cyrilzakka/clinical-trials huggingface dataset:
Aromatherapy With Lavender as Anxiolysis Prior to Cataracts Surgery

The purpose of this study is to assess the validity of lavender aromatherapy as a method of anxiolysis prior to a cataract surgery, and to see if this effect will extend intraoperatively to minimize patients' intraoperative medication requirements. The study team plans on enrolling 186 participants.

The investigator team hypothesizes that:

1. Participants will have a lower anxiety score after the intervention
2. Participants will require less intraoperative sedation medication compared to participants that did not have the lavender intervention.
3. A decrease in intraoperative medication requirements will lead to a faster discharge time

All participants will arrive at the Hutchinson Campus on the morning of surgery. After nursing intake, participants will be consented into the study. Vital signs will be recorded, as is part of the typical nursing intake. After the consent is completed, participants will receive the visual analogue scale (VAS) anxiety questionnaire. Participants that are part of the experimental group will then have the Bioesse lavender patch placed on the chest, according to manufacturer recommendations. After the lavender has been in place for 5 minutes, the same VAS anxiety questionnaire will be provided for completion. The control subjects will only receive the initial VAS questionnaire.

After this, all participants will receive the same premedication, including fentanyl and midazolam prior to cataract surgery, and will have monitored anesthesia care (MAC) during the case.

In the second phase of the study, chart review will be completed to monitor the patients' intraoperative sedation requirements . Additionally, demographic data will be taken at this time, including age, race, and sex.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* ASA (American Society of Anesthesiology) score \<=3
* Patients must be able to consent to participating in the study

Exclusion Criteria:

* ASA score \>4
* Patients with a psychiatric diagnosis or who are on psychiatric medication
* Patients with a history of asthma
* Patients with an allergy to lavender
* Patients under an anesthetic plan that has been switched from local anesthesia with sedation to general anesthesia
* VAS score \> 60 pre-operatively (high anxiety score)
Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (\> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (\< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Esophageal disruption with or without loss of SES

Exclusion Criteria:

* Esophageal Complex stenosis
* Mediastinitis
* Severe sepsis
* Coagulation abnormalities
* Contra-indications to general anesthesia
90% Effective Dose of Phenylephrine Infusions Under Intensive and Standard Treatment in Preeclamptic Patients

The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥160 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Effects of Music Therapy on Sleep Quality in Patients Who Had Hematopoietic Stem Cell Transplantation

In patients undergoing hematopoietic stem cell transplant; Side effects associated with high-dose chemotherapy and radiotherapy, night treatment and care, social isolation cause emotional problems and deterioration in sleep quality in this patient population. In a meta-analysis conducted in 2014, it was reported that music can be effective in improving sleep quality.

In this study, an experimental design with pre-test - post-test control group will be used to evaluate the effect of music therapy on sleep quality given to patients undergoing hematopoietic stem cell transplantation. It will be held between December 2020 and May 2021 at the Bone Marrow Transplantation Unit of Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital. The population of the study will be the patients hospitalized in the unit within the specified date range and the sample number was determined as 30.

Research Universe and Sample:

The population of the study will be the patients who applied to the Bone Marrow Transplantation Unit of Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between December 2020 - May 2021 and accepted the study. Considering the previous years in the date range of the study, it is predicted that an average of 25 patients will be hospitalized for stem cell transplantation. In a study conducted in 2014, it was reported that sleep disturbance continued in the long term after the transplantation in half of the patients who underwent hematopoietic stem cell transplantation. In the light of this information, the sample size was calculated as 24 using the OpenEpi program. Considering the possibility of patient or treatment-related disruptions during the study, it was planned to include 30 patients, 15 of which were experimental and 15 were control group.

Data Collection Tools The age, gender, type of transplant, habits and sleep of the patients created by the researcher during the data collection phase.

The "Patient Identification Form", which consists of 14 questions related to patients such as problems, and developed by Richards in 1987, was developed by Karaman Özlü et al. "Richard Campbell Sleep Questionnaire", whose validity and reliability study has been made, will be used.

Musical Intervention

In determining the music to be used, a quiet music containing the sounds of nature was determined in consultation with the music therapist.

It will be applied to the experimental group by using an mp3 player in the patient room, starting on the day before the transfer (D-1), every evening for 10 days and each session for 30 minutes. It will be applied between 23:00 and 24:00 in the evening so as not to prevent the standard treatment and care of the patients. After 10 days, the sleep quality of the patients will be re-evaluated using the Richard Campbell Sleep Questionnaire.

Eligibility Criteria:
Inclusion criteria in the study;

* To be conscious
* hospitalization for hematopoietic stem cell transplantation

Exclusion criteria;

* Deaf
* Terminal period
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures

The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures.

The primary purpose of the investigation is to demonstrate the claimed clinical benefit and safety of Injeq IQ-Tip™ system.

IQ-Tip™ is similar to common spinal needles with a custom-made stylet that enables the real-time bioimpedance measurement at the tip of the needle. The needle is connected to the analyzer device, which provides real-time CSF detection during lumbar puncture from the very tip of the needle and by these means assists conducting the medical procedure.

The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology patients requiring lumbar punctures.

The investigation is conducted in the pediatric hematology and oncology units of three Finnish university hospitals

Eligibility Criteria:
Inclusion Criteria:

* Pediatric hemato-oncology patients whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample or to inject drug or other substance
* Written and signed informed consent before the procedure from the parent and/or patient depending on the age of the patient

Exclusion Criteria:

* Parents and/or patient refusal to participate or parents and/or patient unable to give informed consent
* Any contraindications to a lumbar puncture. Contraindications include skin infection around the puncture area, unstable hemodynamics, bleeding tendency and increased intracranial pressure
Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis

Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older.
* New small to medium-sized ischemic stroke (defined as less than 1/3 of the MCA territory) in the territory of 70% or greater carotid stenosis.
* Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

* Patients judged to be a poor surgical candidate by the treating physicians.
* Unstable neurological status.
Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors

Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study.

The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

For a period of 15 years starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have received lentivirus-mediated genetically engineered T Cell Receptors in an Adaptimmune sponsored clinical trial. The study is designed in accordance with FDA and EMA guidance on gene therapy trials.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. The study will include subjects who have received various T cell receptors including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
* Subjects who have provided informed consent prior to their study participation

Exclusion Criteria:

* Not applicable
Study on the Response to Tetanus Vaccination of People Living With HIV

The response to primary tetanus immunization of HIV-infected children is lower than that of uninfected children.

Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received primary vaccination prior to infection is not known.

Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10 years. In general population, this recall is made only at 25, 45 and 65 years, then every 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Person aged ≥ 18 years
* Person infected with HIV followed in the infectious diseases department of CH Niort
* Born in France
* Affiliate or beneficiary of a social security scheme
* Being able to give free and informed consent to participation in research

Exclusion Criteria:

* Persons with a contraindication to tetanus vaccination
* Persons under guardianship or curatorship or without civil law
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.


Eligibility Criteria:
Inclusion Criteria:

* participants with active RA
* completed 24 weeks of treatment in WA16291 or WA17043
* eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28 joints \>=2.6)
* females of childbearing potential using reliable contraception

Exclusion Criteria:

* participants who participated in rituximab studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials
* previous rituximab non-responders
* current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies
* participants with known active infection of any kind
* evidence of any new or uncontrolled concomitant disease or development of any new contraindications which would preclude repeat treatment with rituximab
* history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* female participants who are pregnant or breastfeeding
MIND-VR: Virtual Reality for COVID-19 Operators' Psychological Support

Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support. Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely. Within this context, this randomized controlled study aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic.

Since the COVID-19 pandemic began, several psychological support programs for health care workers have been implemented, especially group or individual counseling sessions delivered face-to-face or using phones and video conferencing platforms. However, there are significant barriers to the delivery of such psychological initiatives. In this context, digital interventions to improve health services and care outcomes are recommended for implementing and providing remote psychological support.

Virtual reality can play a relevant role in providing psychological care to healthcare workers facing COVID-19. New commercial head-mounted display have made virtual reality accessible even to the mass audience, breaking down the barriers in the diffusion and use of this technology. Thanks to this fact, virtual reality can now be autonomously used by people and offered to provide psychological assistance remotely.

Within this context, this randomized controlled trial (RCT) aims to investigate the efficacy of a virtual reality home-based program for diminishing stress and anxiety in a sample of Italian healthcare workers involved in the COVID-19 pandemic. In particular, the objective is to compare the efficacy of this type of training with respect to the same program without virtual reality and a waiting list.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18, \< 65;
* Having worked on the front line as a doctor or nurse during the COVID-19 emergency (i.e., having assisted COVID-19 patients or having worked in departments dedicated to COVID-19 patients);
* Normal or corrected to normal visual acuity;
* Normal or corrected to normal hearing ability.

Exclusion Criteria:

* Physical illness: cardiovascular issues, neurological illness, epilepsy;
* Pharmacotherapy with: psychotropic drugs, anti-hypertensive drugs, anti-epileptics;
O-arm Assessment of Vertebral Movement Using ST2R Technique

The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.

Visits include the pre-operative visit, 1 and 2 year follow-up visits. Participation includes answering questions and filling out questionnaires. There are no immediate benefits by joining this study, but could potentially help define better techniques for the future spine surgeries. The risks involved in this study are minimal and there are no alternatives to this study.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent idiopathic scoliosis requiring selective thoracic posterior spinal instrumentation and fusion with the PASS LP system (screws, rods, hooks) and UNiD rod technology
* Age between 10 and 21
* Lenke Type 1 curve
* Consent and Assent to participate in the study

Exclusion Criteria:

* Age superior to 21 years
* Spinal deformities other than Lenke 1 type
* Use of implant other than those from the PASS LP system or sublaminar bands
* Neuromuscular or degenerative scoliosis
* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
* Primary muscle diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, Cerebral palsy, or Spina bidifa, Neurofibroma)
* Primary abnormalities of bones (e.g. osteogenesis imperfect)
* Congenital Scoliosis
* Scoliosis requiring anterior release
* Previous spinal surgery
* Absence of required preoperative data (diagnosis, consent...)
Prospective Trial on Noise Reduction in Surgical Operating Theaters

Aim of Study: Adverse effects from noise pollution in operation theatres have been throughly demonstrated. We assessed the impact of a noise reduction program in paediatric surgery.

Methods: A prospective controlled study on 156 operations performed by 16 surgeons was conducted. The sound levels before and after a noise reduction program based on education, rules and technical devices (Sound Ear tm) were assessed. Endpoints were spatially resolved sound levels matched by the surgeon's biometric (saliva cortisol, electrodermal activity) and behavioural stress responses (questionnaires). These were correlated with mission protocols and NoiSeQ for individual noise sensitivity.

We recorded median noise levels in the control vs. interventional group including the count of peak events with different tresholds.

Three phases were conducted: 1. Reference group/phase I 2. Control group/phase II The full data set was recorded by a research clerk present in theatre however all staff were left unaware of the study purpose 3. Intervention group/phase III. The intervention consisted of a panel of work rules including mainly communication regulations (only conversations concerning the current case were allowed, no in and out during surgery, mobile phone ban etc.. Measures were backed by intervention conferences, posters and pictograms. .

A wear off-effect was sought after . Biometrically, we analyzed the surgeon's pre- to postoperative rise in cortisol and the proportion of the surgeon's electrodermal potentials of \>15µS indicating severe stress. Intra-team communication, a decrease in disturbing conversations and sudden noise peaks were investigated and correlated with the individual noise sensitivity determined by the noise Q questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* all operations of our tertiary referral center practice of the regular day programme involving children from preterm babies up to children of 16 years of age including emergencies at regular hours with a duration of \> 20 mins and \< 5 hours

Exclusion Criteria:

* After hour emergency surgery
* Pediatric surgery cardiac cases
* surgeries \<20 mins/\>5hrs