cyrilzakka/clinical-trials huggingface dataset:
Central and Peripheral Fatigue in Individuals With Parkinson's Disease - Evaluation and Training

Fatigue is one of the most common symptoms in individuals with Parkinson's Disease (PD). Past research indicated that more than half of the individuals with PD demonstrated fatigue symptom. The severity of fatigue was also correlated to the quality of life in individuals with PD. Finding the contributions of the central and the peripheral factors to fatigue and developing an effective training program for individuals with PD are very important.

Fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Quantifying the weighting of central versus peripheral factors contributing to the fatigue in people with PD is important.

Most of the conventional strength and endurance training programs were based on the researches of young groups. Almost no training program was design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation is very important for individuals with PD who prone to fatigue.

Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. Combining afferent input with strength training was more effective than strength training along. ES, which is easy to quantify the dose of afferent input, is a feasible method to provide such training.

The purpose of this project is to investigate the effects of the combination of ES at sensory threshold and strength training on voluntary activation in the individuals with PD.


Eligibility Criteria:
Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries for knee.
* Osteoporosis.
* Diabetes.

PD subjects:

Inclusion Criteria:

* Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

* Musculoskeletal injuries for knee.
* Osteoporosis.
* Diabetes.
* Any peripheral or central nervous system injury or disease patients.
Bioinformation Therapy for Breast Cancer

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.

By enrolling patients with unresectable breast cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Automatic Detection of Falls and Near Falls

The aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

The aim of this study is to develop a detailed algorithm which will automatically detect falls and near falls, in the elderly as a general population prone to falls. The algorithm will be used as well in patients with Parkinson's Disease representing neurodegenerative diseases. All participants will arrive at the investigators' gait laboratory for an inhanced assessment, including neurological examination, various questionnaires. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Older Adults
* Parkinson's Disease Patients
* Idiopathic Fallers

Exclusion Criteria:

* Walking Aid
* Other Neurological Diseases than PD
* Significant Disturbance in Vision/Hearing
* History of CVA
* Significant Orthopedic Problem
* Dementia
Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring

Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done.

In this observational study estimation of anesthetic depth by anesthesiologists is compared with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist is included 30 times during study period. The aim of this study is to define conformity between subjective and objective assessment of narcotic depth. In the cases of divergence data of the patient (age, body mass index, comorbidity...), data of the anesthesiologist (age, years of practice...), data of anesthesia (balanced anesthesia, target controlled infusion, endtidal concentration of volatile anesthetic...) and data of the operation (eye surgery, cardiac surgery...) will be analyzed by statistics with regard to underlying or concomitant factors. These findings could help to develop recommendations in the use of EEG-processed monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to be provided for every patient.

Eligibility Criteria:
Inclusion Criteria:

* operation under general anesthesia
* duration of surgery ≥ 10 minutes
* informed consent
* ASA physical status 1-4
* age 1-110y
* performance check of Narcotrend

Exclusion Criteria:

* proximity of EEG electrodes to the operating field
* frontal skin lesion
* frontal cerebral pathology
* hypoxic brain damage
* hypothermia (≤33°C)
* language barrier
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing

The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.


Eligibility Criteria:
Inclusion Criteria:

* Applicants for Huntington's Disease and Presymptomatic Testing
* Aged 18 years and above
* Huntington disease family member
* Subject gave its written consent

Exclusion Criteria:

* No national health insurance affiliation
* Being under guardianship
* Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.
* Patient with movement disorder
Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients By Novel Computed Tomography-Lymphography Guided Technique

A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.

In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.


Eligibility Criteria:
Inclusion Criteria:

* node negative early breast cancer

Exclusion Criteria:

* • Unfit patients for general anaesthesia

  * Previous axillary surgery
  * History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
  * Known hypersensitivity to the dye
  * Patients with clinically positive or suspicious axilla
  * Pregnant females
Emotion Regulation Group Skills Training for Adolescents and Parents

To evaluate if emotion regulation group therapy skills training for adolescents and parents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.


Eligibility Criteria:
Inclusion criteria:

* Being enrolled as a patient at the child- and adolescent psychiatric clinic in Linköping
* Having an adult participant joining the skills training
* Being between the ages of 14-17 years
* Having sufficient knowledge of the Swedish language

Exclusion criteria:

* Clinical diagnosis of schizophrenia
* Clinical diagnosis of psychosis
* Clinical diagnosis of severe anorexia nervosa
* Clinical diagnosis of severe autism spectrum disorder
* Having a cognitive disability
* Having an ongoing drug or alcohol abuse
* Clinical diagnosis of bipolar disorder
* Insufficient knowledge of the Swedish language
Acupuncture in Mothers of Very Low Birth Weight Infants

Does ear acupuncture reduce anxiety in mother of very low birth weight infants?


Eligibility Criteria:
Inclusion Criteria:

* can read and write in portuguese

Exclusion Criteria:

* breastfeeding contraindication
* use of lactogogues
Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure

The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone.

Volume overload is an important clinical target in heart failure management, typically addressed using loop diuretics. An important and challenging subset of heart failure patients exhibit fluid overload despite significant doses of loop diuretics. One approach to overcome loop diuretic resistance is the addition of a thiazide-type diuretic to produce diuretic synergy via "sequential nephron blockade," first described more than 40 years ago. Although potentially able to induce diuresis in patients otherwise resistant to high doses of loop diuretics, this strategy has not been subjected to large-scale clinical trials to establish safety and clinical efficacy. Combination diuretic therapy using any of several thiazide-type diuretics can more than double daily urine sodium excretion to induce weight loss and edema resolution. To our knowledge there are no clinical trials designed to prove the efficacy and safety of combined diuretic therapy (a commonly used therapy) among patients with decompensated heart failure.

Eligibility Criteria:
Inclusion Criteria:

* History of chronic heart failure
* Admission for acute decompensated heart failure
* There is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction
* Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)

Exclusion Criteria:

* Other etiologies of fluid overload different from heart failure
* Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l
* Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission.
* Patients requiring inotropic agents or renal replacement therapies
* Life expectancy \< 6 months
* Prior treatment with thiazide-type diuretics
* Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)
* Pregnancy or breastfeeding period
* Active alcoholism and/or other substance abuse
A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension

The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination

Exclusion Criteria:

* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Early Phase Clinical Trial to Test the Feasibility of an ACT-based Physical Activity Promotion Program for Adults with Depressive Symptoms

The goal of the proposed project is to conduct a feasibility clinical trial comparing group-based acceptance and commitment therapy for physical activity, (ACT; ACTivity) to a time- and attention-matched standard PA intervention (i.e., PA education, goal-setting, and self-monitoring) plus relaxation training comparison condition (Relaxercise) among 60 low-active adults (ages 18-65) with elevated depressive symptoms. Participants will be randomized to treatment condition, followed for 6 months, including the 8-week treatment. Participants will be randomized 1:1 to treatment condition, followed for 6 months, including the 8-week treatment, and receive a 6-month YMCA membership to equate access to PA facilities.


Eligibility Criteria:
Inclusion Criteria:

* Elevated depressive symptoms (CES-D score of greater than or equal to 10)
* Low-active (less than 60 minutes per week of moderate intensity PA)
* Willing and able to attend weekly virtual video sessions via Zoom

Exclusion Criteria:

* Regular mindfulness meditation practice (more than once per week)
* Body Mass Index (BMI) less than 18.5 or greater than 40
* History or presence of any condition that may limit or substantially increase the risks of physical activity
* Active suicidal thoughts or behaviors
* Currently participating in any exercise or weight-loss research studies
* Household member is participating in this study
* Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
* Unable to receive materials in the mail at residential mailing address
* Does not plan to live in Rhode Island for the next 6 months
* Unable to speak, read, and/or write fluently in English
MOTOR PROFICIENCY in RELATION to COGNITIVE FUNCTIONS and SEVERITY in CHILDREN with AUTISM SPECTRUM DISORDERS

To investigate the relationship between cognitive function, the severity of autism spectrum disorder (ASD), and the development of fine and gross motor skills in children with ASD

A sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure cognitive function using the Raven's Progressive Matrices and measure the severity of autism using the Childhood Autism Rating Scale (CARS). These assessments will then be compared with the children's fine and gross motor abilities

Eligibility Criteria:
Inclusion criteria:

1. Children had been diagnosed with ASD.
2. Their chronological age ranged from 5 years to 12 years.
3. Intelligence quotient (IQ) ranged from 55 to 85.

Exclusion criteria:

Any child with the following criteria would be directly excluded from the evaluation for the consistency of the sample and statistically obtained results:

1. The child with ASD and other motor disabilities.
2. Visual or hearing impairment.
Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions

The aim of this study is to evaluate salivary expression of lncRNA DQ786243 as a potential marker for diagnosis of oral potentially malignant lesions compared to normal controls and its effect on salivary expression of miRNA146a.


Eligibility Criteria:
Inclusion Criteria:

* participants will be divided into 3 groups:

Group I: patients suffering from oral lichen planus Group II: patients suffering from leukoplakia Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.

Exclusion Criteria:

* Subjects taking any drugs inducing any changes that could affect the salivary flow.
* Pregnant females.
* Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
* Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms

This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).

It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve subjective wellbeing in trial participants. It is further hypothesized that a second dietary supplement marketed as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.

Eligibility Criteria:
Inclusion Criteria:

* Female over 18 years old
* Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study
* May have self-reported sleep issues
* May have self-reported mild anxiety/depression
* May have self-reported occasional panic attacks

Exclusion Criteria:

* Prior prescriptions for IBS
* Current IBS treatment (e.g. proton pump inhibitors, laxatives)
* Follow an extreme diet intervention
* Experienced severe weight loss in the past 3 months prior to study participation
* Antibiotic usage within 3 months prior of study participation
* Usage any medication or herbal remedies which can affect the GI tract
* Food intolerances/allergies
* Pineapple sensitivity/allergy
* Taking cortisol lowering prescription medication
* Has any of the following medical conditions:

History of GI tract cancers Celiac disease / gluten intolerance GI bleeding Rectal bleeding Heme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate to severe depression/anxiety Moderate to severe panic attacks

- Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Muscle Mass in Patients Over the First Week of ICU Care: RCT

A single-centre, two-arm, parallel randomised controlled trial (RCT) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in ICU. Half of study participants will receive the study intervention (in-bed cycling followed by an intravenous bolus amino acid supplement), while the other half will receive standard of care only.

Critical illness survivors often suffer from severe muscle mass depletion and a profound long-term functional impairment. Hence effective strategies, or a combination of strategies, are needed to reduce skeletal muscle wasting during critical illness. Although amino acids and mobilisation are both known to stimulate the mechanistic target of rapamycin pathway (MTOR) pathway for muscle protein synthesis in healthy adults, there are no trials to date investigating the combined approach of combined cycle ergometry and bolus amino acid supplementation on muscle accretion in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years) admitted to medical/surgical ICUs of Tygerberg Academic Hospital (TBH)
* Expected length of mechanical- or non-invasive ventilation \> 48 hours
* Receiving enteral (EN) and/or parenteral nutrition (PN) as per standard care and for a minimum of 5 - 7 days
* Expected ICU length of stay of 5 - 7 days

Exclusion Criteria:

* Spinal cord lesion or intracranial process associated with muscle weakness
* Acute/chronic degenerative neuromuscular condition
* Fulminant hepatic failure/severe chronic liver disease (MELD score ≥20) or renal failure (based on KDIGO) not on Renal Replacement Therapy
* Untreated thrombosis, or thrombosis where therapeutic levels of anticoagulants have not been reached at the time of inclusion
* Any condition deemed inappropriate by the overseeing doctor- such as precautions or contraindications related to the movement as a result of trauma and/or surgery to the spine, pelvis or lower limbs, or haemodynamic instability.
* Other: imminent death or withdrawal of treatment, pregnancy, lower limb amputation/s or fractures, readmission after previous randomisation, long-term corticosteroid therapy, morbidly obese (BMI ≥ 40kg/m2)