cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Mechanical Characteristics of Tendons of Athletes Using Sonography

The investigators analyzed the strain of the rotator cuff tendon of baseball pitchers obtained using ultrasonography and compared the change in peak tendon strain before and after the regular season.


Eligibility Criteria:
Inclusion Criteria:

* Baseball pitchers in city baseball team

Exclusion Criteria:

* History of shoulder disorder or surgery
Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)

This study investigates the effectiveness of a clinic-adapted version of the Coping Power program compared to individualized child and family treatment for children with disruptive behaviour and their parents.

This project compares the short- and long-term effectiveness of a clinic-adapted manualized group treatment (i.e., Coping Power; CP) to individualized child and family treatment for children aged 9 - 12 with disruptive behaviour. Children and their parents who meet criteria and agree to participate in the project are randomly assigned to either the CP condition or the Individualized treatment condition. In the CP condition, children and caregivers are asked to participate in two separate but complimentary 15-session groups. Child groups target development of children's emotional and cognitive problem solving skills and caregiver groups facilitate cognitive and behavioural parenting skills. In the Individualized treatment condition children and caregivers are asked to participate in 15 one-hour individual and family treatment sessions tailored by the clinician to address the children and parent's presenting concerns. Measurement of behaviour and emotional functioning is done pre- post- and at 6-months following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Parents provide free and informed consent and children assent to participate in the research, complete measures, and participate in either Coping Power or individualized treatment.
* Parents report symptoms consistent with clinical diagnoses of Oppositional Defiant Disorder or Conduct Disorder on the Diagnostic Interview Schedule for Children - DSM IV or parents and/or teacher report at or above a T-score of 60 (93rd percentile; borderline clinically severe range) on the Externalizing Behavior composite scale on the Behavior Assessment for Children - 2nd edition.
* Parents or teachers report clinically severe impairment in social, family, peer or overall functioning demonstrated by scores in the clinical range on the parent or teacher completed Impairment Rating Scale.
* The child's cognitive functioning is at or above a standard score of 80 (Borderline Range) on the verbal and/or nonverbal scales on the Kaufman Brief Intelligence Task - 2.

Exclusion Criteria:

* Evidence of Autism Spectrum Disorder or Asperger's Disorder as reported by parent, teacher or physician referral (if available).
Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.


Eligibility Criteria:
Inclusion Criteria:

* male or female weighing ≥ 5kg and ≤ 25kg
* P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3
* with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion Criteria:

* complicated malaria
* ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks
* severe anaemia
* severe malnutrition
* malaria due to other than P. falciparum

Other protocol-defined inclusion/exclusion criteria may apply
Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics

The purpose of the ALL Study is to determine the effectiveness of the dissemination of the ALL intervention from an integrated care setting into Community Health Centers (CHCs) by measuring changes in diabetes mellitus (DM) population prescription rates for the medications, using a pre-post comparison within clinics and a staggered, randomized implementation across clinics.

The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. Multiple mechanisms supported this intervention at KP. The investigators implemented ALL in 11 Community Health Centers (CHC) in the Portland, Oregon metropolitan area. To our knowledge, this was the first clinical trial testing the translation and implementation of a successful quality improvement (QI) initiative from a private, integrated care setting into CHCs.

The investigators adapted the ALL intervention for CHCs through an iterative, stakeholder-driven process. The investigators then conducted a cluster-randomized pragmatic trial in 11 CHCs in a staggered process with six 'early' CHCs implementing the intervention one year before five 'late' CHCs. The investigators measured monthly rates of cardioprotective prescribing rates. Through segmented regression analysis, the investigators evaluated the intervention's effects in June 2011-May 2013. Participants included 11 CHCs serving \~6,500 adult patients with diabetes mellitus (DM) who were indicated for cardioprotective medications per national guidelines. The investigators also conducted a process evaluation to identify factors important to implementation success.

Our overarching goals were to identify and resolve issues in disseminating a successful program from a large, well-organized health system into CHCs. The investigators hypothesized that cross-setting translation was feasible, and that adapting and implementing proven QI approaches could improve the care CHCs provide without requiring them to develop native initiatives. The investigators anticipated that this implementation would involve substantially adapting potentially 'translatable' practices and interventions, due to the differences between private, integrated care settings and CHCs in terms of patient needs and vulnerability, and system resources.

Eligibility Criteria:
Inclusion Criteria:

* Convenience sample of 11 community health clinics (CHCs) that are members of OCHIN, Inc.

Exclusion Criteria:

* none, for study CHCs
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), \& V3 (2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Is over 18 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
* Has less than 1.00 D spectacle cylinder in each eye
* Is correctable to a visual acuity of 20/20 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the informed consent letter
* Is willing to comply with the wear schedule (at least 40hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lens
* Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; \> 8 hours per day)
* Has a CL prescription outside the range of -0.25D to -12.00D
* Has a spectacle cylinder greater than -0.75D of cylinder in either eye
* Has best corrected spectacle distant vision worse than 20/20 in ether eye
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or sever insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is pregnant or lactating
Biomarkers for Post-Transplant Lymphoproliferative Disorders in Children

Solid organ transplantation is an important therapeutic option for children with a variety of end stage diseases. However, the same immunosuppressive medications that are required to prevent the child's immune system from attacking and rejecting the transplanted organ can predispose these individuals to developing a very serious cancer that is linked to Epstein-Barr virus (EBV).

EBV-associated post-transplant lymphoproliferative disease (PTLD) is the most common malignancy in children after transplant. Diagnosis and effective treatment of the EBV-associated cancer is hampered by our inability to determine which children are at risk of developing these cancers and to detect the cancer at an early stage. In this study, we plan to test new "biomarkers" in the blood of children that will tell us very early on if the child is at risk of developing the EBV-associated cancer or if the cancer is present. These studies provide new opportunities for detection, diagnosis, and treatment of children with EBV-associated, post-transplant cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subject and/or parent or legal guardian must be able to understand and provide informed consent/assent;
* Candidate for or recipient of: heart, liver, heart with liver, small intestine, liver with small intestine, or kidney; and
* Subject enrolled within 3 years of transplant.

Exclusion Criteria:

* Previous diagnosis of PTLD;
* Transplant recipients of lung alone, or in combination with an eligible organ type;
* Pancreas transplantation with the exception of 'en bloc' transplant in combined liver and small intestine multivisceral transplantation;
* Any combination other than listed in inclusion criteria;
* History of any previous solid organ, stem cell, or bone marrow transplantation;
* Inability or unwillingness of the legal guardian and/or the subject to comply with the study protocol.
Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

The human organism is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in case of blood variations in carbon dioxide content. The aim of the present study is to quantify the buffer power, i.e. the capacity to limit pH variations in response to carbon dioxide changes, in critically ill septic patients and compare these results with data collected from healthy volunteers.

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

The human body is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in response to acid-base derangements.

The present study focuses on the acute compensatory mechanisms of respiratory acid-base derangements, i.e., respiratory acidosis and respiratory alkalosis. In this case the non-carbonic buffers are constituted by albumin and phosphates in plasma, with the addition of hemoglobin in whole blood.

Aim of the present in-vitro study is to measure the buffer power of non-carbonic weak acids contained in whole blood and isolated plasma, assess the relative contribution of red blood cells and plasma proteins and perform a comparison between septic patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Septic patients and healthy volunteers

Exclusion Criteria:

* age \< 18 years and pregnancy
Sleep Hygiene, Sarcopenia, and Cognitive Function in Respiratory Disease

We aim to clarify the relationship between sleep hygiene and the onset of sarcopenia or cognitive dysfunction using sleep time, arousal, and sleep quality as indicators in COPD or IPF patients, and clarify the effects of sleep hygiene on disease progression and life prognosis.

Chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) have been reported to be associated with a high rate of sleep-related disorders such as insomnia, sleep-related hypoventilation, and sleep apnea syndrome.Sleep-related disorders cause symptoms such as daytime sleepiness, decreased ADL, and depression, which causes cognitive dysfunction. Both COPD and IPF have been reported to be associated with cognitive dysfunction. Recently, it has been focused on the relationship between sleep-related disorders and sarcopenia. The relationship between sleep hygiene, cognitive dysfunction, and sarcopenia in the patients with COPD or IPF is not well understood.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with COPD or IPF.

Exclusion Criteria:

* Subjects who have been hospitalized for exacerbation of respiratory failure within 1 month of study participation
* Subjects who have already been diagnosed with sarcopenia or cognitive dysfunction
* Subjects receiving long-term oxygen therapy (LTOT) or non-invasive ventilation therapy (NIV)
* Subjects with obstructive sleep apnea who are indicated for continuous positive airway pressure (CPAP)
* Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, malignancy, and neurological disease.
Self-help Lifestyle Medicine for Depression and Anxiety

This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.

This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for reducing depressive and anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). With an estimation of 30% withdrawal, around 124 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Aged ≥ 18 years
* Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
* Able to read Chinese and type in Chinese or English
* Have an Internet-enabled mobile device (iOS or Android operating system)
* Are willing to provide informed consent and comply with the trial protocol

Exclusion Criteria:

* Current involvement in psychotherapy or unstable medication for depression and/or anxiety
* Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
* Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
* Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Autologous Bone Marrow-Derived CD34+, CD133+, and CD271+ Stem Cell Transplantation for Retinitis Pigmentosa

A single arm, single center trial to evaluate the safety and efficacy of autologous purified populations of bone-marrow derived stem cells in patients with Retinitis Pigmentosa (BM-SCs) through a 48 month follow up period.

Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells. This is a single arm, single center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 48 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged retinal tissue, and the availability of clinical-grade purification system (CliniMACS) and microbeads to purify the target cell populations in clinically-approved methods.

Eligibility Criteria:
Inclusion Criteria:

* Retinitis pigmentosa patients diagnosed by ophthalmologists
* Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
* Best corrected visual acuity less than 6/120 by Snellen visual acuity chart

Exclusion Criteria:

* Other eye conditions that could mask the interpretation of the results
* Unable to return for follow up
* Underlying diseases including asthma, heart failure, myocardial infarction, liver failure, renal failure
* Pregnant and lactating women
A Registered Cohort Study of Inflammatory Demyelination Disease

This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect


Eligibility Criteria:
Inclusion Criteria:

1. Outpatient or inpatient
2. Meet the diagnostic criteria of Inflammatory Demyelination Disease.
3. Voluntary participation and informed consent signed by the applicant or his/her family.

Exclusion Criteria:

1. Severe complications
2. Poor prognosis (\<1 year survival)
3. Severe mental disorder and inability to cooperate with the examination.
Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.

This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.


Eligibility Criteria:
Inclusion Criteria:

All Adult participants with COVID-19 confirmed by PCR who meet the following criteria:

* Hospitalised after August 31st,2020
* Receivedat least one dose of Remdesivir(RDV)at anytime during hospitalisation

Exclusion Criteria:

* Received Remdesivir as part of a clinical trial, compassionate use or expanded access program
* Received Remdesivir prior to this admission at any other health facility than the research sites and whose health records are available.
A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
* History of cancer (malignancy)
* Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
* History of a major surgery
* Is lactose intolerant
Patient-Ventilator Dyssynchrony Detection With a Machine Learning Algorithm

This is a diagnostic study aiming to compare accuracy to detect and classify patient-ventilator dyssynchronies by a machine learning algorithm, compared to the gold-standard defined as dyssynchronies diagnosed and classified by mechanical ventilator and esophageal pressure waveforms analyzed by experts.

The main question of this study is:

• Are patient-ventilator dyssynchronies accurately detected and classified by an artificial intelligence algorithm when compared to experts analyzing esophageal pressure and mechanical ventilator waveforms?

This is a diagnostic, observational study, aiming to assess patient-ventilator dyssynchrony automated detection and classification by a machine learning algorithm. Accuracy of the machine learning algorithm will be compared with the gold-standard, defined as dyssynchronies detected and classified by mechanical ventilation experts.

Experts will analyzed airway pressure, flow, volume and esophageal pressure waveforms to detect and classify dyssynchronies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects under assisted or assist-controlled mechanical ventilation and monitored with esophageal pressure balloon.

Exclusion Criteria:

* Refusal from patient's family or attending physician
Polypharmacy-related Adverse Events in Critically Ill Children

The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.


Eligibility Criteria:
Inclusion Criteria:

* Ages 2-\<18 at the time of enrollment
* Admitted to the Duke PICU or PCICU
* Planned or anticipated mechanically ventilation for ≥2 days
* Require sedation to maintain mechanical ventilation
* No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
* Availability and willingness of the parent/legal guardian to provide written informed consent

Exclusion Criteria:

* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
* Previous participation in this study
* Planned receipt of sedatives other than fentanyl or dexmedetomidine
* Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
* Renal failure requiring renal replacement therapy
* Hepatic failure
* Support with extracorporeal membrane oxygenation