cyrilzakka/clinical-trials huggingface dataset:
Study of the Dynamics of Verbal and Non-verbal Interaction in Healthy Subjects, Through the Recording of Body Movements and Non-invasive Neurophysiological Techniques

Based on study literature, the investigators can say that our study aims to give an explanation not only from a behavioral point of view but also with respect to what are the neuronal mechanisms underlying our ability to perceive and analyze our own and others' actions. This is essential to fully understand the complexity of our social behaviors. The knowledge of these mechanisms has a high value and relevant implications for many research fields both within and outside the neurosciences. The project aims to study the neurobehavioral correlates of verbal and non-verbal communication. Through the use of non-invasive behavioral and neurophysiological techniques, the study intends to highlight the neurobehavioral markers that allow to quantify the temporal evolution of communication dynamics in healthy subjects.

Based on study literature, the investigators can say that our study aims to give an explanation not only from a behavioral point of view but also with respect to what are the neuronal mechanisms underlying our ability to perceive and analyze our own and others' actions. This is essential to fully understand the complexity of our social behaviors. The knowledge of these mechanisms has a high value and relevant implications for many research fields both within and outside the neurosciences. The project aims to study the neurobehavioral correlates of verbal and non-verbal communication. Through the use of non-invasive behavioral and neurophysiological techniques, the study intends to highlight the neurobehavioral markers that allow to quantify the temporal evolution of communication dynamics in healthy subjects.

1. the investigators intend to verify whether individual differences in the ability to discriminate the verbal and non-verbal signals of others are reflected in significant differences in the way the same actions are performed.
2. the investigators intend to quantify the behavioral variables during the execution of the action and observe how these are modified in the passage from a single execution to an interaction context.
3. the investigators intend to study how the interactive context influences the cerebral and cortico-muscular oscillatory dynamics during the preparation of the action.
4. the investigators intend to verify whether the activity of the motor system contributes not only to the execution of the action but also, if and, if so, to the perception of the actions of others

Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 55 years
* written informed consent
* healthy subjects

Exclusion Criteria:

* epilepsy or at risk of epileptic seizures,
* cardiac pacemaker wearers,
* presence of an implanted infusion pump,
* metal plaques in the skull or metal objects in the eye and skull taking neuroleptic drugs or tricyclic antidepressants,
* migraine or at risk of developing this disease.
Hippotherapy to Improve the Balance of Children With Movement Disorders

The purpose of this study is to determine if adding hippotherapy treatment will improve balance for children ages 5-17 who have disabilities such as cerebral palsy and down syndrome. We also want to find out if by improving their balance the children increase their participation in age appropriate activities.

The primary purpose of this study is to determine the effects of hippotherapy on the balance of children with developmental disorders that cause mild to moderate balance problems. The secondary purpose is to determine if the use of hippotherapy also improves perceived functional abilities and thus quality of life as measured by the pediatric balance scale and Activities Scale for Kids (respectively)

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 5 and 17
* have a neuromuscular diagnosis or confirmed difficulties with balance
* be able to stand 4 seconds without an assistive device
* be able to follow testing instructions
* must be under 250 pounds
* be able to attend a minimum 10/12 sessions.

Exclusion Criteria:

* any compounding orthopedic or medical condition not related to the primary developmental diagnosis.
* previous hippotherapy intervention or therapeutic riding experience
* allergies or aversion to horses.
* refusal of parents to sign the therapeutic riding center's liability release form
* any new treatments (includes therapies, drugs, or other complementary treatments) within one month of the start of the study or plans for new treatments during the intervention period
* lack of a physician referral for physical therapy
Effect of Educution in Control Nutrition and Fluid Control of Hemodialysis Patient

Hemodialysis patients are required to adhere to diet and fluid restriction. The literature shows that hemodialysis patients have low adherence to diet and fluid restriction.

Failure to adhere to fluid control increases weight gain between two dialysis sessions. Increased weight gain between two dialysis sessions can lead to signs and symptoms, such as heart failure, hypertension, edema and dyspnea. Ultrafiltration is increased during dialysis to remove excess fluid from the body between two dialysis sessions. As a result, this leads to large changes in the patient's weight during dialysis sessions, leading to hemodialysis complications such as hypotension and muscle cramps.

Diet is important to prevent uremic complication for hemodialysis patient. Diet restriction purposes to minimize uremic symptoms and fluid- electrolyte imbalance. As increase failure to adhere diet, serum phosphorus serum potassium rise and weight gain between two dialysis sessions increases. As a result, problems with the cardiac system, respiratory system and bones are experienced.

Diet and fluid restriction helps to prevent complications, to increase the quality of life and to reduce mortality. Therefore, diet and fluid control vitally important for hemodialysis patients.

Nurses have an important place in providing diet and fluid management. Desired success can be achieved in fluid and diet control by giving planned trainings to patients by nurses. In patient education, the Health Belief Model is used as an effective guide, which explains the reason for the person's attitudes and behaviors. This model is based on explain why did the patient not adhere with the treatment and what motivates the patient. The model is based on the premise that they will change their behavior when people understand the severity of the illness.

The Health Belief Model can used education on diet and fluid contol of hemodialysis patients. In this study, Health Belief Model components will be used as a guide in the preparation of the educational content to be given to hemodialysis patients. With this study planned to be done; it was aimed to determine the effect of Health Belief Model-based education on diet and fluid control of hemodialysis patients. The study was planned as a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* He is over 18 years old,
* At least 6 months of hemodialysis treatment,
* At least primary school graduate,
* Does not have a condition that interferes with language, hearing or visual communication,
* Patients who accept to participate in the study are included in the study

Exclusion Criteria:

* That do not meet the inclusion criteria,
* Those who are included in another training program on the subject
Value of Von Willebrand Factor in Portal Hypertension

In patients with liver cirrhosis elevated levels of von Willebrand factor antigen (vWF-Ag) are found frequently but the clinical significance is unclear. vWF-Ag plays an important role in primary haemostasis and development of thrombotic vascular obliteration is discussed as a possible mechanism leading to portal hypertension. Invasive measurement of hepatic venous pressure gradient (HVPG) is the current gold standard for the diagnosis of portal hypertension. The investigators hypothesize that vWF-Ag levels in plasma may correlate with portal pressure and predict clinically significant portal hypertension (CSPH, HVPG \>=10mmHg) and its complications.

Patients with alcoholic, viral (chronic hepatitis C), and cryptogenic liver cirrhosis are included. Portal hemodynamics are assessed by HVPG measurement, vWF-Ag levels were measured by ELISA. Results will be compared. 3 and 6 months mortality will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis

Exclusion Criteria:

* no HVPG measurement
Effectiveness of Aurix Therapy in Diabetic Foot Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers

Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. Prospective observational studies of the effectiveness of Aurix have demonstrated promising results in regard to the healing of DFUs, including severe Wagner grade 3 and 4 ulcers. The aim of this trial is to demonstrate the of complete wound healing in a prospective, open-label, randomized trial in which diabetic foot ulcers will be treated using Aurix to determine the time to heal at 12 weeks. Comparison will be made on a 1:1 basis of Aurix + UCC versus control subjects receiving undefined UCC.

Eligibility Criteria:
Inclusion Criteria:

1. Medicare eligible
2. ≥18 years of age
3. Type I or II diabetes requiring medical treatment as determined by the physician
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a Wagner 1-5 DFU (see Appendix 9 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces)
5. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 0.5 cm2 and 50 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate offloading regimen
9. Duration ≥ 1 month at first visit
10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by Aurix
3. Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
4. Patients on chemotherapeutic agents or any malignancy in the wound area
5. Subjects who are cognitively impaired
6. Serum albumin of less than 2.5 g/dL
7. Plasma Platelet count of less than 100 x 109/L
8. Hemoglobin of less than 10.5 g/dL
9. Subject has inadequate venous access for repeated blood draw required for Aurix administration.
Transcranial Direct Current Stimulation for Post-Stroke Aphasia

This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 21 years
2. Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
3. Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score \<60
4. Fluent English speaker prior to stroke
5. Right-handed prior to stroke
6. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
2. Imaging unavailable
3. Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
4. History of dementia prior to the stroke
5. History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
6. Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.
Cerclage After Full Dilatation Caesarean Section

CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a history of previous caesarean in established labour. This prospective study using clinically acquired cervical length and quantitative fetal fibronectin data will help establish a predictive model of preterm birth \<34 weeks and \<37 weeks.

CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a caesarean section at full dilatation

CRAFT-IMG: Imaging sub-study; To aid understanding of micro and macrostructural features within the cervix which predisposes to preterm birth in women with a previous full dilatation caesarean section. This will use MRI and an advanced transvaginal ultrasound protocol and to assess if structural changes can be visualised in the cervix.


Eligibility Criteria:
CRAFT-OBS

Inclusion Criteria:

* Pregnant women under 23+6 weeks gestation with a history of previous caesarean section in labour.
* Singleton pregnancy.
* Willing and able to give informed consent (with or without interpreter).

Exclusion Criteria:

* Under 16 years of age.
* Inability to give informed consent.
* Previous caesarean section carried out before labour.
* Women who have been commenced on management with progesterone, a cerclage or arabin pessary as part of their care or another research study

CRAFT-RCT:

Inclusion criteria:

* Pregnant women up to 23+6 weeks gestation with a history of FDCS.
* Short cervix (\<=25mm) on transvaginal ultrasound scan.

Exclusion criteria:

* Women with persistent fresh vaginal bleeding evident on speculum examination.
* Women with visible fetal membranes evident on speculum examination or open cervix on ultrasound scan.
* Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
* Known significant congenital or structural or chromosomal fetal abnormality.
* Suspected or proven rupture of the fetal membranes at the time of recruitment.

CRAFT-IMG

Inclusion criteria:

* Pregnant women between 14+0 and 23+6 weeks gestation with a history of FDCS.

Exclusion criteria:

* Contraindications to MRI, e.g. claustrophobia, BMI \>40 kg/m2 (due to technical limitations of scanner) or a women with a non-MRI compatible metallic implant.
Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period.

QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.

The primary objective of the study is:

To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
* If female, is not pregnant, or nursing.
* agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
* Subjects with a prescription dry body weight between 40 and 100 kg

Exclusion Criteria:

* Planned to receive a kidney transplant during the study.
* Has localised itch restricted to the palms of the hands.
* Has pruritus only during the dialysis session
* Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
* Subject is receiving ongoing ultraviolet treatment .
* Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
* Known or suspected history of alcohol or drug abuse/dependence within 12 months prior to screening.
* New or change of treatment received for itch within 2 weeks prior to screening.
Placebo Controlled, Randomized, Double-blind, Multi-center Study to Investigate the Efficacy and Tolerability of BAY58-2667

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP \>/= 18 mmHg.
* Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
* Male or female patients, age 18 years or more.

Exclusion Criteria:

* Females of child-bearing potential.
* Acute de-novo heart failure.
* Acute myocardial infarction and/or myocardial infarction within 30 days.
* Valvular heart disease requiring surgical intervention during the course of the study.
The Investigation of the Neonates With or With Risk of COVID-19

Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.

Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and is contagious to the general population, all the suspected or confirmed newborns will be admitted to the neonatal departments in designated hospitals of China. In this study, the diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical information questionnaires are classified into maternal and neonatal version, which include demographic details, epidemical history, clinical manifestations, tests collected time and results, imaging performed time and results and therapeutic data. Two researchers independently checked and recorded the data to ensure the accuracy of the data.

Eligibility Criteria:
Inclusion Criteria:

* The neonates with COVID-19,or neonates born by infected mothers

Exclusion Criteria:

* The neonates with major anomalies
Extension Program for Bay 43-9006

The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.


Eligibility Criteria:
Inclusion Criteria: - Patients who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment. Exclusion Criteria:- The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
Post-Market Clinical Follow Up Study With Navitor Valve

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

The VISTA Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* The patient is scheduled to undergo a Navitor TAVI procedure.
* The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)/EC (Ethics Committee) of the respective clinical site.
* The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.

Exclusion Criteria:

* Life expectancy \< 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
* In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
* Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
* Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
* Currently participating in an investigational drug or device study that may confound the results of this study
Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty

60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total hip arthroplasty

Exclusion Criteria:

* BMI above 40
* Serious psychiatric, mental and cognitive disorders
* Contraindication for central and/or peripheral nervous blockade
* History of allergic or other adverse reactions on the agents used in the study
* Chronic opioid