cyrilzakka/clinical-trials huggingface dataset:
Dual-task Augmented Reality for PD DBS

The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD with a previously implanted deep brain stimulator (DBS).

Multi-Modal Training in PD patients: In order to treat dual-task impairment (difficulty performing two tasks at once), multi-modal treatment (MMT) was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. Briefly, MMT training consists of simultaneously training a motor and cognitive task. The motor aspect of MMT stresses high velocity, high amplitude training principles while the cognitive aspect stresses commonly impaired cognitive domains in PD such as attention and executive function. An example of an MMT task is marching while spelling words backwards.

Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD: The MMT intervention is well-suited for integration into an augmented reality (AR) platform as it consists of the patient performing a series of cognitive and motor tasks simultaneously while the patient receives knowledge of performance and results from a therapist. The Microsoft HoloLens is an untethered, AR headset used in applications as broad as teaching anatomy, displaying fine art and gaming. With AR, the user maintains contact with the physical world and the people in it. The HoloLens uses AR technology to place holograms, objects made entirely of projected light, into the user's physical environment; hence creating a first-person mixed reality environment. These holograms can be viewed from different angles and distances, can be two-dimensional or three-dimensional, can appear life-like, can move, be shaped, and change according to interaction with users' or the physical environment in which they are projected, depending on the programming. The MMT was previously developed for the Dual-task Augmented Reality Treatment (DART), which delivers MMT training on a head-mounted AR display. The DART platform was successfully piloted in 50 individuals with PD who did not have DBS (IRB # 20-207). The results of the project indicate that DART is an effective method of training for individuals with PD. The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult with a diagnosis of idiopathic PD
* History of deep brain stimulator placement for treatment of PD
* Ability to ambulate \> 10 minutes continuously without an assistive device

Exclusion Criteria:

* Medical diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent

  -\>2 errors on the Short Portable Mental Status Questionnaire
* Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise
* Neurological disease other than Parkinson's disease that impacts motor or cognitive function
Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)

This study will compare the effects of a whey protein supplement or a placebo consumed before the evening meal on health outcomes in night shift workers.

Participants are assigned in random order to two conditions, for 12 days each. The interventions are 1) a 30g whey protein preload consumed 1-1.5 hr prior to their main evening meal every day for 12 days. No other advice will be given. 2) an identical mixed-nutrient drink matched for caloric content, taste and palatability consumed 1-1.5 hr prior to their main evening meal every day for 12 days(placebo). Conditions are separated by a 2-week washout period, during which participants will be encouraged to maintain their habitual diet and physical activity levels. Metabolic testing will be performed at baseline, and at the end of both conditions.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Night shift workers (with a minimum of 6 months in their current shift work schedule)
* 35-65 years
* BMI 28.0-35.0 kg/m2; waist circumference \> 80cm
* Weight stable in the past 6 months

Exclusion Criteria:

* Those working standard day time hours only, or those who work less than three to four night shifts per fortnight on average
* Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia or cardiovascular disease, and/or any other condition deemed unstable by the study physician
* Taking medications known to alter body composition or metabolism, including (but not limited to): any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) analogues \[i.e. exenatide\], thiazolidinediones or DPP-IV inhibitors \[i.e. 'gliptins'\]), medications affecting weight, appetite or gut motility (i.e. diuretics, domperidone, cisapride, orlistat, phentermine, topiramate)
* Participants who are taking stable doses (i.e. \> 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded. Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician
* Pregnant, planning a pregnancy or breastfeeding
* Those who have lost or gained \>5% of body weight in the last 6 months
* Those who consume four or more standard drinks on a single occasion at a 'daily or almost daily' occurrence
* current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
* unable to comprehend the study protocol (i.e. due to English language or cognitive difficulties)
The Effect of Wheat Germ on Gastrointestinal Discomfort, Blood Cholesterol and Postprandial Glycaemic Response

Wheat germ is a by-product of the wheat-milling industry with high nutritional value and therefore could be used as a raw source for the preparation of food products such as bread, cookies, muffins, etc.

The aim of this study is to assess the effects of ingesting wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

This is a crossover, double blinded, placebo controlled randomized trial. The study will compare the effect of consumption of wheat breads with or without wheat germ on healthy individuals, during 2 intake periods of 4 weeks each and 5 weeks washout before crossover.

The study will focus on the effects of wheat breads supplemented with wheat germ on gastrointestinal discomfort, blood cholesterol and postprandial glycaemic response in healthy human volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women
* Age 18 - 60 years
* Healthy volunteers free of chronic diseases with relevant effect on the gastrointestinal system or on visceral motility
* Without a diagnosis of any digestive disease including functional bowel disorders such as IBS
* Non-diabetic, no gastric bypass surgery
* Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
* Non-smoker
* Willing and able to provide written informed consent

Exclusion Criteria:

* Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
* Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
* Subjects with stool frequency of ≤ 1 stool every 7 days
* Subjects not willing to avoid pre- and probiotics for the duration of the study
* Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
* Current use of medication for lowering blood cholesterol or glucose
* Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibres)
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study
* Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
* Known food intolerance or allergy
* Subject involved in any clinical or food study within the preceding month
Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System

1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results.
2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month.
3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Treated by insulin injections

Exclusion Criteria:

* Other types of diabetes
* Treated with insulin pump
Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy. Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during treatment reported by paediatric cancer survivors. Complete prevention of both nausea and vomiting is the goal of anti-vomiting and nausea medications. It is important to understand whether or not certain chemotherapeutic treatments are more or less likely to cause these symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal methotrexate is an important part of chemotherapy for the prevention and treatment of central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be important to optimize treatment for these side-effects of chemotherapy. The primary aim of this prospective study is to evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* 4 years old to 18 years of age (age range in which the PeNAT has been validated) \[18\]
* English speaking (PeNAT has been validated only in English)
* Cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional
* Patients are past their first cycle of maintenance therapy to avoid interactions with the intensive chemotherapy phase.

Exclusion Criteria:

* Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate
The Effect of Su Jok on Dysmenorrhea

This study aims to determine the effect of Su Jok application in reducing menstrual pain.The main question it aims to answer is

-Is Su Jok practice effective in reducing the severity of dysmenorrhea? The researcher will perform a sham application to see the effect of the application.

Participants will perform the application on the first day they have pain during their 3 menstrual cycles. They will evaluate and record their pain with VAS.


Eligibility Criteria:
Inclusion Criteria:

* regular menstrual cycles (21-35 days)
* have abdominal pain in the last three cycles
* Those who want to participate in the study as a volunteer

Exclusion Criteria:

* have any health problems that may affect the menstrual cycle (ovarian cysts, etc.
* use hormonal medications
Supplementation of Infant Formula With Synbiotics

The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* healthy infants of mothers who voluntarily resigned completely from breastfeeding
* infant age 28 days
* delivered between 38 and 42 weeks of gestation
* vaginal delivery
* birth weight \> 2700 g and \< 4200 g
* parent or the subject's legal representative has to speak and understand Polish

Exclusion Criteria:

* fully or partially breastfed infants
* malformations, handicaps or congenital diseases that could affect normal growth
* treatment with antibiotics
* fed infant formula with pre- and/or probiotics
The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity

This is a randomized, masked, placebo controlled study to assess the effect on visual acuity, if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Presence of nuclear or cortical lens opacities in one/both eyes
* Physician diagnosis of age related cataract
* Good overall physical constitution
* All participants must be follow the same regimen for surgery related medications, both pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)

Exclusion Criteria:

* Subjects requiring Premium IOLs/multifocal implants
* Advanced cataract
* Severe Age-Related Macular Degeneration Presence or history of Glaucoma
* Presence or history of Diabetes Mellitus
* Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic retinopathy, etc
* Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion
* Vision loss due to presence of large pituitary tumors or aneurysms
* Vision loss due to optic tract lesions
* Vision loss due to bleeding into aqueous or vitreous chamber
* Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs, hydroxychloroquine, tamoxifen
* Major cardiovascular or cerebral events in the past 12 months
* Allergy to fish oil or safflower oil
* Pregnancy or lactation at any time during the study
* Newly started or increased the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any time during the study
* Participation in any other study involving an investigational drug or device within the past 30 days
Parasternal Block and TENS for Cardiac Surgery

the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy.

Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions and the inability to cough due to median sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional blockade and the use of intravenous (IV) opioids, are used for postoperative pain management. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is effective for postoperative pain management. It has been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery, and it has no side effects. Parasternal local anesthetic infiltration around the sternum has been demonstrated to be useful in providing early postoperative analgesia, reducing opioid requirements and, therefore, producing a potential positive effect on recovery. The present prospective, randomized controlled study included 120 patients, 18 to 65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly allocate patients to one of three treatment groups to relieve postoperative pain during the first 24 h following median sternotomy: parasternal block group (parasternal block combined with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS and PCA); or the control group (PCA alone).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass

Exclusion Criteria:

* previous sternotomy for CABG or heart valve surgery; emergency surgery
* ejection fraction \<40%
* congestive heart failure
* an allergy to amide-based local anesthetics, opioids or benzodiazepines
* inability to provide informed consent
* prolonged cardiopulmonary bypass time (\>145 min)
* previous experience with TENS
Implementation of CPT for PTSD in Diverse Communities

Aim: To identify, assess, and address organizational context and provider-level barriers and facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods approach in a diverse community mental health center (CMHC), Massachusetts General Hospital Chelsea Health Clinic (MGH Chelsea).

Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate, heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider motivation to learn EBT.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years of age
* Speak English
* Be employed at least part time at MGH
* Willing to have focus group/interview audiotaped and transcribed for data analysis

Exclusion Criteria:

* inability to meet the above inclusion criteria
Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection

To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.

Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.

Eligibility Criteria:
Inclusion Criteria:

* the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
* the patient used arsenite sodium chloride injection

Exclusion Criteria:

* Patients with incomplete clinical information
Effects of Polyphenols Supplementation on Cycling Endurance

Endurance performance during high intensive exercises is mainly determined by the capacity of the aerobic metabolism. It generally induces muscle fatigue defined as the reversible decline in skeletal muscle contractile performance. Fatigue is multifactorial and is often associated with many physiological parameters including reduced neural input and disruptive metabolic changes in skeletal muscles such as lactic acidosis and the production of oxidative free radicals. Moreover, it could lead to oxidative stress as a result of an imbalance between reactive oxygen species (ROS) production and intrinsic antioxidant defense.

To alleviate oxidative stress, some ergogenic strategies have been tested. Numerous studies have reported that different types of supplementation such as selenium, vitamin E, vitamin C or polyphenols were of interest to protect against these mechanisms. Indeed, although some studies demonstrated no or harmful effects, most studies observed positive effects of antioxidants on oxidative stress or performance. More particularly, polyphenols, have great antioxidant capabilities and protective effects and it increases the synthesis and bioavailability of nitric oxide (NO)which is well known to be the most important mediator of vasodilation. To date, most of the studies exploring the effects of polyphenols on exercise investigated several days or weeks of supplementations on vascular, blood parameters (blood pressure, NO concentration, oxidative stress markers) or endurance performance. Conflicting results are often obtained. Only few studies investigated the effects of a single intake on immediate performance and recovery capacity. Therefore, the present work aimed to study the effects of an acute intake of a specific profile polyphenols from grape and apple on physical performances. More specifically, performance, in the present study, referred to high intensity cycling exercise until exhaustion revealing the capacity to maintain a constant strong effort hereafter named endurance. The hypothesis was that an acute of polyphenols would increase the time to exhaustion during a high intensity cycling exercise.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index lower than 27 and waist size lower than 94 cm
* physical activity higher than 2 hours a week
* written informed consent

Exclusion Criteria:

* more than 6 hours training a week, regularly trained in aerobic activities
* asthmatic, smokers or under medicinal drugs
* dietary supplement, sports drink, special dietary food or functional food, of any kind, liable or presented as liable to enhance physical performances
The Impact of Sucrose Ingestion Post-Exercise on Liver and Muscle Glycogen Repletion.

Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar) levels. Both liver and muscle glycogen are important for our ability to perform intense/prolonged endurance exercise. Therefore, it is important to replete these stores after an intense/prolonged endurance exercise session in order to recover and perform optimally during a subsequent exercise bout, especially if the next exercise session is within 24h (e.g. stage races such as the Tour de France, tournament-style competitions such as the Olympic games and ultra-endurance events).

Carbohydrate intake has been shown to increase the availability of glycogen in the muscle and liver after exercise. The carbohydrates typically found in sports drinks are glucose and sometimes fructose. It has been observed that the ingestion of glucose will lead to a maximum rate of absorption of approximately \~1 g/min. However, if we also provide a different source of carbohydrate (fructose) then this is absorbed through a different pathway and therefore we can absorb up to \~1.75 g/min of carbohydrate. In addition, both carbohydrate sources are metabolised differently in the human body. By supplementing both glucose and fructose, we can potentially replenish the liver and muscle glycogen stores at a faster rate than ingestion of glucose only.

Sucrose is a naturally occurring sugar that is made up of a single glucose and single fructose molecule. Therefore, theoretically, this can use the two different pathways of absorption and also maximise carbohydrate delivery. It is not yet known however, what impact this has on our liver and muscle glycogen stores post-exercise when supplemented in relatively high amounts. Therefore the aim of this study is to assess whether relative high amounts of sucrose ingestion will improve liver and muscle glycogen repletion after endurance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Endurance trained cyclists/triathletes
* VO2 max ≥ 50 ml/kg/min

Exclusion Criteria:

* Use of medication
* Smoking
* Metabolic disorders