cyrilzakka/clinical-trials huggingface dataset:
Asthma Management Project University Leiden

The long-term course of asthma shows variable outcome with regard to the incidence of exacerbations and the decline of lung function over time. The present study aimed:

1. to investigate whether asthma management additionally guided by the degree of bronchial hyperresponsiveness leads to a better outcome
2. to examine the predictors among clinical and inflammatory disease markers of the long-term decline in lung function

Asthma is associated with a specific inflamma¬tory state of the airways. Assuming that the degree of airway inflammation is a determinant for the long-term disease outcome, it follows that, asthma therapy should be aimed at maximal reduction of airway inflammation, in addition to reducing symptoms. However, according to current guidelines, therapy should only be directed to the clinical severity of the disease. There is increasing evidence that bronchial hyper¬respon¬siveness can be used as a non-invasive reflection of airway inflamma¬tion \[29\]. However, it is still unknown whether bronchial responsiveness provides relevant additional information for adjusting therapy during follow-up of patients with asthma. Therefore, in this study we will:

1. compare the disease outcome in two parallel groups of patients with asthma, receiving therapy aimed at either clinical severity only, or therapy aimed at both clinical severity, and bronchial hyper¬responsiveness to methacho¬li¬ne. The outcome will be assessed at three levels. First, the severity, second, lung function and bronchial responsive¬ness, and third, humoral, cellular, and histological indices of airway inflamma¬tion. To that end we will assess symptoms, lung function, bronchial respon¬siveness, and immunological parameters in blood, every three months. Furthermore, a bronchos¬copy with a bronchoalveolar lavage and bronchial biopsy will be carried out to provide for material for immunologic and pathologic anatomical examination, at the beginning and at the end of the study.
2. analyse the predictors among clinical- and inflammatory parameters of exacerbations and long-term decline in lung function during long-term follow-up

Eligibility Criteria:
Inclusion Criteria:

* Asthma based on GINA guidelines (www.ginasthma.org)

Exclusion Criteria:

* oral steroids
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals aged 19-60 yr
* plasma LDL-C levels \> 3.0mmol/l
* TG \< 4.5mmol/l
* body mass index (BMI) between 20 and 30 kg/m2.

Exclusion Criteria:

* history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
* history of chronic use of alcohol (\>2 drinks/d)
* smoking
* myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months
A Study of Rheumatoid Arthritis Patients on Adalimumab to Evaluate Quality of Life Variables, Effects on Work Productivity and Functional Outcomes in Malaysia

An observational, non-interventional study on social, economic and quality-of-life outcomes of Adalimumab use in participants with moderate to severe active Rheumatoid Arthritis.

This study was designed to evaluate adalimumab therapy in Malaysia on participants' Quality of Life (QoL) using non-invasive epidemiological methods like the Health Assessment Questionnaire - Disability Index (HAQ-DI), the Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS), and the Health Assessment Questionnaire Short Form 36 (SF-36). The primary objective of the study was to evaluate the changes in QoL outcomes in anti -TNF naïve Malaysian RA patients after 6 months of adalimumab treatment. The secondary objectives of this study were to evaluate the changes on QoL outcomes after 1 month and 3 months of adalimumab treatment; and provide an assessment of the safety and tolerability of adalimumab in anti TNF naïve Malaysian Rheumatoid Arthritis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older with a diagnosis of Rheumatoid Arthritis for at least 3 months according to the American College of Rheumatology (ACR) criteria
* Patients who have not been instituted on any anti -Tumour Necrosis Factor (anti-TNF) agents prior to inclusion into this study (anti-TNF naïve patients). Only anti-TNF Naive Rheumatoid Arthritis patients who are scheduled to begin HUMIRA treatment, according to the relevant Summary of Product Characteristics, on the basis of their own physician's judgment (and on the current clinical practice), will be selected for inclusion in this study
* Patients not included in other clinical/observational trials
* Patients providing a written informed consent before the enrollment in the study

Exclusion Criteria:

* Refusal to participate in the study or to sign the informed consent
* Contraindications to adalimumab according to the terms of the local marketing authorization (label)
Loading Gait in Spatic Cerebral Palsy

The purpose of this study is to observe the behavior of kinematic variables in children with spastic hemiparetic cerebral palsy (SHCP), immediately after treadmill gait training with ankle loading.

The children underwent a single treadmill training session with ankle loading. The kinematic parameters were assessed in three phases: before training (PRE); immediately after training (POST); and 5 minutes after the end of training (FOLLOW UP).

The investigators hypothesized that the treadmill gait training with additional lower limb loading would be a disturbance capable of modifying the locomotor strategy of children with SHCP, by the increase in kinematic parameters in the swing phase of gait.


Eligibility Criteria:
Inclusion Criteria:

* Spastic Hemiparetic Cerebral Palsy;
* Being able to walk without an assistive device (levels I or II of the Gross Motor Function Classification System - GMFCS);
* Not having undergone muscle lengthening surgery within the previous year;
* Not having applied botulin toxin to the lower limbs or serial casting in the previous 6 months.

Exclusion Criteria:

* Inability to understand simple commands to perform the training and evaluation;
* Inability to walk on the treadmill with or without load on the lower limbs;
* Presence of any physical pain or discomfort during the course of training.
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking

Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. Amputees choose to walk at speeds 30-40% slower than non-amputees. Preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. Unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. Improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. A prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory.

Hypotheses. Amputees wearing the Massachusetts Institute of Technology (MIT) Powered Ankle-Foot (PAF) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.


Eligibility Criteria:
Inclusion Criteria:

* 20 healthy adult volunteers, 10 unilateral trans-tibial amputees and 10 matched non-amputees, will be recruited and screened
* Amputees must be at least 1 year post-amputation, high-functioning (at least a K3 level of ambulation), and whose cause of amputation is either traumatic or vascular. Medicare defines a K3 level amputee as an ambulator who has the ability or potential for prosthetic ambulation with variable cadence, who has the ability to traverse most environmental barriers and who may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion

Exclusion Criteria:

* None
Prepared Parents Helping Kids

Learning to navigate the US health system is challenging for many new immigrants. This pilot study will determine whether an intervention to teach parents key skills needed to access health care for children is feasible and acceptable to immigrant parents.

This study will also look for evidence of efficacy to inform the planning process for future, larger evaluations of the intervention (i.e., estimate effect sizes).

Parents-particularly those with limited English proficiency (LEP) and limited literacy-may require months or years of experiential learning to master fundamental health care navigation tasks, such as requesting an interpreter. Most programs teaching health care navigation skills are ad hoc and have not be evaluated.

In this study, Investigators will pilot a group-based educational intervention in which a bilingual community health worker will use an interactive curriculum to teach immigrant parents key skills needed to access health care for children.

Parents and caregivers for children \<18 years will be enrolled in closed groups of 6-12 individuals. The 6-12 week intervention will comprise 6 meetings, each of which will be no longer than 75 minutes. Each meeting will focus on one of six skills:

1. Requesting an interpreter;
2. Communicating with a health care facility by telephone;
3. Scheduling appointments;
4. Traveling to health care facilities and registering with the front desk;
5. Obtaining appointments with specialists;
6. Calling 911 for an ambulance.

Each meeting will follow a pre-specified plan that will typically include welcoming activities, a review of prior material, introduction of new material, and a series of activities (e.g., role play) to practice key skills. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years or older
* Parent of a child \<18 years
* Nepali-speaking
* Resident of the US for \<10 years

Exclusion Criteria:

* Scheduled to move away from the study location (e.g., to another city) before the end of the 6-session intervention
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent obtained prior to study procedures
* Histologically- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease
* Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible.
* Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
* ECOG 0 or 1
* Life expectancy of at least 6 months
* Absolute neutrophil (ANC) count greater than 1000/ µL
* Platelet count greater than 50,000/µL
* Estimated GFR \>30mL/min/1.73m2

Exclusion Criteria:

* Known active central nervous system (CNS) involvement by MM
* Systemic rheumatic or autoimmune diseases or acute or chronic infections
* Uncontrolled thromboembolic events or recent severe hemorrhage
* Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels)
* Prior treatment as follows:

  * T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment
  * Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment
  * Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment
  * Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
  * Prior BCMA-directed investigational agents at any time
  * Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time
* Pregnant or breastfeeding
Exercise Capacity of Patients with Dermatomyosis

Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.

The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man\> 18 years,
* Signature of informed consent,
* Muscle biopsy for suspicion of recent inflammatory myopathy (\<6 months) or for exclusion of neuromuscular pathology.

Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:

* "DM" group: DM according to the ENMC criteria;
* "other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
* Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.

Exclusion Criteria:

* - Taking an immunomodulatory treatment within 6 months before inclusion,
* Paraneoplastic form of the disease,
* Presence of associated interstitial pneumonitis,
* Neuromuscular pathology different from inflammatory myopathy,
* Unbalanced cardiovascular disease,
* Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
* Subject under safeguard of justice,
* Subject under tutelage or under curators,
* Pregnancy (positive pregnancy test)
* Breastfeeding.
Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms

Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by identifying underlying causes and tailoring a treatment plan (pharmacological or non-pharmacologic treatments including provision of staff education and support, training in problem solving, and targeted therapy directed at the underlying causes for specific behaviors).

During a 6-months period, patients will be included in both arms, whenever they present a disruptive NPS that requires a specialist consultation based on the long-term care facility (LTCF) staff judgment. In the intervention group, a telemedicine (TM) consultation between the LTCF staff (medical and nurse staff) and the Memory Center from the University Hospital, will occur at inclusion (T0). Then, a second TM consultation will occur at 1 month (T1). In the control group management of NPS will be done as usual care. In both groups, patients' parameters such as non-programmed hospitalizations and/or consultations due to disruptive NPS, psychotropic drugs use, and health costs, will be evaluated at inclusion, 1 month and at 2 months. Acceptability of the TM among the LTCF staff will be assessed during the study in the intervention group.

The two university hospitals are composed of a group of institutions for elderly people located near Toulouse and Limoges.

Eligibility Criteria:
Inclusion Criteria:

* patient aged 65 or more, with a dementia diagnosed by a specialist or the general practitioner;
* patient presenting with a disruptive NPS as defined in French Haute Autorité de Santé (HAS) recommendations (2009), that requires a specialist consultation based on the LTCF staff judgment;
* informed and written consent by the patient or the legal representative or the reliable person when appropriate;
* general practitioner agreement.

Exclusion Criteria:

* patient's life expectancy less than 6 months;
* Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
Thiocolchicoside Injection and Capsule in Treatment of Acute Low Back Pain

To assess two regimens of thiocolchicoside injection and capsule in combination with either diclofenac or ibuprofen in patients with acute low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute low back pain of recent onset (less than 7 days) and defined by spontaneous pain intensity at rest more than or equal to 50mm of the visual analog scale.
* Presence of lumbar muscular contracture

Exclusion Criteria:

* Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), or infective origins
* Patients with psychiatric or mental diseases, or unable to follow the requests of the protocol
* Renal failure (serum creatinine \> 160 µmol/l or \> 1.80 mg/dl) and/or severe hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase and/or total bilirubin \> 2 Upper normal limit).
* Positive history of cerebro-vascular accidents or myocardial infarction in the six months prior the inclusion.
* Severe heart failure.
* Myopathy / myasthenia.
* Patients treated during two days prior to inclusion with steroidal agents.
* Known or suspected hypersensitivity to thiocolchicoside.
* Known or suspected hypersensitivity to nonsteroidal anti-inflammatory drugs
* History of active peptic ulcer or gastro intestinal bleeding.
* History of nonsteroidal anti-inflammatory drugs induced allergic asthma.
* Concomitant treatment with 2-agonists (i.e. clonidine).
* Pregnant or breast feeding women.
* Females of child bearing potential, not taking adequate contraception.
* Patients with history of alcohol, drugs or narcotics abuse.
* Previous inclusion in this study or in another study in the past 6 months.
Modified Sternal Precautions Versus Conventional Sternal Precautions in Physical Function After Sternotomy

This research study Effectiveness of modified sternal precautions versus conventional sternal precautions in improving physical function after sternotomy .After recruitment of the subjects, the intervention group will receive modified sternal precaution while the control group will receive conventional sternal precautions and they will be assess for their physical activity, kinesiophobia, quality of life and post sternotomy pain.

This study will address the scarcity of research and the variations in recommendations regarding sternal precautions and restrictions of upper limb movement in cardiac patients and will help to evaluate the effect of modified sternal precautions on patients' pain and functional activity. As physical therapists are the ones who have maximum exposure to practice and teaching of sternal precautions, therefore this study will help to formulate the guidelines regarding the use of upper limb during cardiac rehabilitation exercises and making standards for sternal precautions and its management following cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Open heart surgery patients (CABG and Valve surgeries)

Exclusion Criteria:

* Unstable vitals
* Patient needing maximum assistance
* Decline consent
Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study

The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study (UDS).

Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization, uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and placement of perineal electrodes are part of the study protocol. During the study the bladder will be filled slowly with sterile fluid and the patient will be asked about sensation of filling. At the end of the study the patient will be asked to void.

Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's emotional health and perception of UDS. To validate the findings from this previous study, the current study aims to implement a MBSR protocol in a randomized prospective study. Patients scheduled for UDS will be randomized into two groups. One group will listen to mindfulness meditation prior to the UDS and the other group won't.

All patients will complete validated questionnaires to assess their satisfaction, anxiety and pain level as well as lower urinary tract symptoms before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients between ages 18 and 99 with clinical indication for UDS ordered by treating physician

Exclusion Criteria:

* None English speakers will be recruited for this study.
* Pregnancy
* Prioners