cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Response to a Course of Repetitive Transcranial Magnetic Stimulation Using Vocal Biomarkers

Voice recordings taken prior to the start of repetitive transcranial magnetic stimulation (rTMS) therapy will be used to develop a predictive model of treatment response using machine learning for patients with major depressive disorders (MDD).

The objective of this study is to investigate whether voice biomarkers taken prior to the start of rTMS can predict the response to a 30-session course of rTMS in patients with MDD with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the commencement of the rTMS course, patients will need to complete several questionnaires. Before the first session, voice tests will be recorded using the Callyope application. Patients will answer questionnaires and assess voice tests weekly and after the final rTMS session to track the progression of depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Having a prescription for a course of rTMS to treat an episod of MDD
* Unipolar MDD confirmed according to DSM-5 criteria
* Moderate to severe MDD (MADRS score \> 19)
* No use of psychotropic medication or use stabilised (no change in dose \< 4 weeks before study entry)
* Able to understand, speak, read and write French
* Express informed consent, after a period of reflection
* Affiliated with a French social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* History of epilepsy or convulsive seizures
* Previous brain surgery
* History of recent cranial trauma (\< 6 months)
* Presence of severe suicidal ideation
* Psychotic disorders
* Metal objects in the head, eyes or brain
* Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
* Clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study
* Active withdrawal from alcohol or other substances
* One or more recent rTMS sessions (\< 4 weeks)
* Other non-drug therapy recently initiated (\< 4 weeks) to treat EDC (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
* Pathology altering phonation based on the perception of the investigator
* Subjects in a period of relative exclusion from another protocol
* Adults protected by law or patients under guardianship or curatorship
* Subjects deprived of their liberty by judicial or administrative decision
* Pregnant or breast-feeding women
Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis

A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis


Eligibility Criteria:
Inclusion Criteria:

* Subject or subject's legal representative informed of the study nature.
* Subject understands the duration of the study and its follow up visit requirements.
* Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
* Subject able to walk unassisted.
* Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.

Exclusion Criteria:

* Life expectancy less than 12 months
* Myocardial infarction less than 3 months prior to procedure
* Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
* Uncontrolled hypercoagulability
Simulation-Based Learning Experience in Strengthening Stoma Care Education

The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.

The main hypothesis it aims to test are:

H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.

H2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.

H3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.

Researchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.

Participants will be asked to;

* Answer the questions (demographic data form and anxiety scale)
* Receive education regarding stoma care (verbal and demonstration)
* Practice stoma care on their own


Eligibility Criteria:
Inclusion criteria

1. Age 18 and above
2. First time having a stoma and having an intestinal stoma,
3. Communicable, open to cooperation,
4. Able to speak and understand Turkish,
5. Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.

Exclusion Criteria

1. Patients who develop surgical complications in their stoma.
2. Patients who are unable to perform stoma care due to any complication
3. Having previously received stoma care training or participated in its implementation for any reason
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.


Eligibility Criteria:
Inclusion Criteria:

* ASA status 1-3
* 0-10 years of age
* Undergoing surgical procedure with planned arterial cannula placement

Exclusion Criteria:

* ASA status \>3
* Older than 10 years of age
* Patient unable to have BP taken on 1 upper and 1 lower extremity
EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

This is a prospective, non-randomized study in which patients who meet eligibility criteria and consent to participate will undergo a minimally invasive procedure using radiofrequency (RF) energy for ablation of the great saphenous vein (GSV).

Subjects who meet eligibility criteria will undergo a procedure using the Venclose Radiofrequency (RF) System to treat the great saphenous vein.

The technique involves percutaneous access and insertion of the endovenous sectional radiofrequency (EVSRF™) catheter into the target vein under ultrasound guidance and relies on the use of local anesthesia and thermal energy, from a radiofrequency generator, applied to the target vein. After each treatment, the EVSRF™ catheter is withdrawn a single length of the heating coil and another treatment is performed, until the entire vessel has been treated.

After the treatment procedure, subjects will be evaluated four (4) times to assess vein recanalization and reflux, and to determine the incidence of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and 18 to 80 years old (inclusive) at time of enrollment (signing of consent).
* Subject has significant venous reflux by Duplex Ultrasound (DUS), defined as reverse flow with reflux duration greater than 0.5 seconds after the Valsalva maneuver or distal augmentation while the patient is standing or in reverse Trendelenburg position.
* Subject is eligible for endovascular treatment, as determined by the treating investigator.
* Subject's general physical condition allows for a significant amount of ambulation after the procedure, as determined by the treating investigator.
* Subject is willing and able to complete study requirements, including all follow-up visits and assessments.
* Subject voluntarily provides written informed consent to participate in this study.

Exclusion Criteria:

* There is evidence of old or fresh thrombus in the subject's diseased vein segment to be treated, as determined by Duplex Ultrasound (DUS) within 2 weeks prior to the index procedure.
* In the judgment of the treating investigator heat energy delivery to the subject would be contraindicated.
* Subject is concurrently participating in another interventional clinical trial.
* Subject is pregnant or plans to be pregnant or lactating at the time of the treatment procedure.
* Subject has known or suspected allergies or contraindications to any general or local anesthetic agents and/or any antibiotic medication that cannot be adequately pre-treated.
Magnesium Sulfate for the Improvement of Cognition in Patients With Alzheimer Disease

This study is to examine the possible effect of supplementing Magnesium sulfate on patients with Alzheimer Disease (AD) in controlling or reducing the amount of amyloid present in the brain, and increasing cognitive ability in individuals that have amyloid deposits.

Recent findings suggest magnesium may be effective in ameliorating symptoms in an Alzheimer's disease-like pathological progression by reducing Aβ-plaque, thus preventing synapse loss and memory decline in transgenic mice. Common forms include magnesium sulfate.

As a nutritional adjunct in hyperalimentation, the precise mechanism of action for magnesium is uncertain. Predominant deficiency effects are neurological, e.g., muscle irritability, clonic twitching and tremors. Hypocalcemia and hypokalemia often follow low serum levels of magnesium. While there are large stores of magnesium present intracellularly and in the bones of adults, these stores often are not mobilized sufficiently to maintain plasma levels. Parenteral magnesium therapy repairs the plasma deficit and causes deficiency symptoms and signs to cease.

To provide a comprehensive clinical evaluation of the effects of Magnesium sulfate in AD patients, this study is designed to assess the impact of magnesium sulfate on amyloid plaque to generate valuable data on clinical utility for the use of diagnostic algorithms and foundation for the development of possible treatment.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with a diagnosis of Alzheimer's disease.
* Exhibiting an onset and progression of cognitive dysfunction during at least 3 months prior to the screening period.
* Subject or representative is willing to sign the consent for prior to enrollment into the study and to participate in all aspects of the study. Prospective subject must give verbal assent if unable to sign written consent.

Exclusion Criteria:

* Patients with neurodegenerative diseases other than Alzheimer's disease.
* Patients with cognitive dysfunction due to cerebral damage resulting from a lack of oxygen, a brain injury, etc.
* Patients with clinically significant cardiovascular disease.
* Patients with history of clinically-evident stroke.
* Patients with history of cancer in the last 5 years.
* Patients with clinically-significant systemic illness that may affect safety or completion of the study.
* Currently taking any medications that are known to interact with magnesium.
* Currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.
Effect of Use of a New Technique for Pediatric Urine Collection in ER

Urinary tract infection is most common serious bacterial infection in children who admit into the emergency department (ED). However the collection of urine from young children is time consuming process. So many children and their family guardian waste time until medical disposition established.

In 2013, Maria Luisa Herreros Fernandez etc have suggested a new urine collection technique for newborn, that bladder and lumbar stimulation technique is fast and safe.

The aim of this study is to determine clinical efficacy of bladder and lumbar stimulation technique (BLST) for pediatric patient in ED.

Bladder and lumbar stimulation technic

Step 1

- Oral or IV hydration : Aprropriate to the weight of the children

Step 2 - Bladder stimulation : Gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 sec

Step 3

- Lumbar stimulation : Lumbar paravertebral zone in the lower back with a light circular massage for 30 sec

Both stimulation manoeuvres are repeated until micturition starts and a midstream urine sample can be caught in a sterile collector

Eligibility Criteria:
Inclusion Criteria:

* Children have unspecific fever and requiring and urine test

Exclusion Criteria:

* Initial shock state
* History of congenial urinary tract abnormality
* Parents who have declined taking part in the research
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab. The main purpose of this study is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, 18 years ≤ age ≤ 75 years；
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically confirmed invasive HER2 positive breast cancer.
* Known hormone receptor status.
* Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by Echocardiogram.
* Been treated for early breast cancer with standard of care duration of trastuzumab.
* If been not treated neoadjuvantly, lymph node metastases need to be confirmed by postoperative pathology; if been treated neoadjuvantly , have not reached totally pathologic complete response.
* Signed informed consent form (ICF) .

Exclusion Criteria:

* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
* History of heart disease.
* Bilateral breast cancer.
* Corrected QT (QTc) interval ≥0.47 seconds.
* History of gastrointestinal disease with diarrhea as the major symptom.
Effects of Berries on Post-meal Blood Sugar

The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.

Berries are rich sources of various polyphenols which may be beneficial in the regulation of blood glucose. In vitro and animal studies have shown that polyphenols and polyphenol-rich extracts of foods, including berries, may inhibit digestion and absorption of carbohydrates and thereby suppress postprandial glycemia. However, current evidence on the effects of berries on postprandial glycemic responses in humans is limited.

The purpose of this study is to investigate the effects of berries on postprandial glycemic responses (blood glucose and insulin) to starch or sucrose in healthy subjects. It consists of five substudies each of which includes 2-4 meals with different berry species typically consumed in Finland and a reference meal without berries. The following combinations of carbohydrates and berries are studied:

* Studies 1-2: white wheat bread (starch) is consumed with several berry species
* Study 3: white wheat bread or rye bread is consumed with a mixture of berries
* Study 4: sugar (sucrose) is consumed with berries and berry nectars
* Study 5: a sugar-sweetened bakery product (starch + sucrose) is consumed with berries and berry nectar.

Eligibility Criteria:
Inclusion Criteria:

* BMI 20-28 kg/m2
* normal fasting plasma glucose

Exclusion Criteria:

* Smoking
* Diabetes or other chronic disease
* Antibiotic medication within the past 3 months
* Blood donation within the past month
Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 3 months
* 8 ≤ Fugl-Meyer Assessment score ≤ 30
* Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* History of surgery of affected upper limb
* Fracture of affected upper limb
Deep Learning for the Discrimination Among Different Types of Keratits: a Nationwide Study

Detecting the cause of keratitis fast is the premise of providing targeted therapy for reducing vision loss and preventing severe complications. Due to overlapping inflammatory features, even expert cornea specialists have relatively poor performance in the identification of causative pathogen of infectious keraitis. In this project, the investigators aim to develop an automated and accurate deep learning system to discriminate among bacterial, fungal, viral, amebic and noninfectious keratitis based on slit-lamp images and evaluated this system using the datasets obtained from mutiple independent clinical centers across China.


Eligibility Criteria:
Inclusion Criteria:

Slit-lamp images with sufficient diagnostic certainty and showing keratitis at the active phase.

Exclusion Criteria:

* Poor-quality images
* Images presenting mixed infections (i.e., cornea infected by two or more causative pathogens)
Primary Repair of Obstetric Anal Sphincter Injuries (OASIS) by Surgeons (PROS Study)

Third- or fourth-degree perineal tears, collectively known as Obstetric Anal Sphincter Injuries or OASIS, may occur following a vaginal birth. OASIS may have catastrophic consequences, including anal incontinence. Satisfactory primary repair of OASIS is prudent in reducing the risk of maternal morbidity. Although Obstetricians are typically involved in the acute repair of OASIS, General Surgeons may be called to assist in cases of severe anatomical disruption.

The investigators have constructed a survey to explore the experience and current practice of Emergency Surgeons in relation to the repair of OASIS. The investigators will gather information including their level of exposure, understanding of current guidelines and confidence in performing these repairs. This will help the investigators identify if further training is required and will enable them to put forward recommendations for future practice. The findings will be presented at conferences and meetings and published in journals.

To date, there is little consensus on who should perform the primary repair of obstetric anal sphincter injuries (OASIS), with the Royal College of Obstetricians and Gynaecologists (RCOG) stating that the repair should be undertaken by a trained practitioner and that 'involvement of a colorectal surgeon will be dependent on local protocols, expertise and availability'.

In cases of severe anatomical disruption, the on-call general surgeon may be summoned upon to assist with the repair. They may not be a colorectal surgeon, and if they are, they may not specialise in pelvic floor surgery. A previous survey of practice amongst UK obstetricians and coloproctologists identified a wide variation in experience, methods of repair, follow up and recommendations for future delivery.

The aim of this study is to explore emergency surgeons' knowledge in relation to the acute repair of OASIS and to compare this with current recommendations and best practice guidance. This, in turn, will help identify if further training is required.

Satisfactory repair of acute OASIS is necessary for the following reasons:

* It may reduce the risk of anal incontinence, a stigmatising condition which may have substantial impact on an individual's quality of life and day-to-day living.
* By reducing the incidence of OASIS-related anal incontinence, the financial burden associated with the management of this condition as well as the risk of litigation will also be reduced

Eligibility Criteria:
Inclusion Criteria:

* Registrar or above
* Cover an Emergency on-call rota for General Surgery
* Working in Great Britain and Ireland

Exclusion Criteria:

* • Senior House Officers or Foundation Doctors

  * Doctors who do not cover an emergency rota
  * Doctors working abroad
Fluid Responsiveness Prediction at the Bedside

The purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.

Severe hypotension is a common life-threatening conditions in critically ill patients. Discriminating between the need for volume expansion or inotropic/vasoactive support is a main clinical goal. Pulse pressure variation are an accurate index of fluid responsiveness, but it needs controlled mechanical ventilation with a tidal volume of at least 8 ml/kg and absence of arrhythmias. This could limit its clinical applicability. Moreover pulse pressure variation accurately predicted cardiac output increment. However the cardiac output increase is not a clinically relevant target in absence of low cardiac output.

The objectives of the present protocol are: 1) to calculate the accuracy of cardiovascular and renal variables to predict either arterial pressure increase or clinically relevant improvement after fluid administration and 2) to verify how often dynamic indices could be applied in clinical practice.

Arterial pressure increase is defined by mean arterial pressure above 65 mmHg or an increment greater than 20 % respect to basal value. Clinically relevant improvement is defined by restoring adequate values of arterial pressure or cardiac index or diuresis or central venous saturation if they are inadequate before fluid administration. These adequate values are 65 mmHg for mean arterial pressure, 2.5 l.min-1.m-2 for cardiac index, 0.5 ml.kg-1.h-1 for the diuresis, 70 % for central venous saturation.

Eligibility Criteria:
Inclusion Criteria:

* mean arterial pressure lower than 65 mmHg

Exclusion Criteria:

* fluid overload
* mean arterial pressure lower than 45 mmHg and mandatory immediate treatment
* active bleeding
* hemoglobin lower than 8 g.dl-1