cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.

The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).

The main question\[s\] it aims to answer are:

• How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%?

Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.

Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected randomly and applied per the protocol. A single calibrated operator (A.A) using randomly selected sealed envelopes that have been previously divided equally according to sample size arms. The selected envelope is then opened by the operator, who applies either the EC or BC topical anesthesia technique based on the chosen envelop. Followed by maxillary local analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is then observed and assessed by the blinded primary investigator (N.A) (to the topical anesthesia technique) for pain perception during local anesthesia infiltration based on the Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below protocol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children (ASA I) aged between 7 - 10 years old.
* Needing any maxillary buccal infiltration (anterior, middle, posterior)
* Had no prior history of local anesthesia.
* Frankl behavior III or IV
* Not taking any painkillers, or other drugs that would influence with their pain perception.

Exclusion Criteria:

* History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
* Active pathology at the site of injection.
* Prior history of intra-oral injection.
* Frankl behavior I or II.
* Children/parents not willing to participate in the study. § Needle phobia.
* Patients require treatment under conscious sedation.
Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy

An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.

The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).

Eligibility Criteria:
Inclusion Criteria:

* Child with unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
* Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age

Exclusion Criteria:

* Age\> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
* Uncontrolled epilepsy
* History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
* Visual or cognitive impairment that may interfere with the management
* Common contraindications to magnetic resonance imaging (MRI) such as metal implants
Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing surgery via a posterior approach for AIS
2. Children ages 11-18
3. ASA physical status 1-2
4. Informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age)
5. Planned correction of at least 8 vertebral levels

Exclusion Criteria:

1. Patient refusal to participate
2. Patients on chronic narcotic medication
3. Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam)
4. Coagulopathy
5. Pre-existing neurological deficit
6. Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment
Correlation Physiological Cost Index

Objective: To compare the efficacy of a gait training program using robotic assistance combined with virtual reality versus robotic assistance alone on energy expenditure in children with cerebral palsy.

Participants: Children with cerebral palsy levels II, III, IV, and V according to the Gross Motor Function Classification System (GMFCS), from different paediatric physiotherapy centres and schools in Valencia, Spain.

Intervention: Gait training using an inexpensive robotic gait training system (CL1Walker) and participation in a virtual reality game, Treasure Hunt (abbreviated here as ACT, from the Spanish A la Caza del Tesoro) in the experimental group (GTVR) and gait training using the same robotic gait training system without using virtual reality in the control group (GT).

Measurements: Assessment using the Physiological Cost Index (PCI) one week prior to and after the intervention. The intraclass correlation (ICC) replicability and the minimum detectable change (MDC) of the PCI.

Design: Longitudinal, prospective, double blind study with two treatment groups and repeated measurements, controlled for the condition without virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cerebral palsy
* Must be able to follow the instructions and participate in the game

Exclusion Criteria:

* Orthopaedic surgery in lower limb
* Botulinum toxin in lower limb
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)

The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years of age or older
* Biopsy-proven breast cancer
* Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
* Primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
* Able to give informed consent
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of FFNP) is negative.

Exclusion Criteria:

* No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
* Unable to tolerate 60-90 minutes of PET imaging per imaging session
Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study

Prosthetic rehabilitation of acquired maxillary defects represents a challenging mission for both the prosthodontist and psychologically traumatized patients. These defects may be due to trauma, pathological conditions, or surgical resection of oral tumors. The resulting main problem is oronasal communication leading to impairment in mastication, swallowing, speech, and facial esthetics

Maxillary obturator prostheses are usually fabricated from polymethyl methacrylate (PMMA) if the patient is completely edentulous, or from PMMA and a cast frame-work if partially edentulous. As the size of the surgical resection increases, the weight of the prosthesis also increases. Traditionally, the weight of the prosthesis has been minimized through the use of hollow bulb obturators and change of manufacturing material.

Polyetherketoneketone (PEKK) has been widely tested in a number of dental applications, such as PEKK dental implants, PEKK obturators, and PEEK RPD frameworks. PEKK has a relatively low Young's modulus of 3 to 4 GPa, which is close to that of human bones, and its tensile properties are similar to those of bone, enamel, and dentin. These properties make it a suitable material for fixed and removable prostheses.(6-8) PEKK is a lightweight material with excellent biocompatibility as it can be used in combination with Computer-aided design/computer-assisted manufacturing (CAD/CAM) in fabrication of maxillofacial prostheses.(9) So the aim of this study will be, evaluation of Patient satisfaction and oral healthy related quality of life of PEKK and metal framework for management of maxillectomy cases. The null hypothesis is that, there would be no significant difference between both frameworks.

Eligibility Criteria:
Inclusion Criteria:

The patient will be selected according to the following criteria:

* Patient with unilateral total maxillectomy.
* Patients will have sufficient number of remaining teeth.
* Free from any signs of inflammation in defect area.
* Patient 3 years after receiving radiation.
* The defect size is small or large.
* Patient with susceptibility of recurrence.

Exclusion Criteria:

* Patient is still receiving radiation.
* Defect result from trauma.
Can Hepatic-splenic Elastography Predict the Risk of Hepatocellular Recurrence After Radiofrequency Ablation?

The study aims to assess whether there is an association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA

The primary objective of the study will be to assess whether there is an association between hepatic and splenic elastography values and the risk of HCC recurrence after treatment with RFA. Secondary objectives, however, will be to test whether hepatic and splenic elastography values have an association with overall and HCC-related survival and with the risk of decompensation after treatment with RFA; further secondary objective will be to evaluate the association between non-invasive biochemical tests and the risk of HCC recurrence after treatment with RFA. The population will consist of hepatopathic patients with HCC who are candidates for treatment with RFA and who are referred to the coordinating center "U.O.C. of Gastroenterology and Digestive Endoscopy" of IRCSS Azienda Ospedaliero-Universitaria, Policlinico di S.Orsola and the Participating Center "U.O. of Gastroenterology," Azienda Ospedaliero-Universitaria Integrata di Modena.

Eligibility Criteria:
Inclusion Criteria:

* Clinical-instrumental diagnosis of chronic liver disease.
* Indication for treatment of HCC with RFA using the Barcelona Clinic Liver Cancer (BCLC staging system) classification system19;
* Performing hepatic or splenic elastography by transient method with Fibroscan® (Echosens, Paris, France) or ARFI method (ACUSON Sequoia Siemens).
* Signature of informed consent

Exclusion Criteria:

* Age \< 18 years;
* Diagnosis of hepatocholangiocarcinoma or other hepatic focal lesions other than hepatocellular carcinoma;
* Previous history of liver transplantation (OLT) and/or liver resection for HCC in the previous two years;
* Liver disease in decompensation (Child-Pugh C) at the time of informed consent or within three months prior to enrollment;
* Patients with other severe and advanced diseases that may affect short-term mortality (e.g. further non-remission neoplasms, heart failure \>NYHA III, chronic renal failure in dialysis, pulmonary diseases dependent on home oxygen therapy).
Rwanda Selenium Supplementation Clinical Trial

Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4 counts, decrease opportunistic infections, decrease viral loads and delay the need for initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.

Patients will be recruited from two health facilities (Kibagabaga District Hospital, and Kinyinya Health Center in Kigali), Rwanda that offer care and treatment for HIV/AIDS patients. Patients will be recruited during a 3-4 month period. Consenting adults who fit the inclusion criteria will be enrolled and followed for 2 years. Study assessments will occur at enrollment, 6, 12, 18, and 24 months after initiation of selenium supplementation.

Participants will be randomized using a simple randomized block design to receive either cotrimoxazole and selenium or cotrimoxazole and an identically appearing placebo taken once daily for 2 years. Participants who do not return to the clinic as scheduled will be followed up at home.

All consenting patients with CD4 count between 400 and 650 mm3 will be selected because they are at similar immunological level and hence they will not be eligible to start ARV treatment at the study start. The study will look at the efficacy of selenium supplementation to this already compromised group of patients at a similar stage of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = 21 years at enrollment
* Confirmed HIV positive with a CD4 range between 400 and 650 mm3
* HIV+ patients willing to participate in the study and who provide informed consent
* Pre-antiretroviral therapy (Pre-ART) at enrollment in study (not yet initiated ART)
* Willing to practice barrier method of birth control at all times

Exclusion Criteria:

* Patients intending to be transferred out of the clinic catchment area before study ends
* Patients scheduled to start ART
* Moribund patients
* Pregnant women
* Unable or not wanting to commit to barrier method of birth control
Post Marketing Surveillance of MENOPUR

The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.


Eligibility Criteria:
Inclusion Criteria:

* Anovulation in women (WHO group II)
* Controlled ovarian hyperstimulation cases for ART

Exclusion Criteria:

* Hypersensitivity to MENOPUR
* Pregnancy, lactation or contraindication to pregnancy
* Ovarian cysts not related to polycystic ovarian syndrome
* Abnormal uterine bleeding
* Tumors in uterus, ovaries and breasts
* Ovarian hyperstimulation syndrome
* Thromboembolism or history of it
* Infertile due to other reason than anovulation
* High FSH level indication primary ovarian failure
Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

* Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications
* Survival and response Analysis
* Response rate
* Overall survival
* Leukemia free survival

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications
Effects of Functional Electrical Stimulation and Inspiratory Muscle Training in Heart Failure Patients

The purpose of this study is to assess the effects of functional electrical stimulation associated with inspiratory muscle training on functional capacity and quality of life in heart failure patients.

The aim of this study is to assess the effects of the functional electrical stimulation (FES) associated with inspiratory muscle training (IMT) on functional capacity and quality of life in patients with heart failure (HF). A randomized clinical trial with 60 HF patients (functional class II-IV) will be randomly assigned to the FES, IMT, IMT associated with FES or control group. FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure. Acute and chronic effects of interventions on functional capacity, quality of life, peripheral muscle strength, pulmonary function, respiratory muscle strength and endurance, endothelial function, autonomic control and oxidative stress will be analyzed in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable heart failure and New York Heart Association (NYHA) class II-IV
* Aged 30-70 years
* Left ventricular ejection fraction less than 35% determined by echocardiography and optimized pharmacological treatment (unchanged 1 month prior to study)

Exclusion Criteria:

* Patients with unstable heart failure
* NYHA class I
* Unstable angina pectoris and ventricular arrhythmia
* Implanted cardiac pacemaker
* Acute pulmonary diseases
* Chronic renal failure or dialysis
* Acute myocardial infarction 3 months before the inclusion in the study
* Acute inflammatory diseases
* Peripheral vascular disease
* Neurologic disease
* Musculoskeletal pathologies
* Malignancies or being an active smoker
Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)

To evaluate the dental status of children using ritalin and suffering from ADHA in comparison to healthy children.

In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and treated with ritalin will be evaluated. Parameters that will be checked are the following: DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations and susceptibility for dental trauma. In addition these parameters will be collected for 30 age and sex match healthy children.

Eligibility Criteria:
Inclusion Criteria:

* children ages 5-12 years healthy children children taking ritalin who suffer from ADHD

Exclusion Criteria:

* all others
The Effects of Nexium on the Side Effects Associated With a Colonoscopy Prep

The purpose of this study is to ascertain if the use of Nexium for 7 days prior to taking a colon prep for a colonoscopy will decrease the side effects that are associated with the colon preparation

The high incidence for colon cancer make it an ideal target for screening. In the United Staes there are approximately 100,00 new cases of colon cancer yearly. Typically the progression from polyps to cancer requires years. This permits a screening procedure to identify polyps befoere they are cancerous. Colon cleansing is required prior to colonoscopy. The gastrointestinal syptoms associted with colonic preps are common and oftn assoicated wwith upper gastrointestinal disorders including GERD, non-ulcer syspepsia, and gastric dysmotoility such as gastropareesis.

Eligibility Criteria:
Inclusion Criteria:

* Subject 18 or older undergoing out-patient colonoscopy

Exclusion Criteria:

* Pregnant females Use of protein Pump Inhibitor within last 4 weeks Use of prescription strength H-2 Blocker within last 4 weeks Use of over the counter strength H-2 Blocker greater than 2x's a week Hospitalized patients PEG-EL purgative contraindicated.
International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly

The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).

The secondary objectives of this study are to:

A. Estimate the intra-patient variability of capillary INR measures.

B. Estimate the time spent in the target INR (TTR) window of dependent elderly patients in nursing homes, under AVK treatment, and with a capillary INR monitoring strategy.

C. Estimate the number of venous thromboembolic events and bleeding events over the 6-month observation period.

Eligibility Criteria:
Inclusion Criteria:

* The patient resides at the establishment for the dependent elderly (nursing home (EHPAD)) in Pont-Saint-Esprit, France
* The patient must be insured or beneficiary of a health insurance plan
* The patient treated with vitamin K antagonist for over six months
* The patient must have given his/her informed and signed consent
* For adults under guardianship, the legal guardian must have given free and informed consent and signed the consent

Exclusion Criteria:

* The patient is under judicial protection
* The general practitioner in charge of the patient at the EHPAD does not want to participate in the study
* It is impossible to correctly inform the patient, or his/her legal guardian
* The patient, or his/her legal guardian, refuses to sign the consent
* The patient is participating in another interventional study, or has participated in another interventional study within the past three months
* The patient is in an exclusion period determined by a previous study
The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome

The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* willing to consent/undergo necessary procedures
* between the age of 19 and 75 years
* diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)

Exclusion Criteria:

* uncontrolled hypertension (Blood pressure \> 170/100 mmHg)
* uncontrolled diabetes mellitus (FBS \> 180 mg/dL)
* malignancy, cerebrovascular disease, cardiovascular disease
* history of abdominal surgery except appendectomy and hernia repair
* inflammatory bowel disease
* clinically or laboratory-confirmed gastroenteritis
* the use of motility drug or dietary fiber supplement in 2 weeks
* allergy to soy fiber
* serum Cr \> 2 x Upper normal limit
* AST or ALT \> 2 x Upper normal limit
* Pregnancy, Lactating woman