cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study on Silver-coated ETT Cleaned With a Novel Device

The purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.

Several studies have suggested that biofilm formation inside the ETT plays a pivotal role in VAP development and drug-resistance induction. Silver-coated ETT have proven effective in delaying but not in preventing ETT colonization and biofilm formation, due to a barrier effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove debris and biofilm and reduce the total ETT microbial load to a certain extent. The Investigators hypothesize that the routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want to assess the reduction of ETT microbial colonization in patients intubated with a silver-coated ETT and cleaned with endOclear compared to the current standard of care of silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the tubes of each enrolled patient after it has been removed, either because the patient does not need it anymore due to his/her better clinical conditions, or because there is a need of tracheostomy or because he/she dies. Specifically they will analyze how the endOclear cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this can determine distal airway inoculation and, ultimately, VAP development.

Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization.

Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from microbial colonization will prevent septic inoculation of distal airways

Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm development will reduce drug resistance rates found in ETT and distal airways isolates

The investigators will conduct a randomized clinical trial on 40 patients intubated with silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the endOclear device.

Eligibility Criteria:
Inclusion Criteria:

* Admission to Medical, Surgical or Neuro ICU
* Subjects must be enrolled within 24 hours from intubation
* Subjects expected to be intubated for at least 48 hours or longer
* Subjects have been intubated with a silver-coated ETT

Exclusion Criteria:

* Current and past participation in another interventional trial conflicting with the present study
* Pregnant women
* Prisoner status
Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex

The aim of this study is to evaluate the treatment effect of magnesium sulfate on the T4 / T1 ratio after reversal with sugammadex deep or moderate neuromuscular blockade induced by rocuronium.

Sugammadex is a novel neuromuscular blocking reversal agent. Its mechanism of action is the encapsulation of rocuronium and vecuronium molecules. Numerous studies show a potential role of magnesium in reducing anesthetic requirements, sympathetic response to surgical trauma, antinociceptive action and neuroprotective effects. However, its use is limited because magnesium potentiates non-depolarizing neuromuscular blocking agents.

Primary outcome: evaluating the effect of treatment with magnesium sulfate the T4 / T1 ratio after reversal with sugammadex deep and moderate neuromuscular blockade induced by rocuronium.

Secondary outcome: evaluate the occurrence of severe respiratory events, the incidence of residual neuromuscular block in the post-anesthetic recovery room, evolution of T1 high, and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2
* weight BMI 18.5-24.9
* otorhinolaryngological surgeries

Exclusion Criteria:

* refusal to participate in the study;
* pregnancy or suspected pregnancy;
* neuromuscular diseases, renal or hepatic impairment;
* hepatic dysfunction;
* story or predictors of difficult airway;
* hypermagnesemia (Mg\> 2.5 mEq / L);
* hypomagnesemia (Mg \<1.7 mEq / L);
* furosemide, aminoglycosides, aminophylline azathioprine; cyclophosphamide, anti-inflammatory and magnesium;
* allergy to drugs used in the study;
* participants from other clinical studies.
NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

The primary objective of this study is to determine the benefits of interventions from a Multidisciplinary Diabetes Care team involved of diabetes nurse practitioners(DNP) on glucose control, perioperative outcomes and psychosocial outcomes for patients with Diabetes Mellitus

About 50% of diabetic patients will undergo at least one surgical operation, and nearly 20% of surgical patients have diabetes.Compared with non-diabetic patients, diabetic patients face greater risks during the perioperative period. Stress factors such as preoperative preparation, anesthesia, surgical trauma, pain, drugs and negative emotions can induce blood glucose fluctuations, which could lead to complications such as hyperglycemia, diabetic ketosis, and hypoglycemia.Therefore, perioperative management has become an important part of diabetes management.

A multidisciplinary collaborative team led by NP can reduce the mortality of patients after inpatient surgery, help patients change their lifestyle, maintain self-management behavior, improve patient experience, and reduce hospitalization costs. This study intends to explore the application effect of NP-led multidisciplinary collaborative team in the perioperative comprehensive management of diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis meets World Health Organization (WHO) (1999) Diabetes Diagnostic Standards
* Orthopedic assessment requires elective surgery and no surgical contraindications
* HbA1c≥8.5% or intravenous fasting blood glucose (FBG)\>10mmol/l
* Informed consent.

Exclusion Criteria:

* Cognitive and communication disorders;
* Pregnancy;
* Participate in other intervention studies.
Scapular Alignment and Upper Limb Function in Children With Cerebral Palsy

Purpose: To determine the effect of scapular alignment on upper limb function in hemiparetic children and to find relation between scapular alignment of the affected, less affected limb and the upper limb function in children with spastic hemiparesis Subjects: Forty children with spastic hemiparetic cerebral palsy, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.

Methods: Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.

Subjects:

Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.

Inclusion criteria:

Children were enrolled in this study according to the following criteria:

1. The age of the selected children was ranging from 3 to 6 years old .
2. Both genders were included.
3. They were able to follow instructions and understand commands.
4. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
5. Postural zone software was assess scapular alignment and pediatric arm function test was assess upper arm function .

Exclusion criteria:

The child was excluded from the study if he / she has one or more of the following:

1. Upper limb surgery in the last 12 months.
2. Children which had contracture, fracture, and fixed deformities in the upper limb.
3. Children with muscleoskletal abnormalities as fixed back deformities.

Methods:

Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the selected children was ranging from 3 to 6 years old .
2. Both genders were included.
3. They were able to follow instructions and understand commands.
4. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.

Exclusion Criteria:

1. Upper limb surgery in the last 12 months.
2. Children which had contracture, fracture, and fixed deformities in the upper limb.
3. Children with muscleoskletal abnormalities as fixed back deformities.
Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease

Brief summary: This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablet in patients with mild to moderate Alzheimer's Disease. This study is to be run in China involving 21 sites. It will enroll approximately 480 patients to ensure 240 randomized with mild to moderate Alzheimer's Disease. The treatment period is 52 weeks and total study duration per patient is approximately 57 weeks.

In this multicenter, randomized, double blind, parallel-group, placebo controlled phase II study, 240 patients with mild to moderate Alzheimer's Disease are planned to be enrolled and randomly assigned 1:1:1 to receive placebo, or different doses of AD-35 tablet (30 or 60 mg). After the first 26 weeks, subjects on active study drug will remain on the current doses, and subjects assigned to placebo will be randomized to receive 30 mg and 60 mg AD-35 tablet in a 1:1 ratio, respectively, for the second 26 weeks. This study will evaluate the safety, preliminary efficacy and pharmacokinetics of AD-35 tablets in patients with mild to moderate Alzheimer's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, 50-75 years of age.
* Formal education of five or more years.
* Diagnosed of probable AD in accordance with the NINCDS/ADRDA criteria (2011).
* Mild or moderate AD subjects: MMSE Score of 15-26 and CDR Score ≥ 0.5 (CDR memory score ≥ 0.5).
* Subjects must have a brain magnetic resonance imaging (MRI) scan that is consistent with a clinical diagnosis of probable AD. Brain atrophy and medial temporal lobe atrophy visual assessment scale MTA grading \>2 points. Mild white matter degeneration may occur, but Fazekas less than or equal to 2 points and supratentorial lacunar infarction lesions less than or equal to 3 points.
* The total score of modified Hachinski ischemia scale (MHIS) ≤ 4.
* Hamilton depression scale (HAMD) has a total score ≤ 17.

Exclusion Criteria:

* Visual, hearing and verbal communication of subjects cannot meet the needs of cognitive function evaluation.
* Inability to tolerate MRI procedures or contraindication to MRI, (such as implanted in the body, MRI incompatible pacemakers, implantable cardioverter defibrillators, cochlear implants, aneurysm clips, implanted injection pump, implanted nerve stimulator, metallic splinters in the eye, other magnetic, electrical and other metal implants) \[note\], or any other situation, in the judgment of the Investigator, is not suitable for magnetic resonance imaging (MRI).
* The investigators believe that other severe or unstable conditions may interfere with the cognitive evaluation in clinical trials.
* Dementia caused by other reasons: vascular dementia, central nervous system infection, endocrine system diseases (such as thyroid disease, parathyroid gland disease) and other reasons.
Acute Beetroot Juice Supplementation in Amateur Climbers

Whereas beetroot juice (BJ) supplementation is shown to increase physical performance in endurance activities, its benefits in neuromuscular function and strength performance has been barely studied. In this cross-over randomized placebo-controlled study, we investigated the effects of BJ acute supplementation in improving neuromuscular performance in amateur climbers


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years
* active climbing for, at least, last 6 months

Exclusion Criteria:

* smoking
* contraindications to BJ diet
* physical limitations, health problems, or musculoskeletal injuries
Obstetric Outcomes of Primigravidae

To determine obstetric outcomes in primigravida at term at women's health centre

A primigravida is a woman carrying her first pregnancy(.1)A woman carrying her first pregnancy is starting a new life and it is a crucial time in her obstetric career as subsequent obstetric performance will depend on how well the first pregnancy was managed.(2).Pregnancy in a primigravida is often viewed with anxiety not only by the patient who is going through the experience for the first time but also her relatives and her caregiver. The obstetric outcome of primigravidae is associated with many complications; therefore, they are considered high risk because of both maternal and fetal concerns(.2).Numerous studies have shown that primigravidae are at increased risk of complications during pregnancy, labor, and delivery and if not properly managed, these complications can result in increased morbidity and mortality for both the mother and baby(3) Reported complications include abnormal labor patterns, increased risk of operative deliveries, increased rate of admissions into neonatal intensive care unit and increased perinatal deaths.(4,5,6) The cardinal observation to be made in a gravid uterus at term in labor is engagement of head which is the initial step in the mechanism of labor. The term "engagement" in normal labor denotes that the greatest diameter of fetal head has passed through the brim of the pelvis.(7) Engaged head in a primigravida at term in early labor is a sign of pelvic adequacy.Unengaged head at the onset of labor is associated with increase in duration of labor and incidence of dysfunctional labor pattern.(8,9) Thus, undue prolongation of labor leads to increased risk of caesarean section(10,11) and its associated maternal and perinatal morbidity and mortality. The adequacy of the pelvis, the efficacy of uterine contractions, the capacity of fetal head to mold and the temperamental resilience of the patient contribute more to the outcome of labor. Hence, the dynamics of labor is equally important with mechanics as it improves the adaptation of fetal head To the pelvic cavity and its passage through it supported by primary and secondary forces of labor. Careful monitoring of progress of labor and timely medical intervention in these cases can reduce the incidence of caesarean deliveries. (11)This study will, therefore, assess the obstetric outcome of vaginal delivery of these women at term considering course \& duration of labour \& the incidence of complication with its associated fetomaternal outcomes

Eligibility Criteria:
Inclusion Criteria:

* Primigravida with singleton live fetus
* Cephalic presentation
* Delivered at term with gestational age(37 -41 weeks)

Exclusion Criteria:

* Multiparous women
* Multiple gestation
* Intra Uterine fetal death th (IUFD)
* Medical condition as preclampsia
* Polyhydramnios and fetal anomalies
* Malpresentation (e.g., breech, face).
Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Subject has given consent
* Willing and able to attend all visits
* Minimum age 18 with no desire for future fertility
* Uterine fibroid \> 300 cc on MRI
* Normal cervical smear
* Screening symptom score \>21
* Pre or peri-menopausal
* Fibroids being device accessible

Exclusion Criteria:

* Pregnancy
* Previous GNRH treatment
* HRT use
* Hormonal Contraception
* Patient on dialysis
* Haematocrit \<25
* ASA score \> 2
* Severe cerebrovascular disease
* Anticoagulated
* Active pelvic infection or history of PID
* Weight\> 250 lbs
* Any contra-indication to MR imaging
* Intolerance to MRI contrast agent
* Unable to remain in prone positions for 3hours
* IUCD
* Abdominal scarring in beam pathway
* Breast feeding
* Non-perfused fibroid on contrast enhanced images
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

The purpose of this trial is to determine the efficacy of ofatumumab in patients with relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).


Eligibility Criteria:
Inclusion Criteria:

* relapsed nodular lymphocyte predominant hodgkin lymphoma
* age 18 - 75
* review of diagnosis by experienced pathologist
* no major organ dysfunction

Exclusion Criteria:

* classical hodgkin lymphoma
* CD20 antibody treatment within the last 6 months prior enrollment
* chronic or current infectious disease requirering systemic antibiotics
* other past or current malignancy
Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies.

This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.

In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.

   1. First cohort: Etanercept is the first biological product prescribed.
   2. Second cohort: Etanercept is the second biological product prescribed.
2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
3. Eighteen (18) years of age or older at time of consent.

Exclusion Criteria:

1. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery

The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility Criteria:
Inclusion Criteria:

* Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
Yoga for Abdominal Obesity

The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to no specific intervention on weight-related outcomes, well-being, and health behaviour in 60 females with abdominal obesity.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference at least 88cm
* Body mass index at least 25
* Sedentary
* Physical and mental ability to participate in the yoga intervention
* Willingness to participate in at least 18 of 24 yoga sessions and the whole-day workshop

Exclusion Criteria:

* Dementia
* Psychosis
* Severe hypertension (diastolic blood pressure more than 120mmHg)
* Type 1 diabetes or insulin-dependent 2 diabetes
* Coronary artery disease
* Myocardial infarction
* Lung embolism
* Stroke
* Regular physical activity or yoga practice
* Pregnancy
Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab

The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* consentment
* patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".

Exclusion Criteria:

* age \< 18
* no consentment
The Effect of Follicular Flushing on Oocyte Retrieval Rate and Embryo Quality

Researchers will investigate the effect of flushing according to follicle size on the success of obtaining oocytes from a single follicle. In addition, by comparing the morphological quality of embryos developed from oocytes obtained with and without flushing, the possible effects of flushing on developing embryo quality will be investigated. By evaluating only one follicle for each patient, it is planned to investigate the effectiveness of the flushing process according to individual follicle characteristics, with a study design that has not yet been included in the literature.

Prior to the oocyte pick up (OPU) procedure, the dimensions (height x width x depth) of the first accessible follicle in any ovary will be recorded in millimeters. In this regard, any follicle larger than 12 mm will be selected for the first aspiration. It is planned to evaluate the effectiveness of the washing process in follicles with different sizes by performing the first aspiration procedure regardless of the follicle size. After aspiration of all the follicle fluid with a double lumen needle (17 Gauge), the remaining fluid in the needle and line will be aspirated by giving 2 cc "flushing medium" to the follicle. In this way, all of the pure follicle fluid will be delivered to the in vitro fertilization (IVF) laboratory with the OPU tube for initial evaluation. After the evaluation, if no cumulus oocyte complex (COC) is observed in the first sample, the washing process will be started. In this regard, flushing and aspiration will be performed respectively by giving 2 cc "flushing medium" to the same follicle 3 times. A total of 6 cc flushing medium obtained after the flushing-aspiration process will be delivered to the IVF laboratory and the presence of COC in it will be investigated again under the microscope. Depending on the retrieval of oocyte by direct aspiration or flushing, each oocyte will be followed individually and its quality will be evaluated in case of embryo development from this oocyte.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-43 years old
* Patients who will undergo ICSI procedure

Exclusion Criteria:

* Patients who will undergo oocyte cryopreservation
* Patients with "empty follicle syndrome" in a previous OPU procedure
* Cases that OPU cannot be performed due to premature ovulation