cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project

The Wellness Incentives and Navigation (WIN) project is designed to help improve health self-management and reduce the incidence and consequences of chronic disease among non-elderly adult Medicaid Supplemental Security Income (SSI) beneficiaries. WIN targets SSI beneficiaries with behavioral health (mental health and substance abuse) diagnoses. Research demonstrates that these individuals are more likely to suffer chronic physical co-morbidities, experience debilitating chronic illnesses earlier in life and have elevated healthcare costs.

WIN uses person-centered wellness planning and navigation facilitated by trained, professional health Navigators, dedicated specifically to the WIN project, who use Motivational Interviewing (MI) techniques, and a personal wellness account. Participants with more serious mental illnesses will be offered additional support in the form of Wellness Recovery Action Planning (WRAP) to enable them to take full advantage of person-centered wellness planning.

The Texas based Wellness Incentives and Navigation (WIN) project uses a continuum of evidence-based "whole person" interventions that take into account clinical, environmental, and social risk factors and co-morbidities. Unlike more traditional didactic approaches to health management, WIN addresses individual behavioral, social, and economic barriers to health and wellness, and promotes continued engagement in achieving, internalizing, and maintaining healthy behaviors.

The study is focused on non-dual eligible adult STAR+PLUS (a Texas Medicaid managed care program for people with chronic illnesses) members (ages 21-55) with a behavioral health disorder including serious mental illness (SMI - e.g., schizophrenia, bipolar disorder or major depressive disorder) or other behavioral health conditions (e.g., anxiety disorder or substance abuse). Key features of the program include the use of professional health navigators, working in collaboration with the three STAR+PLUS plans in the Harris Service Area (SA) (United-Evercare, Amerigroup, and Molina), the use of motivational interviewing (MI) techniques to help members develop and meet personal wellness goals, and a flexible wellness account for the participant to use in meeting his/her goals.

Eligibility Criteria:
Inclusion Criteria:

* Be a resident of the Harris service area
* Be a non-dual eligible member of STAR+PLUS;
* Be 21 to 55 years of age; and
* Have an SMI Diagnosis (schizophrenia, bi-polar disorder, major depressive disorder); or
* Other behavioral health diagnoses (e.g., anxiety, depression, substance use disorder) coupled with a chronic health diagnosis (physical health condition).

Exclusion Criteria:

* Intellectual or cognitive diagnoses indicative of severe cognitive impairment. These could include diagnoses such as 290.X (dementia) and 318-319 (moderate to severe mental retardation).
Perceptual Learning Improve Visual Function in Patients With Keratoconus

This project aims at non-progressive keratoconus patients with unsatisfactory visual acuity corrected by spectacles, and explores the effectiveness and maintenance of visual acuity improved by perceptual learning.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 9 years or older;
2. Has been diagnosed as Keratoconus,BAD-D≥2.6;
3. Change of Kmax \< 1.0 D and change of BAD-D \<0.4175 betweem the last two Pentacam result;
4. The best corrected visual acuity of both eyes was between 0.1 and 1.0;
5. Has voluntarily agreed to participate in the study by signing the statement of informed consent.

Exclusion Criteria:

1. Has history of acute keratoconus;
2. Has other eye diseases or other diseases/conditions causing vision loss;
3. Has eye surgery history in the past 1year;
4. Is currently using local/systemic medications or other interventions that may affect visual function;
5. Receiving other treatments that may affect the results of this study, such as contact lenses during the study;
6. Has any known neurological diseases;
7. Participating in other studies currently that may affect the results of this study;
8. Study other reasons that the physician considers inappropriate for inclusion in the program.
Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders

The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome.

Anxiety disorders are common among children; if untreated, they can negatively affect children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but the causal mechanisms between therapy and beneficial outcomes have not been thoroughly investigated.

Audio and videotaped sessions of children currently receiving CBT and those who received CBT in previous trials will be examined. Various rating scales will be used to rate therapeutic alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate potential process variables that contribute to participant drop-out, this study will compare the early process variables for children who complete treatment and for those who discontinue treatment.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia
* At least one English-speaking parent

Exclusion criteria:

* IQ \< 80
* Psychotic symptoms
COVID-19 Quarantine on Musculoskeletal Status in Hemophilia

Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative and intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic, the Government of Spain, among others, established a total confinement for two months, in order to avoid contagion of the population Objective. To assess the effect of COVID-19 confinement on bleeding frequency, pain perception, and range of motion in patients with hemophilic arthropathy.

Study design. Prospective observational study. Method. 27 patients with hemophilia A and B will be included in this study. Patients will be recruited from the Spanish Hemophilia Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will be: the frequency of bleeding (through a self-report), the perception of pain (measured with the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint Health Score), and the range of joint movement (measured with a goniometer). Two evaluations will be carried out: pre-treatment (carried out in the month of February, as a periodic evaluation) and post-treatment (at the end of the period of confinement in Spain).

Expected results. The aim is to observe the sequelae caused by confinement and a sedentary lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Patients with medical diagnosis of hemophilia A or hemophilia B
* Patients over 18 years of age
* Patients in a prophylactic or on demand regimen with factor VIII / factor IX concentrates
* Patients that have accepted the informed consent document.

Exclusion Criteria:

* Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
* Patients without capacity to walk autonomously or with orthosis
* Patients without access to digital media to complement the measuring instruments.
Quality Assessment Creatinines in Plasma and Urine

In clinical practice the 24-hour creatinine clearance is often used to obtain an impression of renal function. However, the glomerular filtration rate is considered to be the best indicator of renal function. For practical and financial purposes, GFR is often estimated by means of serum creatinine based equations. These equations are also used in internation guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine measurements are important to make reliable estimates of renal function. However, previous research has revealed a large variability in creatinine measurements using different measuring methods. In this study the investigators aim to establish the degree of variability in different methods to measure creatinine in a heterogenous group of Caucasian people with and without renal function loss and the influence of this variability on renal function estimating equations and the 24-hour creatinine clearance.

Apart from the 24-hour creatinine clearance, also formulas to estimate the glomerular filtration rate (GFR) are increasingly used to get an impression from renal function in recent years. Based on these renal function measurements, clinical decisions are made as well as drug dose adjustments. The use of reliable serum creatinine measurements is therefore important to get accurate renal function estimates. However, serum creatinine is one of the most variable routine laboratory tests.

The importance of calibration to a traceable reference measurement of serum creatinine has been stressed. However, this standardization does not correct for analytical non-specificity problems, which occurs in certain techniques to measure creatinine, leading to under- or overestimation of the true creatinine concentration.

The aim of this cross-sectional observational study is to examine the degree of variability between diverse methods to measure creatinine in plasma and urine in a heterogenous group of Caucasian people with and without renal function loss and the influence hereof on the 24-hour creatinine clearance and the Modification of Diet in Renal Disease study equation and the consequences for chronic kidney disease staging.

Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years presenting at the laboratory facility for a 24-hour creatinine clearance, or
* Persons \>18 years, undergoing a renal replacing therapy by means of hemo-/peritoneal dialysis that had a KT/V appointment between May 2010 - January 2011

Exclusion Criteria:

* Patients \<18 years
Serotonin Levels in Atopic Dermatitis Patients

Atopic dermatitis (AD) is a chronic pruritic inflammatory skin disease of unknown aetiology. Global prevalence rates range from 1%-20%.AD is often worsened by stress and anxiety.Plasma levels of 5-HT were found to be positively correlated with the disease severity.

Atopic dermatitis (AD) is a chronic pruritic inflammatory skin disease of unknown aetiology. The condition typically starts in infancy with changing presentations over the years. Incessant pruritus is the main symptom.

Main findings include: xerosis, eczematous lesions, Ig E reactivity, relapsing course and personal or family history of other atopic diatheses .Global prevalence rates range from 1%-20%.

AD is often worsened by stress and anxiety. Moreover, a mutual relationship between the neuroendocrine system and the immune system; including the skin has been suggested. Different mediators are responsible for this relation. Serotonin is considered as one of the most important responsible mediators (5-hydroxy-tryptamine; 5-HT) .

Patients with AD have been reported to have high serum levels of 5-HT. Moreover, plasma levels of 5-HT were found to be positively correlated with the disease severity. However and to the best of the investigators' knowledge, no studies have addressed this point in Egypt.

Treatment of AD includes: Elimination of triggers, emollients, topical therapies, and systemic modalities including SSRIs (Selective Serotonin Reuptake Inhibitors) and TCAs (Tricyclic Antidepressants) in certain cases. SSRIs block the reuptake of serotonin, thus increase the concentration of serotonin within synaptic clefts. The mechanism of action in relation to pruritus is not understood, but SSRIs have been used to treat atopic dermatitis associated pruritus

Eligibility Criteria:
Inclusion Criteria:

* All patients with the clinical diagnosis of AD.
* Age more than 2

Exclusion Criteria:

* Age less than 2 years.
* Any concomitant systemic or dermatological disease.
* Patients on any topical or systemic treatment during the past one month.
* Uncooperative patients.
* Refusal to participate
Identifying Mechanisms of Resistance to mTOR Inhibitors in Cancer

mTOR kinase is part of the mTORC1 complex that promotes cap-dependent protein translation, and part of the mTORC2 complex that activates AKT. Everolimus (Afinitor) is an allosteric inhibitor of mTOR that suppresses mTORC1 activity. Everolimus is FDA-approved for the treatment of ER+/HER2- breast cancer (in combination with exemestane), renal cell carcinoma, subependymal giant cell astrocytoma (SEGA), and neuroendocrine tumors of pancreatic origin (PNET), and is currently being tested in ongoing clinical studies in other indications. While everolimus-based therapies elicit anti-cancer effects, most cancers ultimately progress and exhibit everolimus resistance. This study will evaluate genetic mechanisms of resistance to everolimus.


Eligibility Criteria:
Inclusion Criteria:

1. Treatment with everolimus (as a single-agent or in combination) for any malignancy for ≥3 months.
2. A- Patients who are scheduled to undergo a clinically indicated tumor biopsy (as standard of care, or as part of another study) within 5 years following cancer progression on everolimus are eligible.

   B- Patients who already had such a biopsy procedure performed are eligible. Tumors biopsied shortly after progression on everolimus are strongly preferred.
3. Excess tumor tissue from biopsy must be available for molecular analysis. This will include tumor tissue sufficient to make ≥5 five-micron sections; more tumor tissue is preferred.
4. Patients currently seen at Dartmouth-Hitchcock Medical Center must be capable and willing to provide informed written consent for study participation. Patients who are no longer seen at DHMC will not be consented for use of archived tissues and data.
5. For patients currently seen at Dartmouth-Hitchcock Medical Center, patients must be willing to provide an extra 10-20 mL of blood during a routine, clinically indicated blood draw procedure.

Exclusion Criteria:

none
Understanding Physiology During Float-REST and the Consequential Effects on Subjective and Objective Recovery

The objective of this research study is to assess how the implementation of various modern strategies for augmented recovery and physiological monitoring via wearable biotechnologies and subjective measurements affect sleep quality, and other indices of recovery from physical activity.

Flotation therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salts to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the subject to eliminate the gravitational effects on the body, and along with lack of sound and low to no light (depending on comfort) allows the brain and body to completely relax for augmented physical and mental recovery. To control for potential changes in sleep quality, quantity, and/or stress and anxiety, a control condition utilizing a Metronap nap station to ascertain the effects of standard, horizontal napping with partial sensory deprivation (no light and silence) compared with floating.

To assess whether or not flotation therapy positively influences sleep and perceptual recovery, participants will float for 60 minutes 2 times a week for 8 weeks, use the sleep pod for 60 minutes 2 times a week for 8 weeks, or take part in a cross-over study where the participant will alternate float and sleep pod every 2 weeks for 8 weeks. All participants may wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. In addition, daily, per session, monthly, and pre/post-study questionnaires will be submitted via a smartphone application.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older

Exclusion Criteria:

* Do not have any contagious skin infections or diseases
* Do not have a history of seizures
* Do not have a history of being prone to motion sickness
* An episode of loss of consciousness (last 6-months)
Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency

The long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. For this reason, in this study, it was aimed to investigate the long-term results of inspiratory muscle training in individuals with chronic venous insufficiency.

Initial treatment of chronic venous insufficiency (CVI) includes conservative methods such as reducing symptoms and helping to prevent secondary problems and disease progression. If conservative methods fail, further treatments based on anatomical and physiological pathophysiological features should be applied. Treatment of CVI ranges from simple compression stockings to very complicated venous reconstructions. Physiotherapy applications also have an important place in the treatment of CVI and contain patient education, complex decongestive physiotherapy, intermittent pneumatic compression, compression garment, venous exercise programs, biomechanical stimulation therapy, proprioceptive neuromuscular facilitation, relaxation techniques and hydrotherapy methods.

Researches investigating the effectiveness of new physiotherapy applications in CVI are very limited. In one of these publications, the effects of inspiratory muscle training (IMT) and calf muscle exercise training (CMET) applied in addition to compression therapy (CT) on quality of life (QoL), venous filling time, disease severity, pain, edema, range of motion, muscle strength and functionality were investigated newly. IMT and CT were applied in group 1, CMET and CT were applied in group 2, and only CT was applied in group 3. As a result, groups of 1 and 2 showed more improvement in these outcomes compared to other groups. Acute effects of inspiratory muscle training in CVI was only shown in this study. The long-term effectiveness of inspiratory muscle training is still unclear in individuals with CVI. Therefore, this study aimed to investigate the long-term results of inspiratory muscle training in individuals with CVI.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Volunteering to participate in the study
* Diagnosed with chronic venous insufficiency using duplex ultrasound and being under standard medical treatment follow-up
* Being in one of the C1, C2, C3, C4 or C5 stages according to the Clinical, Etiology, Anatomy and Pathophysiology (CEAP) classification

Exclusion Criteria:

* Acute deep vein thrombosis, active ulcers, psychiatric disorder requiring prior vessel ablation and/or prescription drug therapy,
* Any history of chronic disease or deep vein thrombosis that may interfere with exercise capacity measurement,
* Having SARS-CoV-2 (COVID-19) or any acute infection,
* Being pregnant,
* History of arterial disease,
* Having advanced cardiorespiratory diseases, acute ulcer (\< 3 months) and diabetic ulcers.
A Study of rhGAA in Patients With Late-Onset Pompe Disease

Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective is to evaluate the safety, pharmacokinetics (PK) and efficacy of Myozyme treatment.


Eligibility Criteria:
Inclusion Criteria:

* patient's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related procedures; patient's signature required if patient understands informed consent
* patient must have a diagnosis of Pompe disease based on deficient endogenous GAA activity or GAA gene mutations
* patient must have demonstrable muscle weakness
* patient must be greater than or equal to five years of age and younger than eighteen years of age
* patient must be able to provide 3 reproducible FVC tests in sitting position during screening
* patient must perform muscle function testing
* patient must ambulate 10 meters (assistive devices permitted)
* patient and legal guardian must comply with the clinical protocol

Exclusion Criteria:

* patient requires the use of invasive ventilatory support
* patient requires the use of noninvasive ventilatory support while awake and in an upright position
* patient has received enzyme replacement therapy with GAA from any source
* patient has used an investigational product within 30 days prior to study enrollment, or is currently enrolled in another clinical or observational study
* patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities
* Female patients pregnant, lactating or unwilling to practice birth control methods during study
* Male patients unwilling to use barrier contraceptives during study
Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients

A reasonable and simple algorithm was used to guide the dry weight determination with Body Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (MHD) patients.

298 MHD patients in 6 hemodialysis centers in Taiwan were enrolled in this randomized controlled study. All the participants were randomized into study group ( dry weight (DW) determined by BCM-BIS) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. Body composition monitor based on bioimpedance spectroscopy (BCM-BIS) was performed monthly and concomitant biochemical data and clinical outcomes were collected. Intra-dialysis complications were recorded in every dialysis session. Primary outcome was all-cause hospitalization. Secondary outcomes included 1) complications during DW adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (AFO) or cardiovascular (CV)-related events. The clinical feasibility of the BCM-BIS algorithm was also inspected. Statistical methods: a software (SAS) 9.3 was used for statistical analysis in this study. R 3.0 was used for graphic presentation of parts of the results. Relative risk, incidence rate ratio and Fisher's exact test were used to compare the discrete outcomes in both groups. Survival analysis was used for time-related events. Repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (GLMM) through the procedure for continuous variables (PROC MIXED) and for discrete variables (PROC GLIMMIX) in SAS.

Eligibility Criteria:
Inclusion Criteria:

MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months

Exclusion Criteria:

1. coronary stents or pacemaker implantation
2. metallic devices in body, such as artificial joints or pins
3. contralateral or bilateral amputations
4. pregnancy