cyrilzakka/clinical-trials huggingface dataset:
Nordic Hamstring Exercise After ACL Reconstruction Reconstruction

Anterior cruciate ligament (ACL) injuries constitute a significant portion of major knee joint injuries sustained by young, active individuals, and significantly increase risk for long-term disability. Yet the recommended solution to restore joint stability following injury--ACL reconstruction (ACLR)--does not prevent post-traumatic knee osteoarthritis (PTOA). Post-traumatic quadriceps (dys)function is a hallmark characteristic following ACLR, reported to accelerate the onset of PTOA after ACL injury, making the recovery of muscle function a primary concern to clinicians. However, hamstrings muscle function is drastically underrepresented relative to the quadriceps in the context of recovery from ACLR, which impedes the ability to develop targeted treatment approaches. Persistent hamstrings weakness is widely reported in patients who undergo ACLR with a hamstring tendon (HT) autograft, which increases ACL strain, and may contribute to higher graft failure rates in this population. To effectively treat muscular impairments, underlying neuromuscular adaptations known to occur in response to ACLR must be targeted. Eccentric exercise is uniquely suited to enhance neuromuscular function. The Nordic hamstring exercise (NHE) is a specific form of eccentric exercise that is clinically relevant and easy to implement, but has not been explored as an intervention for hamstrings neuromuscular dysfunction in patients who undergo ACLR with HT. To establish an evidence-based treatment model, the investigators will use a single-blind, randomized controlled clinical trial to establish the feasibility and efficacy of a 4-week NHE protocol in patients who undergo ACLR with HT. Separate factorial ANOVAs will be used to assess the effects of group (NHE, control) and time (baseline, 4 weeks) on selected outcomes. Effect sizes will be calculated for within- and between-group comparisons. The investigators expect to observe improvements in hamstrings neuromuscular function following the NHE protocol, and that those improvements will be greater than the control group. Additionally, the investigators expect the protocol to be feasible in terms of intervention adherence and patient retention. This study will identify specific barriers to the implementation of NHE in patients who undergo ACLR with HT, and will provide support for the application of an easy to implement clinical intervention able to address a complex neurophysiological problem.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* History of primary, unilateral ACL reconstruction (ACLR) with hamstrings tendon autograft

Exclusion Criteria:

* Lower extremity orthopedic surgery prior to ACLR
* Post-surgical complication (e.g. infection, delayed healing)
* Multiple ligament knee injury
* Treated articular cartilage lesion
* Known history of knee osteoarthritis
* Concussion within 6 months
* History of neurological disorder
* Currently taking prescription medication that may alter neural excitability (e.g. stimulants, depressants)
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People

There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. The aim of this project is to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.

With advancing age, there is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance and increases the likelihood that older people will lose their independence. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. Indeed, recent data support the idea that it is fitness level, not age that explains physiological responses to exercise. However, although there are data about how quickly cardiovascular and neuromuscular functions decline throughout life, less is known on the extent physical activity can help mitigate the loss of these functions. The aim of this project is therefore to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 35 for the young group, between 65 and 80 for the old group and over 80 for the very old group.
* Signed consent for the study obtained
* Subject affiliated or entitled to a social security scheme

Exclusion Criteria:

* Pathology or surgical intervention causing a locomotor disorder
* Neurological, cardiovascular or psychological pathology
* Participants will be excluded if resting or exercise ECG responses show any abnormality, or if resting Heart Rate (HR) \> 100 bmp, resting blood pressure \> 144 (systolic) / 95 (diastolic) mmHg, pulmonary and or cardiac disease that could affect the health of the participant (arrhythmias and stroke)
* Mini-Mental State Examination score \< 20 (\>80 years old)
* Significant change in the amount of physical practice over the last 5 years.
Sebum Measurement in Newborn to Detect Hyperexposure to Androgens

The source of PCOS is unknown. Our hypothesis is that over exposure to testosterone of the foetus in utero alters the expression of genes thought to be involved in the cause of PCOS.

Polycystic ovary syndrome (PCOS) affecting 10-15% of the female population causes excess hair, acne, irregular/absent ovulation, infertility and is associated with hypertension, diabetes, heart attacks and stroke in later life.

The economic care-related burden of the syndrome is estimated at $4.36 billion/year in the USA. The root cause is unknown and although mostly familial, the offending genes are unknown. We believe that excess testosterone, to which the foetus is exposed during its life in the womb, causes development of PCOS in adult life. If a mother with PCOS exposes her foetus to high testosterone levels compared to one with no PCOS, this would be the first step in proving the developmental hypothesis for PCOS, opening the door to methods to prevent the appearance of the distressing symptoms of PCOS in adult life.

With no access to the foetal environment, we have used the surrogate measure of sebum on the skin of the newborn, 99% influenced by testosterone. Our pilot study (Homburg et al, 2017) used absorbent paper to measure sebum excretion in PCOS and controls within 24 hours and 1-24 weeks after birth in mother and baby. Higher sebum production in female babies of PCOS mothers strongly supported our hypothesis.

The present proposal utilizes a 30-second, non-invasive, quantitative measurement of sebum (Sebumeter®) in the newborn from PCOS mothers and controls, within 24 hours of birth. We will correlate results with other features in both female and male newborn that may suggest hyper-exposure to testosterone and with maternal testosterone levels in the blood. If confirming the findings of our pilot study in line with the developmental theory of PCOS, this could be used within 24 hours of birth to predict development of PCOS in adult life, induce measures to prevent the symptoms of PCOS and reduce the enormous health burden on patients and economies

Eligibility Criteria:
Inclusion Criteria:

Women (with and without a diagnosis of polycystic ovarian syndrome) aged 18-40 with an uncomplicated singleton pregnancy, who deliver a baby at term (37 weeks gestation or longer). Women in the PCOS cohort will be defined by the ESHRE/ASRM Rotterdam criteria. Women with no signs of PCOS who deliver a term baby will serve as the control group.

Exclusion Criteria:

Patients who decline consent
Participant Satisfaction With the BUILD Mobile Application

This study explores user satisfaction with the BUILD mobile application.

This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18+ years of age and older
2. Must own or have regular access to a smartphone with a recent operating system installed (Android: OS 8.0 or higher, Apple: iOS 13.0 or higher) with reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
3. Must be available and committed to engage with the program and complete assessments for a 2-week duration
4. Must be able to read and write in English
5. Must have primary residence in the United States

Exclusion Criteria:

1. Current suicidal ideation with a plan and/or intent or a suicide attempt within the past 12 months
2. Previous Woebot use
Perfusion Abnormalities in Hypertrophic Cardiomyopathy

The purpose of this study is to investigate whether myocardial microvascular perfusion in patients with hypertrophic cardiomyopathy improved after initiation of cardiac myosin inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertrophic cardiomyopathy
* Subject being initiated on clinically-indicated cardiac myosin inhibitor therapy

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to ultrasound enhancing agent (lipid-stabilized) or regadenoson
* Serious AE to regadenoson
* Hypotension
* Serious bradycardia not addressed by pacemaker
* Moderate or greater reactive airways disease
Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program

Delirium occurs in up to 20% of older adults presenting to the Emergency Department (ED) and is associated with poor outcomes. Failure to identify patients with ED delirium not only prevents initiation of mitigation strategies, but is also a barrier to advancing the field in terms of evaluating management and clinical outcomes. This project studies the potential of an ED Delirium Detection Program (ED-DDP), developed to address the need for consistent and accurate ED delirium detection.

This research will have two objectives:

* Aim 1 will conduct a pilot stepped wedge cluster randomized trial (SW-CRT) of the ED-DDP across 3 diverse EDs to determine preliminary efficacy of the detection training program, and
* Aim 2 will use a mixed methods approach to assess RE-AIM implementation outcomes (Reach, Efficacy, Adoption, Implementation, and Maintenance) of the training program.

Aim 1 will consist of a multicomponent 1-day delirium champion workshop where the training is delivered, real-time direct observation/training of champions via telehealth, practical training of nurses throughout each ED by champions, and patient chart review. In Aim 2, the investigators will assess implementation outcomes using training logs, tele-observation, interviews with champions and nurses, and electronic medical record screening.

The overarching aim of this proposal is to determine the preliminary efficacy of the training program for improving ED delirium screening, detection, and management in older adults, while also evaluating implementation outcomes of the program for champions/nurses. The investigators will use findings from this study to inform a full-scale SW-CRT to evaluate the impact of the program on patient outcomes at Northwell Health. The long-term goal of this study is to implement and disseminate a comprehensive ED-DDP that will improve screening, detection, and management of ED delirium in older adults.

Every three months, with the exception of when a site is in their implementation period, trained study staff members will conduct retrospective in-depth chart reviews on 250 randomly selected eligible patient visits per ED site. These chart reviews will assess presence of delirium as well as any corresponding delirium documentation, including the brief confusion assessment method (bCAM) and delirium mitigation and management strategies employed during the patient's ED visit. Charts will be pulled based on dates the participating site is within their control or intervention period (no chart review will take place during program implementation). A total of N=1,000 patients per ED will be reviewed. Two delirium experts will perform chart checks and adjudicate any uncertain cases.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to a participating study site emergency department (ED) during control or intervention periods
* Survival to ED discharge or to hospital admission

Exclusion Criteria:

* Presenting to a participating study site ED during ED-DDP implementation periods
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes

The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 75 years old, with type 2 diabetes with inadequate glycemic control
* Subjects receiving insulin and metformin and/or a thiazolidinedione
* Body Mass Index \<=45.0 kg/m2
* Serum creatinine \<1.5 mg/dL for men or \<1.4 mg/dL for women
* No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be \<3 g/24 hrs)

Exclusion Criteria:

* History of type 1 diabetes
* AST and/or ALT \>2.5 times the upper limit of normal
* Creatinine kinase ≥3 times the upper limit of normal
* Symptoms of severely uncontrolled diabetes
* History of hypoglycemic unawareness
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
How to Cope With Anxiety and Depression. A Randomized Controlled Trial.

The purpose of this study is to investigate whether citizens experiencing symptoms of anxiety and depression will benefit from a self-management training program with respect to: 1) Self-efficacy, and 2) Symptoms of anxiety and depression, and 3) Self reported measures of Health Related Quality of Life (HRQoL)

* The intervention is a Danish adaption of The Chronic Disease Self-Management Program developed by The Stanford Patient Education Research Center, The Expert Patient Program Community Interest Company (EPPCIC), and The English National Health Service (NHS).
* The Danish adaptation has been performed by The Danish Committee for Health Education.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* Suffering from anxiety and/or depressive symptoms
* Voluntary participation

Exclusion Criteria:

* Potential suicidal behavior
* Potential aggressive behavior
* Significant cognitive impairment
Twentyfour Ambulatory Pulse Wave Velocity and Central Augmentation Index in Type 2 Diabetes

The functionality and reproducibility of pulse wave analysis is investigated in 20 type 2 diabetic patients who had two 24 hour measurements performed within one week with the Arteriograph24 equipment.

Arteriograph24 is a new monitor for measuring ambulatory blood pressure and additional performing brachial cuff based on analysis of a suprasystolic pulse wave.

The study aim to test the feasibility of ambulatory pulse wave analysis every twenty minute (the fraction of missed measurements)and the reprodicility of pulse wave velocity and central augmentation index in type 2 diabetic patients. In addition we will explore the relation between diurnal variation of brachial blood pressure, central blood pressure and pulse wave velocity.

20 type 2 diabetic patients will have 24h ambulatory blood pressure performed twice with an interval of one week.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Atrial fibrillation
Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

Primary Objective:

• To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.

Secondary Objective:

• To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.

The ReX Platform is a class 1 FDA listed device under product code NXB Dispenser Solid Medication as a device that meets the exempt regulation 21 CFR 890.5050. and comprises the following components:

1. A disposable cartridge, a medication container supplied to participants pre-loaded with pills/capsules. The cartridge includes an integral mouthpiece, which dispenses the pill into the participant's mouth following application of an inhalation.
2. ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network.
3. ReX Treatment Manager (RTM) is a web application used for the collection and management of data collected by the ReX.
4. Reminders dispatched to participants and caregivers according to a predefined logic: email, SMS or via support team call.
5. Electronic Patient Reported Outcomes (ePROs) questions, tips, reminders, and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager.
6. Thresholds in cases that participant reports exceed a predefined threshold notifications via email and/or text messages will be dispatched to the specified party.

Eligibility Criteria:
Inclusion Criteria:

Male or female, at least 18 years of age. Diagnosis of HR+ HER2- metastatic breast cancer with ribociclib treatment that begun within last 60 days.

Site has ability to dispense ribociclib in long term. Participant is able to read, understand and sign the IRB research consent for use of their data for research purposes.

Participant is able and willing to complete Patient Reported Outcome (PRO) questionnaires during the study.

Exclusion Criteria:

• Participant has been routinely taking ribociclib for the past 60 days (without ReX platform).

Participants prescribed ribociclib for off-label indications. Participants who failed to pass the learning module during the ReX training process.

Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less.

Participants who have a significant physical disability (including poor fine motor skills, impaired visual or auditory faculties, mental disorders, or another impairment), affecting ability to provide IRB research consent or use the ReX dispensing unit effectively.

Participant is unsuited for participation in the study based on PI discretion

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Health, Integration, Concentration: Mindfulness in Schools

Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children.


Eligibility Criteria:
Inclusion Criteria:

* reading ability
* positive declaration of consent

Exclusion Criteria:

-
Phase I Study to Evaluate the Safety of Dexibuprofen 300mg Under Fasting and Fed Conditions

Phase I Study to Evaluate the Safety of Dexibuprofen 300mg (Apsen Pharmaceuticals A / S.) After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes Under Fasting and Fed Conditions.

A single oral dose of test medicine will be administered to participants in a practical period with the aid of 200 mL of water at room temperature. During administration, participants should stay in seated position. Participants will be confined at least 12 hours prior to administration and will remain for about 24 hours after the same, totaling about 36 hours of confinement.

After 36 hours of confinement the participantes will proceed to the multi-dose use phase for seven days in fed conditions.

To assess safety, an evaluation of the vital signs, laboratory tests and health status of the participants will be carried out throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant able to understand and sign the informed consent of the study;
* Healthy research participant, of both sexes, aged between 18 and 50 years, with BMI between 18.50 and 30.00 kg / m2;
* Participant considered healthy by evaluating the medical history, vital signs and general clinical examination;
* The results of clinical laboratory tests (biochemistry, hematology, serology, urinalysis and ECG certified by cardiologists) within the normal range established by the laboratory or changes that are considered not clinically significant by study physician.

Exclusion Criteria:

* History of any major surgery in the last three months;
* History present or previous history of any cardiac event, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematologic, considered by the investigator as clinically significant and can endanger the participant's health;
* History of chronic alcohol abuse, drugs, drugs and / or smoking in the last 6 months;
* Known hypersensitivity to dexibuprofen, ibuprofen or its related (other nonsteroidal anti-inflammatory drugs) as well as components present in the formulation;
* History of use of drugs that potentially interfere with the kinetics / dynamics dexibuprofen or any other medication considered clinically significant by the investigator with time less than 7 times of drug half-life preceding the period of inclusion;
* Regular consumption of grapefruit and / or their derivatives;
* Pregnant women and nursing mothers;
* Donation or loss of 450 ml or more of blood within 3 months before the study and / or hospitalization for any reason, up to 4 weeks before the beginning of it.
* Participation in any clinical trial in the last 12 months preceding the start of the study.