cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Assisted Lumbar Puncture in the Neonate

Clinicians are often unable to successfully do a spinal tap. Ultrasound has been proposed as a method to improve success but it is not known if it helps. This study is designed to see if ultrasound improves the success rate.

Obtaining cerebrospinal fluid (CSF) through a lumbar puncture (LP) is an essential procedure in the neonatal/infant intensive care unit (N/IICU) for establishing diagnosis and determining treatment. The traditional technique for performing an LP involves palpation of anatomic landmarks followed by a "blind" stick of the appropriate inter-spinous process space. This technique has a failure rate (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) of 15-50%.

Bedside ultrasonography possesses the ability to visualize the anatomic landmarks, including the subarachnoid space. In the adult literature, ultrasound has been shown to reduce the LP failure rate. Its utility has also been shown to significantly improve success rates and accuracy in epidural needle placement in neonates and children undergoing regional anesthesia. Increasing the proportion of successful LPs in the N/IICU could significantly reduce patient/family discomfort, sedation exposure, off unit travel, additional interventional procedures and antibiotic use. However, research on the utility of bedside ultrasound assisted LPs by clinicians working in an N/IICU is lacking.

This is a prospective randomized controlled trial. Eligible subjects will be randomized to undergo LP (performed as part of their standard of care) with ultrasound assisted method or traditional landmark method.

Primary Objective:

-To determine if bedside ultrasound-assisted LP, performed by N/IICU clinicians on neonates and infants aged ≤6 months, increases the proportion of successful first attempt non-traumatic LPs when compared to a traditional landmark palpation technique.

Secondary Objectives:

* To determine if bedside-ultrasound assisted LPs increases the proportion of overall successful non-traumatic LPs within 2 attempts.
* To determine if bedside-ultrasound assisted LPs is associated with a decrease in the length of antibiotic exposure in patients undergoing LPs.

Eligibility Criteria:
Inclusion Criteria:

1. Neonates and infants aged ≤6 months
2. Clinical indication for a lumbar puncture (LP), as determined by the clinical team
3. Availability of study personnel to perform bedside ultrasound

Exclusion Criteria:

1. Known spinal cord abnormality (for e.g., tethered cord, spina bifida)
2. Presence of skin and soft tissue infection at insertion site
3. Recent failed LP traumatic LP attempts within the preceding 48 hours
4. Recent diagnosis of intraventricular hemorrhage, within the preceding 7 days
5. Clinically unstable patient, as determined by the clinical team
6. Eligible patients on the resident care team
A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion

Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health.

The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting.

The aim of this study is to compare the effectiveness of the Dynamax appliance and the Twin-block appliance for the treatment of Class II Division 1 malocclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a Class II malocclusion as defined by British Standards Institute classification.
* Overjet greater than 6mm
* Aged 10-14 years
* Clinical examination indicates a functional appliance is not contraindicated

Exclusion Criteria:

* Orthognathic treatment is required or there is a strong indication it will be required in the future
* Possession of a craniofacial anomaly
* Previous orthodontic treatment and/or premolar extraction
* Hypodontia of more than one teeth in any quadrant excluding third molars
* Inadequate oral hygiene
Glycocalyx Monitoring in Major Abdominal Surgery

The study of the microcirculation and glycocalyx could be an essential element in the monitoring of our patients undergoing major abdominal surgery. It would enable us to better target the objectives of anaesthesia and resuscitation, which until now have been based essentially on macro-circulatory parameters.

This monitoring is possible in real time and real conditions by micro-camera GlycoCheck™ (Microvascular Health Solutions Inc., Salt Lake City, Utah, USA), a non-invasive monitoring allowing the study of sublingual microcirculation and glycocalyx.

Eligibility Criteria:
Inclusion Criteria:

For the HIPEC group :

* Adult patients
* Age \< 75 years
* Receiving HIPEC for primary or secondary peritoneal carcinosis

For the CDP group :

* Adult patient
* Age \< 75 years
* Receiving CDP for pancreatic neoplasia
* Patient who has read and understood the information letter and does not object to taking part in the study
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Secondary distant peritoneal metastases
* Chronic heart failure
* Chronic liver failure at stage C of the Child-Pugh score
* Stage IV or V chronic renal failure
* Inflammation of the sublingual buccal mucosa or injury that may locally influence sublingual microcirculation
* Patient refusal
* Person deprived of liberty by an administrative or judicial decision or person placed under court protection or guardianship
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.

aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery.

Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery.

Study question: considering transabdominal \& transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?


Eligibility Criteria:
Inclusion Criteria:

* Age (20:40 years old).
* Women at term (37:40 weeks).
* With singleton pregnancy.
* Presenting by vertex (cephalic presentation).
* Having adequate liquor.
* Previous delivered by cesarean delivery one time.

Exclusion Criteria:

* Fetal malformations, e.g fetal hydrops.
* Uterine malformations, e.g bicornuate uterus.
* Placental malformations, e.g placenta praevia, placenta accrete.
* Uterine surgery is other than a cesarean, e.g myomectomy.
* Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation).
* Obese patients (BMI \>30 kg/m2)
Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female 18 - 84 years of age, inclusive, who have been diagnosed with IBD.
* Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia.
* Written informed consent document signed and dated by the subject.

Exclusion Criteria:

* Any condition that in the opinion of the investigator should preclude participation in the study.
* A history of aerodigestive tract cancer.
* Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
* IBD limited only to the rectum.
* Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients

The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP)
* Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15)
* Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration
* Written informed consent

Exclusion Criteria:

* Pregnant Patients, patients older than 90 y/o, those with CrCl \< 30 mL/min, patients with a BMI \> 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study
Safety Study of Infant Formula With Partially Hydrolized Whey

The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.

The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.

There will be two study groups, each receiving one of the following formulas:

1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.

The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.

There will be two study groups, each receiving one of the following formulas:

1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

Eligibility Criteria:
Inclusion Criteria:

Healthy term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited

Exclusion Criteria:

* Twins
* Premature or low birth weight (\< 2500 g).
* Chromosomal abnormalities or congenital malformations.
* Jaundice of more than 12 mg% and/or phototherapy.
* Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management

This study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb Orthopaedic Surgeon at the Department of Hand \& Upper Limb Microsurgery of the 'KAT General Hospital' in Athens, Greece. Participants that will be diagnosed with RCRSP by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. Written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. The main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65
* Pain: \>3 months, non-traumatic, unilateral or bilateral of anterolateral location
* ROM: \>50% all planes, AROM painful in forward flexion and/or abduction
* Provocation testing: Hawkins-Kennedy, Neer, Painful Arc, Resisted ER, Empty Can (3 or more out of the 5 +ve)

Exclusion Criteria:

* Pain \< 3months
* History of neck or shoulder trauma
* Radicular signs, shoulder pain reproduced with neck movements
* GH OA
* Frozen Shoulder
* Tears \>C3 according to Snyder Classification
* Fibromyalgia
* Neurological, systemic local or autoimmune inflammatory conditions
* Clinical depression
* No injected corticosteroids or physiotherapy the last 3/12
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.


Eligibility Criteria:
Inclusion Criteria:

* AML patients in first relapse or refractory after all prior therapy
* Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia
* AML secondary to prior chemotherapy for other neoplasms.
* Persistent, clinically significant \> Grade 1 non-hematologic toxicity from prior AML therapy
* Prior treatment with a FLT3 targeted therapy
* Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy
Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema

The trial is designed to compare the efficacy and safety of Fucicort® Lipid cream with the combination treatment of Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, when applied twice daily for two weeks. The trial is designed to demonstrate that treatment with Fucicort® Lipid cream is not inferior to the combination treatment with the mono component drugs, Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream and that treatment with Fucicort® Lipid cream is superior to the treatment with Fucicort® Lipid cream vehicle. This is a 3-arm, parallel group, active- and vehicle-controlled trial comparing the efficacy and safety after 14 days treatment of Fucicort® Lipid cream, to Fucidin® cream followed by betamethasone (Lianbang Beisong®) cream, or Fucicort® Lipid cream vehicle, in subjects with clinically infected AD/eczema.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD/eczema as defined by Williams's criteria with clinical signs of infected AD/eczema on trunk and/or extremities such as fluid drainage, blistered skin, white or yellow pus, severe itchiness and new burning sensation
* A minimum score of 1 for each of the signs in the m-EASI score in at least one of the pre-defined body areas (trunk and/or extremities)
* Subjects between 2 and 65 years of age

Exclusion Criteria:

* History of concurrent diseases that could interfere with trial assessments or pose a safety concern
* Subjects with other skin lesions, e.g. scarring, tattoos, or hyperpigmentation on the treatment area that could interfere with assessments
* Clinical findings such as severe heart, liver, kidney and lung deficiency, which will be impacted by the trial procedures at the investigator's discretion
* Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation at investigator's discretion
* Use of prohibited medication, i.e.

  1. Systemic treatment with immunosuppressive or immunomodulating drugs(including Leigongteng) or corticosteroids within 28 days prior to randomisation
  2. Use of topical or systemic antibiotics and anti-histamines within 14 days prior to randomisation
  3. Phototherapy (e.g. PUVA, UVA or UVB therapy) within 28 days prior to randomisation
  4. Topical treatment with immunomodulators (e.g. pimecrolimus, tacrolimus) within 14 days prior to randomisation
  5. Topical treatment with corticosteroids or any other topical treatment within 7 days prior to randomisation
  6. Use of any non-prescribed systemic or cutaneous medication within 7 days prior to randomisation
  7. The use of analgesics at the discretion of the investigator is allowed before and during the trial
Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma

This randomized pilot study proposes to field-test key logistical aspects of studying an intervention already available to patients on the pediatric ward, namely a discharge medication delivery service, called "Meds-in-Hand," which has been refined via a quality improvement process, but not rigorously studied nor fully implemented.

At this time, Meds-in-Hand is not currently utilized for approximately 40% of patients admitted to the pediatric ward at Boston Medical Center. Currently patients do not receive their discharge medications via the delivery service for a variety of reasons, however they continue to receive the usual care standard employed by most hospitals, where prescriptions are sent to their home pharmacy for pickup after discharge. This study does not change the actual medications patients receive, but how and when they get them. Rigorous study of the relationship between Meds-in-Hand and patient satisfaction and clinical outcomes has not been performed to date, so there is equipoise about the value of the intervention, however observational data in the population in question, namely children admitted for an asthma exacerbation, suggest that patients who receive Meds-in-Hand prior to discharge have a reduced likelihood of a return visit to the Emergency Department in 30 days. The study will focus on parent-patient dyads admitted with an asthma exacerbation where the child is aged 2-17 years, however parents will be the exclusive study subjects. Parents of the patients will be asked a baseline, in-hospital survey as well as participate in phone follow-up interviews to report on the patient experience and parent-reported child health outcomes at approximately 3 and 30 days after leaving the hospital. 60 total parents will be enrolled, 30 in each arm of the study. This pilot study will also obtain empiric estimates of key study parameters to inform future study design and begin to examine trends between the groups of patients who are randomized to the Meds-in-Hand intervention and those randomized to usual care.

Eligibility Criteria:
Inclusion Criteria:

* admission includes treatment for asthma exacerbation
* discharge medications will require a new prescription
* primary care taker speaks english or spanish

Exclusion Criteria:

* patients being discharge outside of the operating hours of the delivery service
Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg

The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.


Eligibility Criteria:
Inclusion Criteria:

1. A condition of general good health
2. BMI 19 to 29

Exclusion Criteria:

1. Currently enrolled in another clinical study
2. Females who are pregnant or breast-feeding
The Effect of Preoperative Hemotologic Markers on Postoperative Long-term and Short-term Outcomes for Laparoscopic Gastrectomy

The purpose of this study is to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.

A prospective cohort study will be performed to explore the effect of preoperative hemotologic markers on postoperative long-term and short-term outcomes for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node envelop important vessels
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values