cyrilzakka/clinical-trials huggingface dataset:
Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events

The main goal of this study is to use data from the Bodyport Cardiac Scale to help detect of worsening heart failure (HF) early.

The overarching goal of this prospective, multicenter study is to utilize data from the Bodyport Cardiac Scale to develop an index that allows for the early detection of worsening heart failure (HF). The Bodyport Cardiac Scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.

The SCALE-HF program will consist of multiple phases. For SCALE-HF 1, patients will be prospectively enrolled and utilize the Bodyport Cardiac Scale on a daily basis. Patients and clinicians will be blinded to the results other than data readily available from other devices such as body weight. There will be no attempt to influence clinical practice. Patients will be followed remotely for suspected clinical events.

Eligibility Criteria:
Inclusion Criteria:

1. Provide informed consent before trial enrollment
2. Age ≥ 18 years
3. A diagnosis of symptomatic HF including a worsening HF event in the preceding 12 months. Worsening HF events will be determined by local clinician-investigators and will typically include the following: a) HF symptoms (eg, dyspnea, fatigue); b) HF signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the event, and treatments targeting acute HF (eg, intravenous diuretics, vasodilators, or inotropes).

Exclusion Criteria:

1. Weight \>170 kg
2. Use of chronic inotropic therapy
3. Prior heart transplant or currently listed for heart transplant
4. Current or planned left ventricular assistance device
5. Chronic kidney disease requiring chronic dialysis
6. Unknown left ventricular ejection fraction (LVEF). The LVEF should be based on the most recent local measurement using echocardiography, multigated acquisition scan, computed tomography scanning, magnetic resonance imaging, or ventricular angiography. Patients with preserved and reduced LVEF will be permitted in the study though enrollment may be capped to ensure no more than approximately 2/3 of the total enrollment includes patients with preserved or reduced LVEF.
7. Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
8. Unable to participate in longitudinal follow-up including daily use of the Bodyport scale. Patients must be able to stand independently on the Bodyport scale.
Platelet Activity in T2DM Using Flowcytometry

-Describe platelet activity in type 2 diabetes as a participant in vascular inflammation. -Compare platelet activity in patients with type 2 diabetes mellitus versus healthy controls. -Study and describe platelet activity in patients with type 2 diabetes mellitus in association with ischemic cardiovascular disease in relation to duration of diabetes mellitus .

Type2diabetes mellitus(T2DM)is most prevalent and costly chronic disease(Leon et al 2015).according to IDF a further increase to 642million diagnosed individual by2040(Ogurtsova et al 2017).the major cause of morbidity and mortality in DM is macrovascular complications.75% of diabetic patients die of cardiovascular disease(CVD)( Ridker et al2017).Platelets are one of blood cells 1,5-3um in size and survive 8-10days ,their function extended beyond homestasis and thrombosis to be an active participant in intiating and sustaining vascular inflammation as well as in prothrombotic complications of CVD(Festa et al2002).platelets are hyperactive in diabetic patients ,the coagulation cascade is dysfunctional ,platelet inT2DM adhere to vascular endothelium and aggregate more readily than those in healthy people(Pretorius2011)\*.platelets are activated when they are in contact with damaged vascular endothelium , once activated they secrete awide spectrum of inflammatory mediators , once they are activated , they intiate reactions by changes in the level of expression of surface glycoproteins(GP)results , which act as receptors for platelet agonist and for adhesive proteins involved in platelet aggregation(Pretorius etal2015)\*\*.platelet activity can be measured by flow cytometry ,as flow cytometry allows the simultaneous detection of surface antigens in a sensitive and specific manner , it is therefore possible to examine aspects of the platelet membrane activity . the available platelet markers areCD41a marker forGP2b ,CD42 a marker for GP1b.both are used for platelet identification.( Pretorius et al 2017)\*\*\*.CD62 a marker for P-selectin ,anti-CD62 react with alpha granule membrane protein which is expressed on the surface of activated platelet.CD63 a marker for GP4 and anti-CD63 react with lysosomal granule-membrane glycoprotein that is expressed on surface of activated platelet. CD62andCD63 are markers of platelet activation (Ibrahim et al 2017).knowing the major role of platelets in inflammatory and healing process in the vascular system especially in diabetic patients ,created the urgency to study the impact of platelet activity in diabetic patients whom has macrovascular risk using flowcytometry.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patient with type II diabetes at age of 30-60 years old with or without ischemic cardiovascular disease. . Controls will be healthy individuals with normal blood glucose level of same matched age group.

Exclusion Criteria: 1)Type1Diabetes mellitus. 2)Hypertensive patients. 3)patients with renal impairment. 4) patients with hepatic impairment. 5)patients with thrombocytopenia. 6)Pregnancy.
Cardiac Stroke Volume at Rest and During Different Exercise Intensities

The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* BMI 18-30
* Resting Blood pressure \< 140/90 mmHg
* Participation in regular exercise

Exclusion Criteria:

* Acute illness
* Pregnancy
* Pace maker
* Artificial joint
* History of a cardiac event
* Insulin or medically treated diabetes
* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
* Abundant use of alcohol
* Use of narcotics
* Smoking of tobacco or consuming snuff tobacco
* Diagnosed depressive or bipolar disorder
* Abnormalities in resting ECG (revised by the study physician)
Time Course of Circulating Myocardial Biomarkers After a TASH Procedure.

The study evaluates the released myocardial substances in blood of HOCM patients after TASH procedure (small "controlled" myocardial infarction). This helps to identify new pathomechanisms and biomarker and thus provides a better understanding of development and progress of cardiac insufficiency.

All patients who receive a TASH procedure in the Medical Clinic I routinely receive routinely implementation of arterial pressure catheter for invasive blood pressure monitoring (usually Arteria radialis) as well as a central venous catheter. Directly after the procedure, the blood is taken through the central venous catheter. The operation is then terminated as planned.

The postoperative treatment is performed according to the Standard Operating Procedures (SOPs) of the Medical clinic I -regular blood sampling is performed to monitor the patient's cardiac, renal and hepatic lab values. The patient is released on the 3-5th post-operative day.

As part of a routine outpatient visit to the Medical Clinic I 1 week and 1 month after the TASH procedure, an anamnestic record as well as a blood analysis is made. One month after the TASH procedure, an echocardiographic follow-up of the HOCM is routinely performed.

Adverse events or serious adverse events are documented, assessed and reported in accordance with GCP (good clinical practice).

Eligibility Criteria:
Inclusion Criteria:

* a clinical indication for TASH procedure
* an access to blood vessels
* a person qualified for legal acts, mentally abte to follow the instructions of study stuff

Exclusion Criteria:

* patients with severe anaemia - Hb \<8 mg/dL
* patients with acute infectious diseases (e.g. pneumonia)
* patients with acute myocardial ischaemia (e.g. angina pectoris or ECG alterations under strain)
* patients with acute coronary syndrome in the last three months
* patients that were hospitalized for Acute Heart Failure during the last month and had to be treated by diuretics or inotropes
* a pregnant and/or breastfeeding women
* Persons that are located by a court or administrative decision in an Institution
* Persons with a relationship of dependency to investigator
* Persons with simultaneous participation in another clinical trial
* administration of an investigational drug 30 days before start of the study
A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices

To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and conventional Laparoscopic surgical suturing among novice

Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform complex minimally invasive surgical procedures across different specialties. This study aimed to investigate the impact of DVRSS on surgical proficiencies among inexperience novice surgeons and compared to conventional laparoscopic surgery.

Methods Twenty medical students (n=20) without surgical experience were enrolled. After a constructive training for basic surgical techniques, participants were randomly allocated into DVR or laparoscopy group. Participants were asked to close five cases (also named five tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time, successful closure rate and pneumatic bursting pressure of gastric incision withstanding were recorded. In addition, participant performance and workload were quantified by using performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index (NASATLI).

Eligibility Criteria:
Inclusion Criteria:

* Medical Students with no prior surgical experience

Exclusion Criteria:

* Surgeons
* Age \< 16 or \> 60
* Disability and not able to control the Da Vinci Robot through the console
Study in Healthy Subjects to Measure Amount of Drug in Blood After Dosing With Different Saxagliptin / Metformin Produc

Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin products.

Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent prior to any study specific procedures
* Males or females aged 18 to 55 years (inclusive) and with a weight of at least 50 kg and a body mass index (BMI) between 18 and 35 kg/m2, inclusive
* Females must have a negative urine pregnancy test at screening and negative serum pregnancy test on admission to the unit, must not be lactating, and must be using an acceptable method of contraception for at least 1 month before dosing
* Female volunteers of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year
* Oral contraceptive and hormone replacement medications are allowed in this study if used together with a barrier contraceptive method.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of gastrointestinal, hepatic, renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (except for cholecystectomy)
* Glomerular filtration rate of less than 60 mL/min (to be estimated at screening only)
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator (eg, seasonal allergies) or history of hypersensitivity to drugs with a similar chemical structure or class to saxagliptin or metformin
Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS

The goal of the proposed observational, multi-site study is to use fNIRS neurophysiological data recorded during a battery of tasks to detect MCI within a cohort consisting of patients and age-matched healthy controls. Furthermore, the investigators aim to explore whether they can measure the severity of MCI symptoms in the patient population. If successful, this approach enables clinicians to track the disease at its source-the brain; possibly allowing for earlier detection of MCI and its progression, and ultimately more efficient interventions.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Must have a diagnosis of MCI (amnesiac or non-amnesiac) as determined by clinician
* Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
* Ability to perform informed consent on their own
* Fluent in English (speaking and reading)

Healthy Controls

* Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
* Ability to perform informed consent on their own
* Fluent in English (speaking and reading)

Exclusion Criteria:

Patients

* Alzheimer's or dementia diagnosis
* Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
* Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
* Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
* Major medical illnesses and psychiatric conditions (other than MCI) including:

  * Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose secondary causes of cognitive decline
  * Parkinson's disease
  * Motor neuron diseases
  * Multiple Sclerosis
  * Brain Tumor
  * Stroke
  * Encephalitis
  * Meningitis
  * Epilepsy
  * TBI with serious results (coma, unconscious for \>2 hrs, or skull fracture)
  * Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)

Healthy Controls

* Prior MCI or memory impairment diagnosis
* First-degree relative with dementia or clinically relevant memory problems
* Alzheimer's or dementia diagnosis
* Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
* Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
* Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
* Major medical illnesses and psychiatric conditions including:

  * Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose secondary causes of cognitive decline
  * Parkinson's disease
  * Motor neuron diseases
  * Multiple Sclerosis
  * Brain Tumor
  * Stroke
  * Encephalitis
  * Meningitis
  * Epilepsy
  * TBI with serious results (coma, unconscious for \>2 hrs, or skull fracture)
  * Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain

The aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.


Eligibility Criteria:
Inclusion Criteria:

* Having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection
* Willing to participate

Exclusion Criteria:

* Spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study;
* neurological disease;
* psychiatric disease;
* serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis),
* pregnant during the study
Effect of Aloe Vera Gel as an Intra Canal Medicament

This research will overview the effect of aloe vera gel (AVG) as intra canal medicament in patients with asymptomatic periapical lesions. It will provide endodontists with scientific evidence regarding the beneficial use of AVG as an intracanal medicament owing to its superior antibacterial and analgesic properties as compared to routinely used commercial intra canal medicaments.

Objective: To evaluate the effect of aloe vera gel based on clinical signs and symptoms as an intracanal medicament in asymptomatic periapical lesions over a period of three weeks. Methodology: Fresh AVG will be prepared. It will be placed as intracanal medicament after cleaning and shaping in patients with asymptomatic periapical lesions in group A while in group B (control group) no intracanal medicament will be placed. Patients will be randomly divided into two groups by randomization in Statistical Package for Social Sciences software (SPSS v24.0). They will be recalled for one week and three week follow ups and in case of no clinical signs and symptoms endodontic procedure will be completed. Statistical analysis: Descriptive statistics will be used for reporting age. Frequencies and percentages will be calculated for categorical variables and intergroup comparison will be done by chi square test

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients presenting with asymptomatic periapical lesions in permanent teeth

Exclusion Criteria:

* History of allergy to AVG

  * Comorbidities likely to impair healing
  * Pregnant women
  * History of previous endodontic treatment in the same tooth
  * Presence of pulp calcification
  * Internal or external root resorption
The LOOP Trial in Treatment of Skin Abscesses

This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.

This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.

Eligibility Criteria:
Inclusion Criteria:

* Subcutaneous skin abscesses necessitating drainage

Exclusion Criteria:

* Abscess was on the hand, foot, or face
* Requiring admission or operative intervention
CETIS-I (CEra Traction Improves Spine-I)

In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.

The efficacy and safety evaluation are conducted before and after the application of the test device. The investigator shall apply an investigational device once when visiting a suitable subject for one day (Arm;Traction treatment) or standard physical therapy including temperature application and traction(Arm;Physical Therapy)

Eligibility Criteria:
Inclusion Criteria:

* Subject who has been diagnosed with intervertebral disc herniation or degenerative stenosis (a person who has been diagnosed in the past or has been diagnosed upon obtaining consent)
* Adult men and women over 19 years of age
* Body mass index (BMI) 18.5 over to less than 30

Exclusion Criteria:

* Subject with fibromyalgia, dystonia, and epilepsy
* Subject with sensory impairment
* Subject with physical irritation-induced skin lesions such as fever and compression (dermatosis, compression urticaria, choline urticaria, fever urticaria, etc.)
Patient Knowledge, Beliefs and Barriers to Hepatitis D Care

A project to understand the determinants of health behaviour among those with chronic hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings College Hospital (KCH). This is to improve and implement pathways and patient information distribution to improve access to care in an ethnically diverse population living with HDV in the UK.

Kings college hospital NHS Foundation Trust is uniquely placed and serves a large diverse population from areas such as pan pacific Asia, Eastern Europe and regions in Africa, where English is not their first language. This diversity is also seen in other London Hospitals but less so in other parts of the UK.

To understand the knowledge patients have around their diagnosis of hepatitis D which is considered a rare disease but the most aggressive form of viral hepatitis. In order to improve the management of hepatitis D, this research aims to identify the current knowledge patients have about their diagnosis, the information provided to them in their preferred language, how they feel about their diagnosis and the stigma attached. This research has been conducted in patients with other forms of viral hepatitis but not in patients living with hepatitis D. There is a lack of research in this area. With this research we aim to improve treatment pathways, access to care and to information.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years or older.
* HDV infection as diagnosed by high levels of anti-HDV immunoglobulin G (IgG) and immunoglobulin M (IgM), and confirmed by detection of HDV RNA in serum.
* Treated HDV infection
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Clinically significant medical or psychiatric illness in the past, present, or being evaluated, that may interfere with participant treatment, safety and assessment.
A Safety and Efficacy Study of JUVÉDERM® VOLIFT® With Lidocaine and Restylane® for Nasolabial Folds in Chinese Adults

This is a safety and efficacy study of JUVÉDERM® VOLIFT® with Lidocaine and Restylane® in Chinese adults with nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

* Presence of nasolabial folds
* Agree to refrain from treatment with other anti-wrinkle/volumizers below the eye for the duration of the study

Exclusion Criteria:

* Ever received semi-permanent fillers or permanent facial implants below the eyes, or plans to receive these treatments during the study
* Undergone temporary dermal filler treatment (eg, hyaluronic acid or collagen) below the eyes within 12 months, or plans to undergo these treatments during the study
* Undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic facial procedures in the face or neck within 6 months, or plans to undergo these treatments during the study