cyrilzakka/clinical-trials huggingface dataset:
Clinical Study for Development of Oral Galactose Single Point (OGSP) Solution (G.S.P. Oral Solution®)

The primary objective is to determine the oral galactose single point (OGSP) cutoff values to discriminate subjects with different hepatic function. The secondary objective is to analyze the correlations between OGSP and other hepatic function assessment methods among this trial subjects.

A novel, simple, clinically useful quantitative liver function test, called the galactose single point (GSP) method, was developed to assess residual liver function by measuring galactose blood concentration 1 hour after galactose was administered (0.5 g/kg). The galactose single point (GSP) method has been used to evaluate liver function in both humans and rats, and GSP concentration has been found to closely reflect changes in enzyme activity and hepatic blood flow. The Federal Drug Administration of the U.S. has recommended the GSP method in its guidelines for industry pharmacokinetics for patients with impaired hepatic function (FDA 2003). The GSP method has also been successfully applied to measure the clearance of drugs that are excreted from the liver but not metabolized, such as promazine and cefoperazone, specifically in patients with various liver diseases. Hu et al. demonstrated that GSP concentration is strongly correlated with the severity of liver disease.

This translate the traditional GSP method to oral galactose single point (OGSP) that will greatly improve the technical simplicity and reduce the burden to patients and will easily applied to patient both in hospital and home to measure the residual liver function.

Eligibility Criteria:
Inclusion Criteria:

Subject must fulfill all of the following criteria to be eligible for the study:

1. Male or female with age between 20-85.
2. Ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires.

Exclusion Criteria:

Any of the following criteria will disqualify the subject from participation:

1. History of serious allergic reaction to galactose and have galactosemia.
2. History of receiving total gastrectomy, subtotal gastrectomy, celiac disease, or small intestinal resection.
3. History of diabetes mellitus.
4. Subjects are children or handicapped people.
5. Subjects with any other reasons considered by the investigator not in the condition to enter into the trial.
Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG

The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.
2. Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.
3. This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 89.
* Able to give verbal consent.
* Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.

Exclusion Criteria:

* Individuals \< 18 and \> 89 years of age.
* Unable to given verbal consent.
Acupressure for Fatigue in Ovarian Cancer Survivors

The purpose of this study is to see if accupressure can help reduce the severity of fatigue experienced by ovarian cancer patients. Acupressure involves applying mild to moderate physical pressure by fingers, hand or a device to specific points on the skin to try to bring about a change in the body's functioning, in this case relief from chronic fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 21 and older
* Diagnosis of ovarian cancer, stages I to IV
* Have average persistent fatigue defined a \>=4 on the Brief Fatigue Inventory.
* Fatigue must have started at or after the diagnosis of ovarian cancer
* Completed all primary cancer treatments (surgery, chemotherapy at least 6 months prior), except maintenance therapies
* No other planned interventions for fatigue other than current stable medication

Exclusion Criteria:

* Medically unstable
* Acupuncture or acupressure receipt in past year
* Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder
* Have a current diagnosis of anemia
* Have a current untreated diagnosis of hypothyroidism
* Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy, etc., or any planned change of medications, supplements or therapies during the study
* Have the possibility of becoming pregnant
The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress

Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Having symptoms of respiratory distress that begin soon after birth,
* \> 34 gestational age,
* \>1900 gr birth weight,
* Family consent

Exclusion Criteria:

* Congenital anomaly
* Chromosomal anomaly
* Hydrops fetalis
* Congenital heart disease
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion

The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.

A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion.

Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days:

* Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged)
* Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days.

The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days.

End of study evaluation will occur at day 90±7 or premature discontinuation.

Eligibility Criteria:
Inclusion Criteria:

1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
2. Age ≥18 years old.
3. The mRS score was 0-1 before onset.
4. ASPECT score of infarction on emergency CT ≥7.
5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \<100 mL, and low perfusion brain tissue volume/ infarct core volume\> 1.2.
7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).

Exclusion Criteria:

1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
4. Taking ACEI antihypertensive drugs regularly and could not stop.
5. Participant with major surgery or severe trauma in the past 2 weeks.
6. Poor compliance and cannot fully follow the study protocol.
7. Pregnancy or lactation.
Ultrasound Guided vs Unguided Intra-articular Knee Injections

To determine the accuracy of unguided versus ultrasound (US) guided knee joint injections in obese patients with no clinically detectable effusion.

Patients with BMI \> 30 and no clinically detectable knee effusions, with clinical symptoms and radiographic evidence of knee osteoarthritis or inflammatory arthritis, who have been referred for an intraarticular knee injection with corticosteroid will be randomized to either receive ultrasound guidance or not receive ultrasound guidance for their injection. One group will use the ultrasound guidance to position the needle. The other group will use landmarks to position the needle. For both groups, once the proceduralist is comfortable with needle placement for the injection, contrast dye will be injected and fluoroscopy used, to determine if the needle placement is correct. If it is determined the needle placement is not correct, fluoroscopy will be used to reposition it. Once needle placement is determined to be acceptable, the injection will be given. Patient demographics will be collected, along with pain scores preprocedure and two weeks post-procedure.

Subjects are responsible for all clinical costs associated with the injection.

There is no remuneration offered for study participation.

Eligibility Criteria:
Inclusion Criteria

* BMI \> 30
* No clinically detectable knee effusion
* Clinical or radiographic evidence of knee osteoarthritis or inflammatory arthritis
* Must be referred to the Pain Clinic for treatment

Exclusion Criteria

* History of surgery on the affected knee
* Evidence of untreated systemic infection or systemic immunocompromise
* Evidence of cutaneous infections near the study knee injection site
* Patients on warfarin with an INR \> 3.0
* Patients on oral antiplatelet or anticoagulant medications will be excluded if they have documented evidence of renal insufficiency (GFR \< 60)
* History of iodinated contrast allergy or significant reaction to corticosteroids or lidocaine
Interest of Catalepsy in the Hypnotic Trance

Catalepsy seems to facilitate hypnotic induction and deepen hypnotic trance, although no work confirms the usefulness of this technique which is in common use in hypnosis. Furthermore, it has been shown that the hypnotic trance state is accompanied by an increase in parasympathetic tone, the non-invasive measurement of which is easy by the ANI monitor (Analgesia Nociception Index).

The research hypothesis is that, by adding a body dissociation, catalepsy could facilitate and intensify the hypnotic trance, the intensity of which can be monitored and is proportional to the parasympathetic tone.

After randomization, subjects will either benefit from the normal hypnotic trance, or from the hypnotic trance associated with catalepsy of the hand.

T0 = installation in a sitting position and collection of an accompanying theme T1 = induction of the hypnotic trance (closing eyes) with restitution of the theme to the patient and suggestion of comfort over a period of 5 to 10 min T2 = validation of comfort by a pre-established signal T3 = return to consciousness (opening eyes) T4 = end of questionnaire about absorption, dissociation and time perception

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Arrhythmia (atrial fibrillation, pacemaker, defibrillator)
* Autonomic nervous system disorder (paraplegia, epilepsy, etc.)
* Pregnant or breastfeeding woman
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties
Ostomy Belt Use Associated Quality of Life

The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.


Eligibility Criteria:
Inclusion Criteria:

* Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
* 18 - 70 years old
* Willing and able to sign informed consent

Exclusion Criteria:

* Patients without stoma or unwilling to wear ostomy belt.
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients

To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes.

The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.

To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program, patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end of training program (T1). The patients will be divided into 2 groups and will conduct two different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of Rome and will perform, in addition to conventional therapy, gait training using an end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait rehabilitation program(Conventional Group, CG).

Eligibility Criteria:
Inclusion Criteria:

* first cerebral stroke
* 2 weeks up to 6 months post the acute event (subacute patients)
* age between 18-80 years
* ability to fit into the end-effector footplates
* no significant limitation of joint range of motion
* ability to tolerate upright standing for 60 seconds
* ability to walk unassisted or with little assistance
* ability to give written consent
* compliance with the study procedures

Exclusion Criteria:

* contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
* medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
* cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
* cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing

Written informed consent was obtained from each subject.
Vitrectomy for Optic Disc Pit Maculopathy

The purpose of this study is to evaluate the efficacy of vitrectomy, without gas tamponade or laser photocoagulation to the margin of the optic nerve, for the treatment of macular detachment associated with optic disc pits and to characterize retinal manifestations during treatment of optic pit maculopathy using optical coherence tomography (OCT). Vitrectomy with induction of a PVD at the optic disc without gas tamponade or laser photocoagulation appears to be an effective method of managing macular detachment due to optic disc pits. OCT scanning pre- and postoperatively suggests that peripapillary vitreous traction with the passage of fluid into the retina through the pit is the cause of the schisis-like separation seen in optic disc pit maculopathy.


Eligibility Criteria:
Inclusion Criteria:

* eyes with optic disc pit maculopathy

Exclusion Criteria:

* eyes without macular elevation associated with optic disc pit
Update on the Detection of Frailty in Older Adults

The main objective is to update the diagnostic assessment of frailty by correlating several variables with the ultrasound image of the frail elderly patient.

Secondarily, the investigators intend to collect and analyze data on functional capacity and quality of life variables on the evolution of musculoskeletal symptoms, as well as on pain and psychological variables. Similarly, it is intended to make a record of different profiles and subtypes of frail older adult patients to be stored in Machine Learning in order to establish therapeutic intervention plans that allow both the evaluation and treatment of patients.

The present cohort study will be conducted in 500 older adults diagnosed with frailty.

The correlation of the demographic variables, physical functionality tests and psychoemotional constructs that will be analyzed in this study with the ultrasound image obtained from the patients will improve the ultrasound diagnosis of frailty, providing new information that will facilitate the work of healthcare personnel in the diagnosis and management of frailty.

Similarly, the use of Machine Learning will allow institutions to extract data on different patient profiles, signs and symptoms of frailty and the different risk factors that affect frailty patients, which will improve treatments and favor the development of educational programs tailored to the patient's needs.

Eligibility Criteria:
Inclusion Criteria:

A diagnosis of signs and symptoms of frailty by a geriatric physician in the research group will be used as the primary inclusion criterion. Frailty will be assessed and diagnosed using the frailty phenotype and the Clinical Frailty Scale.

Exclusion Criteria:

* Acute myocardial infarction in the last 3 months and/or unstable angina pectoris
* Uncontrolled arrhythmia, recent thromboembolism and terminal illness.
* Patients undergoing MMII unloading or MMSS/MMII fractures in the last three months.
* Patients with a functional gait index of 1 (Inability to walk)
* Severe pain (7/10 VAS)
* Previous neuromuscular pathology presenting with weakness
* Medication that does not allow the patient's actual muscle reaction to be assessed
* Severe cognitive impairment that would prevent collaboration and understanding of the tests to be performed.
* Cardiovascularly unstable patients and uncontrolled arterial hypertension.
Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
Haskap and Endurance Running Performance

This study will employ a randomised, double-blind, placebo-controlled, independent groups experimental design. Submaximal, maximal and 5 km time trial running performance will be assessed before and after supplementation with haskap berry or a placebo.

Participants will consume haskap berry powder or an isocaloric placebo for 7 days. They will be required to run on a treadmill before and after supplementation to asses the influence on the intervention on aerobic performance parameters. Other performance parameters such as blood lactate, heart rate, ratings of perceived exertion and respiratory variables will also be monitored throughout the various elements of the exercise trials.

Eligibility Criteria:
Inclusion Criteria:

* healthy non-smoking males
* completed a 5 km run (in less than 25 minutes) within the 6 weeks prior to the study

Exclusion Criteria:

* female
* allergies to fruit or dairy, currently taking any nutritional supplements (e.g. vitamins, antioxidant, herbal or sports enhancing supplements) or medication that might affect the study outcome
* history of gastrointestinal, renal or cardiovascular disease
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors

The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.

Cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. Preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. However, the best exercise mode and intensity has not been well established. Little is known regarding the long term effect. No study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* stage 0 to II breast cancer diagnosed within 5 years
* complete adjuvant therapy \> 2 months, except hormone therapy
* \> 18 years

Exclusion Criteria:

* disease in progress, recurrent, or metastasis
* medical or musculoskeletal condition which resistance exercise is contraindicated
* medication which may alter exercise response
Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis

This project aims to evaluate the effects of an evidence-based training program in combination with an antiinflammatory dietetic intervention on quality of life for patients with knee osteoarthritis

Osteoarthritis (OA) is the most prevalent arthritic disease worldwide characterized by pain, effusion and stiffness leading to functional decline and reduced quality of life (QL). It has been long considered as a degenerative disease of cartilage resulting from bodily wear and tear that affect the entire joint structure. However, there is accumulating evidence that inflammation plays a key role in the OA pathogenesis. Triggered from tissue damage and by metabolic dysfunction, inflammatory processes within the joint may trigger the development of chronic low-grade inflammation.

Factors that contribute to chronic low-grade inflammation include a nutrient overload, a metabolic surplus, pro-inflammatory cytokines and adipokines. Knee OA is the most common form of OA with prevalence rising with age peaked at around 50 years of age affecting more than 250 million people worldwide. Exercise therapy (ET) is an effective component of early treatment and is therefore recommended as a first line treatment. Good Life with osteoArthritis in Denmark (GLA:D®) represents an evidence-based treatment plan for knee OA and optimizes the implementation of ET. However, ET mainly addresses physical and functional deficits in patients with knee OA, but not the inflammatory processes. Due to the association of chronic low-grad inflammation with dietary patterns, nutrition plays a significant role in inflammation-related diseases. A plant-based, anti-oxidative and anti-inflammatory therapeutic diet helps to improve symptoms leading to improved quality of life. When implementing a therapeutic diet, it should be attractive for patients and regional needs should be considered. This might increase adherence to therapeutic diet and will have an environmental impact - the New Nordic Diet (NND) seems to fulfil these requirements. To our knowledge no study has examined the influence of NND on symptoms and QL in OA. Further, there is a lack of knowledge concerning the impact of exercise therapy AND nutrition therapy on symptoms and QL in patients with knee OA.

Aims

1. To evaluate the effect of a nutrition therapy combined with exercise therapy on QL in patients knee OA
2. To investigate the impact of a nutrition therapy combined with exercise therapy on symptoms, nutrition and inflammation status and joint function in patients with knee OA

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate knee osteoarthritis

Exclusion Criteria:

* Musculosceletal disorders which obviates a participation in the training program
* kognitive deficits
* internal, neurological and mental diseases
* drug and/or alcohol abuse