cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Respiratory Muscle Strenght, Peripheral Muscle Blood Flow and Gait Speed in the Elderly

The pourpose of this study is to verify if have relationship between respiratory muscle strenght, peripheral muscle blood flow and gait speed in the elderly.

The hypothesis of this study is that elderly with inspiratory muscle weakness will present lower peripheral blood flow and consequently lower walking speed. The main aim of the study is to verify if the peripheral muscular blood flow in the elderly is different between patients with and without decrease in inspiratory muscle strength. As secondary objectives, it will be evaluated the correlation between inspiratory muscle strength and gait speed and quality of life, as well as gait speed and peripheral muscle blood flow. Fifty elderly patients of both sexes, over 65 years, from Vila Mariana Einstein Outpatient Clinic and Cora Residencial Senior, will be included to evaluate Maximum Inspiratory Pressure (Pimáx), Maximum Expiratory Pressure (Pemáx), Spirometry (FVC, PF, FEV1), 4.6m Walk Test, Quality of life for the elderly (WHOQOL old), Mini Mental Test, Body Mass Index (BMI) and peripheral muscle blood flow by venous occlusion plethysmography.

Eligibility Criteria:
Inclusion Criteria: Elderly of both sexes, over 65 years old

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Exclusion Criteria:

* Mini Mental Test \<24
* Morse ≥ 51
* Clinical instability, according to medical assessment • Structural heart disease, with ejection fraction \<50% and chronic lung diseases with FEV1 \<50% predicted,
* Neurological, orthopedic, or neuromuscular diseases that prevent the performance of evaluations
* Smokers or ex-smokers \<5 years
Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir

The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.

The study is divide into two parts. In Part A the safety and tolerability of romidepsin will be evaluated and the effect of romidepsin treatment on HIV-1 transcription in HIV-infected patients virologically suppressed on cART will be determined.

In Part B the effect of treatment with Vacc-4x + rhuGM-CSF and romidepsin treatment on the HIV-1 latent reservoir in HIV-infected patients virologically suppressed on cART will be measured.

Six patients will be enrolled for part A and the safety and tolerability profile evaluated before enrolling 20 patients in B.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Currently receiving cART and having received cART for a minimum of 1 year
3. HIV-1 plasma RNA \<50 copies/mL for at least 1 year (excluding viral load blips)
4. CD4 T cell count ≥500 cells/mm3

Exclusion Criteria:

1. CD4 T cell count nadir \<200 cells/mm3
2. Previous treatment with an HDACi (Histone deacetylase inhibitor) within the previous 6 months
3. Any evidence of an active AIDS-defining opportunistic infection, active HBV or HCV co-infection, significant cardiac disease, malignancy, transplantation, insulin dependent diabetes mellitus or other protocol defined excluded medical condition
4. Use of any protocol defined contraindicated medication or vaccination
5. Unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol.
6. Males or females who are unwilling or unable to use protocol defined methods of contraception
Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers?

For leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. But for NMs with upwards of 100 direct reports, this can make for a never-ending stream of contact points. This study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout.

The study will be conducted over a six-month period using a quasi-experimental Pre-test/Post-test design using Stamm's (2009) ProQOL Scale. This study is being done as a pilot study with a small sample size. NMs will be recruited as volunteers for participation in the study with an anticipated six-month time commitment. Upon receipt of informed consent, participants will be divided into two groups. Group 1 will receive a list of suggested tools used to decrease the amount of smartphone interruptions after business hours (Appendix B) and Group 2 will receive a work-issued smartphone with instructions for use (Appendix C). Both groups will use a pre-post test format designed to compare the outcomes between the two groups. Post-study analysis will compare pre- and post-tests within each group and will compare Group 1 and Group 2 post-intervention outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participant must hold the title of Nurse Manager or Interim Nurse Manager at Methodist Mansfield Medical Center
* Participant must have greater than 50 direct reports

Exclusion Criteria:

* Participant expects to separate employment with Methodist Health System prior to the conclusion of the study
* Participant does not use their personal smartphone to communicate with direct reports
Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments

Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis patients.

In this study non-IgE-reactive recombinant Bet v 1 (rBet v 1) fragments (F1: aa 1-74; F2: aa 75-160) and the fully IgE-reactive recombinant Bet v 1 (aa 1-160)will be used for skin prick testing and atopy patch testing in birch pollen allergic patients with birch pollen induced exacerbation of atopic dermatitis. For control purposes birch pollen allergic patients without birch pollen-induced atopic eczema, persons with allergies other than to birch and non-allergic people will be tested.

The individuals will be subjected to in vivo skin prick and atopy patch testing with rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2 and an equimolar mix of the rBet v 1 fragments. In parallel, the IgE reactivity, and in vitro T cell proliferation, and cytokine production will be studied. Those analyses should help to determine the relevance of IgE mediated mechanisms to chronic skin inflammation and T cell proliferation in AD patients.

A staining for the surface markers chemokine receptor (CCR4)+ and cutaneous lymphocyte antigen (CLA)+ which reportedly are enriched in inflamed skin will further allow to investigate whether patients with high numbers of T lymphocytes expressing CCR4 and CLA tend to exhibit stronger skin inflammation. Moreover, allergen-specific antibody and T cell responses will be analyzed 6-8 weeks after the epicutaneous allergen application.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years
2. They will be available to complete the study

Exclusion Criteria:

1. Severe general maladies
2. Severe skin inflammation in the test area
3. Risk of non-controllable general reaction
4. Pregnancy and breast-feeding
5. Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
6. Contra-indication for adrenaline
7. Patients under long-term treatment with systemic corticosteroids immunosuppressive drugs, tranquilizers or psychoactive drugs
8. Positive IgE reaction on hypoallergenic Bet v 1 derivatives
9. The subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug.
10. The subject is at risk of non-compliance with the study procedures/restrictions
Prediction of STN DBS Motor Response in PD

Despite careful patient selection for subthalamic nucleus deep brain stimulation (STN DBS), some Parkinson's disease (PD) patients show limited improvement of motor disability. Non-conclusive results and the lack of a practical implantable prediction algorithm from previous prediction studies maintain the need for a simple tool for neurologists that provides a reliable prediction on postoperative motor improvement for individual patients.

In this study, a prior developed prediction model for motor response after STN DBS in PD patients is validated. The model generates individual probabilities for becoming a weak responder one year after surgery. The model will be validated in a validation cohort collected from several international centers.

The predictive model is made public accessible before data collection on: https://github.com/jgvhabets/DBSPREDICT

Predicting motor outcome after STN DBS in Parkinson Disease can be challenging for the clinician. Current prediction studies report non-conclusive results on the most important predictors and are limited by used computational methods. Traditional statistical analyses which focus on correlations are biased by predictor- and confounder-selection by the investigators. Modern computational methods like machine learning prediction models are less limited by sample size and can consider a wider range of predictors which leads to less selection-bias.

Retrospective patient data is collected from multiple international centers. This retrospective, multicenter cohort is used to validate the model which is developed based on a single-center retrospective cohort.

The goal is to develop a prediction tool that provides the clinician with a probability for weak response during the preoperative phase. This could support the clinician in including or informing the patient during preoperative counseling.

The predictive model is made public accessible before data collection on: https://github.com/jgvhabets/DBSPREDICT.

Eligibility Criteria:
Inclusion Criteria:

* underwent STN DBS for Parkinson's disease
* completed one year follow up after surgery

Exclusion Criteria:

- missing data in postoperative UPDRS II, III, IV
Enhancing the Effectiveness of Home-delivery Based Produce Prescription Program Implementation Strategies

Harris Health System is currently participating, along with two other partners, GoldiFresh Inc., and Brighter Bites, in a cross-sector collaborative home delivery-based Produce Prescription Program (PPRx) pilot initiative that provides consistent access to healthy food plus nutrition education to Medicaid-eligible pregnant women in Harris County, TX, deemed to be at high risk of adverse pregnancy or birth outcomes. The objectives of this study are two-fold: (a) to examine utilization of food basket contents and improvements in diet quality in this home delivery based PPRx program, and (b) to evaluate if and the extent to which utilization of food basket contents outcomes improves with support from an interactive AI-based conversational agent to convert food into healthy meals.


Eligibility Criteria:
Inclusion Criteria:

* receiving prenatal care at high-risk obstetric clinics
* \<= 20 weeks medically-confirmed viable pregnancy
* designated as high risk \[Age\>=35 years, or obese or overweight (BMI\>=25.0 at pre pregnancy self-report), or prior history of pregnancy hypertension or gestational diabetes\]
* within the zip code delivery radius

Exclusion Criteria:

* women who were medically recommended bed rest through pregnancy
* substance users
Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method

The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T


Eligibility Criteria:
Inclusion Criteria:

* Gender: male and female
* Age: 35-85 years include
* Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery
* Absence in history of neurological or psychiatric disorders.
* Signature of the Informed Consent and consent to collaborate in all the procedures of the study

Exclusion Criteria:

* Presence of severe neurological / psychiatric pathologies
* to sign the Informed Consense
* of serious cardiological pathologies that can compromise patient safety
* of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments
* of active tumors in the treatment area
Effects of Almonds on Cardiovascular Risk Factors

The purpose of this research is to build the evidence base for approval of FDA health claims related to almonds and cardiovascular disease. A randomized, 2-period, crossover controlled feeding study was designed to compare the effects of two blood cholesterol lowering diets that meet the American Heart Association recommendations. The nutrient profiles of the control diet (no almonds/day) and almond diet (1.5 oz. of almonds/day) are matched for protein, saturated fat, and cholesterol. The study population consists of two cohorts of 25 men and women with moderately elevated LDL-C. The investigators hypothesize that a cholesterol-lowering diet designed with almonds confers greater cardioprotective effects than a cholesterol-lowering diet without almonds on the basis of the LDL-C lowering response, effect on LDL particle size, abdominal adiposity and vascular health.


Eligibility Criteria:
Inclusion Criteria:

* BMI (20-35)
* Low density lipoprotein cholesterol males (128-194mg/dL) and females (121-190 mg/dL)

Exclusion Criteria:

* Pregnant, planning to become pregnant, or lactating
* Smoking; cholesterol-lowering medication
* Glucose-lowering medication
* Over the counter cholesterol-lowering substances (e.g.: psyllium, fish oil, soy lecithin, phytoestrogen)
* The following medical conditions:

  * heart disease
  * stroke
  * Heart attack
  * blood pressure \>140/90
  * diabetes
  * renal or kidney disease
  * rheumatoid arthritis
  * blood clotting disorder
  * liver disease or cirrhosis
  * compromised immune system
  * peripheral vascular disease or circulation problems

    \*\> 10% body weight loss in the past 6 months
  * vegetarian
  * nut allergies
Efficacy Study of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism.

The aim of the present study was to examine the influence of memantine, a noncompetitive NMDA receptor blocker, in depression co-morbid with long term alcohol heavy use comparing to SSRI-inhibitor, escitalopram. Second goal is to compare their influence to cognitive tasks and the third goal is to follow up alcohol-use with these two medicines.

Context Depression is common clinical problem among alcoholics and its treatment has no standard and is controversy. Glutamate NMDA-receptors may mediate the effects of long term alcohol related depression and thus the NMDA-receptor modulator memantine could have effects on it.

Objectives The preliminary aim of this study was to identify possible new treatment for depression of alcoholics and compare the efficacy of escitalopram and memantine in co-morbid depression of alcoholism.

Design and setting Double-blind, randomized, naturalistic study, 26-week trial on alcohol dependent outpatients.

Participants Eighty alcohol dependent depressive adults

Intervention Subjects were randomized 1:1 to receive memantine or escitalopram 20 mg per day. During the study the patient received routine psychosocial treatment at A-Clinic. No concomitant intervention on alcohol consumption and no imposed treatment goals. The patients were met weekly in first month, then after 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. The subject/patient is able to read and understand the subject/patient information sheet.
2. Prior to any screening procedures, the subject/patient must have signed the informed consent form. No study-related procedures may be performed before the subject/patient has signed the form.
3. Age 25-70 years
4. Heavy alcohol consumption (males more than 5 doses/ day, female more than 4 doses/day) for at least 10 years
5. Alcohol dependence (DSM-IV) assessed by SCID-I interview.
6. Major depression (DSM-IV) assessed by SCID-I interview. At least 4 weeks past from the previous inpatient treatment for AWS (alcohol withdrawal syndrome).

Exclusion Criteria:

1. Other drug dependence (screened by urine test)
2. Other serious mental illness (DSM-IV)
3. Hazard of suicide
4. Pregnancy
5. Serious kidney, hart or thyroid problem
6. The subject/patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
7. Liver cirrhosis or liver enzymes ASAT tai ALAT \>200.
8. The person that met the criteria stated in the Finnish Law on Clinical Studies, paragraph 7-10§ (children, pregnant, imamates or mentally handicapped).
Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease

RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age ≥65) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age ≥65) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥65
2. Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks.
3. Capable of self-consent.
4. Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).

Exclusion Criteria:

1. Non-ambulatory.
2. Moderate or severe cognitive impairment.
3. Unable/unwilling to consent.
4. PCI-related groin hematoma that precludes brisk walking.
5. Incarcerated.
6. Unable to use mHealth software in English or Spanish.
7. Severe osteoarthritis, or joint replacement within last 3 months.
8. Parkinson's disease or other progressive movement disorder.
9. Regular use of walker for ambulation.
10. Projected life expectancy \<3 months.
11. Clinical judgment concerning other safety or nonadherence issues.
12. Participants admitted from long-term care facility.
13. Currently listed for heart transplant.
14. Left ventricular assist device recipient.
15. Completion of ambulatory cardiac rehabilitation program within prior 3 months.
Can Applying the Science of Habit Formation to Contemplative Practice Improve Outcomes

In the present study, the investigators will conduct a confirmatory efficacy trial to test whether improving practice automaticity (i.e., habit formation) of self-compassionate touch improves outcomes in the predicted direction. Adults (n=440, including 20% for attrition) will be randomly assigned to: (1) the self-compassionate touch intervention plus habit formation tools ("SCT+HABITS") versus (2) the self-compassionate touch intervention alone ("SCT"). The investigators will conduct assessments at baseline, 3-month follow-up, and 6-month follow-up. The SCT+HABITS condition will be used to evaluate whether providing habit formation tools results in superior effects to SCT. The intervention will be delivered entirely online.

Specific Aim 1: Evaluate whether SCT+HABITS shows more practice frequency and practice automaticity from baseline to 3-month, and to 6-month follow-up compared to the SCT. Hypothesis 1. The SCT+HABITS group will show greater increases in practice frequency and practice automaticity than SCT from baseline to 3-month, and to 6-month follow-up.

Specific Aim 2: Determine whether SCT+HABITS, relative to SCT, will experience increased self-compassion and self-compassion automaticity, and reduced stress and psychopathology. Hypothesis 2. SCT+HABITS will promote greater increases in self-compassion and self-compassion automaticity, and greater reductions in stress and psychopathology from baseline to 3-month, to 6-month follow-up.

Specific Aim 3: Assess whether greater baseline to 3-month follow-up increases in practice automaticity mediate the association between SCT+HABITS and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology. Hypothesis 3. Greater baseline to 3-month follow-up increases in practice automaticity will mediate the association between the SCT+HABITS group and baseline to 6-month follow-up increases in (a) self-compassion and (b) self-compassion automaticity, as well as reductions in (c) stress and (d) psychopathology.

Exploratory Aim: Evaluate the barriers, facilitators, and acceptability of SCT+HABITS and SCT alone. This aim will be addressed via qualitative analyses to characterize barriers and facilitators to habit formation, and the proportion of participants in each condition (SCT+HABITS and SCT alone) who noted each type of barrier and facilitator. Participants will self-report on acceptability and feasibility via questionnaire. Then, the investigators will examine whether SCT+HABITS and SCT alone will meet or exceed the established criteria for acceptability and feasibility.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* English language proficiency.
* Able and willing to give informed consent.
* Resides in the United States of America

Exclusion Criteria:

* Does not have email address or access to email.
* Does not personally own a smartphone device
* Not able/willing to participate in and/or complete the baseline assessments