cyrilzakka/clinical-trials huggingface dataset:
User-centred Assistive System for Arm Functions in Neuromuscular Subjects

Restore a lost function is a special experience for people affected by neuromuscular evolutive diseases. "From the patient's point of view improvement is measured by regaining lost abilities,-by being able to do something -anything-today I couldn't do yesterday ". Upper limb pain, stiffness and activity limitations have a crucial role in reducing patients' autonomy and worsening quality of life.

Real users' needs have been identified thought several workshops, and even if the commercial products might assure a benefit to some users and meet most of their requirements, so far a validation of the use of such devices by people with neuromuscular disease is missing.

We aim at field-testing the improvement in arm functions provided by the use of some commercial devices and assessing their impact to users' quality of life and independence. This step is essential to assure a widespread accessibility to these devices for most of the potential users, possibly providing health providers with direction and guidance towards Health Technology Assessment.

Clinical Trial design - The study proposes on-field validation of JAECO WREX, passive antigravity exoskeleton; and Armon Ayura, motorized arm exoskeleton for gravity compensation in a randomized controlled trial with crossover design. The clinical study will is multi-centric, involving both MEDEA and VALDUCE, and received the Ethical Committee approval.


Eligibility Criteria:
Inclusion criteria

* signed informed consent (we will expose the family the aims of our study and carefully describe the need of compliance with them)
* diagnosis of muscular dystrophy (genetic, histological and biochemical if necessary),specifically with Duchenne, Becker and Limb Girdle type 2 muscular dystrophy. No muscle biopsy will be performed, except in case there is a diagnostic need.
* being wheelchair bound
* having a scoring at the MRC scale for upper limb at the deltoid, biceps, triceps brachii muscles ranging from 2 to 4.

Exclusion criteria

* presence of additional diseases (for example: family history of mental retardation, epilepsy, cerebral palsy)
* behavioral and psychiatric disturbances (emotional problems, depression)
* absence of compliance to the study of the family and the caregivers
Central Venous Pressure and Right Atrial Pressure Measurements in Supine, Semi-recumbent and Trendelenburg Position

Intensive care is directed towards patients with severe illness or risk of serious outcomes following, for example, surgery. Central venous pressure (CVP) is an important part of the hemodynamic assessment of patients in surgery and the intensive care unit (ICU). CVP is normally measured via a central venous catheter (CVC) inserted through the subclavian or internal jugular vein, with the tip placed at the junction to the right atrium. A pressure tubing is connected to one of the branches of the CVC and then connected to a pressure sensor that sends a digital signal to the monitoring screen where CVP can be read in mmHg. To accurately read CVP, the pressure sensor must be positioned at the level of the right atrium. Different external reference points are used nationally and internationally to locate the correct height for the pressure sensor. This study aims to investigate the most commonly used external reference points for CVP measurement in various body positions compared to CVP measured via a solid state pressure catheter in the right atrium (RAP).

A Millar Mikro-Cath solid state pressure catheter is inserted through one of the medial lines of the CVC and guided in position by the pressure curve and verified in position by ultrasound.

CVP is compared to RAP in supine, semi-recumbent, Trendelenburg and lateral position.

CVP, RAP and arterial pressure is recorded in each session with Biopac Acqnowledge.

In each body position PEEP is raised 5 cmH20 and then lowered 5 cmH20.

Ventilator settings, capillary refill time, perfusion index are collected in each setting and before and after PEEP adjustments.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients in mechanical ventilation with an arterial line and a four or five lumen CVC.

Exclusion Criteria:

* under 18 years of age
* in a dynamic phase of their illness i.e. ongoing treatment of severe circulatory or respiratory failure
* positive end-expiratory pressure (PEEP) \>14 cmH20 or intolerance to change of body position.
Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points

The investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with KOA. The safety of acupuncture will also be assessed during the study period.

Participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; Participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. Patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(KOA) are eligible to participate in the study
* The following criteria are used for diagnosis of KOA:

  * refractory knee pain for most days in the last month;
  * joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in X-ray);
  * laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3;
  * morning stiffness continues less than 30 minutes;
  * bone sound exists when joints was taking flexion and/or extension. If a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is confirmed.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

* diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis;
* present sprain or trauma in the lower limb;
* unable to walk properly due to foot deformity or pain;
* present with mental disorders;
* present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;
* females who are pregnant or lactating;
* using physiotherapy treatments for osteoarthritis knee pain;
* have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months;
* received knee-replacement surgery;
* diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic classification) or late clinical stage of KOA;
* have a swollen knee or positive result of floating patella test; or'
* are participating or have participated in the other clinical trials.
Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® IV

This is non-interventional study of voriconazole IV formulation in clinical use, which was mandated by the Korean government agency following the approval of Vfend in the Republic of Korea.


Eligibility Criteria:
Inclusion Criteria:

* Invasive aspergillosis and other serious fungal infections.

Exclusion Criteria:

* N/A
Evaluation of Filtering Blebs Using the "Wuerzburg Bleb Classification Score" Compared to Other Clinical Findings, e.g. the Intraocular Pressure (IOP)

It is well established to assess the functionality of a filtering bleb by intraocular pressure (IOP), either as an absolute value or as a percent reduction, and by the need of additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a clinical score, e.g. the "Wuerzburg bleb classification score" (WBCS). The purpose of this study was to find out whether there is a correlation between clinical findings, in particular IOP and the WBCS.

100 eyes within two years after trabeculectomy were included into the study. Using colour photographs the filtering bleb was evaluated according to the WBCS from two different examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical history were taken by another examiner.

* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria: Diagnosis of glaucoma, status post trabeculectomy

Exclusion criteria: age \<18 Jahre, other optic neuropathy than glaucoma
Novel Skin Care Product for the Management of Acute Radiodermatitis

Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT.

Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed.

The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.

Primary objective Evaluate the efficacy of a novel emollient for the management of ARD in comparison with the current standard of care in breast cancer patients

Secondary Objective 1 Compare the ARD-related symptoms of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 2 Compare the dermatologic quality of life of in breast cancer patients treated with the novel emollient and the standard institutional skin care.

Secondary Objective 3 Correlate the severity of ARD with the applied RT parameters and personal - medical characteristics

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer and underwent lumpectomy or mastectomy
* Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE)
* Age ≥ 18 years
* Able to comply to the study protocol
* Able to sign written informed consent
* Signed written informed consent

Exclusion Criteria:

* Previous irradiation to the breast region
* Metastatic disease
* Patients with pre-existing skin rash, ulceration or open wound in the treatment area
* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
Physiological Values When Breathing in an Air-pocket. Mountain Lab 2019 (ML2019)

The literature describes and report neurologic intact patients surviving an avalanche several hours after they were buried. The most important factor for surviving more than 15-35 min of burial is considered to be the presence of an air-filled space around the head and neck, termed an air pocket. Little is known how the inspired air is influenced by the patients breathing and how oxygen and carbon dioxide diffuse through snow.

In a controlled and simulated avalanche scenario the investigators want to investigate how oxygen (O2) and carbon dioxide (CO2) diffuse and how rebreathing of CO2 in addition to mild hypoxia influence standardized physiological parameters in two scenarios: Fresh air and no fresh air delivered into the air pocket. The project is a field study designed to measure and document gas diffusion through snow. The outcome measures are: (1) Concentration of O2 and CO2 in the air pocket and 50 cm from the pocket. (2) Time interval for development of threshold values for concentration of O2 and CO2. The investigators will also monitor physiologic measures such as: Electrocardiogram (ECG), continuous invasive blood pressure, cerebral oximetry, continuous pulse oximetry, transthoracic impedance, and gas content in expired air. Subjective evaluation of comfort will also be scored. Twenty healthy young volunteers with written consent to participate will be used as test subjects.

The study may have a clinical consequence for better outcome, for victims of avalanches by providing additional air or oxygen close to the patient. The study will also measure specific body measures and spirometry.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be Healthy
* Subject must be non smoking
* Subject must have normal BMI

Exclusion Criteria:

* None
Nocturnal Continuous Positive Airway Pressure in Chronic Obstructive Pulmonary Disease Patients

Static hyperinflation is frequent in Chronic obstructive pulmonary disease (COPD) , resulting in increased end expiratory lung volume and positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Static hyperinflation worsens the work of breathing is increases patient's dyspnea.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Chronic obstructive pulmonary disease (COPD) is characterized by an airflow obstruction, inducing a flow limitation. As a consequence, we observe in these patients an increased end expiratory lung volume and a positive end expiratory pressure (PEEPi) at the end of a normal expiration.

Patients are breathing at higher pulmonary volumes: this is the concept of static hyperinflation.

This worsens the breathing pattern because in this situation, the work of breathing is increased such that dyspnea increases.

The application of a continuous positive airway pressure (CPAP) has been shown to improve static hyperinflation and to decrease the work of breathing.

Sleep is deteriorated in COPD patients, and causal factors includes static hyperinflation, cough, depression. Moreover, normal physiological changes occuring during sleep in COPD patients are leading to deterioration of gaseous exchanges. The purpose of our study is to assess the effect of nocturnal CPAP on sleep quality and functional respiratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic obstructive pulmonary disease patients exhibiting a FEV1\<80 %,

Exclusion Criteria:

* Known sleep apnea syndrome or other sleep disease interfering with sleep quality
* Body mass index \> 30 kg/m2
* heart failure
* hypnotics intake
Health Education Model Led by Community Health Volunteers.

The goal of this intervention study is to investigate the level of knowledge, attitudes, and behaviors of students on schistosomiasis in Pemba Island. It aims to test the effectiveness of establishing a widely applicable Community Health Volunteers model in the Zanzibar region and explore the feasibility of promoting this model in other areas of Africa. This study also aims to provide valuable insights and references for global schistosomiasis prevention and control efforts.

The main questions it aims to answer are:

Conducting a survey to understand the current knowledge levels, attitudes, and relevant health behaviors of Pemba Island students towards schistosomiasis.

Performing qualitative research to analyze the factors influencing students' knowledge, attitudes, and behaviors related to schistosomiasis, as well as observing the facilitators and barriers to conducting health education among student groups, in order to provide a scientific basis for targeted intervention measures.

Testing the effectiveness of establishing a widely applicable community health volunteer model in the Zanzibar region and exploring the feasibility of promoting this model in other regions of Africa, thereby providing insights and references for global schistosomiasis prevention and control efforts.

Participants will select fourth and fifth grade students from two schools located in high-risk schistosomiasis prevalence areas on Pemba Island, with Kilindi Primary School as the intervention group and Shumba Viamboni or Chambani primary school as the control group from Feb 2024 to Feb 2025. Apart from the KAP survey, urine samples will be collected from students three times at least and the prevalence confirmed to compare the effectiveness of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Individuals whose grades fall within the scope of the survey Students who have not received health education intervention on schistosomiasis conducted by community health volunteers Students or parents who agree to sign informed consent and participate in the study Students residing in schistosomiasis-endemic areas

Exclusion Criteria:

* Students whose grades are not within the scope of the survey Students who have already received health education intervention on schistosomiasis Students or parents who refuse to sign informed consent or participate in the study Students who have been diagnosed with other serious illnesses.
Lipid Profile and Weight After Pregnancy

A randomized controlled trial aiming to investigate the effects of diet behavior intervention postpartum on body weight and lipid and metabolite profile in overweight and obese women in Oslo, Norway


Eligibility Criteria:
Inclusion Criteria:

* Women admitted to Adipol, Oslo University Hospital, Norway (outpatient clinic for women with overweight or obesity during pregnancy)

Exclusion Criteria:

* Twin birth,
* Non-Norwegian speaking
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation. The conventional approach for post-procedure care has been for the patient to stay overnight and be discharged the next day. However, the overall incidence of procedure related complications of catheter ablation for atrial fibrillation in high volume centers is low. New technologies have been introduced and improve the safety of the ablation procedure. Discharging patients the same day after ablation is a practice that's currently followed by many centers in the United States and abroad. The investigators' hypothesis is that the currently available advanced technologies allow for the same-day safe discharge of patients after catheter ablation. The investigators propose a prospective single-arm study to evaluate the feasibility and safety of the same-day discharge after AF ablation at MGH. The protocol of same-day discharge will include the use of a commercially available venous closure device, early ambulation, bed-side echocardiogram, and follow-up phone calls at day 1 and 3 post-procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 - Age \< 75 yr
* Documentation of atrial fibrillation (AF) or atypical atrial flutter
* All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements

Exclusion Criteria:

* Heart failure with reduced ejection fraction less than 40%
* Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
* INR \> 4.0 at the time of the procedure
* Mental impairment precluding verbal consent or completing follow up
* Patients with any other significant uncontrolled or unstable medical condition
* Women who are known to be pregnant or have had a positive β-HCG test within 7 days prior to procedure
* Presence of left atrial thrombus
* Patients with prior prostate hypertrophy or bladder surgery
* BMI \> 40 or BMI \<20
* Patients with h/o symptomatic heart failure
* Patients with severe aortic stenosis (AS) or severe mitral regurgitation (MR)
* Patients who require femoral arterial line for blood pressure monitoring
Intensive Instruction on the Use of Aricept

The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.

To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV.
* Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
* Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.
* Outpatients in their own home.

Exclusion Criteria:

* Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment.
* Known hypersensitivity to donepezil or piperidine derivatives.
* Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
Study on the Pharmacokinetic Characteristics of I.V. Hepabig Injection Used for Prevention of Hepatitis B Relapse After Liver Transplantation

An exploratory clinical trial to evaluate the pharmacokinetic characteristics of I.V. Hepabig injection used for prevention of hepatitis B relapse after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≤18 years old
* Patients who understand the informed consent form and signed the form voluntarily
* Patients who underwent liver transplantation due to HBV related disease and will be treated for prevention of hepatitis B relapse after liver transplantation

Exclusion Criteria:

* Multi-organ recipient or reimplantation
* IgA Deficiency
* Serious nephropathy
* Serious cardiovascular system failure within 6 months
* Ischemic or hemolytic anemia
* Condition of immunosuppression and immunodeficiency
* Hypersensitivity or allergic to blood products
* HIV or HCV positive
* Participation to other clinical trial within 3 months
* Pregnancy or breast feeding
* Those who the investigator determines inappropriate to participate