cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain


Eligibility Criteria:
Inclusion Criteria:

* Is an English-speaking man or woman between 18 and 75 years of age who has given written informed consent.
* Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months.
* Is opioid naïve (ie, taking \<20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg \[inclusive\] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study.
* Has stable health, as determined by the investigator,
* If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening and throughout the duration of the study), or is of non-childbearing potential

Exclusion Criteria:

* Has cancer-related pain.
* Has a history of receiving \>240 mg oxycodone (or equivalent) daily within 30 days before screening.
* Has a lumbar spinal infusion pump in use or used within 6 months before screening.
* Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia)
* Has positive urine drug toxicity screen for illegal or non-prescribed drugs
* Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
* Has positive result for cannabinoids (even if legally prescribed).
* Has a history of attempted suicide.
Behavioral Intervention for Children With Attention Deficit Hyperactivity Disorder(ADHD)

ADHD children have executive function (EF) impairments,so we randomize the children to the training or a waitlist to improve EF ,adding contingent reinforcement to ascertain whether EF deficits are amenable to the training in children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of child ADHD
* full-scale intelligence quotient (FSIQ) ≥70
* stable on medication for ADHD children at least 3 months

Exclusion Criteria:

* individuals with major neurological disorders
* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders
Investigation of the Relationship Between Lower and Upper Extremity Selective Motor Control and Sensory Functions in Children With Spastic Cerebral Palsy

Although spasticity, contractures and muscle weakness in children with CP are disorders that can be observed more easily and are more focused and given more importance in evaluation and treatment approaches; Inadequate or loss of selective motor control negatively affects motor functions to a greater extent.

It is very important to reveal the causes and consequences of selective motor disability in children with spastic cerebral palsy, in terms of creating effective treatment plans.

The number of patients to participate in the study was determined as 100. The study will be carried out in Hatay Mustafa Kemal University Research and Application Hospital, Department of Pediatrics.

In our study, demographic information will be filled in, and lower extremity selective control assessment scale (SCALE) for lower extremity, upper extremity selective control scale (SCUES) for upper extremity, and sensory assessment (touch, two-point discrimination and proprioceptive sensory assessment) will be performed on the patients who accepted the study.


Eligibility Criteria:
Inclusion Criteria:

* Giving consent to participate in the study
* To be diagnosed with spastic type cerebral palsy;
* Being between the ages of 4-18;
* Being at level I-II-III according to the gross motor function classification system (GMFCS);
* Not having undergone Botulinum Toxin injection/lower-upper extremity surgery in the last 6 months

Exclusion criteria:

* To be in level IV-V according to gross motor function classification system (GMFCS)
* Having severe mental retardation who does not understand verbal commands
Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts

Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.


Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years of age
* at least one visit to the AIM clinic during previous 6 months
* a cell phone number in the registration system
* fluent in English or Spanish

Exclusion Criteria:

- Receipt of influenza vaccination during the 2014-2015 influenza season prior to randomization
Mind-body Online Therapy in Gynecological Oncology

In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc.
* Sufficient computer skills and internet access
* Availability of an emergency address
* Written informed consent by signing the informed consent form

Exclusion Criteria:

* Patient unable to provide written informed consent by signing informed consent form
* Insufficient knowledge of German
* Moderate to severe depressive symptomatology (BDI \> 18; HAM-D17 ≥ 17) during T1 survey
* Suicidality (BDI suicidality item \> 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey
* Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment
* Male breast cancer patients
Patient Priorities Care (PPC)

Patient Priorities Care aligns healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare. This approach is about aligning what outcomes patients want from their healthcare with what they are willing and able to do to achieve these outcomes. The approach begins with a member of the healthcare team helping patients identify their health outcome goals and their care preferences and preparing them to interact with their clinicians around these goals and preferences. The goals and preferences are transmitted to the patient's clinicians who use them in decision-making and communication with the patient and other clinicians.

Many older adults with Multiple Chronic Conditions receive conflicting recommendations and care that may be fragmented across clinicians. Older adults vary in what's most important when faced with tradeoffs and vary in the health-related activities they are willing and able to complete to achieve their desired outcomes. A potential solution to these problems is to move from decision-making predicated solely on disease-guidelines to decision-making based on achieving each patient's own specific health outcome goals (e.g., relief of symptoms sufficient to allow specific functional activity) within the context of what they are willing and able to do (i.e. care preferences) to achieve these outcomes.

The primary aims of the Patient Priorities Care (PPC) pilot is to assess the feasibility of aligning primary and specialty care to focus on the health priorities (i.e. specific and actionable outcome goals and care preferences) of older adults with multiple chronic conditions (MCC)

Eligibility Criteria:
Inclusion Criteria:

* Age \>65 years
* Member of Pro-Health Practice for \>=3 years
* Determined to be an appropriate candidate evidenced by ANY of the following:

  * Multiple Chronic Conditions (presence of \>3 active health problems)
  * \>10 medications
  * ≥ 1 hospitalization over the past year
  * ≥ 2 emergency department visits over the past year
  * Seen by \>2 specialists (excluding GYN and eye) over the past year

Exclusion Criteria:

* End stage renal disease
* Unable to consent (e.g. dementia)
* In hospice or meeting hospice criteria
* Nursing home resident
* Not English speaking
Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)

The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
* Age 18 years or older at the time of drug initiation
* Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria:

* Below 18 years of age at the time of BDM or DMARD initiation
* Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
Complexity of the Airflow in COPD

Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. The analyzes evaluate complex signals, including large-scale fractal correlations and distributions in time series, and can provide relevant clinical information.

Measures such as approximate entropy and sample entropy have shown great potential in the evaluation of the complexity of the respiratory system, providing information relevant to the understanding of physiological and pathophysiological processes. These measures are based on the concept of non-linearity in the presence of a high number of interconnections, resulting in the complex behavior exhibited by physiological systems.

The approximate entropy (ApEn) is related to the amount of clutter, complexity or unpredictability of a data series over time. In a complementary way, the sample entropy (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to self-similarity.

A study conducted by our group in asthma patients with different levels of bronchial obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in asthma disorders that are associated with complex changes in the pathophysiology triggering breath control, possibly resulting in changes in air flow (V´).

Considering the development "silent" changes of mechanical ventilation in COPD patients and its clinical relevance, as well as the difficulty of identifying such changes through conventional methods, we observed the need to obtain more detailed information, including the complexity of the system breathing for better understanding of factors that contribute to the illness.

In this context, the objectives of this study were: (1) analyze the influence of airway obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate the diagnostic power of the test in identifying the changes caused by COPD.


Eligibility Criteria:
Inclusion Criteria:

* volunteers with COPD for Patients Group;
* volunteers without any respiratory disease for the control group.

Exclusion Criteria:

* individuals with history of tuberculosis or other lung disease,
* heart disease in general and
* disability in the exams.
Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease

Respiratory disease affects one in five people and is a leading cause of global morbidity and mortality. Chronic obstructive airways diseases encompass conditions characterised by expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality of life. The most common conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years, there has been concerted effort in the scientific and respiratory medicine community to improve the diagnosis and management of chronic obstructive airways diseases using personalised or precision medicine (i.e., tailoring therapies and interventions according to specific "treatable traits") and identifying phenotypes or endotypes using validated biomarkers. To date, however, research in this setting has primarily focussed on people with COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases. The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e., large and small airway involvement) and extra-pulmonary manifestations across the spectrum of chronic obstructive airways, and second, to determine how disease-specific treatable traits associate with physical activity and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of airways disease in accordance with European Respiratory Society guidelines.
* Non / ex-smokers (packs recorded as cigarettes per day / years smoked).
* Male or female aged 18-65 years
* Ability to provide written informed consent.
* Full comprehension of spoken and written English language.
* Cystic Fibrosis patients on triple CFTR modulators (90% cohort)
* Cystic Fibrosis patients on no CFTR modulators
* Healthy controls - entirely asymptomatic, no prior history of inhaler medication use and free from respiratory disease.

Exclusion Criteria:

* Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the past two months.
* Absolute or relative contraindications to cardio-pulmonary exercise testing or submaximal exercise testing.
* Absolute or relative contraindications to pulmonary function testing .
* Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e., pregnancy, recent contrast media administration or subject weight).
* Non-ambulant or musculoskeletal impairment that may affect activities of daily living or maximal exercise testing.
* Significant cognitive impairment (i.e., unable to provide written informed consent or safely / successfully perform tests).
* Currently receiving oxygen therapy.
* Inability to consent.
* Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus infection.
* Lung transplantation
* Diagnosis of cardiovascular disease.
* Abnormal blood screening (anaemia, moderate / severe renal failure etc.)
Symptom Based Treatment of Neuropathic Pain

1. Neuropathic pain in spinal cord injured patients

1. Inclusion criteria

   * pain intensity, visual analogue scale \> 3
   * a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
   * aged ≥20
2. Method

   * Stop pain medications
   * Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)
   * Check pain intensity (VAS score) with Baron's classification

In the present study, pharmacologic treatment included pregabalin and oxcarbazepine.

Stop medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days.

1. Pain intensity (VAS score)

   1. 4 spontaneous characters

      * electric
      * burning
      * pricking
      * numbness
   2. evoked pain

      * allodynia
      * heat hyperalgesia
      * pressure hyperalgesia
2. Location of neuropathic pain

   1. neuropathic pain at level of spinal cord injury
   2. neuropathic pain below level of spinal cord injury

2. Side effects

Eligibility Criteria:
Inclusion Criteria:

* aged than 20 years
* Neuropathic pain symptoms : LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
* Visual analogue scale score of 3 and above

Exclusion Criteria:

* No pregnancy
* systemic disease
* psychiatric disease
Changes in Blood Gases, Disturbance of Breath During Sleep and Cardiovascular Co-morbidity in COPD Patients

Respiration failure type 2 is loss of the lungs ability to take up oxygen (O2) and get rid of carbon dioxide (CO2). The diagnosis is based on blood gas measurement of pressures of O2 and CO2. Patients with COPD is often seen to have co-morbidity with cardiac diseases. Chronic systemic inflammation is seen in both COPD and cardiac diseases. The investigators will investigate the sleep quality, CO2-retention, O2-saturation, cardiac arrythmias and markers of inflammation in 120 patients with COPD in different stages of the disease. Our hypotheses are:

* that the first signs of respiration failure type 2 is seen during sleep with alteration of sleep patterns and greater and more long-lasting retention of CO2 in the blood compared to those with a normal lung function
* that the use of alcohol, zopiclone or supplementary oxygen will make these differences even greater
* that cardiac arrythmias correlates with hypoxemia
* that cardiac arrythmias and respiration failure correlates with degree of inflammation


Eligibility Criteria:
Inclusion Criteria:

* COPD (FEV1 \< 80 % of pred. and FEV1/FVC \< 0,7)

Exclusion Criteria:

* other serious disease (like lung cancer, sarcoidosis, restrictive lung disease)
* exacerbation of COPD within 3 weeks before inclusion
* coronary heart disease with unstable angina pectoris or myocardial infarction within 3 months of incl.
* uncontrolled hypertension
* cerebral infarction
* neurological, muscular or skeletal disease/disorder that affect abdominal- and/or thoracal movements (kyphoscoliosis, paresis, etc)
* unstable diabetes mellitus or signs of organ failure (anaemia, kidney failure, liver failure, etc)
* misuse/dependency of alcohol, sedatives, neurostimulating or narcotic drugs)
* obstructive sleep apnoea/hypopnoea syndrome
* using CPAP/BiPAP or home respirator
* pregnancy
* if PSG shows AHI \> 30, or if patient becomes acutely ill between the nights with PSG, he/she will be withdrawn from the study
Quality of Life After an Ambulatory Reconstruction of the Cruciate Ligament

Study to compare the quality of life after reconstruction of the cruciate ligament in hospitalized versus day-clinic patient


Eligibility Criteria:
Inclusion Criteria:

* rupture of the cruciate ligament

Exclusion Criteria:

-
Use of Indirect Calorimetry in Obesity

The investigators will retrospectively analyze and compare data of 2 groups of overweight and obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE) measured by indirect calorimetry and subjects who followed a diet based on REE estimated by the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known differences between the 2 groups


Eligibility Criteria:
Inclusion Criteria:

* BMI \>25
* Age ranging from 20 to 86 years

Exclusion Criteria:

* BMI\<25
* Age \<20
* Age \>86
Maximizing Outcomes for Preschoolers With Developmental Language Disorders

The objective of the proposed study is to evaluate the efficacy of the Enhanced Milieu Teaching-Sentence Focus (EMT-SF) intervention, implemented by caregivers and interventionists, relative to a control condition enrolling 108 30-month-old children and their caregivers. The central hypothesis is that intervention will result in better overall child language skills at 49 months of age.

A multi-site, phase 2, randomized clinical trial will be used to determine whether communication support strategies are effective for improving language outcomes in children with emergent developmental language disorder.

At study entry, 108 children with emergent developmental language disorder (DLD) at 30 months of age will be randomly assigned 1:1 to either the EMT-SF treatment condition or a Business as Usual (BAU) control group. The control group is necessary to determine the efficacy of the EMT-SF intervention. The EMT-SF group is necessary to evaluate the effects of systematically teaching caregivers to use these strategies. Because all children in the study have language delays that will make them eligible to receive the early intervention services through the state early intervention program, children in both experimental conditions will receive state-provided community-based intervention according to their Individualized Family Service Plan - the current standard of care or from private speech language therapy providers. Children in the EMT-SF condition will receive an additional 18 months of interventionist plus caregiver-implemented intervention sessions. Children in both groups will be assessed at the start of the study and every 3 months until the child is 49 months old. The goal is to enroll all children at 30 months of age and provide a minimum of 60 of the planned 66 sessions of intervention to each child in the treatment condition; however, variability in age at study entry (e.g., 30 months), intervention dosage, and number of assessment data points will be addressed in the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Parent or caregiver (mother, father, grandparent) willing to participate in caregiver training over the full 18 months of the study
* Normal non-verbal cognitive abilities
* Receptive and expressive language delay:
* English as the only language spoken to the child in the home
* Provision of signed and dated informed consent form
* Attempts to imitate 10 words

Exclusion Criteria:

* Diagnosis of a neurodevelopmental disability other than DLD (e.g., Down syndrome, ASD, intellectual disability)
* Caregiver report of a major medical condition (e.g., seizures, cancer, stroke, traumatic head injury, cleft lip/palate, cerebral palsy, legally blind, any genetic diagnosis associated - - Caregiver report of preterm birth (i.e., \< 37 weeks gestation)
* Caregiver report of hearing impairment or audiological testing indicating hearing thresholds \> 20dB
* Caregiver report or direct observation of any problems chewing, sucking through a straw, or blowing bubbles.