cyrilzakka/clinical-trials huggingface dataset:
Atmospheric Projection in the Emergency Department

The goal of this clinical trial is to learn about the reduction of pain and anxiety during a minor procedure in the emergency department on adult patients through the visualisation of atmospheric projection as a distraction mean. The main question it aims to answer is :

Can the atmospheric projection of a video reduce pain and anxiety in adult patients receiving painful procedures in the emergency department ?

Participants will look at an atmospheric projection (projection of a media on the walls and roof around the patient) while receiving their planned care procedures. Researchers will compare an active group watching a video with a control group watching a simple colored light to see if the visualisation of an atmospheric projected video reduces pain and anxiety more than the visualisation of a colored light does.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 ;
* Patient requiring one of the following treatment procedures : suturing, plaster cast placement and/or repositioning, fracture or dislocation reduction, ascites puncture, pleural puncture, lumbar puncture.

Exclusion Criteria:

* Patient clinically unstable;
* Patient incapable of discernment or consent ;
* Altered mental status (cognitive disorders, mental retardation, acute state of confusion, acute psychosis);
* Alcoholic patient with University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) score of 10/10 ;
* Patient hard of hearing ;
* Patient with visual impairments preventing him/her from perceiving his/her environment ;
* Patient unable to understand the use of visual analog scales (VAS);
* Impaired sensitivity of the part of the body where the medical intervention is to take place;
* Planned use of analgesia/sedation with a dissociative agent (midazolam, ketamine, propofol);
* Incarcerated patient ;
* Patient transferred from another hospital ;
* Patient having already participated in this study during a previous consultation in the emergency department of the Centre Hospitalier Universitaire Vaudois.
Comparison of Embedded and Added Motor Imagery Training in Patients After Stroke

The purpose of the study is to examine if patients in the embedded motor imagery (MI) training group (EG1) need less time to perform the motor task than patients in the added MI training group (EG2).

The purpose of the study is to examine if patients in the embedded MI training into physiotherapy (EG1) need less time to perform the motor task than patients in the added MI training to physiotherapy (EG2).

A third groups serves a control group (CG) to investigate the effect of the intervention versus a group with a control intervention.

Additionally, semi-structured interviews before and after the intervention will give an insight in the patient's experience with motor imagery (MI), their expectations regarding the intervention and their opinions about MI after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients after a first-ever ischemic or hemorrhagic stroke
* Outpatients or leaving inpatients 3 months after stroke
* Ability to stand with or without a cane for at least 30 sec on a normal hard floor
* Ability to walk for 20 metres with or without a cane or an orthosis
* MMSE with at least 20 points
* Age older than 18 years
* Signed written informed consent

Exclusion Criteria:

* Joint replacements (knee, hip, shoulder)
* Limiting pain in the upper or lower body
* Limiting range of motion (ROM) in the hip, knee, ankle joint or toes
* Body weight more than 90 kilograms
* Compromised mental capacity to give written informed consent
Rotational Thromboelastometry Versus DIC Score in Sepsis

Sepsis results in activation of the coagulation system, which is commonly described as disseminated intravascular coagulation (DIC). The DIC score, which is commonly used to define this syndrome, does not allow to delineate between hypercoagulation and hypocoagulation. The aim of this prospective observational study is to evaluate data from automated rotational thromboelastometry and compare These with the DIC score regarding intensive care unit outcome.

Sepsis results in an intensive interaction between Inflammation and the coagulation system. The activation of the coagulation system leads to consumption of procoagulatory as well as anticoagulatory proteins and platelets. This process may induce microcirculatory thrombosis as well as hemorrhagic diathesis, which is commonly described as disseminated intravascular coagulation (DIC).

The International Society on Thrombosis and Haemostasis (ISTH) recommends the use of the DIC score to describe this syndrome. A score of at least 5 points is defined as an overt DIC. However, the DIC score does not allow to differentiate between a hypercoagulation and hypocoagulation states and whether there could be a difference regarding outcome between the two states.

In this prospective observational study, patients admitted to a medical intensive care unit will be included. The DIC score as well as rotational thromboelastometry (ROTEM) will be evaluated within the first 24 hours after the diagnosis of sepsis as well as on day 3 and 5.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis, defined according to the Sepsis-3 Definition
* informed consent

Exclusion Criteria:

* age \<18 years
* pregnancy and lactation
* known coagulation disorder prior to Admission for sepsis
* known cirrhosis of the liver
* known active malignancy
* surgical procedure during the last 4 weeks
* refusal to participate in the study
Evaluation of the Association Between Right Atrial Reservoir Strain Variation and Fluid Responsiveness in Patients With Septic Shock

Evaluating preload dependence is crucial for managing fluid administration in septic shock patients. To avoid unnecessary fluid administration, it's recommended to use dynamic tests like the passive leg raising (PLR) maneuver or a fluid challenge (FC) to see if a patient's cardiac output will increase after fluid resuscitation. Transthoracic echocardiography (TTE) is preferred for this because it can non-invasively, reliably, and reproducibly measure the increase in cardiac output. A patient is considered a "responder" if their stroke volume (SV) increases by more than 15% after an FC. Two-dimensional (2D) right atrial strain (RAS) is a promising tool for evaluating right atrial function. According to the Frank-Starling law, measuring changes in the RA reservoir strain phase (RASr) can identify acute changes in preload, like those induced by a PLR maneuver or an FC.

The aims of this study are to assess the ability of ∆RASr to identify responders after a fluid challenge (FC) and to evaluate the ability of ∆RASr variation induced by a PLR maneuver to distinguish responders from non-responders to volume expansion.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years old)
* Patient hospitalized in the Intensive Care Unit at Amiens University Hospital with septic shock for less than 48 hours, defined by the presence of all the following criteria: presence of sepsis, hypotension requiring vasopressors to maintain a mean arterial pressure ≥ 65 mmHg despite adequate prior fluid resuscitation, and blood lactate levels \> 2 mmol/l (18 mg/dl).
* Patient requiring fluid resuscitation with crystalloids/colloids
* Patient on invasive mechanical ventilation in assisted-controlled mode.
* Blood pressure monitored via a radial or femoral arterial catheter connected to a MostCareUp (Vygon, France).
* Patient or family informed and non-opposition documented.

Exclusion Criteria:

* Poor echocardiographic image quality preventing RASr assessment
* Patient with a contraindication to the PLR maneuver: severe head trauma or intracranial hypertension
* Patient with a history of pericardiectomy
* Patient with a clinical examination consistent with abdominal compartment syndrome
* Patient with aortic pathology, mitral regurgitation greater than grade 2, tricuspid regurgitation greater than grade 2, mitral stenosis, or intracardiac shunt
* Patient with internal or external atrial/ventricular pacing
* Pregnant woman
* Patient on extracorporeal membrane oxygenation and mechanical circulatory support
* Moribund patient
* Patient with supraventricular or ventricular arrhythmia during echocardiographic measurement series
* Patient on renal replacement therapy during echocardiographic examination
Study to Evaluate Satisfaction and Usability of DuoResp® SPIROMAX® in Asthma and COPD Treatment

The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.

The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.

Eligibility Criteria:
Inclusion Criteria:

* male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
* patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
* patients who recently changed medication to DuoResp® Spiromax or are about to do so
* capacitated person with present declaration of consent

Exclusion Criteria:

* diseases contraindicated in accordance with the summary of product characteristic
* patients who take part in interventional clinical trials parallel or during the last 4 weeks
* patient shows conditions or diseases that might disturb the monitoring according to the physician
* patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
* insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
* patients involved in the planning and construction of the study (Teva staff and employees of the centres)
* patient is incapable of giving consent
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.


Eligibility Criteria:
Inclusion Criteria:

* Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
* Females seeking revision augmentation or revision reconstruction, where problems exist
* Have any of the following conditions or situations present:
* Post mastectomy surgical removal of the breast for cancer or other disease;
* Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
* Severe ptosis requiring reconstruction;
* Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
* Adequate tissue available to cover implants.
* Saline-filled implants are not an appropriate choice.

Exclusion Criteria:

* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
* Existing carcinoma of the breast, without mastectomy.
* Abscess of infection in the body at the time of enrollment.
* Pregnant or nursing.
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
* Show tissue characteristics which are clinically incompatible with mammaplasty.
* Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
* Are not willing to undergo further surgery for revision, if medically required.
* Diagnosis of lupus or scleroderma.
Impact of Postoperative Skin Disinfection With Chlorhexidine on Bacterial Colonization

A double-blinded, controlled study was conducted at one county hospital in Sweden. Patients were randomly assigned, skin samples were collected at four times; baseline, preoperative, after intervention and after 48 hours. Bacterial colonization were assessed.

METHOD Study design

This was a double blinded, controlled, block-randomized intervention study with random allocation to Chlorhexidine- group or Sodium Chloride- group.

Sample and setting Participants was recruited at one county hospital in the southeast of Sweden from august 2019 to mars 2023. Consecutive sampling of adult patients over 18 years of age scheduled for primary elective shoulder arthroplasty surgery was approached for participation.

Intervention According to a predetermined schedule, the surgery site was either disinfected with 5 mg chlorhexidine in 70% ethanol or cleaned with sterile sodium chloride, Skin samples Skin swabs were collected on four occasions: 1. Baseline, 2. After skin disinfection, 3. Post-intervention, and 4. After 48 hours. All samples in the study were collected utilizing the eSwab system with flocked swabs Two swabs were collected on each occasion. The Pencil Eraser Swab (PES)- technique was employed (26). Swabs were gently rubbed in an oscillating motion, moving downward, and then replicating the same motion upward, repeated 15 times. For sample 1 and 2, one swab on each side of the intended incision site was collected. For samples 3 and 4, swabs were taken from each sides of the incision, positioned 1 cm away from the sutures or staples, with one swab collected on each side

Eligibility Criteria:
Inclusion Criteria: Adult patients over 18 years, scheduled for primary elective shoulder arthroplasty surgery.

Exclusion Criteria: Exclusion criteria were previous allergic reaction or perceived adverse effects of chlorhexidine, prolonged treatment with cortisone (\>5 mg), antibiotic treatment within 14 days prior to scheduled surgery, skin disease or ongoing skin infection.

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Botox Injection in Treatment of Cluster Headache

Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. The headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. For a small group of patients with episodic and most chronic form, drug therapy has little effect. For them, surgery can be a solution.

Neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. Furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. The duration of such a blockade is believed to be 3-9 months.

The purpose of the present study is to develop and evaluate a new surgical procedure with injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure.

The main objective of the project is to determine the safety of BTA injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. Secondary objectives are to identify the changes of headache attacks by the method used.


Eligibility Criteria:
Inclusion Criteria:

* Informed and written consent
* Cluster headaches defined in ICHD-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment

Exclusion Criteria:

* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
* Treatment with medication that can interact with botulinum toxin type A
The Impact of Yoga on Endometriosis-Related Pain

The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.

Yoga has been demonstrated to improve menstrual pain associated with primary dysmenorrhea through use of physical exercises, mental meditation, and breathing techniques. Still, there has been limited studies assessing potential benefits of yoga on pain symptoms of endometriosis. It is important to further assess yoga as a complementary therapy for women with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

1. Reproductive aged women 18-45
2. Self-reported prior surgery with pathology confirming a diagnosis of endometriosis
3. No current use of yoga
4. Baseline moderate pain, score greater than or equal to 5 on VAS scoring
5. Access to internet with wifi capability for zoom platform and completion of weekly surveys
6. Access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water)
7. Ability to commit to duration of 12-week yoga course

Exclusion Criteria:

1. Pregnant patients
2. Established yoga participation or moderate exercise regimen
3. Physical trauma or disability
4. Planned surgery or hormonal medication change during study
5. Non-English speaking patients
Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers

A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age 19 - 45 years
* BMI 18.5 - 25.0 kg/m2
* Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening

Exclusion Criteria:

* Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives
* Subjects with a clinically relevant history of allergic reaction
* Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products
* At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results
Prediction Model of Microvascular Ischemic Ocular Motor Nerve Palsy and Inflammatory Ocular Motor Nerve Palsy in Chinese Patients

This study aimed to train and validate deep learning systems (DLS) to differentiate between microvascular ischemic ocular motor nerve palsy (v-OMNP) and inflammatory ocular motor nerve palsy (i-OMNP). The method involves using clearly diagnosed v-OMNP and i-OMNP patients from the Department of Neurology database at Beijing Tongren Hospital for further DLS validation, aiding in the differential diagnosis of the aforementioned diseases.


Eligibility Criteria:
The diagnosis of disease is the outcome of the study. The inclusion criteria and exclusion criteria were as follows:

1. Inclusion Criteria:

   * Patients with acute bilateral diplopia within 1 week of onset at admission.

     1. Ischemic Group:
     1. Sudden onset of unilateral CN III, CN IV, or CN VI palsy.
     2. Isolated CN III (without pupil involvement), CN IV, or CN VI palsy.
     3. Presence of vascular risk factors (VRFs).
     4. Significant symptom recovery no earlier than 2 months after onset, with complete (or nearly complete) recovery within 3-6 months.

     2. Inflammatory Group:
     1. Unilateral painful CN III, CN IV, and/or CN VI palsy.
     2. Symptoms (including pain or diplopia signs) significantly improved within 72 hours after treatment with corticosteroids.
     3. MRI of the cavernous sinus showing inflammation, i.e., abnormal widening/enhancement of the affected cavernous sinus with or without granulomatous changes/inflammatory manifestations of adjacent tissues.
2. Exclusion Criteria:

   * 1. Ocular muscle palsy confirmed to be caused by tumors, trauma, infections, stroke, carotid-cavernous fistula, aneurysms, neuromuscular junction disorders, thyroid-related eye diseases, and hereditary diseases at onset or during follow-up.

     2. Presence of other neurological signs in addition to ocular muscle palsy. 3. Severe systemic diseases of the heart, liver, or kidneys, as well as psychiatric and mental illness.

     4. Pregnant or breastfeeding patients. 5. Patients who did not undergo gadolinium-enhanced MRI of the cavernous sinus. 6. Patients younger than 18 years at the time of enrollment. 7. Onset of symptoms more than 1 week before admission. 8. Incomplete data or follow-up period less than 6 months. 9. Disagreements in disease diagnosis.
Positive Therapy for Autonomic Function & Mood in ICD Patients

The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 \& 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.


Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women (≥18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;
2. Score ≥5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;
3. Able to read and write English
4. Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.

Exclusion Criteria:

1. \>5% atrial or ventricular pacing;
2. Sinus node dysfunction;
3. Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).
4. Long QT syndrome; and other channelopathies such as Brugada syndrome;
5. Hypertrophic cardiomyopathy;
6. Neurocognitive or cognitive impairments;
7. Severe psychopathology that warrants intensive treatment;
8. Participation in another research trial; and
9. Currently in psychological or psychiatric treatment.
10. Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.