cyrilzakka/clinical-trials huggingface dataset:
Immediate Effects on Gait and Spasticity After the Use of Passive Kinesiotherapy Equipment in the Lower Limbs of Neurological Patients

Undergo assessment of muscle tone (Ashworth Scale), gait (BAIOBIT) and risk of falling (Timed Up and Go) before using the device; Use the device on the spastic lower limb(s) for 30 minutes; Go through the same assessment carried out previously.


Eligibility Criteria:
Inclusion Criteria:

* agree and sign the Free and Informed Consent Form or signature of the person responsible
* individuals with spasiticity (hemiparetic, paraparetic, tetraparetic and hemiparetic children with cerebral palsy)

Exclusion Criteria:

* over 18 years old whose ability to sign the Free and Informed Consent Form is compromised, or who understand it, but are not responsible for signing the Free and Informed Consent Form
* present cardiovascular, neurological, musculoskeletal instability or other condition(s) that interfere with the use or positioning of the device or gait assessment
* present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
* For the children's group, participants who: 1) are under 8 years of age and/or over 13 years of age will be excluded; 2) no person responsible for signing the TCLE; 3) present cognitive deficits that interfere with understanding the ICF and/or understanding how to carry out the protocol
Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (RISS) block for patients undergoing modified radical mastectomy compared to bupivacaine only.

Rhomboid intercostal block (RIB); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. The local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes.

Aiming to expand dermatomal coverage, a new modification of Rhomboid Intercostal and Sub-Serratus block (RISS) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. The RISS block is a novel ultrasound-guided block that has been shown to provide analgesia from T2-T11 dermatomes.

Dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic.

Dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. It enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. The mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patient
* Type of surgery; Modified Radical Mastectomy (MRM).
* Physical status ASA II, III.
* Age ≥ 21 and ≤ 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

Exclusion Criteria:

* Patient refusal.
* Patients suffering from coagulation disorders.
* Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
* Patients suffering from neuropsychiatric disorders.
* Pregnancy.
Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.

When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 33 weeks 0 days
* Birth weight less than or equal to 2000g.
* Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks
* At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings.
* Written informed consent has been obtained from the parent/legally authorized representative (LAR).

Exclusion Criteria:

* Peri-/intra-ventricular hemorrhage
* Renal disease
* Hepatic dysfunction
* Major congenital malformations
* Suspected or documented systemic or congenital infections
* Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth
* Suspected or documented maternal substance abuse
* Infants who have received any experimental treatment or intervention
Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study

The goal of this split-mouth clinical trial is to evaluate the effects of Manuka honey applied into periodontal pockets after initial periodontal therapy (NSPT) in the treatment of stage 3 periodontitis.

The main question it aims to answer is:

• does the adjunct of Manuka honey improve the outcome of the non-surgical periodontal treatment.

The intervention in this study was conducted in a split-mouth design, meaning that after completing the NSPT for each subject, Manuka honey was administered as an adjunct to the periodontal treatment in two randomly selected quadrants of the oral cavity around the teeth with a specially designed cannula.

This was followed by oral hygiene instructions and training. The home-performed oral hygiene procedures were focused on interdental cleaning using dental floss and toothbrushing with regular fluoride-containing toothpaste. The subjects were also instructed not to use any form of oral antiseptic (e.g., chlorhexidine) or antibiotic during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders with good systemic health;
* Non-smokers;
* Presence of at least 20 teeth;
* Untreated moderate to advanced generalized chronic periodontitis according to the 1999 Classification 199 , i.e., generalized stage III periodontitis according to the 2007 Classification

Exclusion Criteria:

* Pregnant and nursing women;
* Antibiotics prescribed for dental or non-dental diseases 6 months before the start of the research;
* Systemic diseases or the use of drugs known to affect periodontal tissues, bleeding parameters;
* Acute oral or periodontal inflammation or infection (pericoronitis, necrotizing periodontal diseases, etc.).
Mode Of Ventilation During Critical IllnEss Pilot Trial

Landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. Limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. To provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). Whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. All three modes of mechanical ventilation are commonly used in clinical practice. A large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. The investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated ICU patients with regard to the outcome of days alive and free of invasive mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Receiving mechanical ventilation through an endotracheal tube or tracheostomy
* Admitted to the study ICU

Exclusion Criteria:

* Patient is pregnant
* Patient is a prisoner
* Patient receiving invasive mechanical ventilation at place of residence prior to hospital admission
* Patient receiving extracorporeal membrane oxygenation at the time of admission to the study ICU
A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty

In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the hip
* Spinal anesthesia
* Informed written consent

Exclusion Criteria:

* Neuromuscular disease in the affected leg
* Vascular disease in the affected leg
* Fracture sequelae in the affected hip
* Weight over 100 kg
* Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period
Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors (GIST) and Are Resistant to Imatinib Mesylate

The purpose of this multicenter, single-arm, Simon two-stage, phase II trial is to determine the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with previously treated, histologically proven GIST whose disease has recurred or progressed while receiving 400 mg/day of Imatinib mesylate at any time during at least a 2 months' treatment period.


Eligibility Criteria:
Inclusion criteria:

1. Histological proven diagnosis of GIST
2. Objectively documented evidence of progressive disease according to the RECIST criteria despite at least 2 months' continuous treatment with Imatinib mesylate at a dosage of 400 mg/day
3. Clinical evidence of resistance to Imatinib mesylate on treatment with 400 mg/day Imatinib
4. Progression must be documented on CT or MRI scans. The scans on which progression is documented should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older then approx. 2 weeks
5. At least one measurable lesion (longest diameter ≥ 20 mm on conventional CT or MRI scan; ≥ 10 mm on spiral CT)
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
7. Adequate bone marrow, liver and renal function on Imatinib treatment
8. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks since prior minor surgery and recovered

Exclusion criteria:

1. Female patients who are pregnant or breast feeding, or patients of reproductive potential not employing an effective method of birth control. Because oral, implantable or injectable contraceptives may be affected by cytochrome P450 interactions, an appropriate method of birth control should be used throughout the trial in both sexes. Women of childbearing potential must have a negative serum pregnancy test ≤ 48 hours prior to the administration of study medication
2. Patients presenting with known or symptomatic CNS metastases or leptomeningeal involvement
3. Use of other investigational cancer therapies within 28 days prior to enrollment or which are currently being or planned to be received during the course of the study
4. Patients who previously received rapamycin in combination with Imatinib
5. Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g. known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled infections including abscess or fistulae, etc.)
6. Patients with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
7. Patients receiving glucocorticoids (only if the p70s6 kinase-1 assay is being performed), since glucocorticoids have been shown to inhibit p70s6 kinase-1 activity

Other protocol defined inclusion/ exclusion criteria may apply
CONFIDENCE Financial Education for Caregivers

The purpose of this study is to determine how feasible it is to deliver an online course to reduce out-of-pocket costs of caregiving and reduce financial stress among Latino family caregivers to a family member living with dementia. The investigators hope that that the results of this study will help to reduce high these out-of-pocket costs and improve financial wellbeing for Latino family caregivers.

Caregivers will be asked to to participate in 3 online surveys, in addition to participating in 5, 1.5 hour group-based Zoom learning sessions.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver to someone diagnosed by a physician with probably Alzheimer's disease or a related dementia at least 6 months ago
* Latino or Hispanic ethnicity
* At least 50 years of age of older
* Able to attend 5, 1.5 hour to 2 hour group-based lessons over 5 weeks
* No plans to place family member in a facility within the next 3 months

Exclusion Criteria:

* Unreliable access to email, a computer and internet access
* Does note speak and read English
* Previously participated in CONFIDENCE program
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with previously treated multiple myeloma
* Measurable levels of m-protein in serum \>= 0.5 g/dL \[5g/L\]) or urine (\>= 0.2 g excreted in a 24-hour collection sample)
* ECOG performance status of 0 - 2
* Willing to follow pregnancy precautions

Exclusion Criteria:

* Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
* Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
* Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
* Patients with posterior subcapsular cataracts
* Patients with mental illness
* Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study
* Pregnant or lactating females
* Grade 2 or worse neuropathy
* Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) \< 1,000cells/mL Platelet count \< 75,000/mL Serum creatinine \> 2.5 mg/dL Serum SGOT/AST or SGPT/ALT \> 3.0 x upper limit of normal (ULN)

* Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for \>= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug
* Patients with scars from a recent viscus operation
* Patients with history of a desquamating (blistering) rash while taking thalidomide
* Patients with prior use of lenalidomide
* Patients with known HIV positivity.
* Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy.
* Patients with known history of hypersensitivity to dexamethasone.
Parenteral Drug Administration Training for Nursing Students

This study aims to evaluate the effect of blended self-directed learning with concept mapping on the level of knowledge regarding parenteral drug administration in nursing students. With out-of-class, online, interactive teaching methods, a memorable learning away from complex structure is aimed.

Online learning materials are of great importance in health education where theoretical knowledge and psychomotor skills are developed. The student takes responsibility for learning and has the chance to continue his education outside the classroom. Concept maps are one of the most effective educational materials both in classroom education and online learning. Visual education is concept map training in which each concept is included once on concrete applications and the relationships between concepts are revealed within the framework of the main lines to be taught. Providing parenteral drug administration training with a concept map will reveal the application steps as a concrete step and clear away confusing theoretical knowledge. The use of concept maps will ensure that first-year nursing students who are receiving training on drug administration for the first time will receive an education that is summative and memorable, away from the complex structure. One of the education models that offer interactive education opportunities other than traditional ones is blended learning. Blended learning provides a combination of face-to-face and technology-mediated teaching and learning that not only fully embodies the concept of \&#34;student-centered\&#34; teaching but also enables students to effectively participate in the classroom. The student-centered nature of blended learning also brings about self-directed learning. Self-directed learning is defined as the process of constantly monitoring and improving students\&#39; cognitive states, observing and applying various learning strategies, helping them recognize learning behaviors, and making efforts to create and use physical and social resources that facilitate learning.

Eligibility Criteria:
Inclusion Criteria:

* Receiving Parenteral Drug Administration training for the first time
* Becoming a first-year nursing student
* Volunteering to participate in research

Exclusion Criteria:

* Not participating in posttest and follow-up tests
* Not volunteering to participate in the research
Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.

A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic sleeve gastrectomy
* BMI \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

* documented gastroesophageal reflux
* patients with uncontrolled psychiatric disorders
* active infections or malignancies
* any other concomitant pathology considered as a contraindication for bariatric surgery.
Tailoring Online Continence Promotion

This project seeks to understand whether, and how, tailoring an online continence intervention can increase engagement and uptake of health behaviors known to improve bladder and bowel symptoms.

The investigators will conduct a two-arm, parallel, randomized, controlled trial (RCT) comparing an online continence promotion program with standard weekly reminders (control arm) to an online continence promotion program with tailoring (treatment arm) to determine the impact of tailoring on program engagement. Women in the treatment arm will receive tailored content and digital reminders for 24 weeks based on their individual characteristics, symptoms, and behaviors assessed at baseline, with reassessment of key inputs every 2 weeks resulting in re-tailored outputs. Participants will complete electronic surveys at enrollment, 4, 12, and 24 weeks. To contextualize the findings from all 3 aims, a subset of participants will be invited to complete semi-structured qualitative interviews about their engagement with the program, their adoption of health behaviors, and their perceived barriers to and facilitators of engagement and behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 50 years or older
* Can read \& write English
* Can use email
* Has access to an Internet-connected device to use the online program

Exclusion Criteria:

* Dementia
* Neurologic or musculoskeletal conditions in which pelvic floor muscle exercises are contraindicated
* Hematuria or bloody stools within last 6 months that has not been evaluated by a medical professional
Comparison of Different Surgical Treatments for Different Scales of Cubital Tunnel Syndrome

The purpose of this study is to determine which is the best surgery to treat different severity scales of cubital tunnel syndrome.

The purpose of this study is to determine which one of the simple decompression,anterior subcutaneous and intramuscular transposition of the ulnar nerve has the best outcomes for moderate and severe cubital tunnel syndrome.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed cubital tunnel syndrome
* moderate and severe cubital tunnel syndrome.

Exclusion Criteria:

* Significant cervical spine and shoulder disease
* deformity or distortion of the cubital tunnel due to previous trauma to elbow
* recurrent cubital tunnel syndrome after previous surgery
* mild cubital tunnel syndrome.