cyrilzakka/clinical-trials huggingface dataset:
3D Printed Models for Mandibular Fracture Repair

The investigators will test the hypothesis that patients randomized to the intervention (3D printing with pre-bent plate) arm have less operative room time and less time for the critical part of the procedure than patients in the control arm (no 3D printing, current standards of care). Personalized medicine and care for fracture treatment.

The goal of treatment is to re-establish the patient's preinjury dental occlusion and facial harmony. Fractures that are nondisplaced and exhibit no occlusal changes may be amenable to nonsurgical management, but most mandible fractures will require stabilization for satisfactory healing and to restore pretraumatic maxillomandibular orientation. Various treatment strategies have been described and vary widely depending on the fracture location and surgeon's preference. The patient's demographics, comorbidities, dentition, and fracture characterization will all influence the choice of fixation by the treating surgeon.

There are very few randomized control trials that show outcomes when 3D printing is used for intervention planning and performing a procedure. These data are essential to establish value of 3D printing as a clinical service. There is also anecdotal evidence that a 3D printed model of a mandible fracture can be useful for pre-operative planning because the oral and maxillofacial surgeon can better assess the geometry of the bone lesions and can pre-bend fixation plates before the procedure. This hypothetically decreases the amount of time in the operating room.

The investigators propose a parallel design randomized control trial to study the value of 3D printing for preoperative planning in patients with a fracture of the mandible who require open reduction, internal fixation. The study will be split into two arms: 1) Patients that will have a 3D model generated for the surgical procedure 2) The control group who will follow normal standards of care as outlined above and won't have the additional 3D model created pre-operatively.

Eligibility Criteria:
Inclusion Criteria:

Patient ≥ 18 years of age

* Patients who have received either a cone beam or conventional CT
* Admitted through University of Cincinnati Hospital and Medical Center emergency department
* All isolated mandible fractures referred to University of Cincinnati Hospital Oral \& maxillofacial surgery clinic
* Surgical team members from the division of plastic and otolaryngology

Exclusion Criteria:

* Patient \< 18 years of age
* Patients who have neither cone beam nor conventional CT
* Patients requiring a repeat procedure
* Unexpected exposure of hardware
Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg

A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow to the leg in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Age 30-90 years
* Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
* Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:

  1. Clinically verified grade 2, i.e. Intermittent Claudication:

     * Ancle-Brachial Index (ABI)less than 0.9 or
     * Toe brachial Index (TBI) less than 0.7 or
     * Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
  2. Clinically verified grade 3, i.e. Critical Limb Ischemia (CLI):

     * ABI less than 0.4 or
     * Toe pressure less than 30 mmHg
     * Rest pain since at least 2 weeks or
     * Use of analgesics for rest pain for at least 2 weeks or
     * Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
  3. Clinically verified grade 4, i.e. CLI:

     * Ischemic ulcers or gangrene/tissue loss
     * ABI less than 0.4
     * Toe pressure less than 30 mmHg
     * Rest pain since at least 2 weeks or
     * Use of analgesics for rest pain for at least 2 weeks or
     * Ultrasound and/or CT/MR angiography suggesting stenosis(es)and/or occlusion(s)

Exclusion Criteria:

* Grade 1 PAOD
* Incapable of consenting voluntarily
* Fewer higher than 39 degrees Centigrade
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Severe heart disease such as unstable angina, severe heart failure and severe valve failure
* Severe Polyneurophathy
* Verified Osteomyelitis other than in the Phanlanx
* Currently treated for cancer and With a life expectancy of less than 2 years
The Development and Evaluation of Sleep Intervention for Perinatal Family

Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.

Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.

Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.

Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.

The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics.

Eligibility Criteria:
Inclusion Criteria:

1. First-time mothers and their partners aged 20 and older;
2. Currently 30 weeks gestation or more, singleton;
3. insomnia severity index score greater than 10;
4. living with a husband or partner;
5. Both women and their partners are willing to participate in and adhere to the research protocol;
6. be able to read and speak the Mandarin language

Exclusion Criteria:

1. sleep disorders, depression or anxiety disorders;
2. medical diseases with abnormal heart rate variability, or arrhythmia;
3. taking medicines that may affect the autonomic nervous system or
4. night shift workers;
5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
6. infants with fetal deformity, or neonatal complications;
7. no access to Internet resources
rTMS in Managing Individuals With Chronic Low Back Pain and Comorbid Insomnia

This pilot randomized controlled trial (RCT) aims to investigate the feasibility and efficiency of delivering different rTMS protocols in individuals with CLBP and insomnia. Participants will be randomly assigned to either the primary motor cortex (M1) rTMS, the dorsolateral prefrontal cortex (DLPFC) rTMS, or sham stimulation.

Sleep disturbance exacerbates pain perception, disability, and poor prognosis in individuals with chronic low back pain (CLBP). A recent systematic review demonstrated that improvements in sleep disturbance were associated with corresponding improvements in pain intensity, recovery, and disability in individuals with CLBP. These findings indicate that achieving restorative sleep is likely to mitigate chronic pain symptoms. The application of rTMS at a specific frequency over a focal brain area has been proposed as a promising treatment for chronic pain and insomnia independently. To date, no studies have compared the effectiveness of different rTMS protocols in treating comorbid CLBP and insomnia. Given the above, the current study aims to investigate the feasibility and acceptability of delivering different rTMS protocols in individuals with CLBP and insomnia and explore the relative therapeutic efficacy of these protocols on pain and sleep parameters at immediate post-treatment and one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. participants aged between18 and 65 years;
2. willing to participate in the study and randomization;
3. having stable pharmacological or nonpharmacological treatments for pain or sleep at least one month prior to study participation;
4. having CLBP (defined as pain between 12 ribs and gluteal crease with or without leg pain that has persisted for at least three months)
5. diagnosing insomnia using the Brief Insomnia Questionnaire (BIQ) based on the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

Exclusion Criteria

1. specific causes of CLBP (e.g., spondylosis, spondyloarthropathy, or vertebral fracture);
2. pregnancy or nursing;
3. previous spinal surgery;
4. inflammatory or autoimmune diseases;
5. other sleep disorders (e.g., sleep apnea or restless leg);
6. presence of severe psychopathologies, neurological, or physical disease directly related to the onset of insomnia (e.g., depression, substance abuse, or alcohol abuse);
7. severe dependence on hypnotic drugs;
8. concurrent receipt of new treatments outside the scope of the study;
9. contraindications to use rTMS (e.g., severe head trauma, intracranial hypertension, implanted ferromagnetic devices, history of epilepsy).
Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate


Eligibility Criteria:
Inclusion Criteria:

* Children 1-36 months
* With rectal temperature \>38.0 C
* And no identified source of infection after history and physical examination

Exclusion Criteria:

* acquired or congenital immunodeficiency
Interplay of Self-Criticism and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment

The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.

Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week in-patient treatment, consisting of somatic and psychotherapeutic aspects. After informed consent, patients routinely fill out weekly questionnaires about their self-criticism and their symptom severity. The overall aim of this study is to disentangle stable (between-person) effects of both self-criticism and symptom severity from within-person effects happening over time in order to better understand what drives what, or in other words, their dynamic interplay. The analysis is based on the weekly assessment of the patients. All patients receive the standard care of the in-patient treatment.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik)

Exclusion Criteria:

* none
Correlation of Calcitonin Gene-Related Peptide (CGRP) Levels in Saliva With the Evolution of an Attack of Migraine

To assess CGRP levels in saliva through the evolution of migraine.

The release of CGRP is assumed to be initiated early in the migraine process and increases as the headache intensifies. Levels of CGRP will be measured during the premonitory, mild, moderate, and severe phases of a single migraine attack and compared to the baseline value determined when the subject was headache free. Understanding of the clinical evolution of migraine CGRP release may have significant implications in acute treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to read, understand, and sign the informed consent
2. Subject is between the ages of 18 and 65, either male or female
3. Negative pregnancy test for those of childbearing potential.
4. Adequate birth control as approved by the investigator if of childbearing potential
5. Subjects must fulfill criteria for IHS migraine (1.1 or 1.2) with a history of 1-6 migraines per month within the past 3 months and at least 15 headache free days though out the previous three month time period

Exclusion Criteria:

1. Pregnant or breast feeding
2. Presence of any condition or symptoms that would knowingly alter the content of the saliva
3. Presence of any medical disease or condition that would interfere with the conduct of the study
4. Current use of other medications that would be contraindicated in those patients that will take triptan medications for treatment of migraine symptoms, ie. MAO inhibitors, lithium, methyergonovine, methysergide, or ergotamine-containing products
5. Use of migraine preventive medications in the three months prior to screening
6. History of drug or alcohol abuse that would interfere with the study
7. Any pathology of the salivary glands such as sialadenitis (e.g., Sjorgen's syndrome, viral or bacterial sialadenitis, obstructive sialadentitis)
8. History of hypersensitivity or allergy to triptan medications
9. Presence of diabetes, salivary gland tumors, liver disease, alcoholism, and neuropathy
10. More than 15 days per month of headache within the past 3 months
11. Participation in another investigative drug study within the past 30 days
A Comparison of Management Strategies of Asthma in Pregnancy

Investigate differences in practice patterns in providers who may care for pregnant women with asthma exacerbations. The investigators believe that practitioners of different specialties will practice differently.

The goal of this investigation is to determine how physicians manage pregnant patients with asthma exacerbations using patient vignettes. Vignettes or case studies have been shown in various areas of medicine to be an effective tool for surveying provider's knowledge and application of evidence-based guidelines (9,10,11,12). Specifically, we plan on surveying physicians-in-training and attending physicians in Emergency Medicine, Family Medicine, Internal Medicine, Obstetrics/Gynecology, and Pulmonary/Critical Care Medicine at the Ohio State University Werner Medical Center via electronic mail. Electronic mail addresses will be obtained from each Department or Division's Training Program Director. We have presented multiple, fictional, case-based scenarios and short, multiple-choice questions where the responder indicates how they would manage the case. No existing patient data will be used in the scenarios. In addition, demographic data of the physician including length of time in practice, numbers of patients seen with asthma exacerbations per month, and comfort level with the National Asthma Education and Prevention Program Guidelines (1). The survey is attached. Physicians who do not respond to the first electronic mail will be sent one follow-up electronic mail with a second request to complete the survey. Results from the questionnaires completed by each department/devision of physicians will be compared and analyzed for significant differences. The results will then be used to look for educational opportunities to improve the care of pregnant patients with asthma exacerbations.

Eligibility Criteria:
Inclusion Criteria:

* Physicians-in-training and attending physicans at the Ohio State University Medical Center Emergency Medicine, Family Medicine, Internal Medicine, Obstetrics/Gynecology, and Pulmonary/Critical Care Medicine at the Ohio State University Werner Medical Center
Benefits of MPACT in Locally Advanced Head and Neck Cancer Patients Undergoing Chemoradiotherapy

The goal of this study is to test, in a randomized controlled trial among head and neck cancer patients, the short and longer term effects of the MPACT (Maintaining Physical Activity during Cancer Treatment) program (infused with motivational interviewing and self-determination theory-based strategies) initiated at the time of concurrent chemotherapy with radiation (CCRT), on key outcomes such as functional mobility and quality of life, and ultimately physical activity. The central hypotheses is that in head and neck cancer patients undergoing CCRT, the MPACT program, as compared to usual care controls, will result in less acute decline, faster recovery, and better maintenance of these key outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients greater than or equal to 40 years old with AJCC (American Joint Committee on Cancer) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with concurrent chemoradiotherapy (CCRT) and who are capable of understanding and adhering to the protocol requirements
* Patients must be willing to comply with the study procedures and visits.

Exclusion Criteria:

* Active or symptomatic cardiopulmonary disease
* Substantial dementia
* Acute medical conditions, such as acute flare-up of joint condition or infection
* Participants must not be actively receiving physical therapy in a relevant area, at the time of enrollment, or participating in intensive (30 min per day) aerobic program three times per week.
* Patients are actively being treated for another cancer at the time of enrollment
* Active or unstable metabolic conditions such as brittle diabetes or severe anemia
* Alcohol intake less than 3 ounces per day
* Hemiplegia or lower limb amputation
* Significant orthopedic or musculoskeletal condition that does not allow weight bearing
* Unable to maintain safe stance and walk, either with or without an assistive device
Manage My Pain at Chronic Pain Clinics

The overall objective of this Early Adoption project is to gather evidence for how Managing My Pain Program (MMP), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of Ontario, Canada across 4 sites in urban, community, and rural settings

Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management application, Managing My Pain Program (MMP) that incorporates validated questionnaires can be used to enhance communication between providers and patients and promote self-management to evaluate the extent of patient engagement with the app when used in clinical settings.

The main objectives for this project is to evaluate the engagement in patients using MMP, and to assess improvements in clinical outcomes directly relevant for pain management, as measured by clinically-validated tools.

Eligibility Criteria:
Inclusion Criteria:

* New patients with chronic pain conditions referred to participating sites with pain programs to adopt the MMP tool into clinical practice.

Exclusion Criteria:

* Patients declining to consent for the study
* Patients withdrawing from the study at a later time after consenting
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

Exclusion Criteria:

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)

A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)

This study is a single center, open label, dose escalation trial to evaluate prolongation effect on QT interval of NPC-15 (melatonin 8mg or 16mg).

The trial compose of 3 periods; During the each period, eligible volunteers wll be administered placebo, NPC-15 4g (melatonin 8mg) and NPC-15 8g(melatonin 16mg) as a sequential manner.

Eligibility Criteria:
Inclusion Criteria:

* Subject with BMI ≥ 17.6 kg/m2 and \< 30.0 kg/m2.
* Subject who falls asleep at between 21:00 and 25:00 and wakes up at between 5:00 and 9:00 during 1 week prior to the first study drug administration.
* Subject who is able to comply with the study requirements during the study period.

Exclusion Criteria:

* Subject with QTcF interval greater than 450 ms in male or greater than 470 ms in female on the 12-lead electrocardiogram (ECG), or with clinically significant ECG abnormalities in other findings.
* Subject who has a family history of Torsades de Pointes (TdP) or long QT syndrome.
* Subject who has a history of hypersensitivity or allergies to melatonin or ramelteon.
* Subject who has a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments.
* Subject who received any non-prescription or prescription drug within 2 weeks prior to the first study drug administration.
* Subject who received any product containing St Jones Wart or any supplement containing melatonin within 4 weeks prior to the first study drug administration.
* Subject who has a history of smoking habit or was possibly exposed to passive smoking on a daily basis within 24 weeks prior to the first study drug administration.
* Subject who, in the opinion of the investigator or sub-investigator, is unsuitable to be involved in the study.
Standardization of D2 Lymphadenectomy and Surgical Quality Control: KLASS-02-QC

Gastric cancer is one of the most common cancers in Korea. Having achieved excellent long-term survival for early gastric cancer patients, there is a growing interest in improving the quality of life of these patients without compromising their prognosis. Laparoscopic surgery for early gastric cancer have been found to be safe and feasible with superior short-term outcomes. Although laparoscopic gastrectomy with D2 lymphadenectomy is being performed for patients with locally advanced gastric cancer; the completeness of the D2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized procedure exists. To conduct a clinical trial comparing laparoscopic D2 lymphadenectomy to the open approach, quality control of D2 lymphadenectomy procedure is necessary.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have documented diagnosis of gastric cancer
* Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by evaluation of preoperative CT-scan, upper endoscopy, or endoscopic ultrasound.
* Patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease.
* Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study

Exclusion Criteria:

* Patients without mental competence
* Patients who are illiterate
* Patients who are pregnant
* Patients \< 20 and \> 80 years old