteria:

* women treated with antiviral drugs during pregnancy.
* drug hypersensitivity;
* abnormal renal laboratory results;
* coinfection with human immunodeficiency virus or other human hepatitis viruses.
19G FNB Needle Vs 22G FNB Needle for EUS-Guided Liver Biopsy

EUS-guided liver biopsy (EUS-LB) is increasingly used to diagnose patients with liver disease, especially in anxious patients who need sedation. There is an ongoing debate about the optimal needle size for EUS-LB. Some clinicians prefer a thinner 22-gauge biopsy needle because they presume it to be safer, and some studies show that their performance is the same as a thicker 19-gauge needle. However, some other studies show that the adequacy and diagnostic accuracy of a 19-gauge needle is better, and the rates of adverse events are the same. In this study, we aimed to compare the adequacy and diagnostic accuracy of samples obtained by the same endoscopist from the same liver lobe during the same session.


Eligibility Criteria:
Inclusion Criteria:

* All patients with unexplained elevation of liver enzymes and suspected hepatic paranchymal disease

Exclusion Criteria:

* Patients who had malignancy
* Patients who have decompensated cirrhosis
* Presence of ascites
* Patients with coagulopathy (platelets \< 50.000 μ/ mL and INR \> 1.5)
* The use of anticoagulant agents
* Pregnancy
* Unable to provide written informed consent
Corticosteroids Prevent the Atrial Fibrillation After Cardiac Surgery

Cardiopulmonary bypass and cardiac surgery are associated with a significant systemic inflammatory response that has been suggested playing a causative role in the development of postoperative atrial fibrillation (POAF). The goal of this study is to determine the efficacy of corticosteroids prophylaxis in preventing POAF, or length of intensive care unit (ICU) or hospital stay.

Most cardiac operations are performed under cardiopulmonary bypass, however, it is well known that cardiopulmonary bypass often causes systemic inflammatory response characterized by leukocyte and high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators that may contribute to postoperative complications including atrial fibrillation (AF), prolonged duration of intensive care unit (ICU) and hospital stay.

Postoperative atrial fibrillation has (POAF) been reported in 20% to 50% of patients following coronary artery bypass grafting (CABG) and is even higher after combined CABG and valve surgery.

It may increase stroke rates, trigger hemodynamic instability with heart failure and increase risk of thromboembolic complications.

The relationship between inflammation and atrial fibrillation after cardiac surgery is further strengthened by studies that showed that corticosteroid (CS) prophylaxis can reduce the occurrence of atrial fibrillation after cardiac surgery.

Corticosteroids (CS) can reduce the risk of atrial fibrillation after cardiac surgery in adults and reduce length of intensive care unit (ICU) and hospital stay.

It is a low-cost drug that can effectively inhibit inflammation, limit systemic capillary leakage syndrome and reduce organ damage, thus providing a theoretical basis for its clinical application.

However, the potential risks of CS remain controversial and inconclusive in terms of several side effects of CS such as hyperglycemia, gastrointestinal disturbances, and postoperative infections.

Eligibility Criteria:
Inclusion Criteria:

* Elective first time CABG or combined with valvular surgery.
* Use of b-adrenergic blockade.
* Normal sinus rhythm.

Exclusion Criteria:

* History of heart block
* History of previous episodes of AF or flutter
* History of peptic ulcer disease
* Permanent pacemaker
* Any documented or suspected supraventricular or ventricular arrhythmias
* Renal insufficiency (serum creatinine \>20 mg/dL)
* Uncontrolled diabetes mellitus
* Systemic bacterial or mycotic infection
* Urgent or emergency surgery
* Patient underwent cardiac surgery without using cardiopulmonary bypass
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Subject is willing and able to complete the micturition diary and questionnaires correctly
* Subject has symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for ≥ 3 months
* Subject experiences frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
* Subject must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence, during the 3-day micturition diary period

Exclusion Criteria:

* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
* Subject has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Subject has an indwelling catheter or practices intermittent self-catheterization
* Subject has diabetic neuropathy
* Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Subject receives non-drug treatment including electro-stimulation therapy
* Subject has severe hypertension
* Subject has a known or suspected hypersensitivity to tolterodine, other anticholinergics, YM178, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
* Subject has been treated with any investigational drug or device within 30 days (90 days in the UK)
* Subject had an average total daily urine volume \> 3000 mL as recorded in the 3-day micturition diary period
* Subject has serum creatinine \>150 umol/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2x upper limit of normal range (ULN), or gamma glutamyl transferase (γ-GT) \> 3x ULN
* Subject has a clinically significant abnormal electrocardiogram (ECG)
Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy

Study type:

Observational, prospective.

Objectives:

Primary:

Identify psychosocial and clinical factors that predispose to the occurrence of pain following office hysteroscopy

Secondary:

Stratify risk factors for pain previous Cesarean section and pain score repeat C section and pain score post-menopausal and pain score type of delivery and pain score body mass index and pain score history of dysmenorrhea and pain score, abnormal uterine bleeding and pain score previous surgery upon uterine cervix and pain score Characterize women's psychosocial profile and pain score Establish anxiety as a factor influencing pain perception using (State-Trait Anxiety Inventory for Adults).

Determine if there is a specified population who would benefit from procedure under anaesthesia

Authors tend to compare pain in hysteroscopy in groups by scope size and variation in technique (e.g. 3mm versus 5mm scopes; vaginoscopic versus traditional speculum insertion approach), so score results reflect relative improvement in tolerability between groups, and they do not have as control an examination expected to be free of suffering.

To the investigators' knowledge there has to date never been an adequate judgement of the proportion of women in the group where pain is felt and should therefore be expected. Focus has always been put on the group of patients who are pain free (or where it is deemed acceptable).

Stating office hysteroscopy is painless because VAS score is halved by miniaturization seems an arbitrary statement for a small, but never the less important group of women.

It should be interesting to investigate factors which might contribute to pain in office hysteroscopy despite the fact the majority of the group will bear mild or no pain. The investigator believes that although reduction of scope size has brought about significant reduction in distress, it remains a painful procedure for some patients and therefore subjecting them to this ordeal may be regarded as an aggression; pain control interventions to reduce suffering might be considered (anxiolytic drugs, local, para-cervical or even general anaesthesia could be of interest in selected cases).

Eligibility Criteria:
Inclusion Criteria:

* women scheduled for office hysteroscopy Written informed consent; diagnosis of uterine abnormal bleeding, sonographic evidence of thickened endometrium, sterility workup, endometrial polyps or sub mucous myoma, foreign body extraction or insertion (i.e. sterilization) or other condition with indication for procedure and who meet study eligibility criteria; ability to fill in the study questionnaires.

Exclusion Criteria:

* refusal to participate in study innability to fill in the study questionnaires
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

This is a prospective, randomized, controlled, double-blinded, clinical trial

Subject : 3mo \~ 24mo. aged infants with bronchiolitis

The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.

Randomly assigned to one of three groups

* Group I : nebulized epinephrine + 0.9% saline + placebo
* Group II : nebulized epinephrine + 3% saline + placebo
* Group III : nebulized epinephrine + 0.9% saline + dexamethasone

Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.

The primary outcome is hospital admission within 7 days after the day of enrollment

Eligibility Criteria:
Inclusion Criteria:

* 3mo \~ 24mo aged patients with bronchiolitis visit to emergency departments
* RDAI score 4-15

Exclusion Criteria:

* \< 3mo, \> 24mo
* infants who had received oral or inhaled corticosteroids during the preceding 2 weeks
* infants with a previous episode of wheezing or a diagnosis of asthma
* any chronic cardiopulmonary disease
* immunodeficiency
* infants needed intubation
* infants with a previous history of apnea or intubation
* infants with side effect of dexamethasone
* infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation
Treatment of Patients With Teduglutide (GLP-2) for GVHD and Analysis of Paneth Cells of GVHD Patients

In this study the investigators evaluate the outcomes of six steroid-refractory GVHD patients with gastrointestinal signs of GVHD that were treated with teduglutide.

Preliminary studies have showed that Glucagon-like peptide 2 (GLP-2) has regenerative and protective effects on the gastrointestinal tract after bowel injury. It induces positive effects in the GI tract like nutrient uptake, mucosal growth, protection from inflammation, etc. One of the target organs from GVHD is the GI tract, and since patients suffering from GI-GVHD experience intestinal disorders like loss of mucosal epithelial integrity, diarrhea accompanied by strong abdominal pain that can lead to food inanition, the investigators therefore aimed to examine the outcome of patients suffering from SR-GI-GVHD that are treated with the GLP-2 analogue, Teduglutide. The investigators will determine the outcome of each patient by monitoring the gastrointestinal signs like diarrhea frequency, intestinal absorption measured by serum-albumin concentrations and GI histology, specifically the number of Paneth cells before and during teduglutide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with signs of acute SR-GI-GVHD
* Age ≥ 18 years
* Peripheral blood and stool samples available before and during treatment
* Written informed consent
* Ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* Age ≤ 18 years
* Lack of informed consent
Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications

The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.

This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial. It plans to enroll approximately 258 qualified participants from about 25 research centers nationwide. Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group for the treatment of portal hypertension and its related complications. The primary endpoint of the study is the patency rate of the stents 12 months after the initial surgery. All participants will undergo clinical follow-ups at 1 month, 6 months, and 1 year post-stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years (inclusive); male or non-pregnant female.
* Diagnosed with cirrhosis and associated complications of portal hypertension (such as esophageal and gastric variceal bleeding, refractory ascites), and meeting the consensus recommendations for TIPS indications (see Appendix 5).
* Participants must understand the purpose of the trial, voluntarily participate, sign an informed consent form, and be willing to complete the follow-up according to the project requirements.

Exclusion Criteria:

* Severe right heart failure, congestive heart failure (LVEF \< 40%), or severe valvular heart dysfunction.
* Uncontrolled systemic infection or inflammation.
* Persistent moderate to severe pulmonary hypertension after treatment (tricuspid regurgitant peak velocity \> 3.4 m/s or pulmonary artery systolic pressure \> 50 mmHg).
* Patients in hepatic encephalopathy coma or comatose phase (West Haven Criteria Stage III, IV).
* Severe liver dysfunction, Child-Pugh score \> 13, or MELD score \> 18.
* Serum creatinine (Scr) \> 178 umol/L or on dialysis.
* Stage IIIa or higher liver malignancy.
* Budd-Chiari syndrome, hepatic veno-occlusive disease, or obstructive cholestasis.
* Polycystic liver disease.
* Unrectifiable coagulopathy (INR \> 5 or PLT count \< 20 x 10\^9/L).
* Main portal vein thrombosis occupying \> 50% of the lumen area or cavernous transformation of the portal vein.
* Previous TIPS procedure or planned liver transplantation within a year.
* Allergy to contrast agents or nickel-titanium alloys.
* Life expectancy less than 1 year.
* Participation in other drug or medical device clinical trials within three months before screening.
* Other conditions deemed by the researcher as unsuitable for participation in this clinical trial.
MIND Diet Intervention and Cognitive Performance

This single-center, randomized trial examined the effect of MIND diet intervention on cognition and brain structure changes of healthy obese women over three months. The intervention group was lea to calorie-restricted modified by the MIND diet, and the control group received a calorie-restricted standard diet. The primary end-point was an assessment of cognitive performances measured with a comprehensive cognitive test battery. Secondary end-points were voxel-based morphometry to quantify the differences in brain structures. Our results revealed MIND diet could improve working memory, verbal recognition memory, and attention, more in comparison with the control group. Results also suggest that an increase in inferior frontal gyrus in the MIND diet group. Our study, for the first time, underlined that good adherence to the MIND diet as well as calorie restriction could reverse the destructive effect of obesity on cognition.


Eligibility Criteria:
Inclusion Criteria:

* Middle-aged women (40-60 years),
* Without any metabolic complication,
* BMI 30-35 kg/m2,
* MMSE ≥ 24,
* And no history of severe untreated medical, neurological, and psychiatric diseases which may interfere with the study intervention.

Exclusion Criteria:

* Have gastrointestinal problems,
* Participate in weight loss programs,
* Use weight loss drugs in the last three months,
* Had not wholly followed the dietary pattern,
* Became pregnant,
* And undergo special medical treatments during a three months study.
Transnasal Insufflation (TNI) and Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine wether transnasal insufflation as an alternate form of breathing support for COPD patients will lead to improvement of their medical condition.

Chronic obstructive pulmonary disease (COPD) is a slowly proceeding lung disease which basic pathophysiologic mechanisms are only partly understood so far and which is difficult to access with a pharmacological or sundry approach besides smoking cessation. Average life expectancy is clearly limited especially in advanced stages with respiratory insufficiency . Based on different smaller surveys long-term oxygen treatment is classified to be the routine in COPD treatment when patients develop hypoxemia.

The primary application of non-invasive ventilation Routine is the treatment for COPD patients with acute respiratory decompensation and developing hypoxemia and respiratory acidosis, because it reduces the acute mortality as various prospective randomized studies showed.

On the other side there are no distinct informations and data about the initiation of a nocturnal positive pressure breathing therapy when chronic hypercapnia appear in progression of COPD.

Nocturnal positive pressure therapy appliqued with a mask can be assumed to be the routine treatment for neuromuscular and restrictive thorax diseases, because nocturnal ventilation results in a distinct increase of life expectancy.

In contrast data about positive pressure therapy at COPD are inconsistent and initiation of nocturnal breathing therapy is practised in many places, but is scientifically not confirmed yet.

It is known from various other studies with other patient collectives with nocturnal positive pressure therapy, like patients with obstructive sleep apnoea syndrome, that only 50 to 70% of those patients are using their therapy constantly. Daily practice shows that patients with chronic hypercapnia based on COPD are even harder to accustom oneself to a nocturnal breathing therapy than patients with restrictive lung diseases or patients with obstructive sleep apnoea syndrome.

Reasons for that are not known, but maybe the significant lung distension or increased appearance of depressive or anxiety disorders of COPD patients are responsible for that.

Perhaps patients do not feel a subjective improvement of their medical condition and don't accept a tight closing mask at nights.

As a result an alternate form of breathing support would be desirable.

Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD IV
* PCO2 \> 50 mmHg
* competent patients
* stable respiratory situation

Exclusion Criteria:

* serious acute diseases
* hypercapnic decompensation pH \< 7,30