cyrilzakka/clinical-trials huggingface dataset:
Quantitative Ultrasound for the Evaluation of Simple Bone Cyst Healing

Simple bone cysts (SBCs), also known as unicameral bone cysts (UBCs), are benign bone lesions. Literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. Evidence has shown that bone mineral density (BMD) is a reliable indicator of risk to SBC patients given its association with the mechanical properties of bone. There has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. To determine whether the QUS can provide prognostic information with respect to cyst healing, recurrence or fracture with a SBC, further study is needed.


Eligibility Criteria:
Arm 1 - Simple Bone Cyst Patients

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with implants to stabilize the bone where the cyst is located.
2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
3. Patients who are pregnant or breastfeeding
4. Patients with a simple bone cyst crossing the growth plate

Arm 2 - Healthy Controls

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding

Arm 3 - Fracture patients

Inclusion Criteria

1. Patients ≥ 2 and ≤ 21 years
2. Patients who have undergone any type of casting or surgical treatment for their fracture
3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

Exclusion Criteria

1. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.)
3. Patients who are pregnant or breastfeeding
Clinical and Economic Impact of an Organized Treatment Pathway on AFib Patient Management From the ER

Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.

Management variation such as selecting rate vs rhythm control, timing and need for thromboembolic treatment, ER vs inpatient treatment and cardiology consultation could lead to disparate care of patients. Therefore, there is a need for future studies to standardize practice leading to improved management, decreased rates of hospitalization and overall cost. Investigators developed a multidimensional protocol for the management of AF in the emergency department. Investigators aimed to assess if this new ER AF management protocol would result in better outcomes compared to routine care.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients \> 18 years of age who comes to the ER with AF as the primary diagnosis and is treated according to study protocol.

Exclusion Criteria:

* Patients with established cardiology or electrophysiology care.
Comparison Azathioprine to Mesalazine for the Prevention of Postoperative Recurrence in the Crohn Disease

To show the superiority of Azathioprine comparing Mesalazine in the prevention of postoperative recurrence in Crohn's Disease.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* Clinical remission at inclusion time (CDAI\<150)
* Having ileocolonic or colon resection 21 days before inclusion
* Resection \> 50cm or subtotal colectomy with ileorectal anastomosis

Exclusion Criteria:

* Intolerance to one of both study treatment
* Liver failure (TP\<60%)
* Renal Failure (Creatinine \< Lab results)
Self-management in Type 2 Diabetes Patients Using the Few Touch Application

It is hypothesized that the use of the mobile phone-based self-help system FTA, and with the patients as active players, will improve diabetes self-management reflected by improved glycemic control and lipids, self-care behaviours and lifestyle changes such as improved dietary habits and increased physical activity, compared with usual care. Following this; it is also hypothesized that this will also lead to a reduction in overall risk for diabetes complications (expressed by reduction in e.g., 5 year absolute risk for coronary artery disease as calculated using the Swedish National Diabetes Register's risk calculator) and in the prevalence of the metabolic syndrome (e.g., as defined by the International Diabetes Federation). It also hypothesized that health counselling based on TTM and CBT by a diabetes nurse, and with individualized feedback via sms from the diabetes nurse, may have an important function as a supplement to the self-help system (FTA). In addition, it is hypothesized that the patients' health status and diabetes-related quality of life (HRQL) will improve. The results of this study may show that a commonly used tool like the mobile phone, and also mobile phone together with health counselling, fitted into the patients' daily life, is more effective and cost-effective than standard care.

The purpose of this study is to examine the effectiveness of mobile phone-based lifestyle tools, and health counseling using tailored SMS and individual phone-calls to the patients, for self-management of T2DM. Maintaining daily symptom diaries (described below) by an easy way of self-monitoring appear to offer a valid and reliable way of assessing behaviours. In addition, the patients are able to view their own registrations on the Smartphone, i.e. a programmable mobile phone with a touch sensitive screen. The self-help system, called the "Few Touch application", recently tested on 12 people with T2DM at NST, University Hospital of North Norway (UNN), will form the basis for the patients' mobile interaction system.

Eligibility Criteria:
Inclusion Criteria:

Age \>18; diagnosed T2DM \> 3 months prior to study inclusion; in case the patient is receiving one or more glucose lowering drug (e.g., metformin, sulphonylurea, glinide, α-glucosidase inhibitor, DPP-IV inhibitor, GLP-1 analogue, glitazone, insulin) the treatment should be stabilized (i.e., no change in dosage the last three months prior to inclusion except for insulin treated patients who are allowed ±15% dose adjustment; HbA1c \>7%; capability of understanding and filling in Norwegian questionnaires; be able to use the system provided; be cognitive able to participate.
Bubbles, Stress, Diastole

This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).

The participants will be measured for vital parameters, blood samples and transthoracic cardiac ultrasound before diving (baseline).

Participants will be requested to perform recreational dive, which does not require particular decompression stops, at a depth of 30 meters with a 30 minutes botton time. 20 minutes after dive the same measurements as baseline will be repeated, once at rest and once after a physical effort by performing a series of 10 bending on the legs (squats). The day after dive, the participants will be interviewed by phone (FOLLOW-UP) by a physician. It will be required to report any unusual event, MDD symptom, or neurological complication.

Same procedure will be repeated with three different type of blends (AIR, NITROX, TRIMIX).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60
* healthy subjects
* body mass BMI \< a 30
* physical status ASA 1

Exclusion Criteria:

* subjects with significant clinical impairments such as important head trauma, general pain, low back pain, diabetes, asthma, cardiac and coagulation dysfunctions
* pregnant women
* participation in another study in the last 3 months
* use of drugs and alcohol
* smoking
* psychiatric disorder
Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.

Intervention and treatment protocol as described for the two study arms.

Definition of treatment failure (infant meets at least one criterion):

* Sustained pCO2 \>80 mmHg and pH \<7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
* Fraction of inspired oxygen (FiO2) \>0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
* Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").

Sample size:

Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.

Randomization:

Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.

Data monitoring:

By an independent statistician.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<32+0 weeks
* Birth weight \<1500 g
* Received mechanical ventilation via an endotracheal tube for ≥120 h
* Caffeine treatment according to unit guidelines
* paCO2 \<65 mmHg with pH \>7.2
* FiO2 25-40% to maintain SpO2 at 90-94%.
* Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
* Decision of the attending clinician to extubate

Exclusion Criteria:

* Major congenital malformation requiring surgery
* Duct-dependent congenital heart disease
* Neuromuscular disease
* Participation in another randomized controlled trial
* Death before reaching the eligibility criteria
* Hydrocortisone treatment at the time of enrolment
* Chronological age \>28 days
Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep quality and menopausal symptoms will be examined in individuals diagnosed with knee osteoarthritis during menopause.

The aim of this study is to investigate the effect of aromatherapy massage performed with bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot, placebo and control. In addition to the conventional treatment, the Bergamot group will receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue conventional treatment for 4 weeks. All assessments will be performed before starting treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms Evaluation scale. At the end of the study, the satisfaction of the participants will be evaluated with VAS.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 40-65,
* having entered the menopause,
* being diagnosed with knee OA,
* being at the level of OA 2-3,
* having pain at rest in the knee VAS ≥ 4.

Exclusion Criteria:

* Any knee surgery
* known allergies to the oils to be used
Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)

RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AF aged 19 years or older with one or more comorbidities including heart failure, myocardial infarction, stable angina, hypertension or diabetes mellitus (Patients can be enrolled 3 months after myocardial infarction or percutaneous coronary intervention).
* patients who already took or plan to take rivoxban
* patients who able to use smart phone

Exclusion Criteria:

* creatinine clearance \<15ml/min
* moderate or severe mitral stenosis
* mitral valve operation history
* current alcohol abuse or alcohol abus history
* Not eligible for study due to legal or psychiatric problem
* enrolled other clinical study within 4 weeks
* declined to enroll the study
Physical Activity and Cognitive Behavioural Therapy in Panic Disorder

Physical activity (treadmill) supports the effect of cognitive behavioural therapy in patients with panic disorder with/without agoraphobia

Patients undergo cognitive behavioural therapy consisting of 8 group sessions within 1 month. All patients additionally complete a training of physical activity, which starts simultaneously to therapy and runs for 8 weeks (3 times/week, 30 minutes each). Half of the patients complete training on a treadmill while the other half completes a training programme of low intensity physical activity without cardiovascular activation.

Flanking EEG (electroencephalogram) recordings shall help clarify biological processes underlying the therapeutical process.

Eligibility Criteria:
Inclusion Criteria:

1. Subject familiarized with experimental procedure and had given written informed consent
2. Diagnosis of panic disorder with or without agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
3. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
4. Reachability of patient for treatment and follow-up

Exclusion Criteria:

1. Other psychiatric illnesses like schizophrenia, substance abuse or severe depressive episode
2. Acute suicidal tendency
3. Epilepsy or other illness of the central nervous system (e.g. brain tumor, encephalitis)
4. Existence of contraindication against physical exercise
5. Pregnancy or breastfeeding
6. Changes of psychopharmacological treatment within the last 4 weeks
Advanced Imaging Registry for Diagnosing Pancreatico-biliary Disorders

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

Advanced imaging techniques such as SpyGlass or pCLE (probe-based Confocal laser endomicroscopy) using Cellvizio probes enable high sensitive and specific diagnosis of strictures or tumors in bile and pancreatic ducts. However, advanced endoscopists have only recently started to employ such techniques for diagnostic purposes. Hence we lack enough data to evaluate the sensitivity, specificity, accuracy, technical feasibility and safety of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate advanced imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.

The purpose of this registry is to record information and evaluate the impact of advanced imaging techniques on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by advanced imaging techniques.

This multi-center registry has been initiated:

* To document the impact of advanced imaging techniques in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
* To assess the sensitivity, specificity, accuracy, technical feasibility and safety of advanced imaging techniques in pancreatico-biliary disorders.

The registry will review and document:

* All patients who have had advanced imaging done for pancreatico-biliary disorders.
* No subject intervention is involved in this study. Subject contact is not needed for database review.

Study Design at Secondary sites:

* Other sites must have either a database review protocol and/or a clinical trial that would collect data on advanced imaging done for pancreatico-biliary disorders prior to participating in the registry.
* These sites would have IRB approved protocols to collect and send advanced imaging procedure data to the primary site (WCMC). Additionally, the secondary study sites would mention WCMC as an entity that could receive PHI in their respective protocols and consent/HIPAA forms.
* All secondary study sites' IRB approvals will be sent to the primary/coordinating study center at WCMC. The primary center will then forward these IRB approvals to WCMC IRB as soon as they are received from the secondary study sites.
* Relevant IRB documentation will be maintained at both primary and secondary sites.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone advanced imaging procedures for diagnosis and/or treatment of a pancreatico-biliary disorder.
* Above 18 years of age.

Exclusion Criteria:

* Any patient who has not undergone advanced imaging techniques for pancreatico-biliary disorders.
* Below 18 years of age.
Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

Patients presenting a deterioration of the general state (performance status \[PS\] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment. These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.

Arm A Iressa 250 mg daily PROG/TOX --\> Taxotere 75 mg/m² d1 (d1=d22)

Arm B Gemzar 1250 mg/m² d1 \& d8 (d1=d22) PROG/TOX --\> Iressa 250 mg daily

Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --\> Iressa 250 mg daily

Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB/IV NSCLC
* patients with performance status 2 or 3.
Multidomain Intervention for Older Adults With Major Depressive Disorder

To assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.

Awareness of the necessity and importance of community-based multidomain psychosocial intervention for late-life depression has increased. However, few studies have attempted to integrate several therapeutic approaches in one intervention program.

Main objective of this study is to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.

We plan to conduct a randomized controlled parallel-design study. We plan to allocate study participants to multidomain intervention or supportive therapy group, in a 1:1 ratio. Block randomization using SAS (PLAN procedure) and sample size estimation were performed. We estimated that, with at least 40 participants per group and an attrition rate of 10%, we could achieve a power of at least 0.80 (beta = 0.2, two-tailed alpha = 0.05).

Intervention was based on the financial and human resources of a community mental health service, and involved four home visits and 12 telephone calls over 12 weeks. Four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the multidomain intervention program. To maintain participant motivation, we plan to apply contingency management based on operant conditioning theory.

The primary outcome is the change in depressive symptoms, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Secondarily, we plan to investigate changes in resting-state functional connectivity in the default mode, salience, and central executive networks.

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of non-psychotic, unipolar major depressive disorder, based on the Mini-International Neuropsychiatric Interview
2. a Montgomery-Asberg Depression Rating Scale (MADRS) score of 17 or higher
3. the use of antidepressants at stable dosage for at least 6 weeks prior to study entry, without any recommendation for changes in medication for the 12 weeks of the intervention. Pharmacotherapy was uncontrolled and was provided by physicians.

Exclusion Criteria:

1. a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia)
2. a history of neurological disorder, such as brain tumor, intracranial hemorrhage, subarachnoid hemorrhage, epilepsy, hydrocephalus, encephalitis, metabolic encephalopathy, or other neurologic conditions that could interfere with the study
3. a history of significant hearing or visual impairment
4. a history of physical illnesses that could interfere with the study.
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old-infants (42 to 98 days)
* Available for the entire study period (14 months)

Exclusion Criteria:

* Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
* A previous severe reaction to any vaccine or vaccine-related component