cyrilzakka/clinical-trials huggingface dataset:
The Effect of Backward Walking Training on Balance, Gait and Functional Mobility in Patients With Multiple Sclerosis

Backward walking training can be a useful treatment approach, providing novel balance and gait challenges. It can lead to improve balance, gait and functional mobility in neurologic populations. However, the effect of backward walking training has net been investigated in people with multiple sclerosis.

Multiple sclerosis is a chronic autoimmune disease of the central nervous system. Patients with multiple sclerosis have problems in balance, gait, and functional mobility. This problems can lead to falls, injuries, hospitalization, limited daily living activities, and decreased quality of life. Backward walking is a popular training approach to improve balance, gait, and functional mobility in other neurological disease such as stroke, and Parkinson's disease. Moreover, backward walking performance decreases in multiple sclerosis. However, no study has been performed to determine the effectiveness of backward walking training in multiple sclerosis. Therefore, this study aimed to investigate the effect of backward walking training on balance, gait, and functional mobility in patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years,
* neurologist-diagnosed Multiple Sclerosis,
* Expanded Disability Status Scale (EDSS) score between 0 and 5.5,
* no MS exacerbation within the last 3 months,
* use of stable medication in the last 3 months,
* not received immunomodulator treatment within the last 6 months,

Exclusion Criteria:

* other neurologic disorder,
* Pregnancy,
* Cardiovascular, orthopedic, or systemic any disease hindering the participation of exercise program
Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study

efficacy of the injectable vitamin C to reduce the time of canine traction

Objective. The purpose of this study is to investigate the role and efficiency of the locally injected vitamin C in the enhancement of the palatally impacted canine movement.

Design. Twelve adult patients with unilateral palatally impacted canines were included in this study. The enrolled patients were randomly allocated into the study groups; control group; orthodontic traction and he test group: orthodontic traction enhanced by intraepidermic vitamin C injection. The study duration was 12 months.

Eligibility Criteria:
Inclusion Criteria:

* medically free
* patient with good to fair oral hygiene (gingivitis may be included)
* both sexes were included
* unilateral palatally positioned permenant canines
* absence of previous orthodontic treatment
* absence of supernumerary teeth, odontoms, cysts, traumatic injuries
* the α angle within grade II to III

Exclusion Criteria:

* systemic diseases especially diabetes and bone diseases
* pregnant and lactating mothers
* Local causes (smoking, mouth breathing, local trauma and periodontitis).
Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises

In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).

Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young wistar albino rats

Exclusion Criteria:

* not having any injury
Interventions for English Language Learners At-Risk for ADHD

The goal of this clinical trial is to compare the effect of language and behavioral interventions for students who are English language learners and who have symptoms of attention-deficit/hyperactivity disorder (ADHD). The main question it aims to answer is:

- Which intervention is better for the students: the behavioral intervention, the language intervention, or a combination of the behavioral and language interventions?

Participants will be asked to do the following:

* Participants' parents and teachers will be asked to complete questionnaires about their behavior.
* Participants will be asked to complete tests assessing language, cognitive, and academic abilities.
* Members of the research team will complete classroom observations for the participating students.
* Participants will be randomly assigned to one of four groups: a school as usual group, a language group, a daily report card group, and a combined daily report card and language group.

  * If assigned to the language group, participants will receive an 18-week language intervention.
  * If assigned to the daily report card group, a behavioral consultant will work with participants' parents and teachers to set up a home-school behavior plan called a daily report card.
  * If assigned to the combined daily report card and language group, participants will receive both the language intervention and the daily report card.
  * If assigned to the school as usual group, participants will no study interventions.

Researchers will compare the language group, the daily report card group, the combined language and daily report card group, and the school as usual group to see which group has the best language learning and classroom behavior at the end of the program.


Eligibility Criteria:
Inclusion Criteria:

* Identified as an English Language Learner Level 1 through 4 by their school district
* Enrolled in kindergarten or 1st grade during the year of participation
* 6 or more symptoms of attention-deficit/hyperactivity disorder endorsed by parent or teacher
* Has a teacher who is willing to participate
* Has a parent or primary caregiver who is willing to participate

Exclusion Criteria:

* Participant has an active Individualized Education Plan for language or behavior
* Participant IQ is less than 70
* Participant is diagnosed with psychosis
* Participant is diagnosed with autism spectrum disorder with severity level 2 or greater or another pervasive developmental disorder
* Participant is enrolled in home-school
Diabetic Foot Ulcer Recurrence: Pilot Study

In this prospective pilot study, patients with DFU visiting the Indiana University Comprehensive Wound Center will be enrolled. Patients enrolled in the study will be followed for 16 weeks for wound closure(Phase A), and will then begin Phase B where TEWL measurements and wound recurrence will be followed up for up to 12 weeks.

Diabetes impairs immune defenses such that the ability to fight wound infection is weakened. Thus, infection is a major problem in diabetic foot ulcers (DFUs) . Biofilms are estimated to account for 60% of chronic wound infections6. In biofilm bacteria are encased within extra polymeric substance (EPS) and become recalcitrant to antimicrobials and host defenses.In the biofilm form, bacteria may not form colony. Thus, standard clinical techniques like CFU to detect infection may not detect biofilm infection. Thus, biofilm infection may be viewed as a silent threat in wound care. Using a preclinical swine model of mixed species wound biofilm infection, we struck an unusual observation. Although biofilm infection may or may not influence the rate of wound closure as measured by standard planimetry, it inevitably compromises the functional property of the repaired skin. The wound may close as evaluated visually, but that closed wound lacks barrier function. Such pathology is caused by the perturbation of epithelial junctional proteins in response to biofilm infection. While detecting the biofilm directly is readily not possible at present in the wound clinics, compromised barrier function of the repaired skin can be detected at the point of care of the measurement of trans-epidermal water loss (TEWL). This pilot study, we propose, many DFUs that are currently served with a CLOSED clinical decision may have had a history of biofilm infection and therefore remained functionally open.

Considering that such incomplete wound closure may have a higher risk of wound recidivism, it becomes critically important that wound closure decisions be guided by functional tests in addition to factors currently considered. Importantly, substantial change in health impact may be achieved by a simple functional test as implemented by the measurement of trans epidermal water loss (TEWL). TEWL can be performed by clinical staff at the point of care within 15 minutes with minimum training using inexpensive hand- held pen like commercial gadgets approved for clinical use.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Willing to comply with protocol instructions, including all study visits and study activities.
3. Diabetic foot ulcers
4. Adequate arterial blood flow as evidenced by at least one of the following:

   1. TCOM \> 30 mmHg
   2. Ankle-brachial index ≥0.7
   3. Toe pressure \> 30 mmHg

Exclusion Criteria:

1. Individuals who are deemed unable to understand the procedures, risks and benefits of the study, (i.e. unable to provide informed consent)
2. Wounds closed or to be closed by flap or graft coverage
3. Prisoners
Colistin Dosage Prsonalization Approach

A few studies have evaluated higher doses or the administration or a loading dose, which is routine in adults, in pediatric patients, and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates? What is the incidence of AKI? What is the factors increasing AKI incidence? A single center retrospective and comparative study, cohort study compare low dose 5 mg/kg/day versus 7.5mg/kg/day

Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose

Eligibility Criteria:
Inclusion Criteria:

* Neonates aged between (0-30 days) born before 37 weeks
* Critically ill patients with nosocomial infection with proven culture-resistant gram-negative bacteria.
* Neonates who are indicated for colistin and started colistin therapy for at least 48 hr.

Exclusion Criteria:

* Serum creatinine ≥1.5 baseline before colistin
* Received colistin before NICU stay
* Administration of concurrent nephrotoxic drugs including amphotericin, gentamicin, or amikacin.
* Major congenital anomalies or with previous renal impairment.
Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine

The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
2. lumbar spinal fusion surgical treatment with PLIF;
3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
4. observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion Criteria:

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.
The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

IL-2 is a pleiotropic cytokine which can regulate or stimulate the differentiation and function of CD4+, CD8+ and NK cells. An opened-labelled trial and a retrospective study have indicated the incidence of infection is lower in the treatment of low-dose IL-2 combined with corticosteroid and immunosuppressor. We are going to conduct a multi-center prospective observational study to verify the above results.

We are going to conduct a multi-center prospective observational study, and plan to enroll 500 SLE patients. Low-dose IL-2 is defined as 100IU IL-2 injected subcutaneously every other day for two weeks, followed by two-week break as one treatment cycle, and at least three weeks.There will be 250 patients in low-dose IL-2 group which treat with IL-2 combined with steroid and immunosuppressor. Non-IL-2 group is only treat with steroid and immunosuppressor. These patients are followed by every one month until get infected, otherwise, patients will be followed for two years. We focus on the type, positive microorganisms, grade and treatment of infection. Then, we will compare the differences of above parameters between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* SLE patients diagnosed by the ACR Criteria of 1987;
* Treated with low-dose IL-2, corticosteroid and immunosuppressor for SLE.
* Consent to participate in this study.
* Regular follow-up for at least 2 years.

Exclusion Criteria:

* Other autoimmune disease;
* Without treatment of low-dose IL-2, corticosteroid and immunosuppressor for SLE.
* Mental disorder without regular or specific treatment.
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON)

The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA).

The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).

This is a first-in-human, randomized, blinded, placebo-controlled, multiple-ascending-dose (MAD) study (Part 1) to evaluate the safety, tolerability, PK, and PD of ION464 in adult participants diagnosed with MSA with a long-term extension (LTE) (Part 2). The study will include up to approximately 40 participants. Part 1 of the study consists of a Screening Period of up to 6 weeks, a Treatment Period of 12 weeks, and a Follow-up Period of 24 weeks. The study duration for each participant in Part 2 will be approximately 96 weeks, which consists of a 72-week Treatment Period and a 24-week Follow-up Period.

Eligibility Criteria:
Key Inclusion Criteria:

* Screening single-photon emission computed tomography (SPECT) with DaTscan™ (ioflupane I123 injection) results demonstrating loss (whether symmetric or asymmetric) of dopamine nerve terminals in the striatum consistent with neurodegenerative parkinsonism, as assessed with qualitative, visual read.
* Diagnosed with probable or possible MSA, either parkinsonian-type (MSA-P) or cerebellar-type (MSA-C).
* Must be able to walk unassisted for at least 10 meters (approximately 30 feet)

Key Exclusion Criteria:

* Presence of cognitive dysfunction (defined as Montreal Cognitive Assessment (MoCA) score \<25)
* Family history of ataxia or parkinsonism and known genetic cause of ataxia or parkinsonism.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Learning Health System for Asthma

This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.

If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.

The UK has amongst the highest rates of asthma in the world as well as some of the poorest health outcomes from asthma.

Investigations into asthma deaths in the UK have found that the way patients were managed in the time leading up to their death could be improved significantly and half of asthma deaths are potentially avoidable. For most people with asthma, symptoms can come and go and sometimes be erratic. To prevent these symptoms, there is a window of opportunity to intervene with the appropriate care. This window occurs between when someone experiences early symptoms like night cough or wheeze and when they experience a full-blown asthma attack.

Most people with asthma receive care primarily in their general practice. General practices have a history of using health information technology to care for their patients. The use of this technology over time has resulted in the creation of rich electronic healthcare data. Through this rich data there are opportunities to create a system whereby clinical management can be benchmarked and improvements highlighted.

This study forms an initial phase of work aimed at developing a learning health system (LHS), whereby data relating to asthma is extracted from patient electronic health records (EHRs) across Scotland, analysed to explore variations in clinical practice and then shared with general practices to highlight any improvements that can be made so that they can better support people with asthma.

If successful, the investigators hope to progress to the main quality improvement phase involving an increased number of practices and then incrementally build this up to cover the whole of Scotland.

Eligibility Criteria:
Inclusion Criteria:

• Patients registered with general practices across Scotland.

Exclusion Criteria:

* Patients from general practices that do not to opt-in to the study.
* Patients with a READ code recording dissent from use of their records for research purposes.
The Brain Activity Changes in the Development of Chronic Low Back Pain

The purpose of this longitudinal exploratory prospective study is to investigate the brain changes in the development of chronic low back pain.

Background and Purpose: Chronic low back pain (cLBP) is an adverse symptom not only to individuals but also to society. It impacts negatively on multiple aspects, such as physical activities, functional ability, quality of life and psychological status. Moreover, cLBP causes economic burden to both individuals and society. However, not all low back pain progresses to chronic condition. Cross-sectional studies have shown brain activated differently in people with cLBP as compared with healthy ones during rest and movement. In addition, lower cortical excitability or stronger functional connections between medial prefrontal cortex and nucleus accumbens were observed in those becoming cLBP according to previous longitudinal studies. Also, image studies have shown a shift in brain regions from pain related areas to those that control emotion and memory. According to these results, the brain activity is related to the persistence of pain. However, how brain activity changes during the chronicity of low back pain is still not fully understood. Therefore, the purpose of present study is to compare the brain changes in people with LBP with or without pain chronicity.

Methods: This is a longitudinal exploratory prospective study. Demographic data will be collected at baseline. The outcomes will be measured at entry of the study and at 24 weeks post-pain. Outcomes include pain intensity which is rated by Numerical rating scale(NRS), and brain activities which is recorded by electroencephalography (EEG) during resting and movement conditions.

Statistical analysis: According to the NRS at 6 month post-pain, the participants whose NRS sore ≥ 2 will be grouped in the cLBP group and those NRS ≤ 1 will be grouped in the recovered low back pain (rLBP) group. Two-way ANOVA with repeated-measures and Tukey's post hoc test will be used to analyze the differences between time and between groups. The changes of pain intensity during movement will be used as confounder for the analysis. Statistical significance is set at p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age≧ 20 y/o
* This is the 1st episode of low back pain in the past year
* Pain in the region of the lower back (bound by the thoracolumbar junction superiorly, and by the gluteal fold inferiorly)
* Pain duration \< 12 weeks
* Average pain intensity in the past 7 days is ≧ 3/10 (Numeric Rating Scale)
* Mini-Mental State Examination ≧ 24

Exclusion Criteria:

* Pain onset duration \< 7 days
* History of chronic pain
* Pain area other than the specify area
* Any systematic disease, fracture or cancer
* Present any neurological sign related to pain
* Infection
* Received any brain or spine surgeries, hip arthroplasty or any other kind of surgeries in the past 3 months
* Diagnosed with any neurological or psychological disease
Lactobacillus Plantarum IS 10560 Supplementation in Women With Functional Constipation

In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days


Eligibility Criteria:
Inclusion Criteria:

* Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)
* Having the symptoms and signs of functional constipation refer to ROME IV
* Able to communicate well
* Able to consume 1 bottle of fermented milk each day for three weeks
* Not using antibiotic no later than one week before supplementation

Exclusion Criteria:

* Diagnosed with functional bowel disorder
* Using anesthesia at least 4 weeks before treatment
* Having a serious pathological disorder (carcinoma)
* During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
* Having severe heart disease
* Taking chronic medications such as antidepressants or analgesics