cyrilzakka/clinical-trials huggingface dataset:
Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias

Exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia.

Effective treatments for patients with degenerative spinocerebellar ataxia are scarce. It has recently been shown that intensive coordinative training based on either physiotherapy or exergames (= whole-body controlled videogames; might improve degenerative ataxia, but its effectiveness is still disputed. This situation is even more complicated for degenerative ataxia subjects in advanced disease stages and with high multisystemic disease load. Here, underlying neurodegeneration has progressed to many irreversible states and includes many additional extra-cerebellar systems, making functional plasticity and therapeutic success much less likely. Moreover, intervention outcome assessment in subjects unable to walk freely is more delicate. Correspondingly, nonambulatory ataxia subjects in advanced disease stages are currently often excluded from treatment trials, thus leaving them without prospects of access to novel treatments.

The investigators here hypothesized that exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia. Using a rater-blinded, intraindividual control study design, the investigators show that an individualized exergame training strategy, tailored to individuals' disease stage, improves postural control and ataxia-specific control functions even in advanced disease.

Eligibility Criteria:
Inclusion Criteria:

* Advanced spinocerebellar disease
* Advanced impairments in gait and stance, defined as Scale for Assessment and Rating of Ataxia (SARA) subscore gait ≥3 and stance ≥3, but still able to sit without support \>10 seconds, as defined by SARA subscore sitting \<3
* Age between 5 and 30 years

Exclusion Criteria:

* Any signs of inflammatory, vascular, malformation, or tumor cerebrospinal (CNS) disease
* Visual loss, hearing disturbances, mental retardation and predominant non-ataxia movement disorders (e.g. predominant spasticity, chorea, parkinsonism)
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution

The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The study is a double-masked, multiple- ascending dose trial and will enroll four cohorts of up to 12 subjects. Dose cohorts will receive increasing doses of AKB-9778 ophthalmic solution or vehicle-matched placebo daily for 7 days. Cohort 5 will enroll subjects with open angle glaucoma or ocular hypertension who will continue current prostaglandin therapy during the study. Cohort 5 subjects will receive the maximum tolerated dose from the previous cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

* Aged \> 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in Cohorts 2-4, aged 18 to 80 years inclusive in Cohort 5.
* For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP between 17 and 27 mm Hg (inclusive).
* Central corneal thickness of 480 to 600 μm, inclusive
* For subjects in Cohort 5, diagnosis of OAG or OHT
* For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering

Key Exclusion Criteria:

* Diagnosis of any form of glaucoma in Cohorts 1-4
* Clinically significant eye trauma within 6 months of screening
* Any intraocular ophthalmic procedure within 6 months of screening
* Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye
* Subjects with any known chronic ocular disease (other than incipient cataract or refractive error)
* Any condition preventing valid applanation tonometry measurement, e.g., clinically significant corneal disease, refractive surgery
* Visual acuity (VA) worse than 20/30 in either eye, For Cohort 5 VA worse than 20/100 in either eye
Identification of Anaphylactogenic Antibodies in Peanut Allergy

This project intends the analysis and profiling of specific antibodies against major peanut allergens in peanut allergic individuals and molecular cloning of human antibodies against major peanut allergens.

* Characterization of patient samples reactivity (sera obtained from blood) against major peanut allergens.
* Isolation of antibody-producing B cells.
* Molecular cloning of peanut-specific antibodies from antibody gene sequences obtained from B cells.
* Biophysical and functional characterization of isolated antibodies

Eligibility Criteria:
Inclusion Criteria:

* Participants have a described clinical history of peanut allergy and/or are sensitized to peanut allergens (as evidenced by positive skin prick test and allergen-specific IgE testing)
* Male and female subjects older than 3 years
* Written informed consent

Exclusion Criteria:

* age below three years
* patients suffering from any disease where blood withdrawals might impact the patients' health status such as known anemia.
Effect of Speed of Weight Loss on Compensatory Mechanisms Activated During Weight Reduction

Obesity has become a global epidemic with huge public health implications. Although clinical significant weight loss (WL) can be achieved by a combination of diet and behavioral modification, strong metabolic adaptations, with increased appetite and suppressed energy expenditure, are activated, which compromise WL maintenance and increase the risk of relapse. The aim of this project is to investigate the potential role of WL rate in modulating such responses. More specifically, the investigators want to determine if a similar WL achieved rapidly vs slowly induce the same compensatory responses to weight reduction. A secondary aim is to assess if speed of weight loss can influence motivation. A large battery of assessments will be performed before and after weight reduction including body composition, resting metabolic rate, substrate oxidation, exercise efficiency, fasting and postprandial release of several appetite-regulating hormones, subjective feelings of hunger and fullness and motivation. This project can bring large practical benefits concerning the design of weight loss programs to minimize weight relapse.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18-50 years old)
* Obese healthy volunteers (30\<BMI\<45 kg/m2)
* Weight stable on the last three months (\<2kg), not currently dieting to lose weight and with an inactive lifestyle)

Exclusion Criteria:

* History of endocrine/cardiovascular/pulmonary/kidney disease, anaemia, gout, milk intolerance, depression or other psychological disorders, eating disorders, drug or alcohol abuse within the last two years and current medication known to affect appetite or induce weight loss. Those with a planned surgery during the study period or participating in another research study will also not be accepted to take part in this study
Domestic Violence Enhanced Home Visitation Program (DOVE)

DOVE Home Visit Program is a brochure based intervention delivery by public health nurses which aims to prevent and reduce intimate partner violence against pregnant and postpartum women and their infants.

The purpose of the study is to test the effect of home visits on reducing domestic violence and improving the lives of pregnant women and their children.

Outcomes will provide intervention efficacy data about a public health nurse home visit intervention aimed at reducing and preventing intimate partner violence and children's exposure to IVP as well as prospective information about patterns of intimate partner violence.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 31 weeks or less gestation, over age 18, with a history of intimate partner violence within the past 2 years, and who are willing to participate in the home visit program

Exclusion Criteria:

Age 17 or less. History of partner violence beyond 2 years. Not participating in home visit program. Does not speak English
Kinesio Taping Effect on Postural Balance in Elderly

The elderly population has increased significantly in the last years. The number of falls has also increased due to the decrease of balance. The Kinesio Taping (KT) is a method with the aim to improve muscle physiology, proprioception, coordination and balance. The aim of the study was to investigate the effect of KT on postural balance in the elderly. We evaluated 62 elderly with a mean age of 67.98±5.321, female, submitted to the protocol for the application of KT in gastrocnemius muscles of the midfoot and a placebo tape (3M Micropore) in the control group. The application of the tapes was bilateral. Half of the participants (n=31) received KT in the lower limbs, while the control group (n=31) was applied placebo tape. To analysis of posture and balance, we used a force plate to record stabilometric signals. Both groups were evaluated post-application and 48 hours after application of the tape. The variables used were total displacement in centimeters (cm), amplitude AP (anterior-posterior) and ML (medial-lateral) in centimeters, area (cm²) and speed AP and ML in centimeters for seconds. The experimental protocol was performed in standing posture and the subjects were instructed to stand with feet apart, eyes open to look at the fixed point 1.5 m from force plate in a horizontal direction. It was requested that the elderly maintain the position for a time of 40 seconds to collect data The data were collected immediately post application of tapes and after 48 hours. The data was tabulated, descriptive statistics were calculated. Statistical analysis was performed using the GraphPad Prism 4.0 software (Prism, Chicago, IL). The Kolmogorov Smirnov test was used to verify the data distribution. Differences between the means were evaluated using the Student T test for the normally distributed data, and using the Mann-Whitney test for the data not normally distributed. Significance levels were set at p\<0.05.

The Kinesio Taping Group (KTG) was composed of 31 participants that received the application of KT (K-Taping®) on the gastrocnemius muscle and the muscles of the midfoot. The placebo tape group (PTG) was composed of 31 participants that received the application of a placebo tape (3M Micropore®) on the same muscles of both limbs. The order of application of KT tape and placebo was conducted randomly among the elderly. Before the tape applying the site was cleaned with 70% ethanol for better fixation of the tape and for both groups were determined the application technique in "I" shaped. This technique consist in placing two tapes that format. The first tape was placed along the length of the plantar aponeurosis fixed point in the middle third of the medial gastrocnemius muscle to the metatarsal phalangeal joint. The second tape was also applied in "I" shaped without fixed point was placed around the midfoot arch in the direction of tension lines to assist with the metatarsal arch support.

Eligibility Criteria:
Inclusion Criteria:

* elderly, gender female

Exclusion Criteria:

* No severe orthopedic diseases
The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome

An open clinical trial

The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid

Eligibility Criteria:
Inclusion Criteria:

* Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS

Exclusion Criteria:

* The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.
User Acceptability of a Nicotine Lactate Delivery System (P3L)

This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary nicotine intake, in a manner comparable with their own brand of CC or the VUSE e-cigarette system.

The total duration of the study for an individual subject will be between 3 and 8 weeks, including 1 day for the screening visit, 3 days for the ad libitum use sessions (P3L, VUSE e-cigarette system and subjects' own commercially available non-menthol CC), 1 day for the preference evaluation session (subjects will be given the choice of using ad libitum the P3L or the VUSE), the 2 to 10 days of interval between each visit, and 7 days for the passive safety follow-up period.

The pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, will be evaluated as well as the safety and tolerability of the P3L.

Eligibility Criteria:
Inclusion Criteria:

* Smoking, healthy subject as judged by the Investigator
* Subject smoked at least 10 commercially available non-menthol CCs per day for the last 12 months
* Subject does not plan to quit smoking in the next 60 days

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason)
* Subject has donated or been in receipt of whole blood or blood products within 3 months prior to the screening visit
* Subject has used tobacco products or nicotine containing products other than CCs within 30 days prior to the screening visit
* Female subject is pregnant or breast feeding
* Female subject does not agree to use an acceptable method of effective contraception
* Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy
Cognition and Magnetic Resonance Imaging of Brain Inflammation in Obesity

The rate of obesity in the United States is high and is a risk factor for concurrent cognitive impairment and, in late life, dementias such as Alzheimer's disease. In order to prevent or reduce cognitive impairment, the mechanism underlying the link between obesity and cognitive impairment must be understood. The current study aims to provide preliminary data on whether brain inflammation occurs in obesity and relates to cognitive deficits using magnetic resonance neuroimaging and cognitive testing. It is hypothesized that obese individuals will have greater brain inflammation and lower cognitive function compared to normal-weight individuals. Further, it is predicted that brain inflammation will relate to cognitive function and plasma indicators of inflammation in obese individuals.

Initially, normal-weight or obese potential participants are screened by a phone interview that assesses medical history. Obtainment of informed consent and further screening occurs on the day of the study visit. Participants then undergo a 2 hour oral glucose tolerance test (OGTT) including blood draws for metabolic and inflammatory marker levels in plasma. Lunch is then provided. Participants are then administered 30 minute computer-based cognitive testing from the NIH Toolbox Cognition Battery. After cognitive testing, participants undergo 1.5 hour magnetic resonance imaging (MRI) that includes structural, diffusion tensor, and functional MR imaging.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese (body mass index = 18 - 25 kg/m\^2) or Obese (body mass index ≥ 30 kg/m\^2
* Any race or ethnicity
* Native English speaker

Exclusion Criteria:

* Past or current diabetes
* Current psychotropic medication use
* Past or current neurological illness
* Past or current substance or alcohol misuse
* Past or current mental illness
* Current binge eating disorder
* Magnetic resonance imaging contraindications
* Pregnancy
* Currently lactating
* Tobacco use within past month
* Over 350 lb
Early Childhood, Home Injuries, Mothers ' Knowledge, Mothers' Attitude

Home-Related Injuries among Early Childhood: Rural Mothers' Knowledge, Attitudes and Practice regarding First Aid in Matrouh Governorate, Egypt

Keywords: Home injuries, Early childhood, Rural mothers, First aid, Matrouh Governorate.

Implement health education class to rural mothers about first aid measures to be taken for their injured children"

Eligibility Criteria:
Inclusion Criteria:

* The Mothers have normal preschool children less than 6 years regardless the child gender.
* Educated (minimum accepted level of education is completion of primary education)
* Interested \& willing to participate in the study.

Exclusion Criteria:

-
Effects of Heart Rates and Variability of Heart Rates on Image Quality of Dual-Source CT Coronary Angiography

The purpose of this study is to investigate the effects of heart rates (including maximum heart rate, average heart rate and minimum heart rate) and variability of heart rate on image quality of DSCT coronary angiography without control of heart rate experienced in our department.

The dual-source CT (DSCT) equipped with two X-ray tubes at 90 degree offset in the gantry can provide temporal resolution 83ms using mono-segmental reconstruction technique. The recent studies about the effect of heart rate on IQ of DSCT coronary angiography which concluded in adequate diagnostic IQ of dual-source CTCA without immediate pre-scanning heart rate control included chronic users of β-blocker focused on the influences of average heart rate, heart rate variability and coronary arterial calcifications on IQ. The effect of blooming artifact of calcification on IQ by far cannot be eliminated. Here, we investigate the effects of maximum heart rate, average heart rate, minimum heart rate and heart rate variability on the motion-related IQ of DSCT coronary angiography in patients without both pre-scanning heart rate control and chronic use of β-blocker agent, compared with that in chronic users of β-blocker agents.

Eligibility Criteria:
Inclusion Criteria:

* From Oct 2006 to Jan 2007, CT coronary angiographies of 180 consecutive adult patients, were performed in our hospital using a DSCT scanner. After exclusion of the patients according to the exclusion criteria, totally DSCT coronary angiographies of 133 adult patients (N=133) were enrolled in this study. Among those 133 patients, including 97 males and 36 females with a mean age of 53.9 (ranging from 21 to 78 year old), 50 patients were chronic β-blocker users (group 1) while the other 83 patients (group 2) were not chronic user of any medication controlling heart rate

Exclusion Criteria:

* The patients below 18 year old, patients with status post heterotopic heart transplantation (having two hearts in a chest), patients with status post coronary by-pass surgery and patients with post indwelling of coronary arterial stents
Brown Adipose Tissue in Type 1 Diabetes

Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood glucose levels.

In this study 12 patients with long-standing type 1 diabetes (\>10 years) and with variable exogenous insulin needs will be investigated for amount of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18 years of age or more)
2. Type 1 diabetes diagnose for more than 10 years

Exclusion Criteria:

1. Ongoing pregnancy
2. Ongoing breast-feeding
3. BMI\<19
4. BMI \>30
5. P-creatinine \<110 µmol/l
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate.

Individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* severe hypo- or hyperglycemia during last 6 months
* acute illness
Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)

This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.

This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.

Eligibility Criteria:
Inclusion Criteria:

* Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI\>20
* Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
* Age 18-85

Exclusion Criteria:

* History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
* Inflammatory bowel disease
* Metal implants or other concerns for use of MRI
* Active infection
* Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
* We will exclude patients with onychomyosis of the fingernails on clippings