cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome.

Ultrasound evaluation, with grayscale and color Doppler imaging, is the recommended first-line modality for diagnosing PAS. Grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color Doppler. Magnetic resonance imaging (MRI) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available.

Recently, a new imaging technique utilizing three-dimensional (3D)/four-dimensional (4D) volume rendering ultrasound (VRU) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. By using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of PAS which was subsequently confirmed during surgery. Accordingly, The aim of this study is to examine the diagnostic performance of 3D/four-dimensional (4D) volume rendering ultrasound (VRU) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in their third trimester
* with a single fetus in the current pregnancy
* a previous delivery by at least 1 cesarean section
* having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment

Exclusion Criteria:

* cases with twin or multiple pregnancies,
* cases with a non-previa placenta or posterior low lying or previa placenta,
* cases without previous deliveries by cesarean section
* cases before the third trimester of pregnancy.
Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure

This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.

After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-75 (including 35 and 75).
* Signed the Informed Consent Form (ICF).
* Have chronic left ventricular dysfunction.
* Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
* Have indications for Coronary Artery Bypass Grafting.
* LVEF \< 40% as determined by echocardiogram (data collected up to 6 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
* Weakening or absence of segmental regional wall motion as determined by standard imaging

Exclusion Criteria:

* PRA ≥ 20% or DSA-positive
* Patient received ICD transplantation, CRT or similar treatment.
* Patients with valvular heart disease or received heart valvular disease
* Patients received treatment of percutaneous transluminal coronary intervention (PCI)
* Patients with atrial fibrillation
* Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
* Baseline glomerular filtration rate \<30ml/min/1.73m2.
* Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
* Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation.
* Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
* Coagulopathy (INR\>1.3) not due to a reversible cause.
* Contra-indication to performance of a MRI scan.
* Recipients of organ transplant.
* Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
* Non-cardiac condition that limits lifespan \<1 year.
* On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFα antagonist.
* Patients allergy to or cannot use immunosuppressant.
* Serum positive for HIV, HBV, HCV, TP.
* Currently enrolled other investigational therapeutic or device study.
* Patients who are pregnant or breast feeding.
* Other conditions that researchers consider not suitable to participate in this study.
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers.

This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs.

The study will enroll approximately 1000 participants.

• Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Eligibility Criteria:
Inclusion Criteria:

- Participants with a history of gastric or duodenal ulcer

Exclusion Criteria:

* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
* Participants with active upper gastrointestinal haemorrhage at initiation of vonoprazan therapy
* Participants with a history of hypersensitivity to any ingredients of vonoprazan Tablets
* Participants receiving atazanavir sulfate or rilpivirine hydrochloride
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran

Exclusion Criteria:

* Can not tolerate a minimum daily dose of 50mg milnacipran
* Significant risk of suicidality
* Pregnant or breastfeeding
Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects

The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns.

Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre.

Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values \< 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.


Eligibility Criteria:
Inclusion Criteria:

* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with an expected healing time longer than 28 days. Dark blue color on the palette of the LDI software with flux values below 200
* All clearly full thickness burns on clinical assessment done by two plastic surgeons and thereafter treated with Flammacerium®.
* Wounds treated with a hydrocolloid paste prior to LDI and with low flux values \< 200
* All assessments are done during first days before final decision at day three
* Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation on complete follow-up schedule
* Informed consent has been obtained
* TBSA Full Thickness Burn \< 40%

Exclusion Criteria:

* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with faster healing times ( flux values \>200 )
* TBSA \>40 %
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
* Patient has participated in another study utilizing an investigational drug within the previous 30 days
* Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
* Patients wish to decline from the study
* No informed consent before start of the trial
Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia

All eligible Herpes Zoster patients will be randomized into two groups. Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead control group will receive Placebo.

This study wants to see the role of Pregabalin in acute herpetic neuralgia pain reduction and for the prevention of post herpetic neuralgia incidence as compared to placebo group. For this purpose, all eligible Herpes Zoster patients will be randomized into two groups (41 patients in each group i.e.82 total patients). Group 1 will be the treatment group receiving Pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. Whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except Pregabalin. Instead of pregabalin, control group will receive Placebo. The pain will be evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly follow up for next three months). If it is difficult for the patient to present physically, telephonic follow up will be done to find the pain score in the required time. Also, DLQI (Dermatological life quality index) will be assessed at the first and last visit of the patient.

At the end, pain score will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients of HZ presenting within 72 hours of onset of rash,
* With pain score 40 or above on 100 mm pain Visual Analogue Scale at the screening visit,
* Giving written consent for the study.
* Age between 18-70 years

Exclusion Criteria:

* HZ presenting after 72 hours of onset
* Pain score less than 40 at baseline
* Who took the stable doses of oral analgesics like: NSAIDs, acetaminophen, opioids and antidepressant within six hours of screening visit
* Using Pregabalin and Gabapentin within last 72 hours
* Nerve block therapy within the last 48 hours
* History of hypersensitivity to the drug or its ingredients
* Use of topical medications within 12 hours
* Unable to come for follow up because of severe systemic illness
* Significant hepatic and renal disease,
* Bed ridden patients or those who are physically unfit for follow up visits.
* Ethically considered vulnerable members- pregnant/lactating mothers/newborn/children below 12 years /physically or mentally challenged individuals/HIV/ AIDS/IV drug users
A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo

Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.


Eligibility Criteria:
Inclusion Criteria:

* Age 18≤ Age ≤65.
* patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
* 18 kg/m2≤BMI≤30 kg/m2
* ASA classification I-III
* Patients signed informed consent form

Exclusion Criteria:

* Arrhythmias
* The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
* Severe heart failure (METS\<4)
* The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
* The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
* There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
* History of allergy to anesthetic drugs
* Weight\<40kg
* Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland
Factors Associated With Complicated Pneumonia in Paedatrics

Detecting Factors associated with complicated pneumonia in pediatrics

Community acquired pneumonia is the cause of morbidity and mortality in children worldwide ,complication of Community acquired pneumonia in paedatrics include para -pneumonic pleural effusion ,empyema, necrotizing pneumonia and lung abscess.( Sawicki GS,2008) Pediatric para-pneumonic pleural effusion and empyema are considered different stages of the same pathophysiological process in which pleural inflammation causes fluid to accumulate in the pleural cavity, Necrotizing pneumonia results from pulmonary necrosis and tissue liquefaction. ( Ira Erlichman, MD,2017) Recent reports have characterized the clinical presentation of this complication and have shown favorable outcomes in children.( Sawicki GS,2008) Complicated pneumonia was defined as clinical pneumonia and the presence of pleural effusion, empyema (EMP) or Para-pneumonic childhood EMP was defined as the presence of pus (purulent fluid and/or WBC count\>5,000 permm3) or bacteria in the pleural fluid.

PPE was defined by pleural fluid not fitting criteria of EMP and the diagnosis of NP was made by the presence of multiple cavity gas-filled spaces within a pulmonary consolidation on chest X-rays or liquefaction of lung tissue according to CT scans as reviewed by a pediatric radiologist .( Ira Erlichman, MD 2017) Among patients with pneumonia AS MANY AS half may develop pleural effusions (i.e., fluid in THE PLEURAL SPACE); of these, 5-10 % MAY DEVELOP EMPYEMAN Ingeneral , "complicated pneumonia" refers to pneumonia accompanied by pleural effusion.( Byington CL,2010) Empyema is a serious COMPLICATIO characterized by pus and bacteria in the pleural space which may progress to necrosis, cavitation, or fistulas in the thoracic cavity. S. pneumoniae is the most common cause of complicated pneumonia in children (an M. A. Fletcher ETT 2014) Empyema among children age below 19 years in Utah (USA) (1994-2007)\] and Australia(1998-2010)ranged from 0.9 to 12.5 per 100,000 (Byington CL,2010)the incidence was highest in children aged 0-4 and tend to increase over time. (Strachan RE,2013).

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted at AUCH aged 2months up to 16 years old with sign and synptoms suggestive of pneumonia.

Exclusion Criteria:

* Immunodefiecency
* Hematological And Malignancy.
* NEONATAL PEROID.
Fluorouracil Filtering Surgery Study (FFSS)

To determine whether postoperative subconjunctival injections of 5-fluorouracil (5-FU) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.

Filtering surgery adequately lowers intraocular pressure in most glaucoma patients. However, the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes following unsuccessful filtering operations. Failure of filtering surgery is usually attributed to the proliferation of fibroblasts at the filtering site. The use of 5-FU, an antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture, and in preliminary studies it has increased the success of filtering surgery in a nonhuman primate model.

The Fluorouracil Filtering Surgery Study (FFSS) was a randomized, controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-FU treatment.

Another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-FU injections. Detailed preoperative and postoperative examinations of the cornea, lens, and retina were performed. Systemic toxicity was assessed by preoperative and postoperative hematologic studies.

After the investigators performed the filtering surgery and determined that the new outlet channel was working, patients were randomized to receive either 5-FU injections or standard postsurgical care without 5-FU. The patients treated with 5-FU received subconjunctival injections of 5 mg of 5-FU twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14. There were 213 patients recruited into the study, 162 with previous cataract extraction and 51 with previous filtering surgery.

All patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively. Possible concomitant risks of 5-FU treatment, such as toxic effects to the cornea, lens, or retina, were monitored.

Eligibility Criteria:
Men and women with uncontrolled intraocular pressure greater than 21 mm Hg in one or both eyes despite maximal tolerated therapy and who were aphakic or had undergone previous filtering surgery were eligible to participate.
Effect of Topical Botulinum Toxin Eyedrop on Palpebral Fissure

The purpose of this research study is to test if Topical (applied to the surface of the eye) Botulinum Toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate
* Presence of upper eyelid retraction or asymmetry( \>1mm)

Exclusion Criteria:

* Adults unable to consent
* Individuals less than 18 years of age
* Prisoners
* Pregnant women. o Patients will be asked if they are pregnant by research staff before participation in the study.

Women who are breast-feeding

* Known contradictions or sensitivities to study medication
* Grossly abnormal lid margins, anatomical abnormalities
* Variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm)
* Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
* Presence of an active ocular infection
* Inability to sit comfortably for 15 - 30 minutes
* Botulinum toxin injection in the eyelids during the past 3 weeks.
* Neuromuscular disorders (e.g., Parkinson's disease or myasthenia gravis)
* Medication use known to interfere with the effects of botulinum toxin-A within the previous 1 month (e.g., aminoglycoside or benzodiazepines),
* Previous history of hypersensitivity reactions to botulinum toxin-A
* Dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or Sjogren's syndrome),
Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.

Eligibility Criteria:
Inclusion Criteria:

* Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria

Exclusion Criteria:

* The use of antibiotics within one month prior to faecal microbiota transplantation
* The use of probiotics within one month prior to faecal microbiota transplantation
* History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
* Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
* HIV infection or other active infection
* Renal or hepatic disease (both defined by biochemistry workup)
* Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
* Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score \> 15
* Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score \> 10
* Current pregnancy and lactation
Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

This prospective observational study aimed to obtain ultrasound images for ultrasound-assisted paramedian spinal anesthesia and identify the differences according to sidedness of approach, position and age.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 40 or over 60 years of age who require spinal anesthesia for orthopedic surgery,
* with ASA physical status classification system I, II, III

Exclusion Criteria:

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
* Patients with communication difficulties
* Patient who can not take a sitting or lateral decubitus position (fracture)
* Patients with a history of spinal surgery
* Patient with anatomical abnormality of the spine