cyrilzakka/clinical-trials huggingface dataset:
The Impact of a Patient Education Tool for Appendicitis

Hypothesis/Study question (brief introduction of the question studied; about 5 lines)

Appendicitis is the most common acute surgical admission to the pediatric surgery service at the MCH. The need for surgery can provoke anxieties for patients. Patient education materials are meant to improve knowledge, set expectations, and improve the overall hospital experience for patients and their families, and are already being widely implemented for elective surgeries in the context of ERAS pathways. This study aims to develop an effective patient and family education tool, with the goal of improving patient education and satisfaction with care in the emergency surgery setting.

Study objectives

1. Utilize evidence-based methods to evaluate the success of implementation of a patient and family-centered education tool for appendicitis.
2. Develop and validate a pre- and post- education patient satisfaction and experience survey in the realm of pediatric surgery.
3. Inform the development of the education tool and survey through multidisciplinary and patient/family input.
4. Implement a patient/family-centered education tool in an emergency surgical setting.

Methodology / Study design

1. Pilot phase Convenience sample of 10 patients diagnosed with acute appendicitis and their families will be selected to provide input on the patient and family experience survey tool. A convenience sample of 5 surgeons and 5 surgical nurses will also be solicited to provide feedback. The survey tool will be adapted based on the responses.
2. Pre-implementation phase All patients and their families with acute appendicitis who present to clinic for their routine follow-up appointment or are called for their phone-call follow up will be eligible to take a survey. All responses are voluntary and anonymous. The survey swill be available on an online platform so invited participants may conveniently participate in the study.
3. Post-implementation phase After the education pamphlet has been finalized and its distribution to families has begun, all patients and their families with simple or perforated appendicitis who had their initial presentation after the education pamphlet was available will be eligible to take a survey. All responses are voluntary and anonymous. The surveys will be available on an online platform so invited participants may conveniently and anonymously participate in the study.

Qualitative and descriptive statistics will be used to detect a difference in patient experience and satisfaction between the those who received the education tool and those who did not.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers of all pediatric patients (0-17 years old) with acute appendicitis, including both perforated and non-perforated appendicitis cases, who have undergone an urgent appendectomy.

Exclusion Criteria:

* Patient or family does not understand English or French (education material available in only these two languages).
* Patient presenting for an elective interval appendectomy.
Sleep To Reduce Incident Depression Effectively

This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.

This project will assess the acute and long-term effectiveness of dCBT-I on Research Domain Criteria (RDoC) sleep parameters: Insomnia Severity Index (ISI), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low SES, minority). This will be tested by administering internet-based dCBT-I to people with insomnia and adding face-to-face CBT-I in non-remitters, as well as comparing the RDoC sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. This study will also determine the acute and long-term effectiveness of face-to-face CBT-I in non-responders to dCBT-I on RDoC sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups.

This study will also determine the effects of dCBT-I and CBT-I using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. Specifically, rate of depression of both dCBT-I and CBT-I will be compared to a control group.

This study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.

Eligibility Criteria:
Inclusion Criteria:

* Determination of Insomnia (ISI \> 14)
* And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology \< 11)

Exclusion Criteria:

* Age \< 18
* Current use of antidepressants for depression
* Bipolar or Seizure disorders
* Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
* Current DSM-5 major depressive disorder at baseline.
Laparoscopic Nissen Versus Anterior Partial Fundoplication

The most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. This operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. An anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. The aim with this study is to compare the results postoperatively, both short time and long time results.

Aim: To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. The secondary aims are to establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.

Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are randomised between the two operations. Postoperatively, telephone interview is performed weekly the first two months. One year and ten years postoperatively. The patients are investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age:18-65 years.
* Good results of PPI treatment (\<3 months) resulting in reduced heart burn and acid regurgitations.
* Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring.

Exclusion Criteria:

* Previous surgery on the stomach
* Patients with IBS (criteria ROM II)
* Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement
* Patients with active ulcer disease
* Paraesophageal hernia
* Patient that are incapable to understand the study information (for example mentally disorder, drug abuse)
EUS vs. MDCT in Pancreatic Malignancy

Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.

The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.

Registry procedures:

* HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
* EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
* SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
* HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
* FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).

Eligibility Criteria:
Inclusion Criteria:

* adult (≥ 18 years of age) patients;
* the presence of a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT);
* patients fit and willing to undergo surgery with a curative (R0) intent;
* sign of the informed consent.

Exclusion Criteria:

* the presence of significant co-morbidities that contraindicate pancreatic resection;
* previous neo-adjuvant oncologic therapy;
* distant metastases;
* lack of discernment;
* refusal to sign the informed consent..
Back Pain Prevention in Multiple Myeloma Using an External Spinal Brace

Consenting patients with multiple myeloma (MM) will be randomly allocated to receive either standard medical treatment (chemotherapy, radiotherapy, pain-killing medication) alone or standard medical treatment plus a brace. Patients will be regularly evaluated in research clinics; the results data will inform the design of a full trial. Information will be collected to inform a list of requirements a centre needs to have in place to run an RCT of these interventions.

Multiple myeloma (MM) is a neoplasia of plasma cells mostly within the bone marrow, commonly leading to multiple vertebral collapses. This causes spinal deformity, leading to incapacitating back pain and reduced quality of life. In spite of advances in medical therapy, some patients are left with disabling back pain, sometimes requiring surgical intervention. University Hospitals of North Midlands NHS Trust have observed on an audit of our own practice that application of an external spinal brace as early in the disease process as is possible appears to maintain the overall alignment of the spine, thus minimising risk of spinal deformity and consequent back pain.

The ultimate aim is to undertake an RCT to determine whether the use of an external spinal brace can reduce back pain and spine-related disability in patients suffering from back pain due to multiple myeloma, in comparison to conventional management without a brace.

However, prior to this, a feasibility study is required. The feasibility study is needed to see if the trial processes (providing patient information, consent process, conducting the baseline investigations and outcome measures) can be accommodated without causing too much delay to the application of the brace.

Suitable patients will be consented by the research team and randomised to receive a brace or no brace in addition to their routine Myeloma treatment. After baseline data collection and questionnaires, the participant would be followed up for data collection at 6 weeks and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults with MM
* Myeloma infiltration in the spine confirmed by radiological evidence
* MM-related back pain
* Can attend for the whole follow up period

Exclusion Criteria:

* Presenting with cord compression and neurological deficit requiring urgent decompression and intervention
* Chronic pain syndrome
* Language barrier that cannot be overcome using translation services
* Unwilling or unable to give informed consent
* Painful VCFs at the lumbosacral junction, L4 to Sacrum, where application of brace is not possible.

Not suitable for treatment with a brace e.g. pregnancy
Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension.

It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.


Eligibility Criteria:
To limit bias in this study all patients that with sickle cell anemia and pulmonary hypertension with the pre-specified data required will be included.
Long-Term rIsk, Clinical manaGement and Healthcare Resource Utilization of Stable CAD in Post MI Patients

THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.

TIGRIS is a multinational, multi-centre, observational, prospective, longitudinal cohort study which will include stable CAD patients with history of MI 1-3 years ago and high risk of developing atherothrombotic events in a real world setting. The follow-up period is 3 years.

Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

- Stable CAD patients aged 50 years or older with documented history of presumed spontaneous MI with their most recent MI occurring 1 to 3 years prior to enrollment and have at least 1 of the following risk factors: age ≥ 65 years; diabetes mellitus requiring medication; documented history of a second prior presumed spontaneous MI (\>1 year ago); documented history of angiographic evidence of multivessel coronary artery disease; chronic renal dysfunction.

Exclusion Criteria:

* Presence of serious co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year)
* Current participation in a blinded randomized clinical trial.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient
* Patients receiving treatment of ticagrelor beyond 12 months, or off label use of ticagrelor.
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women

The aim of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate to severe depression in peri- and postmenopausal women.

Perimenopausal period is characterized by an increased risk of depressive symptoms. Major depression is one of the most disabling medical conditions worldwide. At present, it is becoming more difficult to prove that antidepressants actually work better than placebo in clinical trials.Use of homeopathy to treat depression is widespread, but there is a lack of clinical trails about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression in general population. The purpose of this study was to determine whether individualized homeopathic treatment and fluoxetine are more efficient than placebo for moderate depression in peri- and postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Major depression according to DSM-IV
* Moderate to severe depression according to 17-item Hamilton Rating Scale for Depression (14-24 score)
* No current use of homeopathic treatment for depression or antidepressants or anxiolytic drugs 3 months prior to study entry
* Not be currently taking psychotherapy for at least 3 months before study entry
* Early transition to menopause defined by a change in cycle length of 7 days or longer in either direction from the participant´s own baseline for at least 2 cycles
* Late transition to menopause defined as 3 to 11 months of amenorrhea
* Postmenopausal stage defined by 12 months or more of amenorrhea
* Capability and willingness to give informed consent and to comply with the study procedures

Exclusion Criteria:

* Pregnancy or breastfeeding
* Other psychiatric disorders different from moderate to severe depression (severe depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide attempt)
* Alcohol or other substance abuse
* Known allergy to fluoxetine
* Cancer or hepatic diseases
Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer

The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.

Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years or younger
* Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
* Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
* Prostate specific antigen (PSA) level of ≤10 ng/ml
* Bone scan with no abnormalities
* Health status that would permit radical prostatectomy
* Life expectancy of more than 10 years.

Exclusion Criteria:

* PSA \>10 ng/ml
* Bone scan consistent with metastatic disease
* Other evidence that cancer of the prostate is not clinically localized
* Life expectancy less than 10 years
* Serum creatinine greater than 3 mg/dl
* Myocardial infarction within last 6 months
* Unstable angina Class III or IV
* Severe pulmonary disease
* Liver failure
* Severe dementia
* Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.
Safety and Efficacy of a Contact Lens for Daily Disposable Use

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
* Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
* Subjects must be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

Exclusion Criteria:

* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
Hepatic Doppler to Assess Venous Congestion During Invasive Mechanical Ventilation (DOHECOV)

The purpose of the study is to investigate venous congestion using hepatic vein doppler for ICU patients with invasive mechanical ventilastion. The primary outcome is the systolic to diastolic hepatic vein velocity ratio S/D . The objective is to find a significant association between S/D and different congestion indicators.


Eligibility Criteria:
Inclusion Criteria:

* intubated for more than 24 hours

Exclusion Criteria:

* Chronic end-stage renal disease on admission
* Atrial Fibrillation
* Cirrhosis
* Portal thrombosis
* Refusal to participate
* non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
* Under legal protection.
Probiotic Modulates Vaginal Microflora

The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.

1. To evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire.
2. To evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling.
3. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling.

Eligibility Criteria:
Inclusion Criteria:

* Generally, healthy women aged 18-80. - Currently free from urogenital infections such as urinary tract infection (UTI), bacterial vaginosis (BV), or yeast vaginitis.
* Willing to commit throughout the experiment.

Exclusion Criteria:

* Pregnant.
* On vaginal suppository treatments within 4-weeks prior to entering the study.
* On oral medication for vaginal illnesses or any vaginal therapy such as hormones and estrogen within 4-weeks prior to entering the study.
* On long term medication (\> 6 months) for any illnesses.
* Have used vaginal estrogen cream, ring or tablet within 4-weeks prior to entering the study.
* Have used vaginal moisturizers, lubricants or homeopathic preparations within 4-weeks prior to entering the study.
* Have used spermicide agent within 4-weeks prior to entering the study.
* Pelvic or any gynecologic surgery 6-months prior to entering the study.