cyrilzakka/clinical-trials huggingface dataset:
Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects

This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).

Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.

The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 65 years of age.
* Have RMS according to the revised McDonald Criteria.
* Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
* Be willing and able to comply with the protocol requirements for the duration of the study.
* Have given written informed consent prior to entering the screening period.
* Must register with the Rebif® Multiple Support Program.
* Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.

Exclusion Criteria:

* Have any disease other than MS that could better explain his/her signs and symptoms.
* Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
* Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
* Have a diagnosis of clinically isolated syndrome (CIS).
* Participation in any other investigational trial prior to 30 days of Study Day 1.
* Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
* Have received previous treatment with Rebif within 5 years prior to screening.
* Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.
Ephedrine vs Phenylephrine - ECG Changes

ECG changes during caesarean section are common. Incidence of ST depression on the ECG is up to 81% in some studies. Although this may indicate inadequate oxygen supply to the heart muscle (myocardial ischaemia) many other theories have been suggested including air entering the circulation from the placental bed, high heart rate, hormone or nervous system influences and spasm of the coronary blood supply. Perioperative ST depression often reflects an imbalance between heart muscle oxygen supply and demand. At the time of delivery, high heart rate is common and there is a further increase in the amount of blood the heart has to pump every minute due to blood coming back to the circulation from the placental bed. This increases oxygen demand and most ST changes are seen at the time of delivery or within 30 minutes. The clinical significance of these changes is much debated, and apart from a few case reports do not appear to be associated with poor heart muscle function or ischaemia (lack of oxygen supply). Management of the mother's blood pressure during caesarean section has changed greatly in recent years. Intermittent boluses of ephedrine, given when blood pressure is low, have been replaced with prevention of low blood pressure and phenylephrine has become the drug of choice. Ephedrine increases heart rate and contractility of the heart muscle and is likely to increase oxygen demand. Phenylephrine reduces heart rate while maintaining blood pressure which may result in a more favorable oxygen supply demand ratio.

The investigators aim to compare the incidence of ECG changes if the mother's blood pressure is maintained with phenylephrine as compared to ephedrine. To see if these ECG changes are associated with myocardial ischaemia, the investigators will perform troponin T analysis after delivery. Troponin T is a molecule released by ischaemic heart muscle.


Eligibility Criteria:
Inclusion Criteria:

1. Able to give written informed consent
2. \>37/40 weeks gestation
3. Singleton pregnancy
4. Elective caesarean section under spinal anaesthesia
5. In good general health (American Society of Anesthesiology Category 1 or 2, fit and well or with mild systemic disease that has no impact on physical activity )

Exclusion Criteria:

1. Circulatory disease (eg pre-existing hypertension)
2. Cardiac disease/medications (e.g. angina, cardiomyopathy, B Blocker medication)
3. Pregnancy related disease (eg pre-eclampsia)
4. Diabetes pre-existing the pregnancy
5. Hyperthyroidism
6. Renal Disease
7. Closed-angle glaucoma
8. Patients on monoamine oxidase inhibitors
9. In active labour
10. Emergency caesarean section
11. Fetal abnormalities
12. Contraindications to spinal anaesthesia
13. Height \>6 feet/180cm / Height \<5 feet/150cm
14. Body mass index (BMI) \<19 or \>35
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy

The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a relatively invasive endoscopic examination, often badly tolerated, and which, in France, is carried out in 50% of the cases under general anaesthesia. The development of a Capsule Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless exploration of the oesophagus, without infectious risk.The aim of this study is to validate the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these patients, after being informed and to have given their signed assent, will initially have an exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy then by the upper endoscopy will be analyzed by investigators different. This study should make it possible to evaluate the parameters of specificity, sensitivity and predictive values of Esophageal Capsule Endoscopy in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Patient age is 18 years or older
* Patient Suffers from gastroesophageal reflux disease or dyspepsia, did not undergo previous upper endoscopy, with clinical indication to upper endoscopy,able to tolerate an upper endoscopy without general anesthesia
* Patient agrees and signs the Informed Consent Form

Exclusion Criteria:

* Dysphagia
* Known Zenker's Diverticulum
* Known or suspected intestinal obstruction.
* Cardiac pacemakers or other implanted electro medical devices.
* Female pregnant patient
* Upper Endoscopy for control or recent upper endoscopy
* Chronic alcoholism defined by a daily consumption of alcohol over 80 g
* Severe hepatopathy
* Severe, primitive or secondary gastroparesis
* Known cancer
* Abnormalities of coagulation
* Incapacity to understand and sign a sensible consent of participation to the study
Hypofractionated vs. Conventionally Fractionated Concurrent CRT for Unresectable Stage III NSCLC

This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for unresectable stage III non-small-cell lung cancer

Hypofractionated radiotherapy (RT) delivers higher doses of RT over a shorter period of time and may kill more tumor cells and may have fewer side effects. Dose escalation in unresectable stage III NSCLC has been safely achieved up to LEVEL 3 (PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx). Acute toxicities were well tolerable. Further stage II clinical study has found that hypofractionated RT can significantly improve the efficacy of patients with a low toxicity profile. The aim of this study is to compared with hypofractionated and conventionally fractionated concurrent chemotherapy , and evaluate whether hypofractionated RT can improve local control and overall survival in unresectable stage III non-small-cell lung cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years to 75 years

  •.Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of r Unresectable Stage III NSCLC(according to the TNM classification in theUnion for International Cancer Control (UICC) 7th ed.)
* No prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy
* No prior thoracic RT
* No severe perioperative complications and expected postoperative lifespan

  ≥4 months
* ECOG Performance Status 0-1
* Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up

Exclusion Criteria:

* Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
* Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation
* Patients with positive mental disorder that would preclude study participation;
* Contradictory to chest radiotherapy
* Pregnant or nursing women
* Concurrent other anti-cancer treatment
* Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted therapy
Evaluation of Pharmacist-led Medication Reconciliation Service Benefits in Hospitalised Medical Patients

Background:

Transitions of care often lead to medication errors and unnecessary healthcare utilisation. It has been repeatedly shown that medication reconciliation can at least partially reduce this risk.

Objective:

The aim of this prospective pragmatic trial was to evaluate the effectiveness of pharmacist-led medication reconciliation offered to medical patients as part of routine clinical practise.

The main questions to be answered were:

* the effectiveness of pharmacist-led medication reconciliation on medication discrepancies at discharge and 30 days after discharge
* the effectiveness of pharmacist-led medication reconciliation on healthcare utilisation within 30 days after discharge.

Participants in the intervention group were offered the following:

* medication reconciliation on admission
* medication reconciliation on discharge, coupled with patient counselling, provided by clinical pharmacists.

Participants in the control group were offered standard care.

Design: pragmatic, prospective, controlled clinical trial

Setting: Five general medical wards at the University Clinic of Respiratory and Allergic Diseases in Slovenia:

* one intervention ward with a routine pharmacist-led medication reconciliation service
* four control wards

Data collection:

* Data collection and outcome assessment were performed by research pharmacists who were clinical pharmacists or final year clinical pharmacy residents not involved in the treatment of the included patients.
* Data for the assessment of medication errors at discharge were obtained from the patients' medical records and the study documentation.
* The reason for the patient's hospitalisation was obtained from the discharge letter and divided into acute or planned admissions. The main diagnosis was the reason for admission, while all other patient diagnoses listed were used to assess comorbidity.
* Patient comorbidity was assessed using the Charlson Comorbidity Index
* For patients in the control group the BPMH was collected in the same way as in the intervention group. However, it was only used for study purposes and was not documented in the patients' medical records
* Data on healthcare utilisation and medication discrepancies after hospital discharge were collected through patients or caregivers' phone interview.

Eligibility Criteria:
Inclusion Criteria:

* All adult medical patients admitted to the study wards

Exclusion Criteria:

* patients who do not speak Slovenian,
* transferred from another ward,
* previously included in the same study.

Subsequent exclusion from the analysis:

* patients hospitalised only for diagnostic purposes,
* patients transferred to another ward or hospital,
* patients that died during hospitalisation,
* patients from the control group who were offered medication reconciliation
Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia

This is a trial designed to assess the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day followup. The trial population will include male and female subjects between 18 and 64 years (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a prior history of tolerating aripiprazole per investigator's judgement.

Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals between 18 and 64 years, inclusive, at the time of informed consent.
* Prior history of tolerating aripiprazole per investigator's judgement.

Exclusion Criteria:

* Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
* Subjects who use more than one antipsychotic medication at screening.
* Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
* Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
* Subjects currently in an acute relapse of schizophrenia.
* Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
* Subjects who are considered treatment-resistant to antipsychotic medications.
Longitudinal MRI Examinations of Patients With Brain Ischemia and Blood Brain Barrier Permeability

The objective of this trial is to visualize blood brain barrier function and metabolic changes in the first days after ischemic stroke with new investigational MRI sequences.

In this study the investigators will be examining acute ischemic stroke patients on the first and second day after symptom onset using repetitive MRI examinations to visualize blood brain barrier function and metabolic changes of the brain in 5 sub-projects, each containing a specific MRI protocol with one of the following new MRI sequences:

1. T1-Dynamics (measuring disruptions of the blood-brain barrier)
2. pH-imaging (measuring metabolic changes, acidosis)
3. Resting-state MRI (measuring changes in the cerebral perfusion)
4. Quantitative MRI-Angiography (quantification of blood flow in single vessels)
5. Diffusion Tensor Imaging (DTI) for patients with Anterior Choroidal Artery (AChA)-Infarcts (quantification of damage of white matter tracts)

Each sub-projects will be conducted in blocks of a specific time span. Morphological outcome will be assessed at day 5-7. Clinical outcome will be assessed at day 5-7 and day 90. The association of the new imaging parameter with the clinical and morphological outcome measures will be analysed. No specific intervention is assigned to the subjects by the investigators of the study.

Eligibility Criteria:
Inclusion Criteria:

* Suspected stroke or transient ischemic attack (TIA) within 24h from symptom onset

Exclusion Criteria:

* MRI contraindication, age \< 18 years, intracranial hemorrhages
• Sleep Disturbance Among Patients With Psoriasis and Atopy and Comparison Between Them

Comparison between sleep disturbance in atopy and psoriasis and control

Sleep is essential for daytime functioning and health and important for both psychological and physiological wellbeing . A growing body of research indicates that chronic sleep disturbance is associated with impaired quality of life (QoL) and a risk factor for poorer health, for example depression cardiovascular disease, hypertension 1 and diabetes.

insomnia, the most common sleep disorder, is a clinical condition defined as difficulties falling asleep and/or maintaining sleep and/or poor sleep quality despite adequate opportunity for sleep resulting in significant daytime impairment.

The development of insomnia in healthy populations has a bi-directional relationship with psychological factors such as anxiety, depressive symptoms and stress, and may in clinical populations also be associated with physical symptoms, such as pain. the physical symptoms in psoriasis, such as itch, one would expect a higher prevalence of sleep disturbance in this patient group. On the other hand Sleep disturbance is common also in patients with atopic dermatitis (AD). Patients with AD often have sleep disturbances due to pruritus.

Eligibility Criteria:
Inclusion Criteria:

- patients with Psoriasis and Patients with A topic dermatitis

Exclusion Criteria:

* All patient have another dermatological disease
Nefopam as a Multimodal Analgesia for Thoracic Surgery

Acute postoperative pain after video-assisted thoracoscopic surgery is very severe. Because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. In the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for elective video-assisted thoracoscopic surgery
* American Society of Anesthesiologists physical grade I, II, III
* patient aged from 18 years old

Exclusion Criteria:

* history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam
* renal insufficiency
* liver insufficiency
* myocardial infarction
* glaucoma
* pregnant and lactating women at the time of surgery
* patient who did not consent to the use of patient-controlled analgesia
PARASTOP - Paracetamol With Strong Opioids

Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. Taking tablets is burdensome to patients and the study aims to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified.

The study plans to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. Voluntary participants who are taking a combination of paracetamol and a strong opioid are recruited to the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
* ≥50 kg (due to paracetamol dosage)
* Participants who are under palliative care or oncology service review
* Diagnosis of metastatic cancer
* Clinician-predicted life expectancy \>2 months
* Receiving daily regular strong opioids for cancer pain
* Receiving stable scheduled opioid dose last 48 hours\*
* Receiving paracetamol 1 gram x three or four times a day for at least five days
* Average pain intensity past 24 hours ≥ 2 and ≤ 7 (NRS 0-10)\*
* Able to take study drug/placebo as tablets
* Able to comply with all study procedures
* Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

  * It is allowed to repeat procedure within the screening period without considering the participant being a rescreen

Exclusion Criteria:

* History of allergy or hypersensitivity to any of the active substances or excipients in the study drug
* Known severe liver or renal failure equivalent with CTCAE Grade 3 or 4\* precluding continuation of paracetamol. (\*Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0)
* Participants receiving subcutaneous, intravenous, intrathecal, or epidural opioid therapy
* Participants receiving systemic anticancer treatment during the intervention period if they are anticipated to have increasing pain or other symptoms related to the treatment
* Co-enrolment in other drug trials. Participants will not be enrolled in any other on-going interventional clinical trial. Study participants may be enrolled in non-interventional research (e.g. questionnaire, tissue collection studies)
* Previously enrolled in this study
* Pregnant or lactating women
IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil

Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.

This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.


Eligibility Criteria:
Inclusion Criteria:

* Young adults (between 18 and 24 years old)
* Young adults who work, live or study in Porto Alegre
* PHQ ≥ 5 - without suicide ideation

Exclusion Criteria:

* Maniac or hypomanic episode
* Psychotic Syndrome
* Substance Abuse
* Suicide Risk or Ideation