cyrilzakka/clinical-trials huggingface dataset:
A Study of Participants With Squamous Cell Oesophageal Carcinoma Receiving Nivolumab as Part of an Early Access to Medicines Scheme (EAMS) Program in the United Kingdom

This purpose of this observational study is to review medical chart and patient survey data collection within an early access to medicines scheme (EAMS) program. Participant who are eligible, provide consent and enroll into the squamous cell oesophageal cancer EAMS to receive Nivolumab will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Adult participant (≥18 years of age) enrolling into the squamous cell (including adenosquamous) oesophageal cancer early access to medicines scheme (EAMS) and plans to initiate treatment with nivolumab
* Willing and able to comply with the study requirements and provide informed consent

Exclusion Criteria:

• Does not receive at least one dose of nivolumab as part of the EAMS

Other protocol-defined inclusion/exclusion criteria apply
Temperament and Character Traits in Young Men With Idiopathic Scoliosis

This study was designed to investigate whether the temperament and character traits of young men with idiopathic scoliosis differ from healthy individuals of the same age group and characteristics.

All patients who applied to the orthopedics and traumatology department between July 2017 and June 2018 for a medical board examination were evaluated by physical and radiological examination. According to the Cobb method, individuals with a Cobb angle greater than 10° were diagnosed with Idiopathic Scoliosis. In the same period, healthy individuals who applied for the same examination and met the inclusion criteria were determined as the control group by random sampling method. All participants were evaluated by a senior psychiatrist. Before the interview, all subjects fully informed about the purpose and scope of the study. After their permission was obtained the study and control groups completed a socio-demographic data form consisting of questions about detailed personal and medical history and, the participants were asked to fill in the TCI.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were 18 years of age and older, adequate level of education (at least primary school graduates) and capable of taking the tests and structured interview form, agreed to participate in the study, diagnosed with IS and did not have any psychiatric follow-up and treatment history.

Exclusion Criteria:

Individuals who were younger than 18 years of age, did not accept to participate in the study, had psychiatric disorders according to DSM V diagnostic criteria, additional medical disorders, and who were not at the level of education to take the tests and structured interview form were excluded from the study.
Effects of Aromatherapy on Patient Satisfaction With Surgical Abortion at Less Than 10 Weeks Gestation

The investigators propose a single-site, double-blinded, placebo-controlled clinical trial of lavender aromatherapy versus placebo for patient satisfaction in adult women having a surgical abortion before 10 weeks and 0 days gestation. The investigators will evaluate whether lavender aromatherapy is an effective adjunct therapy for patient satisfaction during first trimester surgical abortion. The investigators will measure satisfaction using the Iowa Satisfaction with Anesthesia Scale (ISAS). The investigators hypothesize that women receiving lavender aromatherapy will report higher satisfaction scores compared to women receiving placebo.

Prior studies have investigated the use of aromatherapy in laboring patients, in menstruating women, and in general post-operative populations. No investigations have focused on the use of lavender aromatherapy as an adjunct therapy to paracervical block and/or oral narcotics and anxiolytics in outpatient surgical abortion. Our study is novel in investigating patient satisfaction with first trimester surgical abortion using lavender aromatherapy.

The contribution of this proposed research to the literature is significant because current affordable anesthetic adjuncts to opioids and benzodiazepines are limited.

The investigators propose a single-site, double-blinded, placebo-controlled clinical trial of lavender aromatherapy versus placebo for patient satisfaction in adult women having a surgical abortion before 10 weeks and 0 days gestation. The investigators will evaluate whether lavender aromatherapy is an effective adjunct therapy for patient satisfaction during first trimester surgical abortion. The investigators will measure satisfaction using the Iowa Satisfaction with Anesthesia Scale (ISAS). The investigators hypothesize that women receiving lavender aromatherapy will report higher satisfaction scores compared to women receiving placebo.

Prior studies have investigated the use of aromatherapy in laboring patients, in menstruating women, and in general post-operative populations. No investigations have focused on the use of lavender aromatherapy as an adjunct therapy to paracervical block and/or oral narcotics and anxiolytics in outpatient surgical abortion. This study is novel in investigating patient satisfaction with first trimester surgical abortion using lavender aromatherapy.

The contribution of this proposed research to the literature is significant because current affordable anesthetic adjuncts to opioids and benzodiazepines are limited.

Eligibility Criteria:
Inclusion Criteria:

* Women18 years or older
* Have decide to have a pregnancy termination with no sedation or oral sedation.
* Are less than10 weeks 0 days gestational age with viable pregnancy.
* Agree to being randomized to aromatherapy or placebo

Exclusion Criteria:

* Contraindications or allergies to ibuprofen, lidocaine, or jojoba oil.
* A non-viable intrauterine pregnancy
* A pregnancy greater than or equal to 10 weeks gestational age.
* Adults who are unable to consent or who are currently incarcerated.
Study to Evaluate Safety and Effectiveness of Dynamic Stabilization Versus Lumbar Fusion in Treatment of Multilevel Lumbar Disc Degeneration Disease

The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.

Study aims are:

1. To evaluate superiority of Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in lumbar range of motion;
2. To compare Surgical treatment with posterior dynamic stabilization compared to Surgical treatment with internal fixation and fusion in functional outcomes as measured by change in Oswestry Disability Index;
3. To compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age between 30 and 75 years inclusive
3. Radiographic evidence of multi-level lumbar disc degeneration disease
4. Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
5. Preoperative ODI ≥ 30%
6. Clinical symptoms consistent with diagnosis of lumbar DDD:

   * Radicular back or lower extremity pain and/or
   * Decreased muscular strength and/or
   * Abnormal sensation
7. Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment

Exclusion Criteria:

1. Cauda equina syndrome
2. Patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
3. Osteoporosis defined as T-score ≤ -3.5. BMD will be measured by DEXA performed on lumbar spine
4. Systemic infection such as AIDS and active hepatitis
5. Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation
6. Participation in a clinical trial of investigational drug or device within the past 30 days
Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth

To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.

The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.

During these childbirths, the midwives also indicated a shortening of the working time.

The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.


Eligibility Criteria:
Inclusion Criteria:

* Women of more than 18 years old
* Primipara
* Patients joining the antenatal classes dispensed by the midwives.
* Patients affiliated to a national insurance scheme or benefiting from such a diet
* Patients having given a written consent form

Exclusion Criteria:

* None
Management of Perforated Peptic Ulcer

Perforated peptic ulcer (PPU) is a common surgical emergency. Exploratory laparotomy and repair with the omental patch are routine surgical intervention till now. In developing counties, laparoscopic repair is still not considered the gold standard in this emergency condition. This study was conducted to evaluate laparoscopic management of PPU in terms of peri-operative outcomes.

Files of all patients admitted to our hospital with perforated peptic ulcer in the last 4 years and underwent operative management.

Demographic, clinical and perioperative outcomes will be collected tabulated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

- All patients with perforated peptic ulcer admitted to our hospital in last 4 years and underwent surgical intervention.

Exclusion Criteria:

Uncompleted patents files.
ZnO Nanoparticles Coated Orthodontic Molar Tube

Orthodontic treatment is an elective procedure to improve the patient's dentofacial appearance. The complex design of fixed appliances provides a platform that leads to increased plaque accumulation around orthodontic brackets. So, the risk to develop demineralization area adjacent to orthodontic brackets is a major barrier in achieving this goal. Oral hygiene is greatly complicated following the placement of fixed orthodontic Appliances. Molar tube in place are considered for nearly all patients experiencing fixed orthodontic therapy over the whole treatment period, which normally lasts 1.5 to 2 years. To the best of the authors' knowledge, the application and antimicrobial efficacy of zinc oxide (ZnO) nanoparticles coating on orthodontic molar tube material has not been integrated clinically. White spot lesions during orthodontic treatment have a documented etiology. Briefly, the accumulation of plaque and food around brackets, bands, wires, and other attachments caused decreased pH and increased S. mutans colonization, which led to the possibility of clinical demineralization.

The aims of study are to assess the antimicrobial effect of nanoparticle coated stainless steel orthodontic molar tube material (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT) against the streptococcus. mutans\& lactobacllius bacteria that cause white spot lesion around the fixed orthodontic appliance. .

Aim:

The aim of this prospective randomized clinical trial is to assess the antimicrobial efficacy of nanoparticle coating stainless steel orthodontic molar tube (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT).

Objectives:

1. Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT).
2. Evaluate and compare the clinical bond failure rate between the coated OMT and the UOMT. The null hypothesis is that there is no significant difference in the antimicrobial effects and the rate of bond failure between the non-coated and coated stainless steel orthodontic molar tube using ZnO NPs.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are seeking or under orthodontic treatment with fixed appliances Subjects must be healthy \&well fit medically.

  * Subjects with no signs or symptoms of oral mucosal disease.
  * Subjects should not receive oral antimicrobials or antibiotic therapy for more than 3 months prior to sample enrolling.
  * non-pregnant or lactating Female patient.
  * Subjects is not smokers

Exclusion Criteria:

* Patients with a greater tendency to accumulate plaque (e.g., having congenital anomalies such as cleft lip and palate) or undergo orthognathic surgery
Postoperative Analgesic Effect of Nefopam

Nefopam will be administered to the patients undergoing laparoscopic gastrectomy under the total intravenous anesthesia (TIVA).

The investigators will evaluate whether the nefopam can decrease the total amount of remifentanil administered during the operation, which will reduce the acute opioid tolerance and following consumption of fentanyl during postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Early or advanced gastric cancer

Exclusion Criteria:

* Refusal
* Use of preoperative analgesic drugs
* Pregnancy
* Recurred gastric cancer
* Seizure
* Cardiac disease
* Monoamine oxidase inhibitor
* Urologic disease
* Previous intrabdominal surgery
* Body mass index \> 30 or \< 16
UNDISTORT Correction of Distortions in Diffusion MRI V1.0

This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and brings together a team from UCL Division of Medicine, Computer Science and University College London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical algorithms to reduce the distortions in MR images, especially of the prostate.

This is a three-year project funded by a Cancer Research UK Multidisciplinary Award and brings together a team from UCL Division of Medicine, Computer Science and University College London Hospital. The aim is to develop Magnetic Resonance (MR) sequences and mathematical algorithms to reduce the distortions in MR images, especially of the prostate. Current NICE guidelines include a type of MR imaging called Diffusion Weighted MRI for the detection of tumour within the prostate, and for active surveillance of low risk confirmed disease. However, approximately 40% of prostate diffusion images suffer from severe localised distortions and this is most marked in the peripheral zone of the prostate where 75% of prostate cancers occur. The source of these distortions is magnetic field imperfections due to the presence of rectal gas or metallic hip implants.

The research study will ask both healthy volunteers and patients to undergo research MR scans and use the acquired data for analysis. For patients, the scans may be either additional sequences acquired during an extended clinical session, or a separate additional session entirely for research.

The output from the research will be modified ways to run an MR scanner and compute the final images.

The work should lead to improved diagnostic accuracy and a reduced number of non-diagnostic studies. It will have broader impact through application to diffusion imaging of other body sites, including whole-body diffusion MRI and non-cancer applications. If successful, the results would provide evidence for a larger trial with the eventual outcome being manufacturers incorporating modified MR sequences and data processing into clinical systems worldwide.

Eligibility Criteria:
Inclusion Criteria:

* For the development and testing phases, there are no specific inclusion criteria. Assessment of the primary outcome measure (reduced distortions) also does not require specific inclusion criteria. The intended application of our methods is to prostate cancer and this is reflected in some of the secondary outcome measures. Recruitment will come from the UCLH imaging bookings system. This list will include many men having prostate scans and many of these will subsequently be found to have at least a suspicion of cancer. Note there is no requirement for a suspicion of cancer to be recruited for the study.

Exclusion Criteria:

* Subjects unable to have an MRI scan due to contraindications for MRI, for example, pacemaker and certain other implants, severe claustrophobia.
* Subjects unable to give informed consent.
* Children and vulnerable populations.
Prehabilitation and Heart Valve Surgery

To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surgery (CABGs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients.

A review stated that " the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline.

In the previous study held in pre-operative assessment clinic between March 2016 and August 2016, evaluated that PREHAB programme for frail patients undergoing CABG or Valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery.

previous other studies, parental study which is PREQUEL study recruitment started in July 2018 expect patient recruitment and 3 months of follow-up will be completed in June 2022 then their analysis will be done.

To improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. In some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role.

Eligibility Criteria:
Inclusion Criteria:

* Patients awaiting heart valve surgery for repair or replacement
* Both gender
* Mild to moderate valvular diseases
* NYHA grade I and II
* Pre-frail to moderately frail patients with a CFS of 4-6
* Patients with an estimated 6-8 weeks of surgical waiting list time.
* Able to perform 6MWT at baseline with RPE\<13

Exclusion Criteria:

* Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction).
* Patients with unstable or recently unstable cardiac syndrome
* Other than valve surgeries e.g. CABG
* Hospitalization for arrhythmias/ congestive heart failure
Clinical Pediatric Pneumonia Score in Critically Ill Children

The purpose of the study is to create a clinical pneumonia tool that can be used to predict the cause of community-acquired pneumonia, which is a lung infection that began outside of the hospital in critically ill children therefore limiting unnecessary antibiotic use. The investigators will enroll critically ill children admitted with acute respiratory failure and suspected pneumonia. Each patient will receive a clinical pneumonia score blinded from culture and respiratory viral panel results. All care after samples obtained will be at the discretion of the PICU team. The investigators believe that our clinical pneumonia scale with procalcitonin will accurately designate viral from bacterial etiologies.


Eligibility Criteria:
Inclusion Criteria:

* All intubated pediatric patients
* Age 1 day to 21 years
* Admitted to the LLUCH PICU with suspected pneumonia for the next 6 months
* Have received antibiotics for less than 12 hours
* Have been intubated for less than 24 hours
* Patients must be English or Spanish speaking for consent purposes.

Exclusion Criteria:

* Patients who have received antibiotics for greater than 12 hours
* Patients who have been intubated for greater than 24 hours
* Patients who are unable to tolerate non-bronchoscopic bronchoalveolar lavage
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography

Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing radial access coronary angiography
* Have myocardial bridge

Exclusion Criteria:

* A history of coronary artery bypass grafting (CABG)
The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy

The aim of this study is to compare the effect of occupational therapy intervention through two-way video call, versus occupational therapy home program in written form; on handwriting skills, occupational performance, fine motor and hand skills in children with diplegic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with diplegic cerebral palsy
* Being between the ages of 7-12
* Being able to read and write
* To be at level I-III in the Manual Ability Classification System (MACS)
* To have the necessary devices (phone, tablet or computer) for video calling
* Not being able to come to the faculty to conduct the first evaluation face to face
* Not receiving occupational therapy in any special education center

Exclusion Criteria:

* Presence of another neurological and/or psychiatric disease
* Not giving consent to the study Individuals included in the study will be randomly assigned to the intervention and control groups. It is planned to keep the number of individuals in the intervention and control groups equal.
SVT-15652 Otic Solution for the Treatment of Otomycosis

Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.


Eligibility Criteria:
Main Inclusion Criteria:

* At least 18 years of age
* Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
* Signs/symptoms of pruritus, otalgia and ear fullness.
* Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

* Known bacterial otitis externa or malignant otitis externa.
* Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
* Structural ear anomalies which may difficult the evaluation of the therapeutic response.
* Uncontrolled diabetes mellitus.
* Any infection requiring systemic antimicrobial or systemic antifungal therapy.
* Concomitant medicines that may interfere with the study evaluations.