cyrilzakka/clinical-trials huggingface dataset:
Functional Circuit Training in Older Adults With Congestive Heart Failure

The goal of this study is to determine the effect of a functional circuit training program as compared to standard cardiac rehabilitation or control exercise in improving physical function and activity.

In older (65 years of age or older) patients with congestive heart failure, we propose to:

1. Assess: a) Peak aerobic capacity (peak VO2) during a monitored, standardized treadmill test; b) Oxygen uptake kinetics and heart rate during a standardized submaximal treadmill test; c) Performance on a set of functional mobility tasks; d) Self-report of physical disability and difficulty in performing daily tasks, and physical activity.
2. Conduct a 12-week randomized controlled trial, comparing changes in these assessed measures in patients randomized to three different groups: 1) standard cardiac rehabilitation using bicycle exercise; 2) group functional circuit training focusing on exercises that involve functional mobility tasks and a home-activities exercise component; 3) a chair-based, flexibility and "toning " (low level resistance) group control exercise.
3. Reassess all groups after an additional 12 weeks in the measures identified above to identify how well the three groups maintain their function.
4. Examine the mechanisms underlying change in functional mobility performance and self-reported function as a result of the interventions

Primary hypothesis 1: Compared to chair-based exercise controls at the end of week 12, both the cardiac rehabilitation and functional circuit training groups will show improvements in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function.

Primary hypothesis 2: Compared to the other two groups that are given exercise instructions only, the functional circuit training group, who continue their home activities exercise program, show less decline by week 24 in measures of peak aerobic capacity, submaximal oxygen uptake kinetics, functional mobility performance, and self-reported function.

Secondary hypothesis: Measures of submaximal oxygen uptake kinetics are better predictors of changes in functional mobility performance and self-reported function than peak aerobic capacity, muscle strength, joint range of motion, balance, and behavioral factors (such as depression).

Eligibility Criteria:
Inclusion Criteria:

* Congestive Heart Failure

Exclusion Criteria:
Standardized Patients to Measure and Address Intersectional Stigma

This study aims to develop and evaluate an intervention to reduce enacted stigma in healthcare settings aimed at people living with HIV (PLWH) and men who have sex with men (MSM) in China. Enacted stigma will be measured using a quality of care score collected through unannounced standardized patient (SP) visits to consenting providers in sexual health clinics.

Standardized patients, or trained actors from the community, will conduct a baseline round of unannounced clinic visits with consenting providers for the purposes of observing their clinical performance. SPs will present clinically standardized case scenarios, but the HIV status and sexual orientation of each case will be randomly varied in order to quantify the extent to which HIV stigma and/or homophobia contribute to the deterioration of care quality. Care quality will be calculated using a global score based on a standard checklist administered to SPs following each visit. Results of the baseline visit will inform the development of a stigma reduction intervention for consenting providers employed at clinics randomized to the treatment arm of the study. Design of this intervention has been informed by results of the baseline study and incorporates expert input from members of community advisory boards (CAB), one made up of community members and the other of providers. The intervention will consist of both didactic and skills-building methods and will be delivered both in-person and through follow-up modules online. Didactic portions will include content on topics including clinical management of common STIs, shared decision making, sexual history taking, and working with marginalized populations. Skills-building sessions will include group-based discussion and medical simulation and feedback with trained standardized patients. Follow-up data collection will begin within 2 months of completing the stigma reduction intervention using the same approach as for the baseline data collection. All research activities will take place in Guangzhou, China.

Eligibility Criteria:
Inclusion Criteria:

* Eligible facilities will be those with:

  1. formal government accreditation as a medical center (a basic tenet of all public hospitals in China); and
  2. possession of an accredited on-site laboratory with capacity to provide enzyme-linked immunosorbent assay testing for HIV, treponemal (e.g. Treponema pallidum particle agglutination) and non-treponemal tests (e.g. rapid plasma regain) for syphilis.
* Within eligible and consenting facilities, eligible providers will be those who are licensed at the time of the study to practice dermatovenereology in China.

Exclusion Criteria:

* none
Two Anger Management Programs for Teens.

The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.

In this pilot randomized-controlled study, we evaluate the effects of MBB as compared with an established anger management program (Real Deal), in helping youth prone to anger develop tools to effectively reduce and control their anger, and potentially reduce other negative emotions and feelings that might be associated with their anger.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* self-, or allo-referred (parents, peers, court-ordered, school, etc.), based on their propensity for displaying various disruptive, externalizing behaviors, including, anger, hostility, oppositional behavior, and temper outbursts, and as such identified by Youth Services (YS) as a suitable candidate to attend a YS anger management program.

Exclusion Criteria:

* none
Pathway Study WS3 - Home Based Metacognitive Therapy for Cardiac Rehabilitation Patients

Depression and anxiety are highly prevalent in people with heart disease, causing immense human and economic burden. Available pharmacological and psychological interventions have limited efficacy and the needs of these patients are not being met in cardiac rehabilitation services despite emphasis in key NHS policy.

Extensive evidence shows that a particular style of thinking dominated by rumination (dwelling on the past) and worry maintains emotional distress. A psychological intervention called metacognitive therapy (MCT) that reduces this style of thinking alleviates depression and anxiety in mental health settings.

This is a single-blind feasibility randomised controlled trial of metacognitive therapy delivered in a home-based format (Home-MCT). The aim of the study is to evaluate the acceptability and feasibility of integrating Home-MCT into cardiac rehabilitation services and to provide provisional evidence of effectiveness and cost-effectiveness on Home-MCT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are referred to the CR pathway who meet Department of Health (DoH) and/or British Association for Cardiovascular Prevention and Rehabilitation (BACPR) CR eligibility criteria:

   * Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
   * Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
   * Stable heart failure
   * Stable angina is chest pain or discomfort that most often occurs with activity or stress
   * Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
   * Heart valve repair/replacement
   * Heart transplantation and ventricular assist devices
   * Adult congenital heart disease identified in adulthood
   * Other (atypical heart presentation: nausea, dizziness, lower chest discomfort, upper abdominal pressure or discomfort that feels like indigestion and upper back pain)
2. A score of ≥ 8 on either the depression or anxiety subscale of the Hospital Anxiety and Depression Scale
3. Minimum of 18 years old
4. Competent level of English language skills

Exclusion Criteria:

1. Cognitive impairment which precludes informed consent or ability to participate
2. Acute suicidality
3. Active psychotic disorders (i.e., two \[or more\] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms).
4. Current drug/alcohol abuse (A maladaptive pattern of drinking, leading to clinically significant impairment or distress)
5. Concurrent psychological intervention for emotional distress that is not part of usual care
6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
7. Life expectancy of less than 12 months
A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B

This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor.

Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welldoc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

Exclusion Criteria:

* Pregnancy
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model

The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.


Eligibility Criteria:
Inclusion Criteria:

1. Demonstrates understanding of the study.
2. Aged 18 to 85 years.
3. Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. Has good general health (in the opinion of the investigator or medically qualified designee).
5. Currently living in the Indianapolis, Indiana area.
6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
7. Have no current active caries or periodontal disease and all restorations in a good state of repair.
8. Have a salivary flow rate in the range of normal values.

Exclusion Criteria:

1. Pregnant or breast feeding women.
2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
7. Recent history (within the last year) of alcohol or other substance abuse.
St. John's Wort for the Treatment of Generalized Social Anxiety Disorder (GSAD)

This study will determine whether the herbal product St. John's wort is safe and effective in treating generalized social anxiety disorder (GSAD).

Study hypothesis: Hypericum perforatum (St. John's wort) is more effective in treating GSAD than placebo.

The use of complementary and alternative medicine (CAM) has grown dramatically over the last decade. Botanical treatments originating from plants have become especially popular for treating conditions such as anxiety and depression. Evidence suggests that the botanical St. John's wort has neurochemical activity similar to that of conventional medications. However, research on the safety and effectiveness of St. John's wort is limited. This study will determine the safety and effectiveness of St. John's wort in treating GSAD, a serious condition characterized by intense fear of various social situations that may cause embarrassment.

Participants will be randomly assigned to receive either St. John's wort or placebo daily for 10 weeks. Self-report scales will be used to assess participants' GSAD symptoms at study entry and at study completion. Blood collection will occur at every weekly study visit to determine the levels of St. John's wort in the blood.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GSAD
* Brief Social Phobia Scale (BSPS) score of 20 or higher

Exclusion Criteria:

* Comorbid anxiety, depressive, or bipolar disorders
* Schizophrenia
* Cognitive impairment
* Substance abuse or dependence within 1 year prior to study entry
* Any unstable medical condition
* Clinically significant laboratory or electrocardiogram (EKG) abnormality
* Currently use psychotropic medications or may need psychotropic medication during the study
* Psychotherapy within 6 weeks prior to study entry
* Failed a previous trial of St. John's wort at doses of 1800 mg/day or greater
* Pregnancy or breastfeeding
Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias

A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias


Eligibility Criteria:
Inclusion Criteria:

1. presence of ventricular ectopic beats (VEB) with left-bundle-branch block morphology or right-bundle-branch block morphology and positive concordance throughout the chest leads, inferior axis and at least one of the following:

1. \>2000 isolated VEB/24h
2. symptomatic monomorphic ventricular tachycardia
3. left ventricular disfunction supposed to be due to tachycardia-induced cardiomyopathy

Exclusion Criteria:

1. known structural heart disease
2. pregnancy
3. life expectancy \< 1 year
Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease

Aims:

1. To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).
2. To compare this electronic process with "present anaemia management" in the traditional outpatient setting.
3. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

CKD Stages 3 to 5 Subjects will be randomised and stratified according to Age, Gender, CKD Stage, Known Cardiovascular Disease, Diabetes and ESA Type into EMAN vs. Control

Details of EMAN synchronization and Dosing:

Monthly dose of ESA is calculated by:

Monthly dose = present dose x (28/present frequency (days))

Synchronization will be achieved by using the formula: "Synchronization dose of ESA = (28-Days until next injection is due)/28 x monthly dose of ESA

The dose of ESA/C.E.R.A. should be adjusted to maintain the individual patient's haemoglobin within a range of 11± 1.0 g/dL of the reference haemoglobin concentration ie. between 10.0 and 12.0 g/dL

Haemoglobin Value Corrective Adjustment

* A single value \>13 g/dL Interrupt treatment until Hb falls below 12 g/dL then re-start treatment at 50% of previous dose
* A single value \<9 g/dL Increase dose by 50%
* Difference between two consecutive Hb values indicates ≥2 g/dL increase Reduce dose by 50%
* Difference between two consecutive Hb values indicates ≥2 g/dL decrease Increase dose by 50%
* \>11.5 g/dL and \<13 g/dL AND deviation from reference value is \>1g/dL. Reduce dose by 25%
* \<10.5 g/dL and \>9 g/dL AND deviation from reference value is \>1g/dL. Increase dose by 25%
* \>12 g/dL Reduce dose by 25%
* \<10 g/dL Increase dose by 25%

Statistics:

Audit of present practice suggests CKD patients achieve only 30% on target (Hb 10-12g/dL) while well audited dialysis units in our service can achieve 60% at target.

If an improvement from 30% to 60% is expected in the EMAN verses Control arm then 100 patients (50 in each group) would be required to show a significant difference p\<0.05 with 85% power.

Patients will be analysed on an intention to treat basis Primary and Secondary Endpoint data will be compared between study and control groups using unpaired student t-tests after normalisation of data as required and/or chi squared analysis.

Statistical significance will be taken at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria

Exclusion Criteria:

* Pregnancy
* Significant acute bleeding such as overt gastrointestinal bleeding
* A known haematological cause for anaemia
* Known metastatic malignancy
* Present participation in another interventional clinical trial • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.

Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of wisdom tooth
* Must be similar in age-height-weight
* Must be similar socio-culturally

Exclusion Criteria:

* Under 18 years of age
* Taking psychotropic medication or psychiatric treatment
* Systemically unhealthy patients
* Pregnants
Topic Cervical Anesthesia for Pain Control During Endouterine Manual Aspiration

To compare the effectiveness of lidocaine gel plus paracervical blockade vs. Paracervical blockade alone in the management of pain during endouterine manual aspiration.


Eligibility Criteria:
Inclusion Criteria:

* Need for a endouterine manual aspiration (incomplete abortion or gynecological bleeding).

Exclusion Criteria:

* Allergy to lidocaine.
Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.


Eligibility Criteria:
Inclusion Criteria:

* Are a candidate for bilateral implantation
* In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
* In need of spherical correction between 10.0 Diopter (D) and 30.0 D
* Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
* Willing and able to complete all required postoperative visits
* Able to comprehend and sign a statement of informed consent
* Pupil dilation ≥ 6.0 mm
* Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

Exclusion Criteria:

Exclusion Criteria Before Surgery - Ocular

* Previous cataract patient without potential of bilateral implantation
* Females of child bearing potential
* Irregular corneal astigmatism
* Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
* Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
* Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
* Clinically significant corneal dystrophy (including Fuch's dystrophy)
* Previous corneal transplant
* Amblyopia
* Glaucoma (medically uncontrolled)
* Clinically significant RPE/Macular changes
* Proliferative diabetic retinopathy
* History of macular edema
* Previous history of retinal detachment
* History of uveitis/iritis
* Extremely shallow anterior chamber, not due to swollen cataract
* Iris neovascularization
* Microphthalmos
* Absent eye or eye with no light perception (NLP) as fellow eye
* Rubella, congenital, traumatic, or complicated cataract
* Optic atrophy

Exclusion Criteria During Surgery

* Other procedures at this surgery
* Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study
Non-Invasive Management of Chronic Venous Insufficiency

The purpose of this study is:

-item one to use two new non-invasive technologies to evaluate scarring and swelling associated with chronic venous insufficiency.

The study hypothesis:

- item one non-invasive technologies can provide a tool for assessing risk of ulcer development based on the tissue edema and alteration.


Eligibility Criteria:
Inclusion Criteria:

* participants with CVI with CEAP class 4 or higher
* participants with no CVI class 0

Exclusion Criteria:

* open ulcers or lower extremity amputation
* diabetics with HbA1C greater than 7.0
* arterial occlusive disease
* BMI greater than 35
* any connective tissue disorder (lipodermatosclerosis and fibrosis)
* participants with metallic prosthesis or implants
* participants with renal impairment
* pregnancy
* inability or refusal to wear compression stockings prescribed by physician (CVI patients only)