cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Trismus in Patients With Maxillary Cancer With and Without Radiation Therapy in the Egyptian Population.

This study aims at evaluating the prevalence of trismus among maxillary cancer patients in the Egyptian population and the effect of radiotherapy on the occurrence of trismus.

The enrolled participants who meet the eligibility criteria and signed the informed consent of participation in the study will undergo clinical examination to determine the maximum mouth opening after performing surgery only and /or after radiotherapy in case of adjuvant therapy

the maximum mouth opening will be measured in (mm) by using a digital caliper device and will be recorded in the patient sheet,

reading of less than 35mm will be considered trismus while above 35mm or more will be considered normal (NO trismus)

Eligibility Criteria:
Inclusion Criteria:

* patients with maxillary cancer

Exclusion Criteria:

* patients under 18 yrs .
* patients with TMJ disorders before surgery
* patients on chemotherapy
* - Tumors in other sites( Tongue , buccal mucosa , salivary glands, mandible)
Virtual Reality During Intrathecal Pump Refills in Children

The aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.

Virtual reality (VR) is a technological rehabilitation tool that allows the user to experience the interaction with a computer-generated environment. It may provide some advantages over conventional care: it allows the simulation of realistic environments and patients feel more motivated by this kind of virtual environment. VR constitutes an enriched environment with augmented multiple sensory feedbacks (auditory, visual, tactile VR enriched environment) that has already shown some efficiency in reducing chronic pain. There is mounting evidence from acute pain conditions, such as wound care, that VR could play a role as an additional treatment method to relieve pain A possible explanation for its mechanism of action is provided by "the gate-theory of attention". VR reduces the perception of pain by diverting attention away from the pain. Most children experience pain and fear when receiving a medical treatment; two feelings which are closely related and affecting one another. Moreover, children often describe procedures involving needles as the most stressful portion of the hospital experience. Children who have been implanted with an intrathecal baclofen (ITB) pump, need to come to the hospital for a refill approximately every 3 months, depending on the exact dose. During the refill, the physician places a needle directly into the reservoir to refill the pump. To alleviate the pain and fear with these refill procedures, it is hypothesized that VR could alleviate pain and make these refills more feasible. Therefore, the aim of this study is to evaluate whether VR is reducing pain during a refill procedure, in children receiving intrathecal drug delivery compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy between 8 and 16 years who have an implanted pump for intrathecal drug delivery
* Child and parents have been informed of the study procedures and have given written informed consent
* Child and parents willing to comply with study protocol
* Child and parents are able to speak Dutch/French (questionnaires)
* Cognitive and language functioning enabling communication between the physician/researcher and the child

Exclusion Criteria:

* Children with susceptibility to motion sickness or cyber-sickness
* Children with susceptibility to claustrophobia
* History of seizures/epilepsia
Mode of Uterine Extraction in Total Laparoscopic Hysterectomy

Hysterectomy remains the most common major gynecological operation worldwide. It may be carried out by three different routes and its variations: vaginal, abdominal, and laparoscopic.

A large uterus will lead to several surgical difficulties during laparoscopic hysterectomy, such as limited operative field, restrictive instrument range of motion, and difficult removal of the specimen.

The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or uterine morcellation approaches after strict preoperative assessment.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total laparoscopic hysterectomies for larger uteri

Exclusion Criteria:

* oncology
Effect of Adaptive Training for Balance Recovery

The long-term objective of this research is a prophylactic approach that can reduce the incidence of falls and the resulting injuries among older adults at risk and thus reduce its escalating medical cost. This project explores perturbation training through the use of treadmill device and a motor learning approach, in which experience with slip-like perturbation generated by that treadmill is used to prepare the motor system to develop and then put to use fall-resisting skills outside of training environment (cross-environment transfer). The computer-controlled treadmill is portable, safe and easy to operate, thus conducive for use in clinics or community centers. The study logically builds on and complements the team's previous and current research programs, and will further test that after such a single session, older adults at risk can retain such cross-environment transfer and reduce their likelihood of falls in everyday living for the next 6 to 12 months. Finally, the study will explore that such reduction of falls does not come merely from these persons' familiarity with the training or testing setup, protocol and environments.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with no known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment that may affect their ability to perform the testing procedures will be included.

Exclusion Criteria:

* Ultrasound calcaneus bone mineral density T score \< -2.5 (osteoporotic)
* Mini-Mental State exam score \< 25 (cognitive impairment)
Changing Habits and Lifestyles in Older Individuals

This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.

Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

Individuals can be considered for inclusion if they meet the following inclusion criteria:

* being over 55 years old
* living in the community
* being able to give consent
* not being allergic to eggs
* not suffering from known renal insufficiency, or having a pacemaker or defibrillator.
* not suffering from known hypercholesterolaemia, or known familial hypercholesterolaemia.
* not having undergone chemotherapy or radiotherapy in the last 6 months
* not suffering from any condition, or receiving medication or treatment that the participants feel affects their eating or sense of flavour.
* being able to perform the physical performance tests (e.g. walk, sit on a chair)
* being able to read and understand English
Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology

Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.

In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.

This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease
* Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease
* Availability of biological material
* Signature of informed consent
* Age between 0 and 30 years

Exclusion Criteria:

* Failure to sign the consent
* Insufficiency of biological material for analysis
* Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior.
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with atopic dermatitis (AD) and moderate to severe pruritus.

The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 7 days after the last dose of study drug.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension upon completion of the Week 12 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).

Eligibility Criteria:
Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

* Subject has clinically confirmed diagnosis of active AD;
* Subject has at least a 12-month history of AD;
* Subject has chronic itch related to AD;
* Subject has moderate to severe pruritus;
* Female subject is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

* Subject has clinically infected AD;
* Subject has pruritus attributed to a cause other than AD;
* Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
Breathing Exercises on Depression in Postmenopausal Women

Evaluate the effect of breathing exercises on depression and sexual function in postmenopausal women

Sixty postmenopausal women will be sourced from the Obstetrics \& Gynecology outpatient clinic at El Mahalla El Kobra general hospital in Egypt, with referrals from gynecologists. Patients will be randomly assigned into two groups.

Study group: It will include 30 women participating in diaphragmatic breathing plus aerobic training.

Control group: It will include 30 women participating in aerobic training.

At baseline and poststudy, the following outcomes will be assessed:

1. Depression (Beck Depression Inventory II scale).
2. Sexual function (female sexual function index questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 3 years after menopause.
* Mild to moderate depression.
* Mild to moderate sexual dysfunction.
* Their ages will be ranged from 45 to 60 years old.
* Their BMI will be less than 30 kg/m2.

Exclusion Criteria:

* Prolapse of the pelvic organs.
* Pelvic tumors.
* Vaginal infections.
* Musculoskeletal/ neurological limitations to exercise.
* Psychiatric disorders.
* Unstable cardiovascular conditions.
* Diabetes.
Laser in Caries Treatment - Patients´View, Pulpal Reactions and Survival of Fillings

The aim of this study was to evaluate the excavation time, patients´ experiences, pulpal reactions and survival of fillings when carious tissue was removed with Er:YAG laser compared to rotary bur. A prospective, single-blind, randomized and controlled investigation was performed. Patients with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique. The time requested for excavation and local anaesthesia were measured. The prevalence of postoperative symptoms, pulpal vitality and the quality of fillings will be investigated during two years after the excavation occasion.

The study is a prospective, single-blind, randomized and controlled investigation. Patients between 15-40 years with at least two primary caries lesions radiographically assessed as the same size were recruited. In each patient one cavity was excavated with rotary bur and one with Er:YAG laser technique after a randomized allocation of the lesions to one of the intervention methods. The time requested for excavation to hard/firm dentin and local anaesthesia were measured. Directly after each treatment a questionnaire focusing on the experiences of the current treatment and if the laser method will be chosen in the future was answered. Postoperative pain was measured with a questionnaire one week after the treatment. Six, 12 and 24 months after the fillings were made an evaluation of pulpal status and the quality of the fillings will be performed.

Eligibility Criteria:
Inclusion Criteria:

* patients should be between 15 and 40 years,
* at least two lesions with primary caries estimated as being of equal size, and needed to be treated, in bite-wing radiographs, and
* comparable pairs of cavities should be located on either occlusal or approximal surfaces.
* the lesions should not involve the inner third of the dentin.

Exclusion Criteria:

* patients with severe general diseases ( ASA\>2) (30),
* cognitive or intellectual disabilities,
* patients who required sedation or general anaesthesia, and
* teeth with periapical pathology, a root filling or non-vital teeth.
Chronic Sildenafil for Severe Diaphragmatic Hernia

The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment.

Congenital diaphragmatic hernia (CDH) is a condition characterized by pulmonary parenchymal and vascular hypoplasia. Severe CDH carries a high rate of mortality, and significant morbidity among survivors. This proposal is a randomized, blinded, placebo-controlled study designed to evaluate the efficacy and potential mechanisms of activity of sildenafil, a phosphodiesterase-5 inhibitor, for treatment of severe CDH. Infants who meet criteria at ≥10d of age predicting a poor outcome \[death or chronic lung disease (CLD) severe enough to require hospital discharge on supplemental oxygen (O2)\] will be eligible for the study. Infants whose parents consent for the study will undergo an initial echocardiogram to assess the degree of pulmonary hypertension. They will then begin either sildenafil or placebo therapy for a 45d course. A final echocardiogram will be performed after the experimental drug course is completed. The pulmonary arterial systolic pressure estimate during hyperoxic conditions will be compared between the sildenafil and placebo groups. Infants from either group who have severely elevated pulmonary arterial pressure (despite supplemental O2) will be considered for open-label sildenafil, which will continue after hospital discharge, depending on the results of a cardiac catheterization performed for clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Congenital diaphragmatic hernia
* 10-42 days (d) of age
* Significant illness severity as demonstrated by:
* Receiving assisted ventilation and

  * FiO2 \>= 0.40 at 10-14d of age, or
  * FiO2 \>= 0.40 for \>=48hours at 15-27d of age, or
  * FiO2 \>= 0.35 at 28-42d of age
* Or, need for extracorporeal support at \>=10d of age
* Or, estimated pulmonary arterial or right ventricular systolic pressure of \>= 2/3 systemic pressure at 14-42d of age

Exclusion Criteria:

* Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect \[ASD\] or non-hemodynamically significant ventricular septal defect \[VSD\])
* Sildenafil contraindicated (until condition resolves):

  * Unable to absorb oral medication, or
  * Unstable systemic blood pressure, or
  * Receiving a drug that may interfere with sildenafil metabolism, or
  * Renal insufficiency
  * Hepatic insufficiency Previous use of sildenafil
Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa

This multicenter, post marketing observational study (PMOS) was designed to evaluate the long-term effectiveness of levodopa/carbidopa intestinal gel (DUODOPA) on motor fluctuations (duration of OFF periods) in participants with advanced levodopa-responsive Parkinson's disease (PD) and severe motor fluctuations and hyper-/dyskinesia (involuntary movements). Secondary objectives of this study were to assess the participants' quality of life; to assess the long-term safety of DUODOPA; to assess disability, cognitive function, and non-professional caregiver burden; and to assess the economic and social impact of family caregiver assistance.

Male or female participants ages 18 years of age who were already on DUODOPA treatment and had concluded the naso-intestinal phase were included in this study. DUODOPA was administered via a portable pump directly into the proximal small intestine via a percutaneous endoscopic transgastric jejunostomy (PEG-J) tube. There were 3 planned visits during the study: enrollment (Visit 1), 1 year (Visit 2), and 2 years (Visit 3).

Eligibility Criteria:
Inclusion Criteria:

* Participants already on treatment with DUODOPA (having already concluded the naso-intestinal treatment phase) according to the local DUODOPA product label and to routine clinical care for advanced PD patients
* Participants with available data on DUODOPA treatment, on previous PD conventional treatments and with at least one of the scales/questionnaires under study already collected on the participant's clinical chart
* Participant or legal representative has given written informed consent
* Non-professional caregiver (relative or familiar who give daily assistance to the patient) has given his/her written consent

Exclusion Criteria:

• History or presence of any condition that might interfere with the long-term continuation of the duodenal infusion of DUODOPA
Effect of Peanut Butter on Gut and Metabolic Health

The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:

Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children.

Secondary Objective(s)

1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children.
2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.

Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:

1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.
2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in elementary or middle school (grades 1-8)
* Aged 6-13 years old
* Ability to speak and read in English

Exclusion Criteria:

* Intake of antibiotics in the last 3 months
* Intake of pre/pro/postbiotics in the last 3 months
* Food allergy to study foods

  * Any allergy to nuts or peanuts
* Any allergy to the isocaloric snack (chocolate or wheat)
* Regular consumption of nuts or peanuts greater than 2 servings / week
* Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \> 9%).
* Known to be pregnant (self-disclosed)
To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Primary:

* To assess complete pathological response rate of both strategies.

Secondary:

* Safety profile
* To assess downstaging rate of both strategies.
* To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
* To compare time to progression and overall survival of both strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal adenocarcinoma.
* Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
* Rectal tumour at distal third, or
* Tumours spread more than 5 mm in perirectal fat
* Functional state ECOG ≤ 2.
* Good hematological, hepatic and renal function

Exclusion Criteria:

* Previous pelvis radiotherapy.
* Previous antitumoural chemotherapy
* Pregnant or breastfeeding women.
* Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
* History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
* Clinically significant cardiovascular disease
* Confirmed peripheral neuropathy.
* Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
* Blood disorders.
* Intercurrent non-controlled or severe infections.
* Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.