cyrilzakka/clinical-trials huggingface dataset:
Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)

Gait pattern difficulties, balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects. There are various treatments used and in recent years, the advent of advanced technologies in rehabilitation and, in particular, devices based on virtual reality, has opened up new possibilities in rehabilitation. Virtual reality is a promising strategy that incorporates many principles crucial to motor learning, such as high-intensity, repetitive, goal-oriented tasks, enhanced synchronized sensory signals, and active participation. The virtual environment is also suitable for personalized treatment based on the needs of the individual patient.

The GRAIL (Gait Real-time Analysis Interactive Lab) is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system, which can be used with both rehabilitation and evaluation goals. To date, there are still few studies of this device in the pediatric field.

The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini, in children and adolescents with congenital and acquired neuromotor pathology.

Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks. The same subjects undergo evaluations before and at the end of the treatment

The study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini.


Eligibility Criteria:
Inclusion Criteria:

* Capable of following verbal requests
* Gross Motor Function Classification System score I to III

Exclusion Criteria:

* Severe spasticity
* Severe cognitive disability
* Severe auditory or visual disability
Surveillance of Rotavirus Gastroenteritis

* Epidemiological studies have shown the diversity of resistance genotypes and the evolution of their prevalence in the paediatric population. This large study conducted in a context of very low vaccination coverage will generate more precise data on the natural epidemiological evolution of rotavirus, notably the G9 genotype, which has appeared relatively recently.
* This study will allow us to identify and document rare or unusual strains of human or animal origin. The complete genetic characterization of these strains will also make it possible to study their ability to recombine and to assess the risk of emergence. Among these still rare strains, the investigators are particularly monitoring G12 rotavirus, whose ability to recombine raises the risk of emergence.
* For at least one of the centres taking part in the study, the paediatric population studied will be given strong vaccination coverage. It will be extremely interesting to compare the results obtained in the vaccinated population with non-vaccinated children to assess the impact of this vaccination on the distribution of rotavirus genotypes


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized or consulting in one of the participating centres since January 2007 for acute gastroenteritis (AGE). AGE is defined by at least 3 soft or liquid stools or at least 3 bouts of vomiting within 24 hours or one of the following signs - diarrhoea or vomiting accompanied by at least 2 additional symptoms among diarrhoea or vomistin, abdominal pain, fever.

Exclusion Criteria:

* Children older than 5 years.
* Children presenting chronic diarrhoea (\> 2 weeks).
* Children presentant immune deficiency.
* Children presenting nosocomial gastroenteritis. The nosocomial nature will be determined by the onset of acute diarrhoea occuring after 48 hours following admission
Speech in Hepatic Encephalopathy (HE)

This is an observational study that will test the clinical significance of speech features in patients with cirrhosis. It aims to assess if speech is associated with cognitive function at baseline, if speech predicts changes in cognition, and if speech predicts future events of hepatic encephalopathy (cirrhosis-related confusion), as well as to assess the dynamics of speech over time, especially with episodes of overt hepatic encephalopathy (OHE) and treatment interventions.


Eligibility Criteria:
Inclusion Criteria for Patients with Cirrhosis:

* Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation
* Able to provide informed consent in English

Exclusion Criteria for Patients with Cirrhosis:

* Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
* Prior stroke or Transischemic Attack (TIA)
* English not primary language for communication

Inclusion Criteria for Patients without Cirrhosis:

* Able to provide informed consent in English
* Fibroscan with stiffness \<7 kPa

Exclusion Criteria for Patients without Cirrhosis:

* Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>5 times the upper limit of normal in the last year
* History of cirrhosis by imaging or histology or clinical decompensation
* Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
* Prior stroke or TIA
Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease

Loss of kidney function results in accumulation in the blood of molecules that are either excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity. Indeed, these URMs have been linked to increased levels of inflammation markers, chronic kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/ or hemodialysis patients. Therefore, interventions that target the production or absorption of URMs from the gut might decrease inflammation and oxidative stress that are commonly seen in the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III) data show that high dietary fiber intake is associated with decreased serum levels of C-reactive protein (CRP) in those with and without CKD and these associations are much stronger in the CKD population. A possible explanation of this effect is that a high fiber diet in CKD patients modulates the bacterial production, intestinal absorption and finally the serum levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease in inflammation.

OBJECTIVES:

Hypothesis:

1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage 4 CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2 CKD (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by the higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4 CKD, and
2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum levels of inflammation markers and urinary levels of transforming growth factor (TGF)-β, a marker of kidney fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with or without diabetes and Stage 1 or 2 CKD (estimated Glomerular Filtration Rate \> 60 mL/min/1.73 m2) with urine dipstick positive for protein or urinary albumin/ creatinine \> 30 mg/g of creatinine; or
* Stage 3 or 4 CKD (estimated Glomerular Filtration Rate \< 60 to 15 mL/min/1.73 m2).

Exclusion Criteria:

* Pregnant women
* Prisoners
* Bowel obstruction
* Enrolled in other interventional studies.
Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.This is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.


Eligibility Criteria:
Inclusion Criteria:

* Children between 1 year and 3 years, 11 months and 29 days of life.
* Be accompanied by legal guardian.
* Apply only one injectable vaccine at the time of the research.

Exclusion Criteria:

* Refuses to sign the consent form.
* Have already been included in the study previously.
Prospective Trial of Two Hypofractionated Radiotherapy Regimens Versus Conventional Radiotherapy in Diffuse Brainstem Glioma in Children

This Trial offers a reduction in patient burden, which is especially preferable in children with a poor compliance and poor performance status. This prospective randomized trial was extension to the previous controlled prospective study performed in Children's Cancer Hospital, Egypt and registered at clinicaltrials.com (NCT01635140). The ultimate aim of this work is to demonstrate noninferiority of the hypofractionated regimens relative to the conventional regimen in a controlled randomized clinical study.

In this study will add a third arm in which we will increase in the total dose to 4500 cGy in 15 fractions in 3 weeks may lead to improvement in Over-all survival or Progression-Free Survival.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed patients with a diffuse intrinsic brainstem glioma
2. Aged 2-18years,
3. Have symptoms for less than 3 months and at least two findings of the neurologic triad: cranial nerve deficits, ataxia, or long tract signs.
4. No performance criteria were required for entry onto the study.

Exclusion Criteria:

* Children were not eligible if they had received any prior therapy other than steroids Treatment
Polycan in Combination With Glucosamine for Treatment of Knee Osteoarthritis

The objectives of this study is to examine the Safety and Eﬃcacy of black yeast beta-glucan produced from Aureobusidium pulluluns SM-2001 (Polycan), in combination with glucosamine in reducing knee osteoarthritis (OA) associated symptoms. This study is a double-blind, randomized, active-controlled trial conducted with 100 OA patients, aged 35-80 years using a formulated product


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of knee osteoarthritis (OA)
* OA ranging from grade 1 to grade 3 by Kellgren and Lawrence system
* Agree to participate into the study

Exclusion Criteria:

* OA ranging from grade 4 by Kellgren and Lawrence system
* Allergic or contradicted with oral NSAIDs (Meloxicam)
* Pregnant and breastfeeding women.
Comparative Evaluation of Cocaine and Adrenaline as Topical Vasonconstrictor Agents in Cosmetic Rhinoplasty

This study aims to compare two vasoconstrictive agents topically applied in cosmetic rhinoplasty: cocaine HCl 5% and adrenaline 1:1000. Blood loss during surgery as well as systemic effect of the studied agents are evaluated.

A prospective non-randomized study is conducted. Female patients undergoing cosmetic rhinoplasty are included in the study.

All procedures are performed by two surgeons, both with more than ten years of experience in cosmetic rhinoplasties. One surgeon uses cocaine as the vasoconstrictor agent of choice in his daily practice, whilst adrenaline is the preferred option for the other. Both practitioners participate in all surgeries, one of them as main surgeon and the other as assistant alternatively until the study is concluded.

Vasoconstrictor effect of cocaine and adrenaline will be assessed by quantitative and qualitative evaluation. Blood loss is quantified by measuring blood aspiration during surgery and gauze weighing. Aspiration is collected in a graduated bottle; at the end of surgery fourty cc of saline is flushed through the suction system. Difference of ribbon gauze weights before and after the procedure is also measured. Adding the previous measurements gives an estimate in blood loss. Qualitative analysis of vasoconstrictive effect is based on evaluation of surgical field by each surgeon using a linear scale of 1 to 5 (1 poor, 5 excellent).

Systemic effect of vasoconstrictor drugs is assessed by heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP) variations during the procedure. Patients are monitored with continuous electrocardiogram tracing and automated blood pressure. Once cocaine or adrenaline packs are placed, measurements are taken every two and a half minutes during the first ten minutes and thereafter every five minutes until the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Provide written consent authorization.
* Preoperatively assessed as ASA l or ll.

Exclusion Criteria:

* Known allergy to any ester based anesthetics.
* Pregnant or nursing mother.
* Any alteration of nasal mucouse that might interfere either with absorption of topical vasoconstrictor agents or with the normal wound healing process.
* Patient has used acetylsalicylic acid or NSAID 5 days prior to surgery including: ibuprofen, diclofenac, naproxen, diclofenac, indometacin, tolmetin.
* Has a known personal or family history of pheocromocytoma or adrenal tumor.
* The patient uses or has a prescribed need for stimulant drugs (amphetamines, ephedrine, norephedrine or pseudoephedrine).
A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's Disease

The purpose of this trial is to assess whether it is possible for subjects with idiopathic Parkinson's Disease to switch from ropinirole, pramipexole and cabergoline to rotigotine transdermal system (SPM 962) overnight without worsening of Parkinson's Disease symptoms.

Subjects who meet eligibility criteria will be switched overnight to treatment with rotigotine transdermal patches at a dose considered equivalent to the dose of dopamine agonist that the subject is currently taking. Subjects on ropinirole or pramipexole will take their last dose at bedtime and then apply rotigotine patch(es) upon awakening the next morning. Subjects on cabergoline will apply rotigotine patches 24 hours after the final dose of cabergoline. Subjects will continue rotigotine treatment for 28 days, during which dose can be increased or decreased as needed. At the end of treatment, subjects can select to enroll in an open-label extension trial.

The first subject was enrolled on 28 December 2004. The last subject was enrolled in June 2005 and the last subject visit was conducted in July 2005. This study is now closed.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease

Exclusion Criteria:

* Not taking a dopamine agonist
The Effectiveness of Pharmacopuncture on Acute Tension Headache

This study is a double blind, randomized controlled trail. condition/disease: acute tension headache treatment/intervention: Pharmacopuncture

"Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.

This treatment is known to be an important part of Korean medicine treatment. However, there has been no specific value for the effect of this treatment.

Therefore, the investigators are going to conduct a randomized controlled trials to verify the efficacy and safety of Pharmacopuncture. From September 2022 to December 2023, the investigators are going to collect 80 inpatients who are suffering from Tension headache with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=40), the investigators will conduct Pharamacopuncture on suboccpital muscle three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=40), just Korean medical treatment except Pharamacopuncture on suboccpital muscles will be conducted.

For these two groups, the investigators will compare Numeric Rating Scale(NRS) of headache, NRS of Neck pain, Headache Disability Index(HDI), Headache Impact Test-6(HIT-6), EuroQol 5-Dimension (EQ-5D-5L) and Patient Global Impression of Change (PGIC)."

Eligibility Criteria:
Inclusion Criteria:

* Patients who needs hospitalization due to acute tension headache that occurred within 7 days after traffic accident
* Patients with NRS ≥ 5 for headache
* Patients aged 19-69 years on the date they sign the consent form
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

* Patients with a specific serious disease that may cause headache: malignancy, cerebral hemorrhage, dural hematoma, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms- Patients who have had surgery or procedures within the last three weeks
* The cause of pain is due to soft tissue disease, not the nerve system disease: trigeminal neuralgia, glossopharyngeal neuralgia, etc.
* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* If pharmacopuncture and acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
* Patients who are pregnant or planning to become pregnant
* Patients with a serious mental illness
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic
Ethnicity Data in HIV Positive Men Who Have Sex With Men

Are there differences between the way that non-White men who have sex with men living in London with HIV describe their own ethnicity and the way in which their ethnic group is recorded in NHS clinics? We aim to describe the way in which clinics in London currently record a patient's ethnic group. Without accurate data for an individual's ethnic group we are unable to draw meaningful conclusions about their experiences of HIV care. It may be the case that patients from particular ethnic groups require specific ways of monitoring and treating their HIV but without knowing if these people are in a particular group any services directed to them may be wasted or underused.

HIV Doctors will be identified at each of the London HIV treatment centres and details of the project will be communicated to them via email.

These doctors will then be sent paper copies of the patient information sheets (PIS), patient questionnaires and clinician questionnaires.

Eligible patients (i.e. men having sex with men with HIV from non-white ethnic groups) will be identified by their doctors and will be asked to read the PIS and complete the questionnaire. This will be a single questionnaire and no follow up for the patient will be required. No personal information (e.g. date of birth, hospital number) will be recorded. Eligible patients will be all those coming to clinic for HIV care between 1st June and 31st of July 2011. Based on estimates from 2009 data held by the HPA, each doctor will on average be asked to recruit 30 patients over the two month period.

The questionnaire will ask questions regarding self description of ethnicity, sexuality, parents' ethnicity, country of birth and other countries of residency (if relevant). It is anticipated that to read the PIS and complete the questionnaire should take no longer than 15 minutes.

The doctor will then return the paper questionnaire (in an addressed envelope supplied) to Dr Williams. Dr Williams will then bring together and analyse the data from the questionnaires and write up her findings for publication and presentation at a national conference.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with HIV
* Male patients who have ever had sex with other men (bi- or homosexual to both be included)
* Patients of non-white ethnicity (patients described as being of "mixed" or "other" ethnicity are to be included)

Exclusion Criteria:

* Female patients
* Male patients who have only ever had sex with women
* Patients whose ethnicity is described as "White"
* Patients unable to read or understand the written questionnaire
Pharmacokinetics of BIBB 515 BS and Effect of Food After Oral Administration in Healthy Subjects

To assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg BIBB 515 dose in capsules as well as the tolerability of BIBB 515 BS capsules


Eligibility Criteria:
Inclusion Criteria:

* Healthy male caucasian subjects as determined by results of screening
* Written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
* Use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial)
* Excessive physical activities (≤ 10 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance