cyrilzakka/clinical-trials huggingface dataset:
Using Hypnosis and Virtual Reality During Pre and Postoperative Cardiovascular Surgery.

Nowadays, the use of cognitive behavioral therapies has become quite common in the clinical care. Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of acute and chronic pain (Pourmand et al., 2017; Vanhaudenhuyse et al., 2009). A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception.

100 patients who are undergoing a cardiovascular surgery at the Liège University Hospital will be randomly assigned to four conditions (control, hypnosis, VR and VRH). Each participant will receive two sessions of one of the techniques: one the day before the surgery and one other session the day after, in intensive care units.

Physiological parameters will be taken and participants will fill in a questionnaire which evaluates their level of perceived immersion, their level of anxiety, fatigue, pain and relaxation. A short interview will also be conducted to give participants the opportunity to openly describe their experience.

This study will help to expand the knowledge regarding the influence of these techniques on patient's cognition, perception and sensation .

Primary outcome (anxiety) and secondary outcomes (pain, fatigue, relaxation and physiological parameters) will be investigated at four measurement times: the day before the surgery (Day -1) before the intervention (T0: baseline) and after the intervention (T1); the day after the surgery (Day+1) before the intervention (T2) and after (T3).

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing cardiac surgery
* Who have given consent for their participation.

Exclusion Criteria:

* Psychiatric antecedents
* Claustrophobia
* Acrophobia,
* Heavy hearing
* Visual impairment
* Infectious cases (example: conjunctivitis)
Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.

Treatment of dermatophyte infection in our country is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness and feasibility of a newer antifungal drug like voriconazole is the need of the hour in resistant cases.

Objective: To compare the efficacy of oral 200 milligram voriconazole once a day vs twice a day in the treatment of resistant dermatophyte infections (tinea corporis and cruris).

Material \& Methods: This randomized controlled trial using non-probability sampling technique will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval from ethical review committee of the hospital has been taken. Total 106 patients will be divided into two groups, Group A and Group B, each consisting of 53 patients. Group A will be given oral voriconazole 200mg once a day and Group B will be given twice a day for a maximum of 28 days. Efficacy will be assessed at day 14 and day 28, and relapse will be noted at the 2-month follow-up visit. Data will be recorded on a preformed Proforma for each patient and wiil be analyzed using SPSS 24. A p-value of less than 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Resistant cases of tinea cruris and tinea corporis: Those cases who received the standard dosage of oral antifungals i.e. oral terbinafine 5mg/kg per day for 4 weeks or oral itraconazole 5mg per/kg/day for 4 weeks but they did not recover from the infection.
2. Skin area: Groin and trunk
3. Total diameter of the lesions: 5cm to 80 cm

Exclusion Criteria:

1. History of hypersensitivity to azoles
2. All those individuals having immunocompromised state (malignancy, tuberculosis, AIDS, history of organ transplant and history of immunosuppressive drug treatment etc.)
3. Patients of diabetes, liver or kidney disease.
4. Lactating mother
5. Pregnant female
Primary Aldosteronism In Hypertensive Patients in China

To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly diagnosed hypertension.

This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai, Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and saline infusion test) will be performed if the result of case detection is positive. This study will be completed in two years.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed hypertension(with a course less than six months);
2. Drug negative, or voluntary to discontinue/change the anti-hypertensive medications;
3. Aged between 18-80 year, gender is not limited;
4. Voluntary to sign on the informed consent.

Exclusion Criteria:

1. patients with severe cardiac, hepatic or renal dysfunction;
2. suspicious or confirmed other types of secondary hypertension, including Cushing's syndrome, pheochromocytoma and renal artery stenosis.
Selective Versus Routine Shunting in Carotid Endarterectomy Patients

The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.

The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.

The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of \> 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is \< 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a SP \>= 50 mmHg will be randomized to receive a shunt or not receive a shunt.

Exclusion Criteria:

* Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of \> 30%.
* Finally, consented patients with a stump pressure of \<= 50 mm Hg will be excluded from the study and receive standard of care.
Sensory Phenotypes of Autism Spectrum Disorder

This project plans to establish sensory phenotypes of a Taiwanese ASD cohort across lifespan, including variety of sensory modalities, sensory domains, and clinical correlates.

Also, we will clarify the relationship between sensory phenotypes and social impairment by two specific sensory-social paradigms targeting eye gaze avoidance and social touch anxiety, as well as the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.

Sensory disturbance of autism spectrum disorder (ASD) are life-long highly-impairing challenges for the individual. Anxiety and fear around the sensory issues significantly threatens the psychological and mental health. As a newly introduced diagnostic criteria of ASD, sensory characteristics becomes a recent focus of ASD research. The ASD population is aging, how their sensory features naturally change with age is particular relevant for their adaptation. However, current literature are limited to childhood and young adults and mostly rely on behavioral report, lacking a clear whole picture of changing sensory phenotype in terms of different sensory modality and sensory domains. Besides, how sensory characteristics in ASD can be quantified by objective measures or explored by qualitative approach, how the sensory sensitivity contributes to the core social deficits in ASD such as eye gaze or social touch avoidance are unclear. This project plans to achieve the following aims:

1. Establish sensory phenotypes of a Taiwanese ASD cohort across lifespan, including variety of sensory modalities (i.e., visual, tactile, auditory, smell/taste, proprioception, etc.), sensory domains (i.e., low registration, sensory seeking, sensory sensitivity, and sensory avoiding), and clinical correlates.
2. Clarify the relationship between sensory phenotypes and social impairment by two specific sensory-social paradigms targeting eye gaze avoidance and social touch anxiety, which are hallmarks of ASD. Factors of emotion types as well as familiarity of faces or social/object touch will be manipulated to examine how they moderate eye tracking and pupil response.
3. Identify the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.

Eligibility Criteria:
Aim#1

Inclusion Criteria:

* Diagnosis of autism spectrum disorder Aim#2 and #3

ASD group:

Inclusion Criteria:

* Diagnosis of autism spectrum disorder
* Age above 12-40 years old

Exclusion Criteria:

* No diagnosis of autism spectrum disorder
* Pregnant woman
* Metal implant in the body

TD group:

Inclusion Criteria:

* No diagnosis of autism spectrum disorder
* Age above 12-40 years old

Exclusion Criteria:

* History of major psychiatric disorders
* Pregnant woman
* Metal implant in the body
DEXCOM ONE: Continuous Glucose Monitoring in the Real World, Utility of Sustained High Alerts

The purpose of this study is to gather feedback on a new continuous glucose monitor (CGM), called DEXCOM One. Unlike some other CGMs which allow a low (hypoglycaemic) and a high (hyperglycaemic) glucose alarm to be set, the DEXCOM One sensor has the unique feature of the 'Sustained Hyperglycaemic Alert', where the alarm is only activated if the glucose is above a certain threshold for a pre-specified amount of time.

International consensus guidance states that people with diabetes should aim for 70% time in the range 3.9-10 mmol/L. After meals there is usually a rise in blood glucose, so it is not unexpected for the glucose to go above 10 mmol/L for a short time even if the insulin dose already given before a meal is correct. Therefore, people with a high glucose alarm set at 10 mmol/L on their GCM may unnecessarily inject extra insulin and risk a low blood glucose. However, DEXCOM One's Sustained Hyperglycaemic Alert would only notify patients if their blood sugar was high for a prolonged period, and so may reflect a time when it would be genuinely advantageous to inject more insulin.

The aim of this single-centre, non-randomised, observational study is to gather experience from a range of users to assess the utility of this unique attribute, and the optimal settings. We aim to recruit 80-100 patients, and each participant's involvement is in 2 phases; for the first 3 months DEXCOM One sensors will be used, and for months 4-6 there will be the option of continuing to use the DEXCOM One sensors with the addition of a FitBit to track physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18+ years
* A patient registered in the diabetes service at Sheffield Teaching Hospitals NHS Foundation Trust
* HbA1c within the last 3 months of \>70 mmol/mol

Exclusion Criteria:

* Unable to provide informed consent
* Unable to communicate in written and verbal English
Efficacy of rTMS in the Treatment of Patients With Migraine

Migraine is a condition thought to be related to cortical hyperexcitability. Repetitive transcranial magnetic stimulation (rTMS) can modulate the cortical excitability by means of long-term potentiation or long-term depression. This study will will test the safety and efficacy of rTMS in the treatment of patients with Migraine.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-65 years
* Diagnosed as migraine (with or without aura)
* More than 4 attacks per month for at least 3 months prior to study
* No preventive medication used
* Must be able to sign permit

Exclusion Criteria:

* History of seizure or family history of seizures
* Women in pregnancy or breast-feeding
* Patient with medication overuse
* Patient with other medical, psychologic, or surgical illness
* Patient under preventive medications
* Prior rTMS examination one month within
Family Involvement in The Treatment Of a Mentally Ill Relative

* Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities
* Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients.
* We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the "Experience of Caregiving Inventory".

* The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks;
* Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large.
* The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle.
* Participants will be asked to fill the "Experience of Caregiving Inventory" twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.

Eligibility Criteria:
Inclusion Criteria:

* siblings of persons with mental illness

Exclusion Criteria:

* persons junior then 18 years old
3V- Improve Venous Access in Pediatric Anesthesia

Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.

Eligibility Criteria:
Inclusion Criteria:

* children aged less than 7
* DIVA score ≥ 4
* patient needing venous peripheral access for general anesthesia

Exclusion Criteria:

* no social security
* opposition of the parent(s) to the participation of their child in the trial
Clinical Evaluation of Extensive Direct Composite Restorations With Polyethylene Fiber

The aim of this clinical trial was to compare the clinical performances of composite resin restorations with/without the polyethylene fiber to the first permanent molar teeth with extensively carious pediatric patients. A total of 75 restorations with (FC; n=38)or without (C; n=37) fiber were placed in the first permanent molar teeth.

Restorations were evaluated at baseline-6-12-18 months according to the modified-USPHS criteria. Data were analyzed with Chi-Square and Cochran's Q (p\<0.05).

Fiber reinforced composite restorations developed in recent years have been presented to improve the negative properties of composite resin systems applied by the traditional method thanks to the fact that the fibers act as a crack stopper, reduce polymerization shrinkage by decreasing the the mass of composite resin material between the remaining dentin structure and the fiber. Many authors having conducted tremendous experience in this field of research have reported that the polyethylene fiber is an innovative approach because it not only increases the flexural strength but also improves fracture toughness. Its woven fiber orientation provides the stresses to be dispersed throughout the restoration, and therefore reinforces the restoration and the remaining tooth structure in multiple directions.

Eligibility Criteria:
Inclusion Criteria:

* no hypoplasia or any tissue abnormality in the teeth,
* deep dentin caries with three tubercle loss in the teeth, need of three surface restorations with coverage of at least two adjacent cusps.
* no evidence for pulpal complications
* in occlusion

Exclusion Criteria:

* partly erupted teeth;

  -.absence of adjacent and antagonist teeth
* poor periodontal status;
* adverse medical history;
* potential behavioral problems.
Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors

The objective of this pilot randomized controlled single blinded, parallel-group study is to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired stroke survivors.

The current proposal aims to conduct a pilot randomized controlled single blinded, parallel-group study design to detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1) experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute HEP. A blinded assessor will complete assessments on each subject at three distinct time points of pretest, post intervention, and 1 month post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a stroke resulting in a Upper Extremity Fugl Meyer score \>17 \< 49
* Experienced a post stroke \> 6 months
* \> 24 on the Folstein Mini Mental Status Examination
* Experienced only one stroke
* Discharged from all forms of physical rehabilitation intervention
* Visual acuity of 20/50 or greater with or without corrective lenses
* \> 19 on the Hooper Visual Organization Test
* Unilateral stroke only
* Cerebral stroke
* Age of onset of stroke greater than 18 years old.

Exclusion Criteria:

* \< 18 years old
* \> 5 on a 10-point visual analog pain scale in the affected UL
* \> 2 on the Modified Ashworth Scale in the affected UL to exclude individuals with hypertonia, spasticity, joint rigidity, and joint contracture
* Participating in any experimental rehabilitation or drug studies
* Uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
* Neurological disorder other than stroke
* \> 31 on Beck Depression Inventory ("Severe Depression")
* Unable to regularly attend treatment sessions and follow-up due to distance from the center or inadequate social support
* Cerebellar stroke with ataxia
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Eligibility Criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

* Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
* Must have a baseline EDSS between 0.0 and 5.0, inclusive.
* Must have relapsing-remitting disease course.

Key Exclusion Criteria:

* Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
* Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Pharmacokinetic Study With Repeated Doses of Stalevo

The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained
* Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms.
* Hoehn and Yahr stage 1-2.5 performed during the "ON" state.
* Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg.
* Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period.
* Age within 30-72 years, inclusive.

Exclusion Criteria:

* Secondary or atypical parkinsonism.
* Patients with moderate to marked wearing-off symptoms or any unpredictable "OFF"-periods.
* Patients with treatment-related peak-dose dyskinesia.
* Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks.
* Use of any iron preparations or other chelating agents.
* Patients with a history of a laboratory abnormality consistent with, or clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness, which may influence the outcome of the study.
* History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
* Any abnormalities in laboratory values, vital signs or electrocardiogram (ECG) with clinical relevance.
* Patients using any antiparkinsonian drugs for rescue medication (including soluble levodopa formulations).
* Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
* Known hypersensitivity to active substances or to any of the excipients of the study drugs.
* Participation in other drug studies within 60 days prior to study entry
* Unsuitable veins for repeated venopuncture.
* Blood donation or loss of significant amount of blood within 60 days prior to the screening.