cyrilzakka/clinical-trials huggingface dataset:
A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Primary Objective:

•To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial.

Secondary Objectives:

To assess the effect of AR versus non-AR control technology in pediatric oncology patients, including:

* Inpatient opioid use
* Average daily inpatient pain score
* Number of opioid requests during the hospital stay
* Inpatient PedsQL (quality of life) questionnaire score
* Ambulation/"out of bed" movement
* Number days to discharge-ready status
* Patient experience assessed by satisfaction scores on a questionnaire designed by MD Anderson Cancer Center Child Life team.
* Outpatient opioid consumption reported at 30, 60, and 90 days
* Outpatient pain scores reported at 30, 60, and 90 days
* Outpatient PedsQL scores reported at 30, 60, and 90 days
* Potential adverse events related to the use of AR (i.e., falls).

Eligibility Criteria:
Inclusion Criteria:

1. Ages 5-15
2. English and Spanish-speaking parents/legal guardians and patients
3. Undergoing major surgery for cancer requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
4. Expected to be prescribed postoperative inpatient opioids
5. Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
6. Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
7. Both the child and a legal guardian are willing and able to provide informed consent.

   * The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (\>15 years of age) were disinterested in the interactive game.

Exclusion Criteria:

1. Patients with any daily opioid use within 30 days before surgery.
2. History of documented peripheral neuropathy secondary to cancer treatment
3. Inability to demonstrate an understanding of the game from English instructions
4. Any additional concerns based on the study physicians' assessments
RIPT of Ibuprofen Topical Gel

This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.


Eligibility Criteria:
Inclusion Criteria:

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study
The Effects of L-arabinose in a Meal in Healthy Men

The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* normal weight (BMI 18,5-25 kg/m2)
* 18-30 years of age

Exclusion Criteria:

* Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders
* Central adipositas (defined as waist circumference \> 94 cm for european men)
* Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.
* elevated alcoholcunsumption(\> 21 units af alcohol pr. week)
* take medicine
* Elite athlete with intensive training
* given bloddonation within the last 3 months
* smoking
Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy

The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).

The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance level will be determined by the chewing performance scale. The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels. Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of cerebral palsy
* Referring by a pediatric neurologist
* Aging between 2 to 12 years

Exclusion Criteria:

* Aging under the age of 24 months
* Using any medicine and/or oral appliances that could affect the chewing performance
Comparing the Diagnostic Sensitivity and Specificity of Pleural Fluid N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) and Other Biochemical Gradient Criteria in Distinguishing Heart Failure and Non-heart Failure Related Pleural Effusions (CENTRE Study)

To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Objective: To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).

Hypothesis to be tested: The PF NTproBNP levels are superior to existing methods including Light's criteria, serum/pleural fluid (S/PF) protein gradient, and albumin gradient, in identifying transudates and distinguishing between HF- and non-HF-associated PE.

Design and subjects: A prospective case-control study involving patients with PE requiring thoracentesis, caused by hypervolaemia due to HF, diseases other than HF, and patients with pleural effusion without hypervolaemia. Patient characteristics, PF results and effusion aetiology will be analysed. Patient outcomes will be followed up to 3 months to confirm the aetiology of PE. Clinical management of patients will not be affected.

Study instruments: PF of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (LDH) levels and NTproBNP. The diagnosis of HF will be based on clinical features, serum NTproBNP and echocardiogram.

Main outcome measures: The performance of PF NTproBNP level in identifying HF-associated PE.

Data analysis: The PF NTproBNP level will be compared between effusions of different aetiologies. The optimal pleural fluid NTproBNP level with largest area under the receiver operating characteristic curve in identifying HF-associated PE will be determined. Performance of PF NTproBNP level in identifying HF-associated PE, and other biochemical criteria in identifying transudates will be compared. Echocardiographic findings will be correlated with the PF NTproBNP levels.

Expected results: The diagnostic performance of PF NTproBNP will be significantly better in identifying HF-associated effusion than other biochemical criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for heart failure and pleural effusion
* Pleural tapping indicated for pleural fluid analysis.
* Aged 18 years old or above

Exclusion Criteria:

* History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space.
* History of surgical decortication or pleurodesis in the ipsilateral pleural space.
* Ipsilateral thoracic or cardiac surgery in the past 3 months.
* Failure to obtain informed consent due to the patient's refusal or cognitive impairment.
Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate

The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.


Eligibility Criteria:
Inclusion Criteria:

* ICSI indicated cycles

Exclusion Criteria:

* severe medical illness
Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain

Dysmenorrhea is a common problem in women of reproductive age. Primary dysmenorrhea is defined as recurrent, cramping pain occurring with menses in the absence of identifiable pelvic pathology .

Primary dysmenorrhea is characterized by a crampy supra-pubic pain that begins somewhere between several hours before and a few hours after the onset of the menstrual bleeding. Symptoms peak with maximum blood flow and usually last less than one day, but the pain may persist up to 2 to 3 days. Symptoms are more or less reproducible from one menstrual period to the other. The pain is characteristically colicky and located in the midline of the lower abdomen and may extend to lower quadrants, the lumbar area, and the thighs.

Menstrual low back pain (LBP) is one of the common complaints among women. Previous studies have indicated that more than 40% to 50% of the population experience LBP during the menstrual phase (days 1-6) of the menstrual cycle .

Eligibility Criteria:
Inclusion Criteria:

1. Thirty adolescent females suffering from menstrual low back pain.
2. Their age will be ranged from 17 to 24 years.
3. Their body mass index will be ranged from 20 to 25 kg/m2.

Exclusion Criteria:

1. Personal and individual differences between the subjects.
2. Psychological and physical status of subjects which may affect the treatment and evaluation stage.
3. Environmental factors which may affect the subject's response
Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines

To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that fit all of the criteria below were selected for this clinical trial.

  1. Male and female adults from 19 to 65 years old at the time of screening
  2. Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
  3. Person who understands and can comply to the process and visiting schedule of this clinical study
  4. Person who gave spontaneous written consent to participate in this clinical study

Exclusion Criteria:

* Subjects that fit any of the criteria below were excluded from this clinical trial.

  1. Person with infection, skin disease, or scar on forehead
  2. Person with symptoms of facial palsy or blepharoptosis
  3. Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
  4. Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
  5. Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods
  6. Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer
  7. Other person who the investigator judges as inappropriate for the clinical trial
A Survey of Factors Associated With the Successful Recognition of Agonal Breathing and Cardiac Arrest.

The overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers in the province of Ontario, Canada to better understand the factors associated with the successful identification of cardiac arrest (including victims with agonal breathing) over the phone. Specific objectives are:

1. To conduct iterative semi-structured interviews to identify behavioural factors influencing identification of cardiac arrest by 9-1-1 call takers;
2. To develop a survey instrument about behavioural factors influencing the ability of 9-1-1 call takers to identify cardiac arrest based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs from the Theory of Planned Behaviour; and
3. To conduct a survey among Ontario 9-1-1 call takers using the survey instrument, and to identify factors and strategies that might be targeted by Knowledge Translation interventions.


Eligibility Criteria:
Inclusion Criteria:

* 9-1-1 call-takers, male or female, full or part-time, employed in an eligible Ambulance Communication Centre

Exclusion Criteria:

* Ambulance Communication Centre Managers, support staff or administrative staff
McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope

Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for a general anesthesia with orotracheal intubation

Exclusion Criteria:

* predictable risk of difficult mask ventilation or of difficult tracheal intubation
* necessity of a rapid sequence induction
* contra-indication to sufentanil, to propofol, or to atracurium
* ENT, thoracic surgery, or intracranial surgery
Obesity and Weight Loss on Reproductive Function

The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.

Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. In males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. Therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure.
* Failed medical weight loss
* Ages of 18-40
* Not using hormonal contraception or sex steroids
* Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy
* Subject's obesity has no medical explanation (hypothyroidism, Cushing's Syndrome, genetic)

Exclusion Criteria:

* Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery
* Subject is pregnant or lactating
* Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery
* Post-menopausal, either surgical or natural
* Subject has had a vasectomy
* Subject is a smoker
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Eligibility Criteria:
Inclusion Criteria:

* 10 years of age or older
* Documented diagnosis of HAE (Type I or II)
* Willing and able to give informed consent
* Acute HAE attack at time of presentation

Exclusion Criteria:

* Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
* Pregnancy or breastfeeding
* Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
* Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered
Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy

Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.

Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old;
* The patient whose tumor (tissue or cell) was first diagnosed by pathology;
* Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
* Have relevant indications for treatment and have no contraindications;

Exclusion Criteria:

* Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.);
* Other circumstances considered inappropriate by the researcher to participate in the study;
Cost-effectiveness Study of miRview™ Mets in Patients With Cancer of Unknown Primary (CUP)

The aim of the study is in cancer of unknown primary (CUP) patients, to compare the cost-effectiveness of miRview™ mets test with conventional work-up in identifying the primary tumor site.

Thousands of patients are diagnosed each year with metastatic cancer; however, about 3-5% of them are diagnosed with Cancer of Unknown Primary (CUP). In order to identify the optimal treatment plan for individual patients with CUP, the primary tumor site must be identified. Patients undergo a wide range of costly, time-consuming, and inefficient tests to identify the primary site of origin, often to no avail.

In this era of targeted therapies, the accurate diagnosis of the primary tumor can be crucial. miRview™ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who present with histologically-confirmed metastatic cancer in whom an initial work-up which consists of detailed medical history, physical examination, basic laboratory studies, histopathological review of biopsy material, and CT scan of the chest abdomen and pelvis fail to identify the primary site.
2. Older than 18 years
3. Performance status \<2
4. life expectancy \>3 months
5. ANC \>1500
6. Platelets \>100,000 if bone marrow is not involved
7. Hb \> 9
8. Creatinine \<2
9. LFTS \< x5 normal
10. Histology proven of malignancy
11. Enough material for miRview test (10 slices of 10 micrometer sections)
12. Member of Clalit HMO

Exclusion Criteria:

1. Patients unable or unwilling to sign the informed consent form
2. Under 18 years old
3. Performance status \>2
4. life expectancy\<3 months
5. ANC \<1500
6. Platelets \<100,000 if marrow not involved
7. Hb \< 9
8. Creatinine \>2
9. LFTS \> x5 normal
10. Not member of Clalit HMO
Effects of Dry Needling on the Behavior of the Shoulder Muscles

The main objective of this study will be to evaluate the effects of the application of the dry needling technique on the activity of the rotator cuff muscles in the shoulder.

The evaluation of the effects of the application of the dry needling technique will be carried out in subjects with and without shoulder pain.To do this, muscle strength, possible thickness changes in the muscle and electromyographic activity will be measured before and immediately after the application of a dry needling technique.

Likewise, other variables will be measured such as the pressure pain threshold (PPT), pain with a Numeric Verbal Scale, kinesiophobia and catastrophism, the shoulder pain and disability index (SPADI) and the influence of expectations about dry needling.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of legal age
* Subjects without shoulder pain or with unilateral shoulder pain of \> 3 months duration.
* Have shoulder mobility of 90º of abduction and at least 30º of glenohumeral external rotation.

Exclusion Criteria:

* Have neck pain.
* Whiplash
* Having had trauma to the shoulder.
* Having fibromyalgia.
* Be pregnant.
* Being afraid of needles.