cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

To date, several studies have focused on the use of transcranial direct current stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of tDCS.

Background:tDCS was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented.

Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of highfrequency tDCS in DOC.

Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of DOC
2. Ages 14 to 65 years old
3. No centrally acting drugs
4. No neuromuscular function blockers and no sedation within the prior 24 hours;

Exclusion Criteria:

1. History with nervous or spirit disorders, or some other serious diseases
2. A contraindication for tDCS
Indirect Approach of C0-1 and C2-3 Segments in Flexion-rotation Test

Restrictions on upper cervical spine are associated with cervical pain. The vast majority of upper cervical spine rotation occurs at the C1-2 segment. Flexion-rotation test is a valid measure that predominantly measures rotation in C1-2 segment, however upper cervical spine rotation also implies C0-1 and C2-3 due to ligament anatomy. Restriction in flexion-rotation may be due to direct restriction in C1-2, but also to a premature tightening of the alar ligament as a result of lack of movement in C0-1 or C2-3.

The objective is to compare the effect of a 20-minutes single cervical exercise session with or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test in patients with chronic neck pain and positive flexion-rotation test.

To carry out the objective, the following will be designed a randomized controlled assessor-blind clinical trial with primary healthcare patients.

This population will be patients with chronic neck pain and positive flexion-rotation test. These patients will be assigned in manual therapy + exercise group or in exercise group.

Exercise will be focused on deep anterior cervical muscles. Manual therapy will combine techniques in C0-1 and C2-3 with this exercise. Flexion-rotation test, neck pain intensity, pain intensity during the flexion-rotation test and cervical range of motion will be measured before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* A medical diagnosis of chronic neck pain with more than 3 months of evolution.
* A positive result in the flexion-rotation test (less than 33º or a difference of 10º or more between the two rotations).
* Being over 18 years old.
* Having signed the informed consent.

Exclusion Criteria:

* Contraindications for manual therapy or exercise.
* Having participated in exercise or manual therapy programs in the last three months.
* Presenting warning signs or having suffered a relevant neck trauma.
* An inability to maintain supine position.
* The use of pacemakers (the magnets in the CROM device could alter their signal)
* An inability to perform flexion-rotation test
* Language difficulties.
* Pending litigation or lawsuits.
Short Term Feeding for Asian Patients With Liver Cirrhosis

The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in Asian patients with cirrhosis who were admitted to hospital for decompensation.

Consecutive patients with decompensated cirrhosis who fitted the inclusion criteria, will be randomised to either naso-gastric or oral feeding. Total feeding will be for 2 weeks only. Following intervention specific nutritional and liver-related parameters will be measured during the 2 weeks and up to 6 weeks later. Comparison between both groups will then be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients with decompensated cirrhosis of any etiology.

Exclusion Criteria:

* Advanced hepatic encephalopathy,
* Variceal bleeding,
* Hepatocellular carcinoma.
The Effects of Ergonomics Awareness Education and Exercise

This study aims to determine the effects of asynchronous and synchronous exercises, which are added to ergonomics awareness education, on musculoskeletal disorders, physical activity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-45
* Working at home at least 5 hours a day
* Not having one or more diagnosed musculoskeletal disorders

Exclusion Criteria:

* Limited access to technology or not being able to actively use the technology
* Had musculoskeletal trauma or surgery
* Pregnancy
Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.

Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Severe or recalcitrant shoulder impingement syndrome
* Subacromial injection is a therapeutic option

Exclusion Criteria:

* Allergy or intolerance to steroids within less than 1 month
* Allergy or intolerance to NSAIDs within less than 1 month
* Pregnancy
* Breastfeeding
* Pre-existing asthma
* Uncontrolled psychiatric illness
* Previous shoulder injection within the past 3 months
* Evidence of confounding shoulder pathology on imaging
* History of a full-thickness rotator cuff tear
* Ipsilateral cervical radiculopathy
* Moderate to severe glenohumeral arthritis
* Systemic inflammatory conditions
* Kidney disease
* Liver disease
* Gastrointestinal ulcer
* Bleeding disorder
* Pending litigation or work-related claims related to the shoulder
* Previous shoulder surgery on the affected shoulder
* Evidence of local infection
* Evidence of adhesive capsulitis
* Evidence of shoulder instability
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis

The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).

AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.

Eligibility Criteria:
Inclusion Criteria:

* Participants 10-70 years of age
* Diagnosis of AD
* History of AD for at least 3 years
* AD affecting greater than or equal to 5% and less than or equal to 40% of total body surface area (BSA) at Baseline
* Investigator's Global Assessment of Disease Severity score of 2 (mild) or 3 (moderate) in the selected treatment area(s)

Exclusion Criteria:

* Contact or atopic dermatitis flare within 28 days of the Baseline (Day 1) visit.
* Concurrent diseases/conditions and history of other diseases/conditions in the selected treatment area(s) that may have an impact on the study assessments.
Effect of Lens Presentation on the Clinical Oculomotor Assessment at Near

This study will compare near clinical oculomotor parameters (heterophoria, vergence ranges, AC/A and accommodative findings) measured when lenses and/or prisms are introduced using three different instruments namely: (i) a standard manual phoropter, (ii) an electronic phoropter and (iii) a wearable adaptive refractor (VisionFit).

Previous studies have demonstrated differences in a number of near oculomotor parameters \[e.g., heterophoria, accommodative convergence to accommodation (AC/A) ratio\] when measured in a manual phoropter versus a trial frame. These differences may be due to variations in proximal vergence, differences in head and eye position and restriction of the peripheral visual field. Further, a number of standard clinical oculomotor procedures require the use of Risley rotary prisms. While prism is typically introduced in a smooth, ramp-like fashion with manual phoropters, step changes in prism are created with electronic phoropters. The precise effect of these variations on clinical measurements is unclear. Accordingly, after a routine refractive examination, a standard clinical near assessment (comprising near heterophoria, AC/A ratio, horizontal vergence ranges, amplitude of accommodation and negative and positive relative accommodation) will be carried out on the same individuals through: (i) a standard manual phoropter (American Optical model 11625), (ii) an electronic phoropter (Topcon CV-5000) and (iii) a wearable adaptive refractor (VisionFit). The latter resembles a trial frame mounted on a helmet carrier (similar to a binocular indirect ophthalmoscope headset) but includes adaptive lenses that can be changed electronically.

Eligibility Criteria:
Inclusion Criteria:

* Corrected visual acuity of at least 20/20 (logMAR = 0.0) or better in each eye

Exclusion Criteria:

* Strabismus, amblyopia, manifest ocular disease.
TCOM Ring Evaluation

Subjects that are currently on a transcutaneous carbon dioxide monitor (TCOM) to monitor the carbon dioxide level in their blood will be placed on an additional TCOM using a non-adhesive sensor application ring instead of the usual adhesive ring to hold the TCOM sensor in place in order to evaluate usability of the non-adhesive applicator.


Eligibility Criteria:
Inclusion Criteria:

1. Premature or term birth newborn infants requiring transcutaneous monitoring
2. Thigh circumference of greater than 63mm
3. Weight greater than or equal to 600g
4. Ability of caretaker to understand verbal and written instructions and informed consent

Exclusion Criteria:

1. Absence of written informed consent.
2. Skin condition contraindicating transcutaneous measurements.
3. Thigh circumference less than or equal to 63 mm
Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study

The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.

In four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. During the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. The investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. The 400 patients with polyneuropathy include the following subtypes of polyneuropathy: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), vasculitis polyneuropathy, Polyneuropathy-Organomegaly-Endocrinopathy-Monoclonal protein-Skin changes (POEMS syndrome), Multifocal Motor Neuropathy (MMN), Charcot Marie Tooth (CMT), hATTR amyloidosis, Diabetic Polyneuropathy (DPN), and idiopathic neuropathy.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria patients:

\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)

Inclusion Criteria healthy controls:

\> 18 years Healthy

Exclusion Criteria:

Exclusion Criteria patients:

Not verified polyneuropathy

Exclusion Criteria healthy controls:

Diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy
Extended-release Naltrexone for Alcohol Dependence in Primary Care

Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.


Eligibility Criteria:
Inclusion Criteria:

* Current alcohol dependence
* Age 18 or older
* English or Spanish-speaking
* Without untreated severe mental illness
* Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal
* Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly
* Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence
* If female of child-bearing potential, must be using adequate contraception
* Able to understand study procedures

Exclusion Criteria:

* Currently opioid dependent or requiring ongoing treatment with opioids for any indication
A Trial of TTA-121 on Autism Spectrum Disorder

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on Autism Diagnostic Interview Revised (ADIR)
2. Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
3. Written informed consent for participating the trial

Exclusion Criteria:

1. Diagnosis of bipolar disorder or schizophrenia spectrum disorder
2. Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectr um disorder
3. Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
4. History of changes in medication or doses of psychotropics within one month before registration
5. Current treatment with more than one psychotropics
6. History of hyper-sensitivity to oxytocin
7. History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
8. History of alcohol-related disorders, substance abuse, or addiction
9. Family history of male breast cancer
10. Subject who has severe complications
11. Known hypersensitivity to some drugs and foods
12. Subject who is not able to consent contraception during study period
13. Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
14. Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products

This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.

In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.

Eligibility Criteria:
Inclusion Criteria:

* Indication for diagnostic or therapeutic EP intervention
* EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:

  * BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)
  * BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
  * BIOTRONIK transseptal sheath (Senovo Bi-Flex)
* BIOTRONIK EP product is planned to be used within its intended purpose
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site

Exclusion Criteria:

* Age less than 18 years
* Pregnant or breastfeeding
* Prior participation in this study with performed EP procedure
* Participation in an interventional clinical investigation in parallel to the BIO\|COLLECT.EP study
Pharmacokinetics of Intravenous Metamizole in Children Less Than 6 Years Old

This study aims to assess the PK parameters of metamizole following a single IV administration of metamizole in children less than 6 years of age.

This is an open-label pharmacokinetics (PK) study. It aims to assess the PK parameters of metamizole and its metabolites following a single IV administration of metamizole (10mg/kg) in children less than 6 years of age.

Thirty-nine children, 3-72 months of age, undergoing elective surgery at the University of Basel Children's Hospital, will receive, on the day of surgical procedure, a single dose of metamizole 10 mg/kg. After this dose, blood and saliva samples will be obtained at predetermined post-dose time points to measure concentrations of metamizole and its metabolites. The maximal duration of subject participation will be 24 hours. Plasma PK parameters (AUC, Cmax, Tmax, t1/2) of each analyte will be derived using noncompartmental methods. A population PK approach will be applied to characterize inter-subject variability and quantify the potential influence of age, sex and body weight on the PK parameters.

There are no published pharmacokinetic studies of metamizole in pediatrics. Furthermore, although Swissmedic provides no dose information for IV administration in infants with a body weight of less than 9 kg, IV is the most frequently used route of administration for direct postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg. Due to the absence of data and the lack of any dosing recommendation for infants with a body weight less than 9 kg, the IV administration of metamizole in infants is "off-label" and inconsistent across hospitals and prescribing paediatricians.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children 3-72 months of age at time of inclusion
* Body weight more than 5 kg at time of inclusion
* Children undergoing elective surgery at University of Basel Children's Hospital (UKBB) with planned administration of intravenous analgesia
* Patients who require surgical procedures that necessitate at least 24 hours in the hospital
* Parent/Legal guardian has been informed about the study and has signed Informed Consent Form

Exclusion Criteria:

* Infants and children who were born prematurely (before 37 weeks gestation), regardless of corrected gestational age
* Known kidney or liver disease
* Known neutropenia, anemia or other hematological disorders
* Known diagnosis of asthma
* Ongoing immunosuppression, except corticosteroid treatment, or primary immunodeficiency
* Treatment with strong inhibitors or inducers of CYP2C19 within 3 months prior to study
* Treatment with drugs known to induce agranulocytosis within 3 months prior to study
* Documented previous adverse reaction to metamizole
* Treatment with metamizole within 30 days prior to screening
* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study
* Family members of investigators