cyrilzakka/clinical-trials huggingface dataset:
Education in Therapy of Parkinson's Disease

Parkinson's disease (PD) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. To improve the medical care of PD patients, the investigator have developed an educational program specific to PD.

The principal aim of this study is to evaluate the therapeutic education Program, comparing the quality of life of PD patients with or without the educational program after six month and one year follow-up.

The secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs.

This is a monocentric, comparative, prospective randomised study. The investigators will evaluate 120 PD patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. Quality of life of PD patients is evaluated using a specific scale (PDQ39) and a generalist scale (SF36) at 6 and 12 months. Motor and psychological states were assessed with UPDRS and HAD Scales. The educational program consisted of both individual and collective educational consultations.

The investigators supposed that the therapeutic education program will improve the quality of life of PD patients. The supposition that this improvement will correlate with the motor and psychological states.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of Parkinson's disease according to the criteria of the UKPDSBB
* Parkinson's disease patients with a score ≤4 on the Hoehn and Year scale
* Patient without cognitive disorders
* Patients treated with dopaminergic antiparkisonian drugs (L-DOPA, dopamine agonists,ICOMT...) or DBS stimulation (since at least 3 month)
* Patients able to fulfil self-administered questionnaire
* Patients affiliated to a social protection program

Exclusion Criteria:

* - Patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies...)
* Parkinson's disease patients with a score\>5 on the Hoehn and Yahr scale
* Patients suffering of parkinsonism induce by drugs
* Patients with important tremors during a OFF conditions
* Patients ever included in another study
* Patients with severe psychiatric disease
* Patients under tutelage, curatelle or law protection
* Patients included in an other clinical study
* Patients unable to fulfil scales of the study
Sedation and Postoperative Cognitive Functions

Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. Patients who were given ketamine and dexmedetomidine for sedation were included in the study. The Mini Mental Status Tests of the patients measured on the first and third days of the operation in the preoperative period were determined from the hospital records and recorded.

Patients over the age of 65 who underwent elective surgery for a hip fracture and were sedated during spinal anesthesia were included in the study. The cognitive functions of these patients, which were evaluated by a Mini-Mental Test in the preoperative period, on the first and third days of surgery, were recorded from routine patient follow-up forms.

Sedation scores of the patients evaluated by Intraoperative Alertness/Sedation Scale (OAA/S) Observer Evaluation were recorded. Intraoperative hemodynamic data were recorded. The interventions applied to the patient were performed by anesthesiologists who were not involved in the study according to their preferences as part of the routine. The researchers were not involved in any intervention performed on the patient, only the data were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 65 who underwent surgery under spinal anesthesia due to hip fracture
* Volunteered to participate in the study

Exclusion Criteria:

* Patients who are under the age of 65
* Patients with known histories of dementia
* Patients with Alzheimer's disease
* Patients with central nervous system disease
* Patients who scored 15 or less according to the Mini Mental Status Test (MMSE)
* Patients who underwent surgery under general anesthesia
* Patients who refused to voluntarily participate in the study
Tongmai Jiangtang Capsule for Cardiovascular Clinical Outcomes in High-Risk Metabolic Syndrome Patients

1. Conduct a large-sample, multicenter, superiority, double-blind, randomized controlled clinical trial to verify the efficacy of TJC in reducing the risk of cardiovascular and cerebrovascular events in patients with metabolic syndrome at high cardiovascular and cerebrovascular risk (HCR-MS).
2. Further construct an evaluation system for the long-term cardiovascular and cerebrovascular benefits of traditional Chinese medicine in regulating glucose and lipid metabolism through the evaluative study of the cardiovascular and cerebrovascular benefits of TJC.


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be aged ≥65 years.
* Participants must meet the diagnostic criteria for metabolic syndrome according to the 2020 Chinese Type 2 Diabetes Prevention Guidelines, which includes at least three of the following criteria:①Central obesity: Waist circumference ≥90 cm for men, ≥85 cm for women.②Hyperglycemia: Fasting blood glucose ≥6.1 mmol/L or 2-hour post-load glucose ≥7.8 mmol/L, or a confirmed diagnosis of diabetes with ongoing treatment.③Hypertension: Blood pressure ≥130/85 mmHg or a confirmed diagnosis of hypertension with ongoing treatment.④Elevated triglycerides (TG): ⑤Fasting TG ≥1.70 mmol/L.

Low HDL cholesterol: Fasting HDL-C \<1.04 mmol/L.

* Participants must meet the criteria for "Qi-deficiency and Blood Stasis" syndrome, which includes specific symptoms and signs such as fatigue, shortness of breath, stabbing pain, ecchymosis, and a tongue with purple discoloration or petechiae.
* High Cardiovascular Risk: Participants must have at least one of the following:

  * History of myocardial infarction.

    * History of stroke or transient ischemic attack. ③History of coronary, carotid, or peripheral artery revascularization.

      * Coronary, carotid, or lower limb artery stenosis \>50%. ⑤Positive exercise stress test or documented symptomatic coronary heart disease, or unstable angina with ECG changes.

        * Chronic heart failure (NYHA Class II-III). ⑦Chronic kidney disease (eGFR \<60 ml/min/1.73m²).

Exclusion Criteria:

* Secondary Abnormalities: Secondary abnormalities in lipids, blood pressure, or blood glucose.
* Type 1 Diabetes: Participants with Type 1 diabetes mellitus.
* Special Populations: Pregnant or breastfeeding individuals, or those with a history of allergy to the study medication.
* Recent Acute Events: Acute coronary or cerebrovascular events within the past 14 days.
* Upcoming Revascularization: Planned coronary, carotid, or peripheral artery revascularization.
* Severe Heart Failure: Chronic heart failure (NYHA Class IV).
* End-Stage Liver Disease: Participants with end-stage liver disease.
* Solid Organ Transplantation: History of solid organ transplantation or awaiting solid organ transplantation.
* Malignant Tumors: Participants with a history of malignant tumors.
* Other Serious Conditions: Any other serious medical conditions that may interfere with the study or pose a risk to the participant.
Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial

The aim of this study is to investigate the effectiveness of the family and behavioral theory based mobile-health behavioral intervention in enhancing adolescents'good oral health behaviors (mainly oral hygiene practice and free sugar intake control) and preventing common oral diseases (dental caries and periodontal diseases).

The investigators propose a 30-months clustered randomized controlled trial to investigate the effectiveness of Health Belief Model (HBM) and family-based mobile-health intervention in enhancing the adolescents' good oral health behaviors and preventing oral diseases.

This is a three-arm parallel-design cluster-randomized controlled trial. Parents and their children (12 to 15-year-old) will be recruited and randomized into 3 groups based on the school sites.

Messages targeted on six domains guided by HBM will be sent to the adolescents and their parents via mobile phone. Two blocks of HBM-based oral health messages, reminders, feedback and reinforcement messages will be delivered to both students and parents by mobile phone for 24 weeks; while the intervention of the other 2 groups will target on students only or using prevailing oral health education.

The primary outcomes will be caries increment of the adolescents 2-year post-intervention. Change in oral health self-efficacy and behaviors, dental plaque and gingival bleeding index will be the secondary outcomes.

The investigators anticipate the proposed family- and HBM-based behavioral intervention is more effective than HBM-based mobile-health intervention on adolescents alone or prevailing oral health education in improving the adolescents' oral hygiene behaviors, reducing free-sugar intake and preventing oral diseases.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity;
* Student living with their own parent(s) or primary caregivers;
* Both student and parent(s) or primary caregiver having their own access to a personal mobile phone with certain Apps to receive the messages in time

Exclusion Criteria:

* Student currently on a special diet (e.g. severe inflammatory bowel disease);
* Student has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis);
* Enrollment in other oral health promotion programs or research studies.
Vasopressor Requirements Depends on Sedation Strategy

Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.

Sedating a patient is a complex process, especially after heart surgery. Sedation has a negative hemodynamic effect. This leads to a decrease in blood pressure and increases the frequency and dose of vasopressors used. The choice of drug for sedation may have an impact on reducing the frequency of use of vasopressor therapy. The goal of the research is compare three strategies: propofol ( sedative agent), dexmedetomidine ( selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative effect) and their combination for sedation after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Multi vascular lesions of the coronary arteries according to coronary angiography;
* Heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
* Age of patients from 18-80 years;
* Patient consent to participate in the study;
* Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;

Exclusion Criteria:

* Refusal to participate;
* Hypersensitivity to propofol, dexmedetomidine;
* Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
* Occurred ischemic stroke;
* History of the ischemic stroke;
* History of the neurodegenerative diseases;
* History of the mental disorders;
* Use of neuroleptics, antidepressants for the last 5 years;
* History of the cardiac surgery in the past;
* Patients with chronic pulmonary disease (GOLD 3-4)
* Patients with asthma (moderate or severe),
* Participation in any other clinical trial;
* Gastric or duodenal ulcer with risk of bleeding;
* Chronic renal failure (ClCr less than 50 ml / h)
* Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
* Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR\> 1.5)
* If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
* History of the hematological disease;
* Alcohol abuse in the anamnesis (3-4 times a week).
* Condition after chemotherapy;
* Pregnancy, lactation.
A Research Study in Italy to Understand How the Dose Check App Used With Xultophy® Works in the Treatment of People Living With Type 2 Diabetes

This study will look at how a mobile based app called 'Dose Check' used along with Xultophy® helps the treatment in participants with type 2 diabetes mellitus (T2DM). Participants will get Xultophy® as prescribed by study doctor or will continue already prescribed treatment with Xultophy®. Participants will also be prescribed to use Dose Check app by study doctor. Participants will be asked to install the Dose Check app in their mobile phone, which will be supported with the correct dose of Xultophy®. The study will last for about 6 to 8 months.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 21 years at the time of signing informed consent.
* Diagnosed with T2DM \>=12 weeks prior to signing consent.
* The decision to initiate treatment with commercially available Dose Check app as a part of treatment along with Xultophy® as per the local label has been made by the patient and the treating physician before and independently from the decision to include the participant in this study.
* Participants who are insulin naive (including the following situations: i. already on treatment with Xultophy® at V1 for less than or equal to (\<=) 12 months and for \<= 15 dose steps and ii. short-term insulin use for acute illness for a total of \<14 days)
* Available HbA1c value \<=12 weeks prior to the 'Informed consent and initiation of Dose Check app visit' (V1) or HbA1c measurement taken in relation with the 'Informed consent and initiation of Dose Check app visit' (V1), if in line with local clinical practice.
* Willingness to continue using the Dose Check app on a compatible smartphone according to the intended use for the entire duration of the study.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having signed informed consent in this study.
* Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.
* Treatment with any investigational drug or software as a medical device (SaMD) within 30 days prior to enrolment into the study.
* Diagnosed with type 1 diabetes mellitus.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Hypersensitivity to the active substance or any of the excipients as specified in the Xultophy® local label.
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML

The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.

Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of high-risk MDS (IPSS int-2).
* No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).

Exclusion Criteria:

* Pregnant or lactating women.
* Absolute QT interval \>460 msec in the presence of serum potassium and magnesium values within the normal range.
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Uncontrolled or severe cardiovascular or pulmonary disease.
Effects of Vagus Nerve Stimulation (VNS) as a Treatment of Persistent Depression With Comorbid Personality Disorders (Impulse-VNS

In this monocentre two-armed double blind randomised placebo-controlled study - in which the control group obtains the VNS therapy within a defined space of time after 12 weeks - the impact of vagus nerve stimulation on depressive symptomatology of patients with therapy-resistant depressive personality disorders shall be analysed. Particularly in comorbid disorders, medicamentous treatment shows exceedingly bad response rates. Against the background of hitherto insufficient treatment strategies for chronic or persistent depression with comorbidities, the proceeding of a study on the effects of VNS on depressive patients with comorbid disorders is absolutely essential.


Eligibility Criteria:
Inclusion criteria

* embedding criteria according to "VNS manual for doctors"
* diagnosis of a recurrent depressive disorder (based on ICD-10 criteria) and a comorbid personality disorder (according to SKID I/II) with an ailment period of more than six months
* age 18-80 years
* verbal IQ (WST) 85 points
* HAM-D sum score \> 20 points
* at least four depressive episodes in the anamnesis
* no amelioration of current depressive episodes under two different antidepressants in appropriate dosage for six weeks
* constant medication within the last two weeks (at the discretion of the supervising doctor)
* written consent after informing the patient about the study
* no VNS treatment to date
* no misuse of illegal drugs or alcohol
* Women in childbearing age are not permitted to participate in the study if a doctor has asserted the non-existence of pregnancy before the beginning of the study. Furthermore, the procedure of a pregnancy test is recommended after the completion of the study. During the study, a reliable type of contraception (such as the Pill) should be taken. The doctor provides further information.

Exclusion criteria according to "VNS manual for the doctor"

* present hospitalisation according to the federal states' PsychKG
* clinically relevant unstable bodily concomitant diseases
* former VNS treatment
* reduction of intelligence with verbal IQ \< 85 (WST)
* conceivable use of an MRT examination after the implantation of the VNS-system
* for diagnostic examinations with the dTMS and the MRT: electric devices (such as cardiac pacemakers, medicine pumps etc.) or pieces of metal (ferromagnetic, e.g. screws after bone fractures) within or at the body, or large-scale tattoos
* conditions that do not allow to use VNS, such as relevant dysfunctions of the heart's stimulus conduction system or cardiac arrhythmia, stomach ulcer, dysphagia, palsy of parts of the n-vagus nerve
* insufficient knowledge of the German language
* pregnancy or lactation
* current misuse of substances
A Digital Twin for Exoskeleton Pilot

Although exoskeletons have been studied for many years, actual products have been sold on the market. However, there are still many limitations in the practical application of exoskeletons, and the control logic is also limited to the level of motor torque compensation, and lacks the consideration of overall motion stability (such as whether the wearer (driving, pilot) will fall). The purpose of this project is to establish a digital twin of this driving, which will perform the driving action in parallel, and calculate in parallel in the virtual environment the torque required to provide each joint torque to maintain stable walking without falling, and this torque can be used as a monitoring basis for the auxiliary torque of each axis for the exoskeleton. When the exoskeleton's movements are out of range of a stable gait, the controller can warn and attenuate the output of auxiliary forces, and on the other hand, it has the opportunity to analyze whether the intention of driving is to switch the movement mode - such as stopping, or sitting, squatting, etc.

This project is expected to use different machine learning models to make accurate predictions of human intent when healthy people drive different actions or action transitions of common human actions. Drivers will wear sensors such as inertial measurement unit (IMU) and electromyography (EMG) in the lower limbs to measure body signals of participants during actions in a non-invasive way, and let the system calculate the joint angle, angular velocity and angular acceleration of each joint of the driving lower limb related human signals.

Eligibility Criteria:
Inclusion Criteria:

1. Can stand independently and walk for more than 5 minutes.
2. According to age, it can be divided into: elderly groups (aged between 50\~80 years old); Young people (aged 18\~50 years).

Exclusion Criteria:

1. Have current or previous neurological diseases of the lower extremities, such as: acute neuritis, stroke, Parkinson's disease.
2. Have current or previous orthopedic diseases of the lower extremities, such as: knee replacement, rheumatoid arthritis, or sports injuries and other symptoms.
The Impact of Real Time Ventilation Feedback on Ventilation Rate and Tidal Volume During Cardiac Arrest.

During out-of-hospital cardiopulmonary resuscitation, patient are first ventilated without ventilation feedback (but with a flowsensor connected), hereafter patients are ventilated with the use of ventilation feedback.

During cardiac arrest, patients are intubated, ventilation is performed using a manual resuscitator. Hereafeter, a flowsensor is connected. During the first cycle, patients are ventilated without any feedback (whilst the sensor is recording the delivered ventilation). During the second cycle, realtime delivered flow is shown on the screen, informing the user on the delivered ventilation volume and ventilation rate. Data is saved automatically after use.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Traumatic cardiac arrest Inability to intubate patient