cyrilzakka/clinical-trials huggingface dataset:
The Influence Of a Natural Anti-Inflammatory Product On Levels Of Inflammatory Markers In Cases With Osteoarthritis Of Knee

This is a randomized, placebo controlled study. The first subject is expected to be enrolled in July 2014, and the last subject is expected to complete the study by July 2015. Each subject will be provided with the PRN Joint Comfort Formula, placebo or PRN Flex Omega Benefits® combination depending on randomization (1:1:1 at each site) during the course of the study. Instructions and frequency of use will be determined by the labelling.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 90 at the time of informed consent.
* Subjects with symptomatic moderate arthritis of the knee defined as per
* Kellgren-Lawrence grade II or III (Appendix B). Subjects with bilateral arthritis of the knee will also be recruited, but only one knee will be enrolled into the study.
* Ability to walk 50 feet unassisted.
* Lequesne's Functional Index score greater than 7 points

Exclusion Criteria:

* Subjects with systemic inflammatory conditions such as inflammatory bowel disease, psoriasis, eczema, and others
* Subjects with seropositive or sero-negative inflammatory arthritis of the knee such as rheumatoid arthritis or ankylosing spondylitis.
* Subjects taking hormone replacement therapy
* Intra-articular corticosteroid injections 3 weeks prior to enrollment.
* Hypersensitivity to fish oil.
* Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver of kidney function tests, history of peptic ulceration and upper gastrointestinal hemorrhage, congestive heart failure, Hypertension (BP\>140/90), cancer and hyperkalemia.
* Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders.
* High alcohol intake (\>2 standard drinks per day). Pregnant, breastfeeding or planning to become pregnant during the study
* Subjects awaiting surgery on the affected knee within three months.
* Consumption of any other vitamins/supplements will be allowed, provided the dose is not increased, and same brand is continued with. Also, the regimen should not contain the same active compounds tested in the PRN Joint health formula product.
* Vitamins/supplements cannot be introduced during a subject's participation in the study.
Foot Care Assessment and Relation to Diabetic Complications

Screening for diabetic foot in patients attending at Diabetic center at Assiut university and its relations to diabetic microvascular complications (nephropathy, neuropathy and retinopathy) and macrovascular complications (stroke , myocardial infarction and peripheral arterial diseases).

Footwear assessment in diabetic patient. Evaluation of integrated foot care program in moderate and high-risk patients for diabetic foot.

Evaluation of knowledge and practice of diabetic foot

The International Diabetes Federation (IDF) has identified Egypt as the ninth leading country in the world for the number of patients with T2D. The prevalence of T2D in Egypt was almost tripled over the last 2 decades. This sharp rise could be attributed to either an increased pattern of the traditional risk factors for T2D such as obesity and physical inactivity and change in eating pattern or other risk factors unique to Egypt .

Diabetic foot complications are the most common cause of non-traumatic lower extremity amputations in the industrialized world, may cause death or physical and psychical disability, has a great impact on quality of life, and represents a high cost for society ( .

The term diabetic foot encompasses any lesion in the feet: infection, ulcer, and destruction of deep tissues occurring as the result of diabetes and its complications .

The absence of symptoms in a person with diabetes does not exclude foot disease; they may have asymptomatic neuropathy, peripheral artery disease, pre-ulcerative signs, or even an ulcer.

Every diabetic patient will be subjected to

1. Medical history.
2. Therapeutic history: Antidiabetic drugs (type, duration), other medications for obesity, hypertension and dyslipidemia
3. Complete physical examination.
4. The following work up;

   * Knowledge questionnaire developed by Hasnain and colleagues and the Nottingham Assessment of Functional Foot Care (NAFFC) .
   * Screening for diabetic foot .
   * Fundus examination
   * ECG
   * The following investigations: Alb/cre ration, HBA1c, lipid profile, blood urea, serum creatinine
   * Abdominal ultrasound
   * Ankle brachial index (ABI)
5. Integrated foot care program will be applied to moderate and high-risk patients for diabetic foot with follow up after 6-12 months vs conventional education

Eligibility Criteria:
Inclusion Criteria:

Adult patient with diabetic mellitus

Exclusion Criteria:

Major amputation of lower limbs. End stage organ failure. Diabetic patient less than 18 years or more than 75. Pregnant diabetic women. Connective tissue disease
IndieTrainer: Enabling Individuals With Cerebral Palsy to Receive Gamified Power Mobility Training in Their Own Manual Wheelchairs

Power wheelchairs (PWCs) offer children who are unable to independently opportunities for participation in social, educational, and leisure activities. Unfortunately, children who have severe cognitive, motor, or sensory impairments may need extended training to be able to master the PWC skills needed to "qualify" for their own PWC. The IndieTrainer system was developed to address this need. The IndieTrainer system is comprised of the IndieGo device and video-game modules. The IndieGo device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. The video-game modules are integrated into the IndieGo device such that the video games can be played on a TV screen using the specific access method used to control the IndieGo (i.e., switch or joystick). The IndieTrainer system is designed to allow a child to practice power wheelchair skills as part of the video-game modules or as part of more traditional power wheelchair skills training activities wherein children are able to actively explore the environment and practice executing actual wheelchair skills. This study will evaluate the use of the IndieTrainer system in children with cerebral palsy, ages 5-21 years.


Eligibility Criteria:
Inclusion Criteria:

* Has a diagnosis of cerebral palsy or similar conditions with functional abilities consistent with a Gross Motor Classification System Classification System Level IV or Level V
* Inability to functionally self-propel a manual wheelchair
* Does not have an individually prescribed powered wheelchair
* Currently using a manual wheelchair or adaptive stroller that can be safely used with the IndieTrainer system (i.e., functioning wheel brakes to remain locked onto platform, etc.) as assessed by the PI
* Has at least one parent/caregiver who is able to converse in English (as assessed by the PI during interactions over the phone and in person) due to safety concerns

Exclusion Criteria:

* Any condition or issue that would prevent a child from safely using the IndieTrainer system as determined by the PI, a licensed physical therapist.
* The child and his/her manual wheelchair or adaptive stroller combined must weigh \<300 pounds to safely use the IndieTrainer.

  * A diagnosis of a progressive condition with the potential for functional decline across the study period, such as spinal muscular atrophy, Duchenne muscular dystrophy, etc.
Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge

Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.

Sixteen patients will be randomly allocated into two groups. Ridge splitting followed by osseodensification will be performed with simultaneous implant placement in group I.

Osseodensification will be performed with simultaneous implant placement in group II.

Alveolar ridge width and Implant stability will be assessed clinically. Alveolar ridge width and bone density will be assessed radiographically.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
* Patients should be systemically healthy.
* Patients available during follow up periods.

Exclusion Criteria:

* Pregnant females.
* Smokers.
* Poor oral hygiene.
* Vulnerable patients
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life

To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University

Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management

Eligibility Criteria:
Inclusion Criteria:

* children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis

Exclusion Criteria:

Patients presenting with :

* Abdominal pain or diarrhea that wakes the child from sleep
* Delay in onset or progression of puberty.
* Faltering growth.
* Family history of inflammatory bowel disease, celiac disease.
* History of significant weight loss .
* Bleeding per rectum.
* Persistence of severe vomiting or diarrhea
* . Persistent joint pain.
* Recurrent unexplained fever.
* Unexplained pallor
Effect of Caffeine on Preterm Infants' Bone Mineral Content

The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture.


Eligibility Criteria:
Inclusion Criteria:

Preterm infants with gestational age of 34 weeks or less consecutively admitted to the neonatal intensive care unit

Exclusion Criteria:

Renal or endocrinal diseases Congenital anomalies Suspected chromosomal aberrations Receiving diuretics or steroid therapy
Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism

This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.


Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for selective mutism
* Verbal with at least 1 parent or caregiver
* Child fluent in English

Exclusion Criteria:

* Any mental health difficulty significantly more impairing than selective mutism
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy.

II. Assess how infantile spasms interfere with development and whether this is partially reversible.

III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to 1 of 2 treatment groups. The first group undergoes sequential antiepileptic therapy with pyridoxine, corticotropin, valproic acid, carbamazepine, and nitrazepam. The sequence of administration may be altered based on drugs taken prior to entry. Any drug may be omitted due to medical contraindications or prior use at study doses or higher.

The second group undergoes surgical resection of the zone of cortical abnormality. A functional hemispherectomy is performed for hemiparesis or diffuse unihemispheric dysfunction.

If seizures are controlled in the first group at 3 months, the current medication is maintained; if seizures are not controlled, sequential therapy continues to completion. Patients experiencing uncontrolled seizures at 6 months cross to surgery.

Surgical patients experiencing uncontrolled seizures at 3 months or persistent seizures after taper of pre-study antiepileptics cross to drug therapy.

All patients are followed at 6 months and 1, 2, 3, 5, 7, and 10 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Infantile spasms or seizures with diagnosis based on the following: short muscular contractions leading to flexion or extension; Single or repetitive electroencephalogram (EEG) consistent with diagnosis, i.e., hypsarrhythmia, modified hypsarrhythmia, multifocal spike and wave abnormalities; developmental quotient less than 70
* Zone of cortical abnormality in 1 lobe, contiguous multilobes, or 1 hemisphere; confirmed by historical, neurological, and physical evidence, including EEG, closed circuit televised EEG, computed tomography, magnetic resonance imaging, and/or positron-emission tomography; at least 2 abnormal test/imaging results required
* No treatable seizure etiology such as metabolic disease or infection

Prior/Concurrent Therapy

* Failed standard therapy, i.e., refractory to corticotropin (at least 40 IU/day for 14 days) as follows: persistent infantile spasms OR recurrent spasms after discontinuation or taper OR complications requiring dose modification
* At least 1 month of standard antiepileptic drug with documented therapeutic blood levels

Patient Characteristics

* No medical contraindication to surgery
* English-speaking family
Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers

Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3


Eligibility Criteria:
Inclusion Criteria:

* African American
* 18-75 years of age
* Smoke more than 10 cigarettes per day
* Have a functioning telephone number
* Be interested in quitting smoking
* Be willing to take 3 months of Chantix
* Be willing to complete all study visits

Exclusion Criteria:

* Renal impairment
* Evidence or history of clinically significant allergic reactions to Chantix
* Cardiovascular event in the past month
* History of alcohol or drug abuse/dependency in the past year
* Major depressive disorder in the last year requiring treatment
* History of panic disorder
* Psychosis, bipolar or eating disorder
* Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone
* Use of tobacco products other than cigarettes
* Use of nicotine replacement therapy, bupropion, clonidine or nortriptyline in the month prior to enrollment
* Prior use of Chantix
* Women who are pregnant, contemplating getting pregnant or breastfeeding
* Plans to move from Kansas City during the 3 month treatment phase
* Another household member enrolled in the study
Effects of Intravenous Infusions of Gut Hormones on Appetite and Metabolism.

The purpose of this study is to investigate the effects of intravenous infusion of two gastrointestinal hormones, PYY3-36 and GLP-1, alone and in combination, on appetite in healthy obese men. The investigators hypothesize that an intravenous infusion of each hormone alone will decrease food intake at a buffet meal and decrease appetite, and that in combination, there will be a greater decrease in food intake and appetite compared to each hormone alone.


Eligibility Criteria:
Inclusion Criteria:

* Men age 18-50 years
* BMI ≥30
* healthy

Exclusion Criteria:

* Diabetes mellitus
* psychological illness
* on special diets (eg vegetarian, Atkins)
* weight change of \>3kg within the 2 months prior to screening
* Hypothalamic or genetic aetiology of obesity
* diagnosed cancer
* chronic illness or disease
* Eating disorder (anorexia or bulimia)
* smoking
* substance abuse
* Use of any prescription or over the counter medication that can affect metabolism
* Excessive intake of alcohol (\>7 drinks/week)
* Excessive intake of caffeine (\>300 mg/day)
* High level of physical activity (\>10 hours/week)
* Lack of desire or willingness to take part in and follow study protocol
Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in Hungary: Analysis of National Health Insurance Fund Database

The objectives of this study are to describe patient demographics, clinical and disease characteristics and treatment patterns of Chronic Lymphoid Leukaemia (CML) in Hungary.

The primary endpoint of this study is the overall survival of CML patients treated with tyrosine kinase inhibitors in Hungary. The Overall Survival (OS) of all enrolled patients, OS by sequence pattern and by the number of treatment lines will be analyzed.

Secondary objectives are description of the treatment length in 1st and later lines, incidence and prevalence of CML, the patient demographics (as age, gender, comorbidities), average number of patients' comorbidities, most frequent comorbidities and patient number with comorbidities at baseline and at different treatment lines by investigated Thyrosine Kinase Inhibitor (TKI), distribution of the investigated TKI therapies by treatment lines


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients diagnosed with chronic myeloid leukemia
* Patients receiving tyrosine kinase inhibitor therapy under the terms of the current marketing authorization

Exclusion Criteria:

* Patients receiving TKI for non-CML diagnoses
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity

Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin.

The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.

In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients. The investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of PPH in these patient populations.

Eligibility Criteria:
Inclusion Criteria:

* patients who give written informed consent
* patients requiring elective primary or 1st repeat Cesarean section
* patients with gestational age 37-41 weeks
* non-labouring patients, not exposed to exogenous oxytocin
* Cesarean section under spinal anesthetic
* patients \<30 years of age with a normal pre-pregnancy BMI (20 and 24.9 kg/m2)
* patients ≥40 years of age with a normal pre-pregnancy BMI
* patients with a BMI≥40 kg/m2 and age \<30 years

Exclusion Criteria:

* patients who refuse to give written informed consent
* patients who require general anesthesia
* patients who have had more than one previous uterine surgery/CS
* patients with placental abnormalities (abruption, accreta, percreta)
* patients with bleeding disorders
* presence of any other risk factors for PPH
a Single Intraarticular Injection of PRP for Early Knee OA

This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular injection of PRP for the treatment of early knee OA.

In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and received a single intraarticular PRP injection. Several outcomes were measured.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-70 years
* symptomatic knee OA with pain for at least 6 months despite conservative treatment such as analgesics, NSAIDs and/or physical therapy
* average knee pain of at least 30 mm on a 100-mm visual analog (VAS) scale
* grade 1 or 2 knee OA according to the Kellgren-Lawrence grading system based on -radiographs taken within the previous 6 months
* Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

* previous orthopedic surgery on the spine or lower limbs
* disabling OA of either hip or foot
* knee instability or marked valgus/varus deformity
* history of severe knee trauma; intraarticular injections into the knee in the past 6 months
* infections or skin diseases around the target knee
* women ascertained or suspected pregnancy or lactating
* presence of malignancy, hematological disease, collagen vascular diseases, or autoimmune diseases;
* therapy with anticoagulants or anti-aggregating agent
* serious medical conditions that would interfere with the assessments during the study.