cyrilzakka/clinical-trials huggingface dataset:
Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training.

This study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy.

Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading cause of chronic disability in children, making them physically and mentally handicapped and socially unapproachable. The low tone of the torso also causes postural instability, lack of mobility, and muscle stiffness in the legs. Therapeutic intervention for children with cerebral palsy should be composed of goal directed, functional, and meaningful activities by considering the clinical type, degree of disability, cognitive level and interest of the child. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Since children with cerebral palsy show damage not only in the function and an ability to accomplish tasks, but also in the quality of movement. The objective of this study will be to help clinicians regarding the effectiveness of task-oriented training and gross motor functional training for children with cerebral palsy.

This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with cerebral palsy will be assigned randomly for the study. Population will be taken from Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking consent, demographics including age, gender and birth history etc. will be recorded. Questionnaires will be distributed among parents and their responses will be collected. Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0.

Eligibility Criteria:
Inclusion Criteria:

* Children with spastic cerebral palsy
* Both boys and girls
* Age 5 - 12 years old
* Able to follow verbal commands
* Having level I or II of GMFCS

Exclusion Criteria:

* Uncooperative
* On antiepileptic and anti-spastic medications
* Having visual or intellectual impairments
* Having hearing deficit
* With any cardiac anomalies affecting exercise tolerance
* Less than 6-month post-orthopedic surgery or post-botulinum toxin injections
Pompe Disease QMUS and EIM

Study Objectives:

1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
2. Determine the reliability of EIM measures performed in the home through use of a hand held device.
3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Pompe disease.

Exclusion Criteria:

* Age \<18 years
* Inability to provide informed consent.
Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

The objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 12 years of age
* discharged from an initial Emergency Department visit within 12 months

Exclusion Criteria:

* Subjects with COPD or treatment for COPD
Evaluate Treatment Outcomes For AI-Enabled Information Collection Tool For Clinical Assessments In Mental Healthcare

In the proposed study, the investigators aim to test an AI-prototype which adaptively collects information about a patient's mental health symptoms at the time of referral in order to support and facilitate the clinical assessment.

In the proposed study, the investigators aim to test an AI-prototype which adaptively collects information about a patient's mental health symptoms at the time of referral in order to support and facilitate the clinical assessment.

The AI-system consists of a machine learning model which produces a probabilistic prediction about a patient's most likely presenting problems (ranking different diagnoses based on their probability) based on standard referral information collected through Limbic Access (e.g. free-text description of the patient's symptoms, GAD-7 \& PHQ-9 etc). Based on the ML prediction, up to two additional anxiety disorder specific measures (ADSM) will be administered in order to collect additional insights about the specific mental health symptoms experienced by the patient (i.e. tailored to the specific patient). The collected ADSM scores will be attached to the final referral information in order to support and facilitate the clinical assessment and ultimately improve the diagnosis process while saving clinical time. For this trial, the AI-model will only function as a support tool for the clinical assessment by collecting additional data ahead of time.

Specifically, the investigators are interested in evaluating whether the AI supported information collection improves treatment outcomes, reliability of clinical assessment, reduces waiting and assessment times as well as reduces treatment drop out rates.

Eligibility Criteria:
Inclusion Criteria:

* Participant meets minimum age requirements for the service
* Participant's registered GP is within the IAPT CCG catchment area

Exclusion Criteria:

* Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)
Possible Effects of Supplement Therapy With Oral Phenolics on Cluster of Differentiation 163 (CD-163) Biomarker of Patients With Age-related Macular Degeneration

In this multi-center study, possible effects of supplement treatment with oral phenolics on plasma CD-163 and progression of dry and wet age-related macular degeneration (AMD) via evaluating the CD163 before and after the prescription of this drug will be evaluated in patients with dry type AMD and Neo vascular age-related macular degeneration (nAMD).

Both AMD subgroups will be recruited. In terms of evaluation of the effects of phenolics (500 mg caplets/day) on AMD progression, patients will be randomized and divided into 2 subgroups i.e. (i) receiving phenolics supplementation; and, (ii) receiving placebo for 1 month. The phenolics/placebo caplets will resemble completely and be encoded at origin; Neither the participants nor the researchers will be informed about the codes until the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of intermediate to late AMD (dry AMD and nAMD )
* Age-matched controls without any sign of AMD
* Signed informed consent

Exclusion Criteria:

* Systemic disease or other eye-related diseases (diabetes, immunologic or inflammatory, active or chronic infectious disease, active malignancy, uveitis, retinal vascular occlusive disease, glaucoma)
* Systemic therapy with corticosteroids or biological drugs.
A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic pain


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic, intractable pain for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has participated in another clinical investigation within 30 days
9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
10. Subject has been diagnosed with cancer in the past 2 years.
Metabolic Fate Modifications of Saturated Fats After an Overfeeding

The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).

Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid, d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years old
* BMI 18 to 30 kg/m²
* Stable physical activity
* Safety subject during medical consultation

Exclusion Criteria:

* Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)
* Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
* Eating disorder
* Intensive sportive activity
* Subjects who Smoke
* Claustrophobic subjects
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction

The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and revision total hip arthroplasty.

This multi-center, prospective, non-controlled, consecutive cohort post market surveillance study will serve the purpose of confirming long-term safety and performance of the Hyperion® system. The performance of the Hyperion® THA System will be evaluated using standard scoring systems (Merle d'Aubigné Score, HOOS Score). Safety will be evaluated by adverse event reporting.

The study will be performed at 6 sites, enrolling in total 70 patients. Follow-up visits are planned after 3 to 6 month, 1, 2 and 5 years. The scores will be filled in pre-operatively and post-operatively until 5 years. In order to obtain mid- to long-term patient satisfaction data the patient questionnaire will be send to the patient at 7 and 10 years, additionally. Xrays will be done pre-operatively, immediate post-operatively and at each of the Follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Patient age at least 18 years
* Fully conscious and capable patients
* Signed informed consent
* Stationary treatment
* Merle d'Aubigné \< 12 Points, WOMAC Score \> 25 Points
* Patients with at least one of the following indications:

Indications for primary hip replacement:

* Non-inflammatory diseases of the joints such as osteoarthritis and avascular necrosis (head necrosis)
* Rheumatoid arthritis
* Functional deformities
* Provision of non-endoprosthetic previous operations of the hip joint (e.g., transposition osteotomies)
* Treatment of pseudarthrosis, femoral neck and trochanter fractures, as well as fractures of the proximal femur affecting the head, which can not be treated by other techniques

Revision THA:

* Revision of endoprosthesis-treated hips as a result of septic or aseptic loosening, sub- and periprosthetic fractures or material failure (eg fracture of the prosthesis)
* Bridging of large bone defects (precondition: suitable proximal bone situation for a stable anchorage), i.e. for tumors

Exclusion Criteria:

* Infections
* Patients under 18 years
* Pregnant or breastfeeding patients
* Known alcohol abuse (at least 20 g alcohol per day for women and at least 40 g per day for men) or drug abuse
* Legal incapacity or restricted capacity
* Participation in another clinical trial within the last 30 days or planned participation in another clinical trial within the next 3 months
* Patients who are unable to attend to follow-up
Comparing Angiography: Multislice CT Versus Invasive Heart Catheterization (CACTI)

The purpose of the study is to compare the pictures of heart arteries obtained by MSCT scanner to the pictures obtained during heart catheterization. Our specific question is whether the MSCT scanner is accurate enough to replace heart catheterization in some situations for the evaluation of coronary heart disease.

QUESTION: Compare the accuracy of multi-slice CT angiography (CTA) with invasive catheterization (Cath) in detecting and grading coronary lesions.

EXPERIMENTAL DESIGN: A prospective cohort analysis comparing the quantification of coronary atherosclerosis by Computed Tomographic angiography to that of invasive Catheterization. Subjects will be patients who are scheduled for non-urgent cardiac cath based on a clinical need to evaluate the coronary anatomy. Cath may be scheduled after a positive stress test or on the basis of concerning symptoms. If a patient consents to participation they will be scheduled for CTA no less than 3 and no more than 30 days prior to Cath. Comparison of lesions detected by the two imaging modalities in the proximal, mid and distal coronary arteries will be made. Grades of disease used will be the following 1). less than 50% 2). 50-75% 3). greater than 75% 4) Uninterpretable. Sensitivity and specificity will be calculated for CTA; in addition PPV and NPV will also be calculated. The 2 readers of the CTA will be blinded to the invasive angiography results. The 2 readers of the invasive angiography, who are blinded to the CTA results will be the standard of comparison. Analysis of data will be performed on a segmental, vessel, and patient basis.

POTENTIAL RISK: Risks associated with contrast exposure include the risk of allergic reaction and renal injury. There is a small risk of excessive bradycardia and hypotension with administration of metoprolol and nitroglycerine. CTA is associated with radiation exposure similar to the lower range of diagnostic catheterization.

POTENTIAL BENEFITS: No direct benefits are expected for the subjects of this study as the information will not be used to alter clinical decisions. Benefits to future patients may include the development of an non-invasive alternative to cardiac catheterization.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects \>18 years old with stable clinical symptoms who are scheduled for outpatient cardiac catheterization.
2. Able to provide written informed consent in accordance with the IRB.

Exclusion Criteria:

1. Symptoms of unstable angina/acute coronary syndrome
2. Known allergy or adverse reaction to CT radiocontrast and/or iodine.
3. Known absolute contraindication to Metoprolol.
4. Significant kidney disease including creatinine \> 1.5 mg/dL or GFR \< 60 ml/min.
5. Inability to breath-hold for up to 30 seconds.
6. Women who are Pregnant or Nursing
7. Atrial Fibrillation or any other arrhythmia that makes attaining a regular slow rhythm unlikely.
8. History of previous stent placement or coronary bypass surgery.
Intensity Modulated Radiation Therapy for Head and Neck Cancer

Many normal tissues, including the eyes, brain, and spinal cord are very close to cancers in the nasopharynx. The dose of radiation delivered to the cancer is limited by tolerance of these normal tissues. Standard radiation treatment techniques using three or four radiation beams cannot avoid delivering some dose of radiation to these normal tissues that do not need to get radiation. Intensity Modulated Radiation Therapy (IMRT) uses many hundreds of computer-controlled radiation beams aimed at your cancer to try to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that your doctor thinks may have cancer cells.

The doctors at Princess Margaret Hospital are conducting this study in order to test whether the use of IMRT techniques can improve the chance of controlling your cancer in the head and neck region.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma requiring primary radiation
* less than 70 yrs of age
* Stage T1-T4; N0-N3; M0
* KPS less than 70
* no prior RT to H\&N or chemotherapy for H\&N
* no other malignancy except non-melanomatous skin cancer
* no distant mets
* no contraindication to RT or chemotherapy
* adequate organ function
* informed consent

Exclusion Criteria

* Major medical or psychiatric illness, which would interfere with either completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy.
Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy

Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Eligible to receive prostate brachytherapy as per the Ontario Provincial Guidelines will be eligible for this study (i.e. prostate specific antigen \[PSA\] \< 10, Gleason score \<7, Stage \<= T2a)

Exclusion Criteria:

* Patients already taking anti-inflammatory drugs
* Patients with allergic-type reactions, including asthma and urticaria, to aspirin or nonsteroidal anti-inflammatory agents (see product information)
Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome

By integrating sexuality and disability literatures, theories, and research methodologies, this study aims to: 1) contribute to the limited knowledge professionals have of parents as the primary sexuality educators; 2) create a resource for parents in order to be sexuality educators for their young adults with I/DD; and 3) evaluate the effectiveness of the Home B.A.S.E. for Developmental Disabilities Curriculum.

In order to meet the objectives the study seeks to answer the following questions:

1. What is the effectiveness of a sexuality education workshop for parents of young adults with DS on improving the self-efficacy and attitudes around sexuality and healthy relationships for young adults with DS as well as increase the parent-child communication on sexuality topics?
2. What are parents' concerns that impact their ability to be the primary sexuality educators for their young adults with DS? It is proposed that parent confidence and comfort talking about sexuality topics with their young adult with Down syndrome will increase thereby increasing the parent-child communication as a result of this study.

Enrollment will begin and will end once 30 eligible subjects have been identified. Anticipated duration is one year. Participants will enroll in one of the 4 different training series. Each series will have 3 dates they must attend. Once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. Participants will be expected to attend 3 training sessions over a 4 week period, each are up to 3 hours in length. There will be a follow-up post-survey one month after the last training and an optional phone interview that will occur 2 months after the final training. Participants will be compensated for their time with a $50 gift card once the final post-survey has been received. The gift card will be mailed to the family. Data analysis will begin once all trainings have been completed. Investigators anticipate completing the study, including primary analyses, within two years from the date recruitment begins.

Eligibility Criteria:
Inclusion Criteria:

* Parents of young adults with Down syndrome ages 20-30.
* Be able to communicate in English

Exclusion Criteria:

* Parents of young adults between the ages of 20 and 30 without Down syndrome
* Parents of individuals with Down syndrome younger than 20 or older than 30.
* Parents unable to attend 3 training sessions.
* Not fluent English communicators.
* Any vulnerable populations including pregnant women, neonates, prisoners, children, cognitively impaired adults, or adults unable to consent
Sexual Dysfunction in Patients With Myofascial Pain Syndrome

This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters.

The frequency of sexual dysfunction in reproductive-aged married women with primary myofascial pain syndrome will be evaluated in a prospective, cross-sectional survey-type study. The medical history of each participant was obtained and they underwent a detailed physical examination. Sociodemographic and clinic characteristics of all participants (age, education, marital status, employment status, family structure, income status, Body Mass Index(BMI), disease duration, number of pregnancies, sleep quality, etc.) were recorded. Pain and fatigue levels of the patients were measured by the visual pain scale (VAS), mood states by the Beck depression index (BDI), sexual function of the participants was assessed by the 0-10 Visual Analog Scale (VAS) to assess the degree of importance of sexuality (the sexuality-importance score). In addition, weekly/monthly sexual intercourse frequency was asked to all participants (patient and control groups). The questionnaires were administered to all participants in a room where they were alone with a female physician, and a suitable environment was provided for the patients to fill out the questionnaire. Patients were assured of the confidentiality of their information. Only questions that were not understood by the patient were explained without guidance.

Eligibility Criteria:
Inclusion Criteria:

* Myofascial pain syndrome (\>3 months) was diagnosed in a female.
* Being between the ages of 18 and 50, married, sexually active, and not menopausal
* Volunteering to participate in the study, and being able to communicate easily.

Exclusion Criteria:

* a history of systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, etc.)
* major psychiatric illness, mental retardation
* uncontrollable respiratory system problems
* endocrine diseases, neurological diseases
* previous hysterectomy or vaginal surgery, a history of sexually transmitted diseases
* urinary or anal incontinence
* limited motion in the upper or lower extremities
* Fibromyalgia
* inflammatory rheumatic diseases (such as rheumatoid arthritis, ankylosing spondylitis, etc.)
* cervical/lumbar radiculopathy or myelopathy
* communication problems
* pregnancy, lactation
* taking estrogen therapy
* use antidepressant, anxiolytic, and antiepileptic drugs
* chronic alcohol users