cyrilzakka/clinical-trials huggingface dataset:
D-chiro-Inositol in Overweight Type 1 Diabetes Patients

The purpose of this pilot study was to evaluate the effect of D-chiro-Inositol (DCI) oral supplementation in addiction to folic acid compared to folic acid alone on glycaemic control as assessed by HbA1c in overweight or obese T1D patients undergoing intensive insulin therapy.

A 24 weeks, prospective, randomized control trial was carried out in T1D patients, aged 17-50 years (13 males, 13 females), with disease duration \> 1 year and BMI \>25, attending as outpatients the Endocrinology and Diabetes Unit of University Campus Bio-Medico in Rome


Eligibility Criteria:
Inclusion Criteria:

* T1D patients
* aged 17-50 years
* disease duration \> 1 year
* BMI \>25

Exclusion Criteria:

* learning disabilities
* presence of chronic conditions potentially able to influence daily activities (visual or auditory disability, motor impairment for neurological or orthopaedic problems).
* T1D patients affected from diabetic complications
* pregnancy
Creatine Metabolism in Rett Syndrome

Rett syndrome (RTT) is an X-linked severe neurodevelopmental disorder. Despite their good appetite, many females with RTT meet the criteria for moderate to severe malnutrition. The pathological mechanism is barely understood. Although feeding difficulties may play a role in this, other constitutional factors as altered metabolic processes are suspected. Preliminary research showed elevated plasma creatine concentrations and increased urinary creatine/creatinine ratios in half of the RTT girls.

The aim of this study is to confirm previous findings and examine the functionality of the creatine transporter in RTT girls.

The investigators assume that previous findings will be confirmed, and are due to an altered functionality of the creatine transporter.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RTT (meeting consensus diagnostic criteria (Hagberg et al, 2002));
* MECP2-mutation;
* Complete neurophysiological work-up;
* Participant preliminary research (research protocol NL25356.068.08).

Exclusion Criteria:

* Male gender
PEMF in the Treatment of Fresh Distal Radius Fractures

Distal radial fractures (DRF) are the most common fractures encountered in health care. Annualized estimates in the United States alone suggest an incidence of approximately 640,000 cases, and rising, per year. Most fractures may be treated in a plaster cast, but unstable fractures tend to displace without a surgical procedure. 1

Pulsed electromagnetic field (PEMF) is one modality commonly used to stimulate bone generation throughout various clinical settings including orthoapedic surgery. PEMF has been shown to primarily effect vascular generation, formation and neovascularization2,3. This may help decrease time to healing and allow patients to return to normal activities sooner.

Additional study demonstrated that PEMF exposure increased cell proliferation, adhesion and the osteogenic commitment of MSCs, even in inflammatory conditions. In this in-vitro model PEMFs increased the expression of anti-inflammatory cytokines, such as IL-10, and reduced the expression of the pro-inflammatory cytokine IL-1 4.

The distal radius fracture was chosen as the model to test the effects of PEMF treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints.

The purpose of the study is to determine whether the use of FHP by means of pulsed electromagnetic fields in acute distal radius fractures will accelerate healing both clinically and radiotralogically


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with closed unilateral dorsally angulated fracture of the distal radius (Colles') visible by x-ray.
2. Subjects treated conservatively by immobilization ± closed reduction
3. Age \>18 years
4. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.

Exclusion Criteria:

1. Subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation.
2. Subjects with pins or plates in the wrist
3. Sustained previous fractures or bone surgery in the currently fractured distal forearm
4. Synovial pseudarthrosis
5. Subjects with multiple trauma (several fractures at once)
6. Subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm.
7. Pregnancy
8. Women who are breast-feeding.
9. Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
10. presence of a life supporting implanted electronical device
Epidemiology of Cardiovascular Disease in Diabetes

To locate and identify genes contributing to the genetic component of subclinical cardiovascular disease (CVD) in Type 2 diabetes and to evaluate the impact of lifestyle and environment on the expression of these genetic components of subclinical CVD.

BACKGROUND:

Atherosclerosis is the most important complication of diabetes and the reason for its accelerated course in patients with this condition is poorly understood. Diabetes is increasing in prevalence and will exact a heavy disease burden on the United States population over the coming years. Secondary prevention of atherosclerotic complications would be of great value. The rationale underlying genetic studies is that new pathways could be identified through functional genomics.

DESIGN NARRATIVE:

The following hypotheses are tested: 1) The risk of developing Type 2 diabetes-associated cardiovascular disease (CVD) has a significant heritable component that can be measured, and 2) The chromosomal locations of genes contributing to CVD in Type 2 diabetes can be determined and the genes identified using modern molecular genetic approaches. The investigators predict that these genetic factors can be detected in studies of sibling pairs with Type 2 diabetes through genetic epidemiology methods and linkage analysis. Type 2 diabetes-affected sibling pairs, unaffected siblings, and parents, if available, will be recruited and multiple clinical and subclinical measures of subclinical CVD risk will be assessed, including coronary artery calcification (CAC), carotid arterial wall thickness (IMT), ECG variables, and prevalent CVD. Data on the patients are collected in one visit to the General Clinical Research Center (GCRC) which includes an interview and physical examination, a resting 12-lead electrocardiogram (ECG), B-mode ultrasound of the carotid arteries, retrospectively gated helical CT (RGHCT), and a spectrum of clinical laboratory measures. Genetic and epidemiological methods will be used to evaluate the familial aggregation of subclinical CVD taking into consideration the effects of shared environmental exposures (e.g. smoking, diet, alcohol intake and physical activity) and clinical measures (e.g., body mass index, blood pressure, lipids, age, sex, etc.). Initial estimates of heritability suggest a significant heritable component to subclinical CVD. Clinical evaluation will be followed by a comprehensive molecular genetic analysis of the sib pairs/families including a genome wide screen, which will be followed by a focused effort to create a high quality dataset by regenotyping or replacing problem markers. Evidence for linkage to quantitative trait loci (QTLs) influencing CAC and IMT will be pursued in those chromosomal regions showing suggestive evidence for linkage and then performing further analyses to detect associations with these "saturation" markers.

Eligibility Criteria:
No eligibility criteria
the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents

The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:

the differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 6-9 years old, gender unspecified;
2. Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;
3. Best corrected visual acuity of at least 1.0;
4. Ability to sign an informed consent form with the presence and understanding of a parent or guardian.

Exclusion Criteria:

1. Allergy or intolerance to ω-3 PUFAs or cycloplegics;
2. Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;
3. Currently using myopia prevention measures.
Physician-assisted Dying in Mentally Ill Patients - Which Criteria Are Decisive?

Physician-assisted dying (PAD) is currently a highly controversial topic in medical ethics and public debates worldwide. It poses a moral conflict between the ethical principle of respect for patient autonomy and the ethical principle of beneficence in the sense of preserving life. Switzerland gives higher weight to the former principle: Article 115 of the Swiss Penal Code (StGB) permits PAD, provided it is not performed for "selfish reasons", and thus, occupies a special role in international comparison. However, the Swiss federal law does not regulate who exactly is entitled to access PAD, and there is no universal agreement in the concerned professional societies. Additional uncertainty arises when not the wish for PAD of a somatically ill person but that of a mentally ill person is to be assessed. It is therefore important for Switzerland - but also internationally - to regulate PAD for the mentally ill. On the one hand, mentally ill persons must not be discriminated in their desire for PAD compared to somatically ill persons while at the same time, their vulnerability must be taken into account. On the other hand, treating physicians must be protected in their ethical integrity and need security when they have to decide on PAD-requests. With the present study, we aim at contributing to the discussion of PAD in mentally ill patients and, with the help of an online/telephone survey, provide insights of the current situation in Switzerland within the general population and in the medical profession. This study addresses the following research questions: What is the attitude of the general population towards the current Swiss Academy of Medical Sciences (SAMS) ethical guidelines? What is the attitude of medical professionals? To what extent does the public discussion reflect the current situation in clinical practice? Does the stigmatization of the mentally ill have an influence on the assessment of their wish to die, and if so, where do prejudices need to be reduced? The study thus aims to expand the scientific literature on this highly relevant, currently controversial topic.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for participants from the general population are: (1) between 18 and 65 years old, and (2) sufficient knowledge of German, Italian, or French. Medical professionals are included if they are registered in one of the cantons Basel-Stadt, Basel-Landschaft, Aargau, Lucerne, Graubünden, Ticino or Vaud. Physicians from all specialties are to be surveyed to be able to draw a comparison between the different medical professionals.

Exclusion Criteria:

-
High Intensity Resistance Training In Postmenopausal Women (HIRT)

Menopause is defined as a permanent cessation of menstrual cycle for 12 months due to intrinsic diminution of ovarian oocytes among women in older age. Globally reported mean age for menopause is 48.78 years (ranges from 46-52 years). Menopausal age reported among Asian and African population was lower as compared to European women . Among postmenopausal women, age related various central nervous system, musculoskeletal, urogenital, metabolic and skin changes ensue along with osteoporosis (T-score = ≤ -2.5) and decreased bone mineral density due to estrogen deficiency that is directly associated with fragility fractures and disability among this age group. Therefore, recruitment of older adults in resistance training program is crucial in inducing increases in muscle strength and ameliorating glucose tolerance and increased insulin sensitivity along with improvements in BMD and BMR.

Physical activity is extremely crucial in maintaining quality of life and estrogen metabolism among postmenopausal women, owing to the increased risk of falls, age related decline in cardiopulmonary, musculoskeletal endurance and cognitive capacity. In Pakistan, fitness of women specifically of postmenopausal age group is ignored due to some cultural norms. Performance of physical activity in the form of resistance training (RT) is one of the best known methods to improve physical fitness in the elderly. So the current study is planned with objectives to determine effects of High Intensity Resistance Training in Postmenopausal Women. Supervised exercise training will be provided for 3 months and functional performance will be measured accordingly.

After initial screening of postmenopausal women including history and anthropometric details, females meeting inclusion criteria and willing to participate in high intensity resistance exercise trial will be recruited in the study. After that; physical fitness, performance base testing for functional performance outcome measures and MENQOL assessment will be done at baseline and after 3 months. Patients will perform resistance training twice a week, 40-50 min/session for 12 weeks respectively. It is hypothesized that supervised high intensity resistance training will improve functional performance, physical fitness and Quality of life among postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Age: 45-70 years
* Sedentary life style

Exclusion Criteria:

* High risk of fracture as calculated by WHO online FRAX tool.
* Presence/history of fragility fracture.
* MMSE \< 20
* Systemic illness: hyperthyroidism, hyperparathyroidism, renal failure, any malignancy, extensive radiation exposure.
* Any orthopedic injury/disorder hindering performance of exercise.
* Not willing for exercise.
Diode Laser Treatment of Onychomycosis

The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
* Fitzpatrick Skin Type I-IV
* Written and verbal informed consent
* Able to comply with study instructions and to return to the clinic for required visits
* Agrees to refrain from other active topical, laser or light-based treatment to the great toes
* Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis

Exclusion Criteria:

* Pregnancy, breastfeeding or planning to become pregnant
* History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
* Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
* Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
* Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
* Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
* Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
* Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
* Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
* Immunocompromised status, or with existing (or history of) cancer/skin malignancy
* Distal nail thickness of greater than 2mm in the affected great toenail
Acellular Dermal Matrix Investigation in Breast Reconstruction

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.


Eligibility Criteria:
Inclusion Criteria:

* Genetic female
* Age 22 or older at time of consent
* Undergoing immediate breast reconstruction
* 2 stage breast reconstruction using pre pectoral technique
* Nipple or skin sparing mastectomy
* Willing and capable of providing informed consent
* Able to comply with study requirements

Exclusion Criteria:

* Planned concurrent reconstruction with pedicled flaps or free tissue
* Pregnant or breast feeding
* Investigator has determined tissue is unsuitable for two-stage breast reconstruction
* History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
* Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
* Vulnerable subject populations
* Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
* Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
* Active abscess or infection in the intended reconstruction site
* Residual gross tumor at the intended reconstruction site
* Active use of any tobacco/nicotine products
* Has body mass index (BMI) \>35
* Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
* Is currently taking medications including systemic steroids
* Is scheduled to undergo post-operative radiation therapy
Krill Oil and Muscle in Older Adults

The aim of this study is to determine the effects of krill oil supplementation on muscle mass in function in older adults. Half of the participants will receive krill oil supplements and the other half a placebo.


Eligibility Criteria:
Inclusion Criteria:

* BMI less than 35kg/m2

Exclusion Criteria:

* Diabetes
* severe cardiovascular disease
* seizure disorders
* uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* cancer or cancer that has been in remission \<5 years
* ambulatory impairments which would limit ability to perform assessments of muscle function
* dementia
* taking medication known to affect muscle (e.g. steroids)
* have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump)
* on anticoagulant therapy
* allergies to seafood
* regular consumption of more than 2 portions of oily fish per week.
A Comprehensive Prospective Assessment of the Physical and Biological Effects of Upper Tract Urothelial Cancer (UTUC)

There are many controversies and limitations in the management of Upper Tract Urothelial cancer. A prospective registry is set up for patients in our hospital, aim to have a comprehensive prospective assessment of the physical and biological effects of Upper Tract Urothelial cancer in our patients

Although Upper Tract Urothelial Carcinoma (UTUC) is relatively uncommon, the incidence rate is increasing. There are many controversies and limitations in the management of Upper Tract Urothelial cancer.

In this study, investigators would like to establish a local registry for upper tract urothelial cancer to facilitate the collection of clinical information and outcomes of upper tract urothelial cancer management, and to collect blood, urine and tumour tissue samples to investigate for new diagnostic and therapeutic agents. Hopefully, our registry can provide information regarding the epidemiology, natural history, and treatment outcomes of upper tract urothelial cancer in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* Male patients \> 18 years old
* Patients who has presence of UTUC and pending for surgery
* Patients who has history of UTUC with any intervention performed

Exclusion Criteria:

- Patients fail to provide informed consent
Lower Extremity Dynamometry Assessment in Neurotypical Children

The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.


Eligibility Criteria:
Inclusion Criteria:

* typically developing children,
* between the ages of 5 and 16 years,
* have the capacity for voluntary motor control

Exclusion Criteria :

* undergone any treatment or intervention that could impact neuromuscular performance, such as surgery or medication use,
* experienced a recent injury
* demonstrating low levels of compliance during assessments are not included in the study.
Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY)

GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive.


Eligibility Criteria:
Inclusion Criteria:

1. Genetically-confirmed diagnosis of a sex chromosome aneuploidy condition
2. Any age
3. Any gender
4. Informed consent for individuals \>18 years of age, parent/guardian permission for individuals \<18 or proxy-consent from legally authorized representative if impaired decision making

Exclusion Criteria:

a. Lack of documentation of genetic testing confirming SCA diagnosis