cyrilzakka/clinical-trials huggingface dataset:
Influence of Sensory Electrical Stimulation on Hand Functions in Chronic Stroke Patients

This study investigates the impact of sensory electrical nerve stimulation (SENS) on hand function in chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessments conducted before and after the intervention included measurements of grip strength, pinch strength, wrist range of motion, and performance on the Action Research Arm Test (ARAT).

This study explores the effectiveness of sensory electrical nerve stimulation (SENS) in enhancing hand function among chronic stroke patients. Thirty participants were randomly divided into two groups:

Study Group (A): Received SENS combined with task-specific training.

Control Group (B): Received only task-specific training.

Assessment Methods:

Before and after the intervention, both groups underwent evaluations using:

Grip Dynamometer: To measure grip strength.

Pinch Dynamometer: To assess pinch strength.

Digital Goniometer: To determine wrist flexion and extension range of motion.

Action Research Arm Test (ARAT): To evaluate upper limb functional performance.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have experienced their first-ever ischemic stroke in the carotid system domain.
* Age range: 40 to 65 years old.
* Duration of illness: 30 to 180 days since stroke onset.
* Spasticity of the affected hand muscles (wrist flexors, finger flexors, and finger adductors) must be grade 1+ or less according to the Modified Ashworth Scale.
* Hand dysfunction severity ranges from mild to severe, defined by a score of ≤ 4 on the Medical Research Council Scale.

Exclusion Criteria:

* Presence of a deformity in the paralytic upper limb before the stroke.
* History of a lower motor neuron lesion in the impaired upper extremity (e.g., polyneuropathy) before the stroke.
* Skin abrasions or ulcerations on the affected upper limb.
* Unstable health conditions, including cardiac dysfunction, end-stage renal failure, unstable diabetes, or uncontrolled hypertension (\>190/110).
* Presence of a pacemaker or other implanted electrically sensitive devices.
* Significant orthopedic conditions or chronic pain syndromes.
* Chronic use of medications that may influence motor or sensory excitability (e.g., anti-epileptic or antipsychotic drugs).
* Pregnancy.
Peer-Supported Diabetes Self-Management Support

The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1c\>9%
* African American or Hispanic ethnicity
A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics

The purpose of this study is to compare capillary (the smallest of a body's blood vessels) and venous whole blood and plasma concentrations of 5 antipsychotics after given of a single oral, immediate-release dose to healthy participants.

This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of patients will be treated at the same time), single-center study. Participants will be randomly assigned to 1 of 5 cohorts (groups) defined by the antipsychotic drug (aripiprazole, quetiapine, olanzapine, risperidone or paliperidone). Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Participants will enter the investigational site in the morning of Day -1 and stay until the morning of Day 2. Participants will return to the study site for subsequent assessments as per study's schedule. The total study length for a participant is approximately 26 days, except for participants receiving aripiprazole for whom the total study length is approximately 39 days.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (weight \[kg\]/height2 \[m\]2) between 17 and 35 kg/m2 (inclusive), and body weight not less than 50 kg
* If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
* If a woman, must have negative pregnancy test at screening
* If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

Exclusion Criteria:

* History of or current clinically significant medical illness or condition that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for laboratorial tests
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen), oral contraceptives and hormonal replacement therapy, within 14 days before the study drug administration is scheduled
* Positive test for alcohol or drugs of abuse at screening
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
Effects of Integrative Medicine on Infectious Respiratory Diseases Including COVID-19

The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international proportions when it was declared by the World Health Organization (WHO) in January 2020. Since then, the virus has spread internationally and the WHO has classified the outbreak as a pandemic. In the context of the increasing reporting of this pandemic and the increasing governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is so far little scientific evidence for the effects of a healthy lifestyle on the disease. The aim of this study is to compare the potential of different, possibly protective lifestyles using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000 participants using mobile website technology.


Eligibility Criteria:
Inclusion Criteria:

- Present declaration of consent

Exclusion Criteria:

- Lack of consent to participate in the study
Cardionomic STOP-ADHF Study

STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.

The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF).

The CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator.

Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital with a principal diagnosis of ADHF
* BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
* LVEF ≤ 50%
* At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent)

Exclusion Criteria:

* Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment
* Requires mechanical support
* Cardiogenic shock or impending cardiogenic shock
* Systolic blood pressure \< 80mmHg or \> 140mmHg
* Symptomatic hypotension
* eGFR \< 25 mL/min/1.732
Clinical and Instrumental Treatment's Predictors in Subjects With Neurological Diseases Using G-EO Robotic System

The aim of this work is to elaborate a statistical model to predict the effectiveness of robotic treatment in subjects with neurological diseases. The model will be used to understand which subjects are most responsive to this type of treatment

In recent years, robotic devices have been used to assist balance and gait rehabilitation of people with neurological disorders. In particular, the G-EO system (Reha Technology AG, Switzerland) is a robotic end-effector device guiding the movement of the feet. It is currently unclear which variables are the predictors of treatment success. Indeed, the effectiveness of the GEO treatment may depends on the characteristics of the treatment itself (instrumental parameters defined by the physiotherapist using the device) and on the characteristics of the subject receiving the treatment. Therefore, it is necessary to measure these clinical and instrumental characteristics to understand which are predictors of treatment effects. Parameters obtained from this assessment can be used to elaborate statistical models. In our study the statistical model will be defined as follows: The change in the primary outcome measure after the robotic treatment will be considered as dependent variable of the model. All the "secondary" clinical outcome measures will be measured only at T0 and will be considered in the model as independent variables, along with the participants characteristics (age, gender, disease, disease duration, falls number, numbers of comorbidity, type of hospitalization) and the treatment characteristics (sessions number, frequency, duration, step length, cadence, gait speed, body weight support, distance traveled). The results of the model will suggest which subjects are most responsive to this type of treatment and which variables can be considered as predictors of the treatment success.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis, Parkinson Disease, Stroke or acquired brain injury
* Minimum number of sessions: 10 sessions with the GEO system
* Minimum frequency of sessions: 2 per week
* Age ≥ 18 years
* Ability to walk for at least 10 meters, also with aid
* Indication of robotic treatment in the therapeutic plan
* Body size suitable for the robotic device
* ability to maintain verticality for 7 minutes;
* ability to maintain the sitting position without support for 30 seconds;

Exclusion Criteria:

* severe limitations of articular range of motion;
* medical problems compromising walking (e.g. fractures, pain, severe osteoporosis or severe spasticity);
* Presence of skin lesions in the areas of contact with the device;
* Presence of seizures that may be triggered by the use of the G-EO system.
The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients.

In addition, the study aims to evaluate the change in insulin resistance value after treating patients from HCV.

There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.

Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy (Brawn et al., 2018).

The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years Chronic infection with HCV GT 4 No prior HCV treatment experience

Exclusion Criteria:

* Co-infection with HBV or HIV, clinical evidence of ischemic heart disease, the presence of diabetic ketoacidosis, Patients admitted to the intensive care unit (ICU), or expected to undergo surgery during the study period, and Child Pough score C.
Dose Response to Recombinant Factor VIIa When Administered for Bleed

This trial is conducted in the United States of America (USA). The purpose of this trial is to investigate the dose response to recombinant factor VIIa in healthy volunteers when administered for bleed.


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years - 60 Years

Exclusion Criteria:

* - -
Incidence of Commuting Accidents Among Non-physician Staff of a Large University Hospital Center From 2012 to 2016

Over the past thirty years, risk of road traffic accidents has decreased but remains high and accounts for 44% of fatal work-related accidents for commuting and mission-related accidents. The aims of this study were to estimate the overall incidence of commuting accidents for non-physician professionals in a major university hospital and by gender and different professional categories, and to assess its evolution over a 5-year period. A descriptive analysis was performed on 390 commuting accidents from 2012 to 2016 extracted from the university hospital's occupational health service.


Eligibility Criteria:
Inclusion Criteria:

* non-physician staff
* commuting accidents

Exclusion Criteria:

* work accidents
* on-duty road accidents
* physician staff
The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease

This study attempts to replicate the findings published in Nature Medicine by Nation and colleagues (2019). By using a large observational cohort (DZNE - Longitudinal Cognitive Impairment and Dementia Study; DELCODE) consisting of cognitively healthy individuals, individuals with subjective cognitive decline, mild cognitive impairment, and dementia due to Alzheimer's disease, an association between the blood-brain barrier and cognitive dysfunction is investigated. The integrity of the blood-brain barrier is investigated by using a novel MRI protocol as well as a novel biomarker in the cerebrospinal fluid.


Eligibility Criteria:
Inclusion criteria:

- ≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia

Exclusion cirteria:

* no current or prior history of any neurological or psychiatric condition, which might affect cognitive function
* no neurodegenerative disease other than AD
* specifically no extensive vascular white matter dementia or vascular dementia
PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery

The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups.

Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty.
* Age ≥18 years
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Previous ophthalmic surgery on the same eye
* Known allergy or inflammation reaction to suture material similar to Vicryl® Rapide or Novosyn® Quíck in previous surgery.
* Cicatrisation base alterations
* Concomitant medication, that might affect wound healing (e.g. immunosuppression therapy, anti-diabetic drugs, etc.)
Effect of Music Intervention on Infants' Brainstem Encoding of Speech

Infants' frequency-following response (FFR) to a nonnative lexical tone, reflecting early sensory encoding of speech in the auditory system will be evaluated pre- and post- music intervention at 7 mo and 11 mo of age. The lab-controlled music intervention starts at 9 mo of age and consists of 12 sessions of social and multimodel musical activities with the aim to synchronize infants' movements with musical beats.

Families with healthy infants with no family history of hearing, speech and communication disorders will be recruited at 7 months of age to participate in the longitudinal music intervention study that will last for about 4 months.

At recruitment, infants with 3 or more ear infections and infants who have already been/ have had participated in infant music classes will be excluded.

Infants will complete a pre-intervention brainstem measures at 7 months of age upon enrolling in the study: the frequency-following response measure (FFR). Participants will have to complete the measurement to proceed to the intervention phase. At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained on techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.

The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study. Upon finishing the intervention, infants will repeat the FFR measurement at 11 months of age.

Eligibility Criteria:
Inclusion criteria:

* healthy
* no family history of speech, hearing or language disorders
* no more than 3 ear infections
* no prior experience in infant music classes
* monolingual English speaking household

Exclusion criteria:

* birth date more than 14 days before or after due date
* birth weight less than 6lbs0oz or more than 10lbs0oz
* family history of speech, hearing or language disorders
* history of 3 or more ear infections or hearing difficulties
* history of participating in infant music classes
* have significant exposure to languages other than English
Extensively Diseased Left Anterior Descending Coronary Artery: On Pump vs Off Pump CABG?

Diseased left Anterior descending coronary artery (LAD) is one of the most challenging conditions in Bypass surgery. we investigate whether on-pump coronary artery bypass grafting (CABG) is more beneficial in those critical patients or off-pump surgery.


Eligibility Criteria:
Inclusion Criteria:

* any patient with diffuse LAD disease indicated for open heart surgery

Exclusion Criteria:

* no concomitant valve disease
* any patient can be treated by medical treatment or PCI
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
* If female, participant must meet the contraception requirements

Exclusion Criteria:

* Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
* Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

* Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
* Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.