cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants

The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers

A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of does required to protect UK infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation programme. The vaccine used in the US protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. Infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the UK. The infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib together with meningitis C vaccine which is currently only used in the UK and a few other countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their MMR vaccine. All children in the study received a booster dose some months later. The response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by parent/guardian for receipt of study vaccines and for blood samples
* Age at first dose: Infants 7-11 weeks; toddlers 12-18 months

Exclusion Criteria:

* Previous bacteriologically confirmed pneumococcal or meningococcal disease
* Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996.
* Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study
* Children participating in any other clinical trial
* Immunocompromised
* Acute systemic illness or fever \> 38C on day of vaccination - deferral
Necessity of Anti-Arrhythmic Medication After Surgical Ablation for Atrial Fibrillation

The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation.

Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject must be diagnosed with Persistent and/or Longstanding Persistent Atrial fibrillation as classified by the HRS Guidelines 8 \[0\]
* Subject must be selected as a candidate to undergo the Cox- Maze procedure for ablation of atrial fibrillation
* The Cox Maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy:
* Subject has a Left Ventricular Ejection Fraction (LVEF) ≥ 30%
* Subject would normally be prescribed Amiodarone as an anti arrhythmic medication post surgical ablation
* Subject is able and willing to provide written informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist)
* Subject has a life expectancy of at least one year

Exclusion Criteria:

* Subject has undergone previous attempts at surgical Maze procedure or other AF operation, including surgical or catheter ablation Subject has an accessory pathways disorder (e.g. Wolff-Parkinson-White syndrome)
* Subject is in Class IV NYHA
* Subject has had a documented MI within 6 weeks prior to study enrollment
* Subject needs emergent cardiac surgery (i.e. cardiogenic shock)
* Subject has known carotid artery stenosis greater than 80%
* Subject has a current diagnosis of active systemic infection
* Subject is pregnant, planning to become pregnant within 12-14 months, or lactating
* Subject requires preoperative intra-aortic balloon pump or intravenous inotropes
* Subject has renal failure requiring dialysis
* Subject is diagnosed with hepatic failure
* Subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
* Subject has a known connective tissue disorder
* Subject is incarcerated
* Subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids
* Subject is an intravenous drug and/or alcohol abuser
* Subject is participating in concomitant research studies of investigational products ( e.g. Appendage closure devices, atrial septal defect patches)
M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries.

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and the abdominal lateral wall, and may be an opioid-sparing strategy with satisfactory quality improvement in patients undergoing laparoscopic surgery.

M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries.

In this study, we aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic inguinal hernia repair surgery. Our primary aim is to compare the postoperative pain scores (NRS), and our secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia

Exclusion Criteria:

* Bleeding diathesis
* Receiving anticoagulant treatment
* Known local anesthetics and opioid allergy
* Infection of the skin at the site of the needle puncture
* Pregnancy or lactation
* Patients who do not accept the procedure
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

* patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.

This is a Phase 1b, open-label study to investigate the use of LS301-IT (investigational medicinal product \[IMP\]), a fluorescence imaging agent used for visualization of tumor margins and other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.

Up to 24 patients (4 dose cohorts, up to 6 patients each) for Phase 1b study (total of 24 patients maximum). There will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma).

As safety is the primary objective of this study, the safety of each dose level will be assessed by the Safety Review Committee (SRC). Based upon the safety results of the first cohort, the SRC will recommend to the Sponsor which dose levels of LS301-IT may be administered in subsequent cohorts.

Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status of 0 to 2
* Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
* Are scheduled to undergo surgical thoracoscopy and resection of the lung.

Exclusion Criteria:

* Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
* No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery

History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.

Known sensitivity to near infrared light

Patients with impaired renal function as defined by a creatinine clearance (CrCl) \<60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)

History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) \> 470 ms
Evaluation of the Results of Lateral Suspension Surgeries Performed With the V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique

It was aimed to evaluate the quality of life and sexual function of patients by Pre- and postoperative POP-Q (Pelvic Organ Prolapse Quantification) staging and PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) test of patients who underwent lateral suspension operation with V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery) Technique.

NOTES technically means a surgical intervention performed by entering the abdomen through one of the body's natural openings such as mouth, anus, vagina, and urethra. With the flexible endoscope, a hole is made in organs such as stomach, colon, vagina, bladder, and the peritoneal cavity is entered and the area to be studied is provided by filling air. With the V-NOTES (vaginal Vaginal-Natural Orifice Transluminal Endoscopic Surgery) method we will apply, we reject the bladder from the cervix and reach to abdominal cavity by piercing the visceral peritoneum. The abdomen will be viewed via trocars placed in this region and a lateral suspension operation, which is a kind of suspension surgery of pelvic organ prolapsus, will be performed.The POP-Q staging that will be performed before the lateral suspension operation with the V-NOTES Technique will be compared with the POP-Q staging 6 after the operation. In addition, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) test will be used for the evaluation of pelvic organ prolapse, urinary incontinence and sexual function in the same intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 2nd and 3rd degree uterine prolapsus
* Patients with more than 2nd and 3rd degree cystocele

Exclusion Criteria:

* Having endometriosis
* Having a history and/ or active pelvic inflammatory disease
* Having uterine fibroids
* Having an adnexal cyst with risk of malignancy
* Being pregnant
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer.

Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)


Eligibility Criteria:
Main selection criteria:

* Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (\> 15 cm from the anal margin)·
* Complete resection of the primary tumor without gross or microscopic evidence of residual disease
* Treatment within 7 weeks following surgery
* Age 18-75 years old
* ECOG PS £ 2
* No prior chemo, immuno or radiotherapy
Radiomics Analysis Based on MRI to Detect Brucella Spondylitis

Brucella spondylitis, an infectious spinal disease caused by the invasion of Brucella bacteria into the body. Its diagnosis relies mainly on laboratory and imaging tests. Due to the limited diagnostic ability of X-ray and CT for Brucella spondylitis, MRI has become the main diagnostic tool. In recent years, functional magnetic resonance technology has demonstrated great advantages in the diagnosis and therapeutic evaluation of brucellosis spondylitis, which can provide pathophysiologic information about the disease and is also a noninvasive and noninvasive diagnostic tool with a broader application prospect. Radiomics, an emerging approach, has also shown better diagnostic efficacy for this disease.

The investigators will incorporate 100 confirmed cases of Brucella spondylitis (BS) patients diagnosed at Affiliated Hospital of Inner Mongolia Medical University. The patients receive routine scan with a Siemens Skyra 3.0T MRI scanner and the investigators collect clinical data and blood test results from the patients.The investigators segment the affected vertebral bodies by ITK-SNAP software on STIR images to create three-dimensional regions of interest. Then use Onekey software to extract radiomics features from the affected vertebral bodies. Employed t-tests and Lasso regression to select radiomics features. Then separately use radiomics features and combining it with clinical information to build random vector machine(SVM) and random forest(RF) models . All the models are constructed in the training set and their performance are evaluated on the validation set.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients/Inpatients
2. Age 18-70 years
3. Meet diagnostic criteria for brucellosis
4. Meet symptoms of brucellosis spondylitis
5. Voluntarily sign an informed consent form
6. Can cooperate with MRI examination

Exclusion Criteria:

1. Patients with serious diseases of other systems
2. History of malignant tumors of the vertebral body
3. History of tuberculosis
4. Contraindications to magnetic resonance imaging
Automated Fetal Femur Length Measurement by Five-Dimensional Ultrasound

The purpose of the study to evaluate Five-Dimensional Ultrasound in automated measurement of the fetal femur length at third trimester of pregnancy.

This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.

Ninety pregnant women will be recruited from the the Fetal Care Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.

All cases will be subjected to:

1. Full history taking including patient's age, parity, last menstrual period, estimated gestational age by dates, past history of medical disorders, clinical examinations (General and abdominal).
2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases for assessment of fetal femur length .

The FL at Two-Dimensional Ultrasound (Gold standard) will be made from the center of the 'U' shape at each end of the bone.

The FL at Five-Dimensional Ultrasound will be measured by Pressing Five-Dimensional Ultrasound long bone Button to extract Fetal Long Bones automatically.

The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be compared to gestational age calculated by accurate dates of the last menstrual period.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. At third trimester of pregnancy.
3. The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.

Exclusion Criteria:

1. Multiple pregnancies.
2. Fetal anomalies.
3. Amniotic fluid index \< 5 cm.
4. Medical disorder as diabetes mellitus, hypertension.
5. Obese patients. BMI \> 30
6. Intrauterine growth retardation.
7. Post term pregnancy \> 41 weeks.
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes

Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.

The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.

With the continuous evolution in vitrectomy techniques and instrumentation, an increasing number of vitreorential disorders are being successfully managed with pars plana vitrectomy (PPV). Cataract is one of the most common complications seen in phakic patients following PPV, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies.

Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.

The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.

Eligibility Criteria:
Inclusion Criteria:

1. patients with visually significant cataract following PPV
2. After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
3. After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
4. The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
5. Willing and able to comply with clinic visits and study-related procedures
6. Provide signed informed consent

Exclusion Criteria:

1. Eyes with a history of acute angle-closure glaucoma, trauma,
2. Eyes with a clinically dislocated or subluxated lens.
3. Active ocular or periocular infection in the study eye
4. Uncontrolled Blood Pressure
5. Pregnant or breast-feeding women
6. Participation in another simultaneous medical investigator or trial
Targeted Perfusion Based Haemodynamic Management in Critically Ill Patients Using Urethral Perfusion

To assess the safety and feasibility of the IKORUS device in critically ill patients and to gather exploratory data on haemodynamic coherence


Eligibility Criteria:
Inclusion Criteria:

* Within 24 h of ICU admission
* Predicted length of ICU stay at least 5 days
* Receiving \>0.1 mcg/kg/min of noradrenaline at time of study enrolment

Exclusion Criteria:

* Palliative treatment intent
* Contra indication to urethral catheterisation or complication during previous urethral catheter insertion
* Contraindication to fluid or vasopressor challenges in the opinion of the attending clinician