cyrilzakka/clinical-trials huggingface dataset:
Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications

purpose of this study is to evaluate the level of pain perceived by patients using a transdermal cream and/or transdermal patch with or without an oral medication as a pain management solution.

The purpose of this minimal risk, observational study is to observe and document patients' perspective on how the combination of transdermal cream and/or transdermal patch(s) with or without oral medication can help reduce or eliminate the use of opiate(s).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with an ICD10 code indicative of chronic pain
* Participants must be starting a new regimen of topical therapy with or without non-narcotic oral medication that has been deemed medically necessary and is independent of the study
* Participants must be expecting to receive therapy for at least 12 weeks
* Participants must be between 18 and 64 years of age
* Participants must be able to provide sound verbal informed consent

Exclusion Criteria:

* Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)
* Participants must not have a diagnosis of cancer within the past 5 years
* Participants who have chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer
TPE in Rennes Hospital

To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years

Indications were recorded from the patients electronic chart. Side effects were identified from the review of TPE monitoring forms completed prospectively by the nurse who performed the TPE during the course of the procedure

Eligibility Criteria:
Inclusion Criteria:

* All adult patients who underwent TPE in Rennes University Hospital 2011-2018

Exclusion Criteria:

* Absence of the monitoring sheet during the EP session
* Refusal of patient participation after receipt of the information letter
* Persons over the age of majority who are subject to legal protection (protection of justice, guardianship, guardianship)
The Effects of Kinesio® Tape on Neck Pain and Disability

This study is a within-subjects design; therefore, the participant will serve as their own control. Participants will be included in the study if they have neck pain or disability defined by a score of more than 14 on the Neck Disability Index. They will be excluded if they have any diagnosed disc pathology. A mask-associated pain questionnaire will be completed by the participants prior to the study to determine their perceived effect of mask-wearing on neck pain. This questionnaire is adapted from the HAPPE study on mask-associated headache pain. A baseline pain rating will be recorded a numerical pain scale. Next, active cervical range of motion will be measured, three times in each direction to be averaged. A pain rating will be recorded for pain during cervical motion. Kinesio® Tape will be applied to activate the cervical extensor muscles. The participant will sit with the tape on for 20 minutes, then active cervical range of motion and pain will be recored again.


Eligibility Criteria:
Inclusion Criteria:

* Neck Disability Index Score of more than 14

Exclusion Criteria:

* cervical disc pathology or injury
* previous neck surgery
* prior history of general medical conditions involving joints, muscles, bones or connective tissue such as fibromyalgia, osteoporosis, etc.
* an NDI score of less than 14 or more than 24
* reported allergies to Kinesio® Tex Tape or any other adhesive material
* any contraindications for the usage of Kinesio® Tape
Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years of age
* An acute onset of at least 3 of the following signs and symptoms (new or worsening):

  1. Cough
  2. Production of purulent sputum
  3. Shortness of breath (dyspnea)
  4. Chest pain due to pneumonia
* At least 1 of the following:

  1. Fever
  2. Hypothermia
  3. Presence of pulmonary rales and/or evidence of pulmonary consolidation
* PORT Risk Class II, III, or IV
* Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
* Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

* Ventilator-associated pneumonia
* Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
* Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
* Presence of known:

  1. Viral or fungal pneumonia
  2. Pneumocystis jiroveci pneumonia
  3. Aspiration pneumonia
  4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
  5. Primary or metastatic lung cancer
  6. Cystic fibrosis
  7. Active or suspected tuberculosis
* Known HIV or myasthesia gravis
Electrostimulation, Skeletal Muscle Function, and Exercise Capacity in Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to test the following hypothesis:

The benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in COPD patients

Background: Because it has little impact on ventilatory requirements and dyspnea, muscle electrostimulation appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, the physiological mechanisms underlying the proposed benefits of electrostimulation training have not been explored.

Objective: To evaluate in COPD patients the physiological mechanisms of changes in exercise tolerance after electrostimulation training.

Method: We propose to conduct a controlled, randomized and double blind clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 24 patients with COPD. Patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. Before and after training, patients perform endurance shuttle walking test, muscle function testing, muscle biopsy, blood sampling and health-related quality of life questionnaire.

Planning analysis: The main outcome will be change in the strength of the quadriceps over the 6-week electrostimulation program. The other end-points will be mid-thigh and calf muscle cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue, operational lung volumes at iso-time and walking time during an endurance shuttle walk, muscle hypertrophying/atrophying pathways and muscle aerobic capacity. For each group, pre- and post-training comparisons will be made using a repeated measures design. The magnitude of the pre- and post-training changes will also compared between both groups with a two-way ANOVA (group, training effect) with repeated measures on the second factor (training effect). A p value \< 0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* FEV1 \< 60% predicted value and FEV1/ FVC \< 70%
* 6-minute walking distance \< 400 m

Exclusion Criteria:

* Patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test
* Patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed)
* Patients with room air PaO2 \< 60 mm Hg will be excluded.
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

The purpose of this study is to evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma


Eligibility Criteria:
Inclusion Criteria:

* HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment
* Diagnosis of HCC confirmed by histology
* Child-Pugh class A cirrhosis with adequate remnant liver parenchyma
* Measurable disease
* Fit enough to undergo surgery to resect the primary liver tumour

Exclusion Criteria:

* Prior systemic therapy for HCC
* Presence of extrahepatic metastasis
* History of liver transplantation
* Peripheral sensory neuropathy with functional impairment
* Uncontrolled hypertension/ cardiac disease
Non-vascular ICD Electrode Configuration Feasibility Study

This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.


Eligibility Criteria:
Inclusion Criteria:

1. Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines
2. Patient must be at least 18 years of age
3. Subject must provide written informed consent prior to any clinical investigation-related procedure.

Exclusion Criteria:

1. Pacemaker dependency
2. Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
3. Currently taking amiodarone or a Class IC antiarrhythmic drug
4. Hypertrophic cardiomyopathy
5. Anticipated high risk of stroke
6. Anticipated high surgical risk or risk of infection
7. Severe aortic stenosis
8. Severe proximal three vessel coronary disease (over 70% in each vessel)
9. Greater than 50% left main stem disease
10. Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
11. Medical conditions that preclude defibrillation testing
12. Chronic renal insufficiency including patients on dialysis
13. Subject is currently participating in another clinical investigation.
14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks, based on self-reporting.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer) which has an impact on cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (CYP2A6) activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.
Do Patients Suffering a Cardiac Arrest Present to the Ambulance Service With Symptoms in the Preceeding 48hrs?

A cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. We aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.

The UK ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (OHCA) each year. Hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (IHCA) have been deteriorating for the preceeding 48 hrs and suggest that many IHCA are potentially avoidable if this deterioration is identified and actued on promptly. No similar study has been performed to see if patients suffering OHCA have also presented with warning signs in the preceeding 48 hrs that were overlooked.

Eligibility Criteria:
Inclusion Criteria:

• All patients seen by SCAS ambulance crews and suffering a cardiac arrest within the following 48 hrs

Exclusion Criteria:

• None
Obstructive Airways Diseases in Emergency Department (OADED) Study

This is an observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both Chronic Obstructive Pulmonary Disease (COPD) and Asthma patients.

This is a feasibility observational study which aims to evaluate the possibility of using data from a capnography device to assess obstructive airway severity in both COPD and Asthma patients. The study will include adults asthma and COPD patients (age \>18) that arrive at the Emergency Department (ED). Patients will be enrolled on a continuous basis and will be monitored by a capnograph and an oximeter before, during and after lung function assessment and medical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. Ability and willingness to participate the study and sign informed consent form
3. Asthma / COPD patients

Exclusion Criteria:

1. Pregnant women
2. Asthma or COPD patients with FEV1 \> 60%
3. Disability or unwillingness to undergo capnography measurement
4. Cannot be assessed for FEV1
5. Oxygen supply \>5 L/min
Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery

This is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.

The study will include adult patients of both sexes scheduled for elective cardiac surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined).

The patients included in the study will be randomized in 1:1 ratio using computer generated numbers into two groups. The first group of patients, upon arrival to the intensive care unit will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h. Dexmedetomidine infusion will be discontinued before weaning from mechanical ventilation and extubation. The second group of patients, upon arrival to the intensive care unit will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h. Propofol infusion will also be discontinued before weaning from mechanical ventilation and extubation.

Sedation level will be assessed using Richmond Agitation and Sedation Scale (RASS) every two hours. Postoperative analgesia will be managed according to protocol (opioid analgesics, non-steroid anti-inflammatory drugs, paracetamol), with pain level assessment using visual analog scale (0 - no pain; 10 - unbearable pain).

The following data will be registered: age, sex, body mass index (BMI), hemoglobin, heart rate, and LVEF. Among the postoperative parameters, the following will registered: duration of mechanical ventilation (in hours), extubation time, ICU and hospital length of stay (in days), postoperative hemoglobin, blood product transfusion rates, occurrence of atrial fibrillation and assessment of delirium. Assessment of delirium will be performed using the confusion assessment method for intensive care unit (CAM-ICU) every 12 hours during five postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined)
* left ventricular ejection fraction (LVEF) \>40%.

Exclusion Criteria:

* preoperative atrial fibrillation
* previous history of interventionally treated arrhythmias
* second and third degree atrioventricular block
* bradycardia with heart rate ≤50/min
* pacemaker
* renal or hepatic insufficiency
* emergency procedures
* history of serious mental illness, delirium, and severe dementia
Effects of Gamma-tACS on EEG Periodic Activity

In this study on healthy subjects, the effect of transcranial alternating current stimulation (tACS) will be investigated. In particular, the distinction between periodic and aperiodic electroencephalogram (EEG) activity will be considered, as well as the state-dependency phenomenon. Participants will take part in two experimental sessions that will include tACS stimulation (one real, one control). Before, during, and after stimulation, subjects will have their EEG recorded during rest or during tasks.

The aim of this study is to investigate how the modulatory effects of gamma-tACS interact with intrinsic neural activity, measured in terms of periodic and aperiodic activity, as well as neurophysiological and behavioral modulation, taking into consideration the state-dependency phenomenon, which refers to the brain's activation state prior to stimulation.


Eligibility Criteria:
Inclusion Criteria:

- Healthy adults

Exclusion Criteria:

* Common exclusion criteria
* Left-handedness (assessed through the Oldfield test)
* Diagnosis of neurological or psychiatric disorders
* Vision problems that prevent reading, not correctable with lenses
* Diagnosis of substance dependence on drugs or alcohol
* Presence of hearing aids/prostheses
* Diagnosis of epilepsy or family history up to the second degree with it
* Episodes of febrile convulsions or recurrent fainting
* Head trauma
* Presence of surgical clips or metal implants in the head
* Diagnosis of heart disease
* Presence of a cardiac pacemaker or artificial heart valve
* Presence of hearing aids/prostheses
* Hearing problems or tinnitus
* Vision problems not corrected with lenses (such as color blindness)
* Taking tricyclic antidepressant medications
* Taking neuroleptic medications
* Diagnosis of headache or migraine
* Taking more than 3 alcoholic units in the last 24 hours
* Taking 2 or more cups of coffee or caffeine from other sources in the last 2 hours
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)

Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.

The mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.

This double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.

All patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).

Eligibility Criteria:
Inclusion Criteria:

* possessing at least one painful aphthous ulcer in the last 3 days
* older than 10 years of age

Exclusion Criteria:

* systemic disease or specific syndrome (such as Behcet's)
* pregnancy
* breastfeeding
* allergy to NSAIDs
* history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders
* consumption of anti-inflammatory medications in the last 24 hours