cyrilzakka/clinical-trials huggingface dataset:
Effects of Taping on the Proprioceptive System

Kinesiotape (KT) is a widely used technique, although the scientific evidence on its effectiveness is limited and conflicting. KT has not yet been scientifically proven to have an effect on proprioception and a possible placebo effect of this technique cannot be ruled out. The main objective of this experimental study is to evaluate the effect of the application of KT in the anterior side of the forearm on the force sense and the positional sense compared to a placebo intervention in healthy subjects. A randomized, single-blind, crossover clinical trial will be carried out, where each subject will undergo three situations in their dominant forearm: no intervention, intervention using sham tape and intervention using KT. In the present design, in a randomized manner, all subjects go through the 3 conditions on different days: KT, sham tape, and no intervention. Measurements will be made before and after the intervention and proprioception will be measured using the variables of sense of force (with a dynamometer) and joint position (with a goniometer). The main intervention will be the application of a KT strip on the anterior face of the forearm and a sham tape of another material following the same procedure. The study population will be made up of healthy students from the university community of the Faculty of Physiotherapy of the University of Vigo.

The main objective of this experimental study is to evaluate the effect of the application of kinesiotape (KT) in the anterior side of the forearm on the force sense and the joint positional sense of the wrist compared to a placebo/sham intervention in healthy subjects.

Study hypothesis: the application of KT on the anterior side of the forearm produces better results in the force sense evaluated by a grip dynamometry and on the joint position sense of the wrist compared to a sham intervention or not intervention.


Eligibility Criteria:
Inclusion Criteria:

* The participants will be members of the University of Vigo who participate voluntarily in the study.
* Participants must be healthy subjects (men and women) of legal age (\>18 years).
* All subjects must sign the informed consent prior to experimentation.

Exclusion Criteria:

* Suffering from dermal disorders, fragile skin or allergy to adhesive tape.
* Excessive skin hair in the region to apply the tape.
* Have received a bandage on the upper limb (MMSS) in two weeks prior to the experimentation.
* History of orthopedic / traumatic alterations in upper limb (deformities, arthropathy, muscular injuries, fracture or tendinopathy), neurological disorders (central or peripheral), systemic disorders, circulatory disorders (edema, heart failure, thrombosis, kidney failure), hormonal disorders or surgery in upper limb in the last 6 months.
* Have done strength training in the MMSS in the 48 hours prior to the study.
* Limitation in the range of motion of the MMSS that may affect the grip strength.
* Consumption of alcoholic beverages or medications 24 hours prior to the experimentation.
The Effect of Cycling, Running, and Playing Rugby on Three Biomarkers That May Indicate Brain Injury

The goal of this clinical trial was to determine if and how the biomarkers neurofilament light (NfL), brain lipid binding protein (BLBP), and amyloid precursor protein (APP) accumulated over 72 hours in venous blood following running, cycling, or playing rugby as compared to a non-exercising control group. Participants in this study were recreationally active and healthy males and females 18 - 49 years of age. The main questions it aimed to answer was:

Do NfL, BLBP, and APP increase following exercise? Researchers compared the accumulation of NfL, BLBP, and NfL among runners, cyclists, rugby players, controls, and between sexes in each category.

Participants were asked to either run, bike, play a rugby match, or abstain from exercise. In the exercising group, blood was drawn from a vein prior to the activity, immediately after the activity, 30 minutes after the activity, 1 hour after the activity, 24 hours after the activity, 48 hours after the activity, and 72 hours after the activity. In the non-exercising group blood was drawn from a vein one time.

Participants were recruited for this study from fall 2021 - spring 2022. Participants recruited to play in a rugby match were current members of the university men's and women's club rugby team. Running participants consisted of members of the university's men's and women's running teams as well as recreational runners. Cycling participants consisted of members of the university's cycling club as well as recreational cyclists. Male rugby athletes played two 40-minute halves while female rugby athletes played two 20-minute halves. These are typical match times for men's and women's rugby. Runners were asked to run 6.44 kilometers at their own pace, and cyclists were asked to cycle 39 kilometers at their own pace. A control group comprised of both sedentary and recreationally active individuals was also recruited and asked to refrain from exercise for 24 hours.

Blood was drawn from an antecubital vein in the exercising groups before and after exercise as well as 30 minutes, 1-, 24-, 48-, and 72-hours after exercise. Only one blood draw was taken in the control group.

The blood biomarkers neurofilament light (NfL), brain lipid binding protein (BLBP), and amyloid precursor protein were then measured in the venous blood and compared within groups, among groups, and between sexes.

Eligibility Criteria:
Inclusion Criteria:

* Apparently Healthy
* Those in the running group must be able to run 6.44 kilometers
* Those in the cycling group must be able to cycle 39 kilometers
* Those in the ruby group must be members of the university club rugby team

Exclusion Criteria:

* Individuals with diabetes
* Individuals with heart disease
* Individuals who are pregnant
* Individuals who get light-headed or dizzy while donating blood
Patient Acceptance of Whole Body Magnetic Resonance Angiography

Investigation of how the patients experience whole body MRA. After the WB-MRA the patients will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the patient felt during the examination.

We expect that the patients will report a high degree of satisfaction with the WB-MRA procedure, with little discomfort.

WB-MRA is performed in patients referred for conventional x-ray based angiography. The WB-MRA is performed first in all patients.

After both examinations are completed the patients will be asked to fill in a questionnaire containing questions about their experience of the 2 procedures.

We will then compare the results for the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease
Medication Adherence Program

Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) \>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.


Eligibility Criteria:
Inclusion Criteria:

* fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
* continuously enrolled in BCBSLA for one year
* planning to remain a member of BCBSLA for next year
* English-speaking
* telephone access
* aged ≥40 years
* diagnosis of essential hypertension (ICD-10-CM code I10)
* currently filling antihypertensive medication
* low antihypertensive medication refill (proportion of days covered (PDC) \<0.8)
* low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)
* uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)
* desire to improve BP

Exclusion Criteria:

* living in a household with someone already enrolled in the study
* enrollment in another clinical trial for drug adherence or BP control
* moderate to severe cognitive impairment
A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
2. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
3. ECOG: 0-1;
4. Adequate organ and bone marrow function;
5. sign an informed consent.

Exclusion Criteria:

1. Patients with brain malignant tumor or active CNS metastasis;
2. UGT1A1\*28 homozygous mutants;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Dietary Approaches for Cardiometabolic Health

This pilot study aims to recruit 30 adults with abdominal obesity, without major chronic disease, and test whether clinical dietary advice that is solely focused on the timing of eating (time restricted eating), has an effect on cardiometabolic health compared to standard dietary advice for cardiometabolic health, which is focused on content. The goal of this pilot study is to develop and hone dietary counseling approaches for time restricted eating for RD's in a clinical practice paradigm, and collect data on testing this intervention compared to standard dietary counseling approaches for cardiometabolic health.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal obesity (waist circumference ≥35" for women and ≥40" for men; if Asian ethnicity, ≥35" for men and ≥31.5" for women)
* weight stable over the previous 2 months
* medications stable for \> 3 months
* self-reported 24-hr sleep-wake patterns within the appropriate range as defined by the National Sleep Foundation (self-reported habitual sleep duration 6-10 hours during nocturnal hours)
* regular meal patterns
* from the greater UCI and Orange county area
* willing to incorporate a dietary approach aimed at improving cardiometabolic health and weight management
* able to speak, read and understand English or Spanish

Exclusion Criteria:

* Self-reported unstable hypertension
* Type 1 or 2 diabetes mellitus
* heart, renal, or liver disease
* cancer or active neoplasms
* hyperthyroidism unless treated and under control
* taking any medications known to affect clinical risk measures of interest or weight/energy expenditure (except for stable blood pressure medication)
* active usual smoking (tobacco or marijuana)
* alcohol intake \> 3 drinks/day
* pregnancy, current lactation, or plans to become pregnant during the study
StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat.

The burns will:

* be on 3-49% of the participant's total body surface area (TBSA)
* require surgery for skin replacement
* include intact dermal elements

The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged.

The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin.

All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one.

This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.


Eligibility Criteria:
Inclusion Criteria

Subject-specific criteria:

1. Men and women aged ≥ 18 years
2. Written informed consent
3. Sufficient healthy skin identified and reserved as a donor site in the event that the StrataGraft treatment site requires autografting
4. Clinical expectation that the study donor site will heal without grafting
5. Complex skin defects of 3-49% TBSA

   * Total burn may consist of more than one area

   Treatment site-specific criteria:
6. Thermal burn(s) with intact dermal elements for which excision and autografting are clinically indicated
7. Total of both study treatment areas can be up to 2000 cm2
8. First excision and grafting of study treatment sites
9. Thermal burn(s) on the torso, arms, or legs

Exclusion Criteria

Subject-specific criteria:

1. Pregnant women
2. Prisoners
3. Subjects receiving systemic immunosuppressive therapy
4. Subjects with a known history of malignancy
5. Preadmission insulin-dependent diabetic subjects
6. Subjects with concurrent conditions that in the opinion of the investigator may compromise subject safety or study objectives
7. Expected survival of less than three months
8. Participation in the treatment group of an interventional study within 90 days prior to enrollment

   Treatment site-specific criteria:
9. Full-thickness burns
10. Chronic wounds
11. The face, head, neck, hands, feet, buttocks, and area over joints
12. Treatment sites immediately adjacent to unexcised eschar
13. Clinical or laboratory determination of infection at the anticipated treatment sites
Evaluation of the Distortion Correction Data Collection (DCDC) App Software

The purpose of the research study is to evaluate how well the Distortion Correction Data Collection (DCDC) App works. The DCDC App is an experimental software application that is being developed at the University of Nebraska Omaha. The DCDC app will map and draw the visual distortions of patients with Age-related Macular degeneration.

This research study is a phase 1 clinical trial to evaluate the efficacy of the Distortion Correction Data Collection (DCDC) App on a computer tablet system. There are two objectives in this study. The primary objective is to evaluate the functionality of the visual distortion app on the tablet computer. Patients will draw their distortions on the tablet screen, and the app will record and correct the distortions.The second objective is to create a distortion data repository (DDR) that contains retinal maps, data pertaining to the anatomical and functional aspects of patients retinas and the distortions. This DDR will be used to correlate retinal health to distortions.The correlation will be key in improving the correction software of the app. Long term, the app will be used to create a diagnostic tool and improve image processing in retinal prosthesis systems.

Participating subjects must be at least 55 years of age or older with age-related macular degeneration (AMD). After consent, a chart review will be performed. At the baseline visit, subjects will have an electroretinogram (ERG). At the single study visit, to be scheduled within 2 weeks of the baseline visit, subjects will use the DCDC app on a tablet computer to trace their visual distortions on an Amsler grid. Up to 5 subjects who meet the inclusion/exclusion criteria will be enrolled. The duration of the study is a 2 hour baseline visit and a 1 hour study visit, all within 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or greater
* Diagnosed with age-related macular degeneration (AMD).
* Best corrected visual acuity (BCVA) of (20/40 to 20/200 Snellen equivalent).
* Visual distortion is present in at least one eye, as determined by Amsler grid evaluation.
* Have had the following imaging tests completed within the past three months as part of standard of care: optical coherence tomography (OCT), scanning laser ophthalmoscopy (SLO), and Fluorescein angiography (FA).
* Capable of understanding the requirements of the study, willing to follow study instructions, able to provide written informed consent to participate, and willing to comply with all study requirements.
* Women who are post-menopausal or not otherwise of child-bearing potential -

Exclusion Criteria:

* Visual field loss from diseases other than AMD.
* Visual distortions from the following conditions other than AMD: epiretinal membrane, diabetic macular edema, central retinal vein occlusion (CRVO) with edema, and cystoid macular edema.
* A medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease ability to follow study instructions.
Feasibility Study on the Use of Mindfulness-based Intervention for Family Carers of People With Dementia

The aim of this study is to examine which mindfulness-based intervention protocol, MBCT or MBSR, is more suited for use among local carers of people with dementia (PWD), as measured by better mental health outcomes in PWD such as reductions in stress and improvements in mental well-being.

60 subjects will be recruited in the community and randomized into either the MBCT or MBSR group. Both MBSR and MBCT will be delivered through a face-to-face teaching session followed by regular telephone follow-ups.

The primary outcome measures of the dementia caregivers will be stress with Perceived Stress Scale (PSS; Cohen \& Williamson, 1988). The secondary outcome measures of the dementia caregiver will be 1) anxiety with Hospital Anxiety and Depression Scale (HADS; Zigmon \& Snaith, 1983), 2) depression with Center for Epidemiologic Studies Depression Scale (CESD; Radloff, 1977), and 3) burden with Zarit Burden Inventory (ZBI; Zarit, Reever, \& Bach-Peterson, 1980). The control measure will be their level of mastery of the five facets mindfulness with Five Facets Mindfulness Questionnaire (FFMQ; Baer, Smith, Hopkins, Krietemeyer, \& Toney, 2006). Focus group interviews with each group of participants will be conducted post-intervention to explore their experiences and perceptions.

Data will be collected at baseline (T0), at 2 months (the mid-point of the intervention; T1), 4 months (immediately after the intervention; T2), and 7 months (the follow-up assessment; T3). Adherence rates, response rates, and drop-out rates will be collected and analyzed. The triangulation of both qualitative and quantitative data will be performed to determine the suitability and benefits of MBSR and MBCT for carers of PWD in the local setting.

Eligibility Criteria:
one participant (family carer) for each PWD (dementia of any type) living in the community

Inclusion Criteria for the family carer:

* is the primary carer
* of an adult with a confirmed diagnosis of dementia.

Exclusion Criteria:

* has a major active psychiatric illness such as bipolar disorder or schizophrenia.
* is currently undergoing cancer treatment.
* has severe chronic pain (lasting more than six months).
Pre-Eclampsia Prediction By Doppler Screening Of Uterine Arteries And Angiogenic Factors In Second Trimester Of Pregnancy

BACKGROUND: Pre-eclampsia complicates about 2% of pregnancies. It accounts for at least 50 000 maternal deaths per year worldwide and is the second most common cause of maternal death in the developing world. Also, Pre-eclampsia is the commonest cause of iatrogenic prematurity, It frequently coexists with intrauterine growth restriction (IUGR) and placental abruption, other important causes of adverse prenatal outcome.

There have been many studies investigating whether the disease can be prevented. In order to achieve this, one needs to be able to identify firstly those women that are at highest risk of the disease.

Early studies showed that impedance to flow in the uterine arteries decreases with gestation in normal pregnancies, while in pregnancies with established pre-eclampsia or IUGR the impedance is increased.

These observations led to a number of screening studies in the second trimester, which assessed if it is possible to predict those pregnancies destined to have complications of impaired placentation. These studies showed that women with increased impedance to uterine artery blood flow have an increased risk of developing pre-eclampsia, and detection can be further increased by using angiogenic factors (That are involved in the pathogenesis of Pre- eclampsia and could be useful for early prediction of the disease: VEGF, PIGF, PP13, sFLT1) in combination with uterine arteries Doppler study in the second trimester.

METHODS: In this study we would like to add uterine arteries Doppler to the early routine detailed ultrasound examination (14-16 weeks), in 3000 women in Jerusalem. in addition we would like to check angiogenic factors from the serum blood taken for the routine triple test in these women (16-18 weeks).pregnancy outcome would be collected after labour from the medical centers participating in this research.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women in second trimester that took the routine triple test, and are having an early routine detailed ultrasound examination, in Jerusalem, Israel

Exclusion Criteria:

* none
Prospective Study of Undiagnosed Celiac Disease

Direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of GI symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. However, the precise benefit is unknown and the motivation for this proposed study. If these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease.


Eligibility Criteria:
Inclusion Criteria:

* At least 60 years old
* Male and female

Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study