cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Lumbar Plexus Block Success With Near Infrared Spectroscopy (NIRS)

Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient.

Near Infrared Spectroscopy (NIRS) measures the differential absorption and reflection of near infrared light transmitted by human tissues, providing a tissue-oxygen saturation index. Modern NIRS-based instruments use multiple detectors to filter spectroscopy data from skin structures to detect subcutaneous tissue oxygenation.

Successful regional anesthesia results in decreased sympathetic activity within the distribution of blocked nerves. Regional oxygen saturation (rSO2) has been shown to increase in innervated areas after sympathetic block.

The aim of this study was to show whether the success of lumbar plexus block applied in lower extremity orthopedic surgeries can be evaluated by Near Infrared Spectroscopy (NIRS), which is used to measure tissue oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* femoral neck fracture,
* femoral shaft fracture,
* hip replacement surgery
* who will undergo velumbar plexus block will be included in the study.

Exclusion Criteria:

* BMI\>40 kg/m2
* infection in the block area
* peripheral neuropathy,
* hemoglobinopathy
* peripheral vascular disease
* allergy to local anesthetics
* patients with contraindications for lumbar plexus block
Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy

The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy

In the current clinical study, attempts are made to assess the safety and efficacy of omega-3 fatty acids by comparing between omega-3 fatty acids and the placebo in Korean patients with IgA nephropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patient of both sexes age 18 or above
* Biopsy-proven IgA nephropathy
* Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male)
* Able to give written informed consent

Exclusion Criteria:

* Hypertension SBP\>160mmHg and/or DBP\>100mmHg
* Subject, who in the investigator's opinion, has a systemic disease that would contraindicate participation in this study
* Use of omega-3 fatty acids or analog supplement
* Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception
* Current or recent (within 30 days) exposure to any investigational drug
* Subject who has hypersensitivity to this agent as a previous illness
* Low platelet(\<100,000/㎕) or the subject who has a high risk of bleeding
* Use of corticosteroid during the treatment period or less than 3 months prior to the screening
* Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening
* Subject who in the investigator's opinion, would be confronted with a difficulty
Physiotherapy Critical Thinking in Clinical Practice Questionnaire

A greater need for user-centered care and an evidence-based clinical practice are factors that emphasize critical thinking as a professional competence. Furthermore, critical thinking is an essential competence that allows clinical reasoning, problem solving and decision-making in the critical clinical practice of all specializations in Physiotherapy. However, no instrument has been found that specifically assesses the critical thinking of physiotherapists in their clinical practice.

Multicenter, descriptive, cross-sectional and correlational study in two phases. Phase 1: adaptation of the N-CT-4P to the population of physiotherapists; Phase 2: analysis of the psychometric properties of the new instrument and levels of critical thinking through a cross-sectional study. Sociodemographic and professional variables and variables referring to the measurement of critical thinking (total score of the questionnaire and of each of its dimensions) will be collected. Its psychometric properties, internal consistency, repeatability analysis, discriminant validity and construct validity will be analyzed through confirmatory factor analysis and a multiple regression analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Be a Graduate, Diploma or Bachelor of Physiotherapy
* Have an employment contract, as a care physiotherapist at the time of answering the questionnaire.

Exclusion Criteria:

* Have a contractual continuity of less than 15 days.
Surgical Offloading Procedures for Diabetic Foot Ulcers

100 consenting subjects with Texas grade 1a diabetic foot ulcers will be randomized to surgical offloading or non-operative offloading.

Background: Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence. Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. While casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. The surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient's dependence on expensive shoes and orthotics, with a lower chance of recurrence. The purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or Keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a crossover designed RCT.

Methods: 100 patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. Group 1 (surgery) will have surgery within 1 week. Group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). Following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. If offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. Follow-up will take place till 2 years following randomization. Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications.

Discussion: The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions that the non-surgical options available at present. To promote surgery, randomized controlled trial (RCT) level evidence of efficacy is necessary.

Eligibility Criteria:
Inclusion Criteria:

* Single Texas A1 or A2 ulcer.
* ulcer attributable to an anatomic deformity.

Exclusion Criteria:

* Unable to understand language of informed consent.
* Ischemia.
Can Myotonometry Quantify Dry Needling Effectiveness on Myofascial Trigger Points?

The main objective of this study is to assess effects of Dry Needling into Myofascial Trigger Point compared Dry Needling into Taut Band point based on the outcomes of myotnometric measurement in healthy subjects.

Hypothesis: Deep Dry Needling of the latent medial Myofascial Trigger Point (MTrP) of the soleus muscle will achieve changes in myotonometric measures compared to Deep Dry Needling of the Taut Band of the soleus muscle.

Methods:

It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Toledo older than 18 years.

There will be a MTrP Group (dry needling into the medial MTrP of soleus muscle) and a TB Group (dry needling distal to the MTrP but into the taut muscle band of soleus muscle). The intervention will be a unique session.

Intervention:

Dry needling technique will be performed by locating the taut band and the Myofascial Trigger Point. Depending on the group, a thin needle (0,32x40mm) is introduced 10 times (fast in and fast out) directly within the Myofascial Trigger Point or within the Taut Band.

Assessment:

Myoton device is a simple and portable tool to obtain quantitative and objective assessments of mechanical properties of muscle tone. Myoton has been adopted to characterize the viscoelastic properties of skeletal muscle as tissue displacement when a mechanical perturbation is applied to the muscle.

The device incorporates a probe and an acceleration sensor. The probe was kept perpendicular with its end touching the muscle belly. 10 mechanical impacts (with a duration of 15 ms, a force of 0.4 N and a local deformation in the order of a few millimetres) are delivered to MTrP and TB points.

Outcome measures:

Outcome measures will include myotonometric measurements (frecuency, stiffness and decrement) and they will be evaluated before, at 10 min and 1 week after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-40 years.
* Healthy volunteers.
* Presence of a latent medial MTrP of the soleus muscle.
* Being able to provide written informed consent.
* Being able to follow instructions and realize clinical tests.

Exclusion Criteria:

* Any history of ipsilateral lower limb severe injury or intervention (e.g. fracture, surgical intervention).
* Pain or musculoskeletal injury, ligament injury, tendonitis or plantar fasciitis in the ipsilateral leg for six months previous to the intervention.
* Peripheral or central nervous system neurological disease.
* Altered sensitivity in the treatment area.
* Treatment of a myofascial trigger point in the sural triceps in the six months previous to the intervention.
* Changes in physical activity which would have affected muscle tone during the study.
* Fear of needles.
* No tolerance to pain caused by dry needling.
* No continuance commitment.
Italian Validation of the Revised MDS-Unified Parkinson's Disease Rating Scale

The present study is part of an international program and deals with the translation and validation program for the Italian version of the MDS-UPDRS.

The program will be articulated in three steps:

* Phase I: translation and back-translation of the MDS-UPDRS in Italian (completed)
* Phase II: Cognitive testing. This step is aimed at a preliminary testing of a subset of potentially culturally sensitive items in a limited set of PD patients (approximately 10). Should this phase identify issues in the understanding and ease of use of some items a revised translation of some individual items might be envisaged.
* Phase III: large validation testing: this phase will involve 350 PD patients from 12-14 Italian PD centres.

The IRIS protocol deals with phase II and III of the program.


Eligibility Criteria:
Inclusion Criteria:

* Written and signed informed consent;
* native Italian-speaking patients or either sex;
* patients suffering from Parkinson's disease ranging from mild to severe, based on clinical judgement;
* presence of a native Italian-speaking caregiver.

Exclusion Criteria:

* Patients with evidence of other central nervous system disorders;
* patients with a degree of depression or dementia which may prevent and/or affect ratings.
SPL026 With or Without SSRIs in Participants With MDD

The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine \[DMT\] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.


Eligibility Criteria:
Inclusion Criteria:

* MDD diagnosis
* Previously tried at least one approved method of treatment for their depression
* No monoamine oxidase-inhibitor class antidepressants for at least 3 months
* Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine
* No psychedelic drug use in the 6 months before dosing until the end of the study
* Willing to follow the contraception requirements of the trial
* Willing to be contacted by email and video call, and have online access
* Able to give fully informed written consent
* Test Cohort only: currently on a stable dose of an unspecified single SSRI alone and not in combination with any other psychiatric medications, for at least 6 weeks prior to Screening with no intention of making any changes
* Control Cohort only: no antidepressant medication for 6 months before dosing

Exclusion Criteria:

* Substance use disorder
* Current or clinically relevant history of a psychotic disorder, or first-degree relatives with a clinically relevant history of a psychotic disorder
* Significant history of mania
* Significant risk of suicide
* Clinically relevant abnormal findings at the screening assessment
* Blood pressure, heart rate, or QTcF outside the acceptable ranges
* Acute or chronic illness (other than MDD) or infection
* Clinically relevant abnormal medical history or concurrent medical condition (other than MDD)
* Use of any serotonergic psychedelics within 6 months prior to dosing
* Patients of child-bearing potential who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception
* History of a severe adverse reaction to any drug or sensitivity to serotonergic psychedelic drugs
* Use of over-the-counter or prescribed medication (excluding oral contraceptives, hormone replacement therapy and SSRIs \[Test Cohort only\]) within previous 28 day before dose of trial medication; or paracetamol or ibuprofen within 4 hours prior to dosing
Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease

The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's Disease Endoscopic Index of Severity is the main score used in controlled trials to assess the endoscopic severity of lesions in Crohn's Disease.

The investigators aim to conduct a prospective pilot study primarily to evaluate the applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule endoscopy lead to comparable overall severity evaluations.

Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and to compare these data with those obtained by conventional ileocolonoscopy. If overall severity evaluations derived from the two examinations are not comparable, the secondary objectives will be used in an attempt to understand the reasons of this discrepancy.

Twenty-four patients with CD will be included in the study on the basis of the need for an ileo-colonoscopy whatever the indication.

* Males and females patients more than 18-years-old
* Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
* Ileocolonoscopy scheduled
* Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy.
* Previous imaging of small bowel (one or more) by Small Bowel Follow Through (SBFT), Magnetic Resonance Enteroclysis (MRE) or Computed Tomography Enterography (CTE) performed in the last 12 months

Eligibility Criteria:
Inclusion Criteria:

* Males and females patients more than 18-years-old
* Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
* Ileocolonoscopy scheduled
* Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy

Exclusion Criteria:

* Surgery of one or more segment of the colon or terminal ileum
* Non colonic CD
* High risk for capsule retention defined by the presence of clinically significant obstructive symptom related to intestinal or colonic stricture detected by small bowel imaging
* Stenosis of the colon or ileum not passed by the colonoscope
* Treatment with antiTNF or biotherapy after the ileocolonoscopy and before the CCE procedure
Catheter Ablation Versus Antiarrythmic Drugs for Atrial Fibrillation in China

The mainstay of treatment for atrial fibrillation remains pharmacological;however,catheter ablation has increasingly been used over the last decades. The relative merits of each strategy have not been extensively studied. Our study was designed to determine if catheter ablation is a feasible option as first-line therapy for treating patients with symptomatic AF.


Eligibility Criteria:
Inclusion Criteria:

* 1 Patients with symptomatic AF recorded by ECG or Holter 2 Age:18-75 years 3 Patients who are willing to enroll in the trial

Exclusion Criteria:

* 1 Patients accompanied hyperthyroidism 2 Patients with sever liver or renal dysfunction 3 Patients with sever cardiac dysfunction 4 Patients had previous radiofrequency catheter ablation in the LA or Maze surgical procedure 5 Patients with emboli in atrium 6 Pregnant woman
Autoimmune Basis for Postural Tachycardia Syndrome

The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.

The present study is designed to test the hypothesis that muscarinic autoantibody-mediated parasympathetic dysfunction contributes to the pathogenesis of POTS, and that parasympathetic (vagal) stimulation improves POTS symptoms, autoimmunity and inflammation.

Define and determine the prevalence, burden, and clinical significance of muscarinic autoantibodies in a well-phenotyped cohort of POTS patients with and without gastroparesis and a matched cohort of healthy control subjects.

Evaluate the impact of vagal stimulation on antibody suppression, inflammatory inhibition, and symptom improvement in POTS patients. Non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve (tragus stimulation) will be used to increase parasympathetic activity.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old, female or male
* Either healthy control or individual with postural tachycardia syndrome (POTS) defined as heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\>6 months), and in the absence of other acute cause of orthostatic tachycardia
* Able and willing to provide informed consent
* Understand and be able to comply with the study procedures and restrictions

Exclusion Criteria:

* Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening
* Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min of standing)
* Cardiovascular disease, such as myocardial infarction within 6 months
* History or presence of significant immunological or hematological disorders
* History of vagotomy
* Currently pregnant women or women planning on becoming pregnant ≤ 3 months
* Inability to comply with the protocol
* Patients with active implants (such as a cardiac pacemaker, or a cochlear implant)

Healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. Healthy control subjects will be group-matched to the POTS patients for age and gender.
Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)

The aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted T\&E home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable Alzheimer's Disease.

Primary and secondary outcomes will be measured at T0 (one week before the begin of the intervention) and T1, (one week after the eight weeks of the intervention) at home of the participants.

Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session.

Twelve participants will take part at this study.

Eligibility Criteria:
Inclusion Criteria:

* Must living at their own home,
* Clinical diagnosis of mild or probable Alzheimer's Disease,
* Must be medical stable,
* Must be able to walk with or without assistive device without physical assistance of another person,
* Must be able to follow one-step commands,
* Family caregiver's must agree to participate at the training sessions.

Exclusion Criteria:

* Severe vision and verbal impairment,
* Any serious orthopaedic condition,
* Any major neurologic or musculoskeletal comorbidity that might affect their functional mobility,
* Any limiting cardiac or pulmonary condition.
Comparing the Performance of 1 Day Multifocal Contact Lenses

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.

The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 42 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
7. Has refractive astigmatism no higher than -0.75DC;
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; near addition or LOW, MEDIUM, HIGH).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Habitually wears one of the study contact lenses;
3. Has any known active\* ocular disease and/or infection that contraindicates contact lens wear;
4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
5. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
6. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
8. Has undergone refractive error surgery or intraocular surgery.