cyrilzakka/clinical-trials huggingface dataset:
Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation

Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)

* Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan
* Description of various anatomical situation
* Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard

Eligibility Criteria:
Inclusion criteria:

* Pregnant women attending for 3rd trimester ukltrasound
* Uneventfull pregnancy
* No foetal malformation
* Singleton pregnancy
* Age \>18 years

Exclusion criteria:

- Other condition
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)

To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
* Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
* INR \<= 1.5 or PTT value \< 1.5 x upper limit of normal (ULN) at study entry
* Hemoglobin level at least 6.5 g/dL at Screening visit
* Willingness to be transfused to treat low hemoglobin levels

Exclusion Criteria:

* Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
* Males who cannot comply with birth control use to avoid fathering a child
* Platelet count \< 50 x10\^9/L or absolute neutrophil count (ANC) \< 1 x10\^9/L at the Screening visit
* Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be \> 1.5 x upper limit of normal at study entry.
Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid

The purpose of the study is to evaluate the role of gastric lavage in preventing feeding problems in babies born through meconium stained amniotic fluid. It is a routine practice in many hospitals to perform gastric lavage in all babies born with meconium stained amniotic fluid after stabilisation without any supporting evidence. It is believed that meconium is an irritant and its presence in stomach causes gastritis and vomiting and hence the basis for this practice. Orogastric tube insertion and subsequent gastric lavage is not without complications. Potential complications will be prevented and health resources will be saved if this procedure is not proven to be beneficial. Therefore the investigators decided to study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well as incidence of respiratory difficulties in babies born with MSAF.

Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum.

The routine use of gastric lavage in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium in stomach is hypothesized to act as an irritant and cause vomiting and retching. Surprisingly this recommendation is also made in some textbooks without supporting evidence.

Orogastric tube insertion and subsequent gastric lavage can cause complications like bradycardia, apnea, vomiting, trauma, aspiration and esophageal or gastric perforations. Some researchers have found that gastric suction done at birth is associated with long term risk for functional intestinal disorder. The sequence of prefeeding behaviour is disrupted in children who undergo gastric suction and it can delay initiation of breast feeding. Small elevation in mean arterial blood pressure, increased retching have also been reported The role of gastric lavage in preventing feeding problems and secondary meconium aspiration syndrome has not been systematically evaluated. If this procedure is not proven to be beneficial it will prevent potential complications which may arise due to it in a significant number of babies. Also in a resource limited country the cost of materials required and time of medical personnel will be saved. Hence the purpose of this prospective randomized controlled trial is to compare the incidence of feeding problems and secondary meconium aspiration syndrome, in gastric lavage group vs no lavage group.

Eligibility Criteria:
Inclusion Criteria:

* Gestation \> 34 weeks
* Meconium staining of amniotic fluid
* Vigorous babies

Exclusion Criteria:

* Major Congenital malformation
* Non vigorous babies
* Refusal of consent
Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

* on bone mineral density (femoral T-score) at 24 months
* on bone mineral density evolution (femoral T-score) after 24 months of follow-up
* on bone mineral density evolution (lumbar T-score) after 24 months of follow-up
* on coronary and abdominal aorta calcification scores evolution after 24 months of follow-up
* on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
* on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
* the tolerance after 24 months of follow-up

Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab:

* on bone mineral density (femoral T-score) (by bone densitometry) at 24 months
* on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up
* on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up
* on coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up
* on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) after 24 months of follow-up
* on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up
* the tolerance after 24 months of follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patient of 65 years or older
* Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
* Patient with osteoporosis (history of bone fracture or T-scoring \< -2.5 SD)
* PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.

Exclusion Criteria:

* Cinacalcet treatment
* Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines
* Suspicion of lower bone remodeling
* Hypersensibility to active substance or one of excipients of denosumab
* Patient with a cancer or myeloma
* Patient with severe heaptic cytolysis
* Patients with severe teeth problems
* Patient positive for HIV
* Patient involved in another biomedical research
* Vulnerable patients (protected by the law, under guardianship, deprived of freedom)
Comparison of Autogenous Dentin Matrix Versus Bovine-Derived Xenograft for Socket Preservation

The present study is a human, prospective, randomised controlled clinical trial will be conducted to explore and compare the clinical, radiographic and histomorphometric outcome of autogenous demineralised dentin(DDM) versus bovine derived xenograft(DBM) for socket preservation procedure.

* After local anesthesia a full thickness flap will be minimally reflected buccally and lingually around the tooth not exceeding 3mm apical to the alveolar crest.
* Tooth extraction will be performed using atraumatic extraction methods using Periotome.
* After extraction, the socket will be thoroughly curetted, inspected and irrigated with sterile saline solution.
* The socket satisfying the inclusion and exclusion criteria will be randomly allocated to either test or control group.
* Intra surgical measurements will be recorded.
* Socket preservation will be performed with either Demineralized dentin matrix DDM(TEST) or bovine derived xenograft DBM (CONTROL). Bone graft will be extended to the height of intra proximal bone.
* Collagen membrane will be placed over the grafted site extending approximately 3mm apical to buccal and lingual crest.
* Flaps will be approximated with sutures.

Eligibility Criteria:
Inclusion Criteria:

* Teeth indicated for extraction and subsequent implant placement
* Age group of 18 to 55 years
* Single rooted tooth indicated for extraction due to endodontic failure, caries or Fracture
* Presence of \>2 mm keratinized tissue to allow flap management
* Extraction site should have adjacent tooth on either side
* Systemically healthy patients
* Class II or III extraction socket defects according to Hammerele and Jung(2008)
* Full mouth plaque score(FMPS)\<25% at baseline.(PI)
* Full mouth bleeding score(FMBS)\<25% at baseline. (BI)

Exclusion Criteria:

* .Presence of dehiscence or fenestration in any of the socket, more than 50% of bone loss in any of the socket walls
* Medical conditions contraindicating surgical interventions
* Known smokers and alcoholics
* Subjects with known bone metabolic disorders.(Pagets disease,fibrous dysplasia etc.)
* Acute infections at the site of extraction. Eg , Abscess
* History of malignancy
* Patients who have undergone radiotherapy or chemotherapy
* Periapical pathology such as granulomas, cyst, hypercementosis, ankylosis.
* Pregnant and lactating women
* Maxillary and mandibular 3rd molars.
Imaging Study of Allocation of Pacing Targets in Cardiac Resynchronization Therapy

Magnetic Resonance Image guided delivery of Left and Right Ventricular Leads to optimal myocardial targets will result in improved clinical response to CRT using Left Ventricular remodeling criteria.

Cardiac Dyssynchrony and scar are important variables for realization of clinical response to cardiac resynchronization therapy (CRT). Results from a previous study suggest that paced heart segment characteristics do predict this response and our ability to identify venous pathways to optimal segments is feasible using cardiac CT and MRI. In an ongoing feasibility study we are using these capabilities to guide the delivery of CRT lead systems to optimal myocardial targets. A computer software program has been developed that can create an interactive, 3D integrated cardiac model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony. Although this feasibility study is ongoing, early results show this method of guiding the CRT leads to optimal targets with these individualized models to be safe and effective.

This trial will be a larger multi-centre randomized blinded trial to determine the therapeutic impact of MRI guided Left Ventricular and Right Ventricular lead placement with respect to improving clinical response rates for CRT.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Ejection fraction ≤ 35 %.
3. QRS duration ≥ 120 msec.
4. NYHA class II-IV.
5. On maximum tolerated heart failure medication therapy ≥ 6 weeks.
6. Clinically accepted for CRT device implantation.

Exclusion Criteria:

1. Failure to provide consent.
2. CCS class III-IV angina.
3. Recent Q-wave myocardial infarction or revascularization procedure ( ≤ 3 months).
4. Standard contra-indications to MRI.
5. Documented severe allergy to intravenous contrast dye ( iodinated CT contrast or Gadolinium MRI contrast).
6. Estimated Glomerular Filtration Rate (eGFR) ≤ 45 ml/min/m2.
7. Patient is pregnant.
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage III with bone lesions related to Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
* Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following clinical characteristics:

A. At least 1 osteolytic bone lesion demonstrable in a conventional X-ray film. B. The patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial.

- Ambulatory patients aged ≥ 18 years.

Exclusion Criteria:

* Treatment with bisphosphonates in any moment during the last 12 months before visit 1. except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older.
* Patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone X-ray (simple film).
* Patients with a Serum Calcium level of ≤ 8 g/dl (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L)
* Treatment with other investigational drugs within 30 days before inclusion in the trial.
* Serum Creatinine levels of \> 3 mg/dl (265 umol/L).
* Total Billirubin levels of \> 2.5 mg/dl (43 umol/L)
* Patients with a heart condition that has the NYHA criteria for a Grade III and IV functional class

Other protocol-defined inclusion/exclusion criteria may apply.
Gamified Flipped Class Room and Nursing Students' Skills Competency and Confidence

one of the primary components of effective teaching is student engagement and that engagement is critical for learning

In order to increase motivation, it is necessary to eliminate the factors that create boredom and to transform the lectures into a more enjoyable environment. In recent years, the gamification strategy has been used in order to intrigue the students, and to increase their motivation for learning. Gamification is a system that implements game design components on out-of-game contexts and alters the subjects' behaviors.

Eligibility Criteria:
Inclusion Criteria:

* agree to participate.
* Registered fundamental II in second semester year (2020-2021).
* Have access to network at home.

Exclusion Criteria:

* • Previously enrolled in fundamental II course
Urological Injuries During Obstetric and Gynecological Operations

Iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . The objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations.

Embryologically, the urinary system and genital system have a common origin, so anatomically they are so close that predisposes to iatrogenic trauma to it during obstetric and gynaecological operations. The bladder and distal ureters are the most commonly involved organs. The bladder is a retroperitoneal structure, its trigone rests over the anterior vaginal fornix and the base rests on lower uterine segment and cervix.

Risk factors may contribute to intra-operative bladder injury - include :

1. Prolonged labour with distended bladder.
2. Obstructed labour.
3. Previous cesarean section.
4. previous myomectomy.
5. previous laparotomy.
6. Cases with possibility of altered anatomy, fibrosis or direct extension of disease process as in cases of chronic pelvic inflammatory disease, endometriosis, and large fibroids especially in the broad ligament, previous pelvic surgery, malignancy, previous irradiation and congenital abnormalities of urogenital system.
7. Past history of uterine perforation, septic abortion.
8. In presence of labour, station of the presenting fetal part deeper than or equal to +1, and a large baby were independent risks for a bladder injury during caesarean section.
9. Well effacement and dilatation of cervix (uterine incision may fall over vagina and dissection of bladder from vagina is difficult in compare to lower uterine segment).
10. Preterm cesarean section where lower segment is not well formed.
11. During cesarean hysterectomy.
12. Rupture uterus may also be combined with bladder injuries.
13. Placenta percreta may penetrate the bladder and cause injury.

Urinary tract injury can be diagnosed intraoperative :

1. presence of urine in the operative field.
2. Hematuria
3. Methylene Blue test

Eligibility Criteria:
Inclusion Criteria:

* Women that undergo obstetric or gynecological surgery complicated by urinary tract injury
* Aged 15 years or older
* Elective surgeries
* Good performance status

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Metabolic Effects of Honey or Fructose:Glucose Mixtures

The metabolic effects of 7-day weight-maintenance diets containing 10% total energy as acacia honey or a fructose:glucose mixture will be assessed in a group of healthy male volunteers. Primary outcome is plasma total triglyceride concentrations after ingestion of standardized breakfast and lunch containing 25% energy as honey or fructose:glucose mixture; secondary outcome is glucose tolerance and suppression of endogenous glucose production after ingestion of 75 g glucose. Results obtained with 10% honey and 10% fructose: glucose mixture diets will be compared to results obtained with a weight-maintenance, isocaloric diet in which starch is substituted for honey or fructose:glucose mixture

Eight health males volunteers will be studied three times in a randomized order

* Honey: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, 25% acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing honey; on day 8, they will have a 75g oral glucose4 + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
* FG: volunteers will be fed a weight-maintenance diet containg 5% sugars, 20% starch, and 25% of a fructose:glucose mixture matching the composition of acacia honey, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch containing fructose and glucose; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose
* Control: volunteers will be fed a weight-maintenance diet containg 5% sugars, 45% starch, 35% fat and 15% protein during 6 days (day 1-6); On day 7, their plasma metabolites and hormones concentrations will be monitored over 10 hours during which they will receive a breakfast and a lunch with no added sugar; on day 8, they will have a 75g oral glucose + 375 mg 13C-labelled glucose tolerance test, and their plasma glucose and insulin concentrations will be monitored over 4 hours; glucose kinetics will be measured by 6,6 deuterated glucose

Eligibility Criteria:
Inclusion Criteria:

* health volunteer

Exclusion Criteria:

* BMI \< 19.5
* BMI \> 25
* Smoker
* Any disease
* current treatment with any drug
Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.

Atrial fibrillation (AF) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. Although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. However, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. Nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias.

Ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. Additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. However, there is no controlled data for the use of ranolazine to prevent recurrence of AF after electrical cardioversion of persistent AF.

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of AF after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. They will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of AF.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with persistent atrial fibrillation, aged 21 or older
* Duration of atrial fibrillation less than one year
* The patient does not have any contraindications for anticoagulation
* The patient is willing to participate in the study for a total of 6 months with 3 outpatient office visits
* The patient has provided written informed consent during the screening visit to any test or procedure being performed, or medication being changed, for this study.
* The patient has no clinically significant abnormal clinical laboratory values, which in the investigator's opinion precludes the patient from safely participating in the study.

Exclusion Criteria:

* Any contraindication for anticoagulation
* New York Heart Association class IV heart failure
* Currently taking anti-arrhythmic drugs
* Chronic kidney disease (serum creatinine less than 2.5mg/dL) or severe liver dysfunction
* Pregnancy/nursing
* Prolonged QT interval (\>500ms)
* Taking other medications known to prolong the QT interval
* Taking other medications known to affect the metabolism of ranolazine