cyrilzakka/clinical-trials huggingface dataset:
4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography

The aim of this study is to develop a 4D-CT (4 Dimensional Computed Tomography) -scan acquisition method for estimating the cause of posttraumatic impairment of the forearm. Both forearms of patients with posttraumatic impairment of one of the forearm will be scanned using a 4D-CT-scan, during forearm rotation. Rotation of impaired and healthy forearms will be analysed and compared to each other. This method is intended to allow differentiation of motion patterns reflecting an osseous impairment from those caused by soft tissue pathology in order to improve treatment choice.

Forearm and wrist fractures are the most common of all fractures and mostly occur at the distal end of the radius. Distal radius fractures are associated with posttraumatic sequelae, which typically involve restricted forearm rotation. Diagnostics of dynamic traumatic pathologies are conventionally based on static (2D or 3D) imaging protocols using MRI (magnetic resonance imaging) or CT. However, interpretation of indirect suggestive findings - such as edema or abnormal bone positions - limits accuracy and inter-observer reliability. Dynamic 4D imaging (adding the fourth dimension of time) has the potential to discriminate whether forearm rotation deficit is due to an osseous deformity causing bony impingement or whether it is due to non-osseous pathology. Hence it may reduce unnecessary corrective osteotomies and guide the patient and surgeon towards the most effective surgical or conservative treatment choice - expectedly resulting in better outcomes and patient satisfaction. In addition, we aim to develop a classification based on the estimated motion patterns and assess its reliability. Furthermore we aim at acquiring knowledge of physiological mechanics of the radioulnar joint and to assess symmetry in radioulnar joint motions between two healthy forearms on 4D-CT-scans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a one-sided posttraumatic impairment of forearm pro- and/or supination at least 3 months after injury
* Patients are above 18 years
* Patients who are willing to give informed consent
* National health insurance cover

Exclusion Criteria:

* A history of trauma to both forearms
* Any shoulder pathology or impairment preventing forward elevation of the arm as required during the scanning protocol
* Neuromuscular pathology
* Not able to understand or give informed consent
* Pregnancy (βHCG positive), breast-feeding or the absence of effective contraception for women of child-bearing age
* Legal incapacity (persons in custody or under guardianship)
* Deprived of liberty Subject (by judicial or administrative decision)
Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube dislodgements, are frequent causes of emergency department visits. The investigators have developed two G-tube dressing designs using commercially available materials and products to decrease the risk of G-tube related complications. The investigators aim in this study is to pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental feedback on device designs, ease of use and G-tube stability in preparation for a final design and trial. Based on the feedback, further iterations will be developed and trialed in eligible study subjects.

In order to address complications associated with gastrostomy buttons (G-buttons) or tubes (G-tubes) in children, the investigators developed two multi-component securement dressings. The purpose of this study is to try these dressings and obtain parental feedback.

This will involve survey using questionnaires before and after the use of two different G-tube dressings. Eligible patients will be identified by a nurse practitioner or attending surgeon. The researcher will obtain consent from the patient or their parents/legal guardian. The investigators will ask a series of questions regarding their current experience dressing and maintaining G-tube stomas. A week supply of each new prototype dressing will be provided to the patient or parent. Caregivers will be educated on the use of each dressing and will be given a number to call should they have any questions or concerns. The dressings will be changed daily and as needed. Once the patient is enrolled and provided with dressings, the investigators will perform a follow up telephone interview at one week to evaluate their experience and ensure they did not experience any adverse events. Caregivers will be given a second questionnaire to collect feedback on the dressings after two weeks either in person or over the telephone. They will be asked to choose their preferred dressing, provide feedback on advantages and disadvantages of each type and report adverse events. For inpatients, the investigators will obtain opinions from parents, patients, nurses and doctors. Photographs will be obtained at each outpatient visit or during the inpatient period for objective comparison.

Once more iterations are developed, they will undergo the same clinical trial process (involving 10-15 subjects).

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pre-existing a G-tube
* Patients presenting to the G-tube or surgery clinic for G-tube replacement at Children's Hospital, Aurora, Colorado.
* Patients admitted to the hospital with a pre-existing G-tube for reasons unrelated to the G-tube will be eligible for the study if they have issues with the G-tube site.

Exclusion Criteria:

* Refusal to participate
* Those with other types of gastrostomy tubes (other than Mini Balloon Button)
* Those whose parents or legal guardians cannot be reached by telephone
* Prisoners
* Pregnant women
* Decisionally challenged subjects
Inspiratory and Trunk Muscle Activity During IMT on Stable and Unstable Surfaces in Stroke Patients

This study aims to investigate the differences in muscle recruitment of the diaphragm (assessed using ultrasound), the sternocleidomastoid (SCM) and trunk muscles (both measured via surface electromyography (sEMG)), during loaded breathing training performed on both stable and unstable surfaces. The goal is to understand the interaction between the inspiratory and trunk muscles during Inspiratory muscle training (IMT) across these two surface conditions.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years and \< 80 years
* Breathing spontaneously
* Clinically diagnosed with ischemic and/or hemorrhagic stroke
* Stroke duration from onset between 1 and 12 months
* No thoracic or abdominal surgery in the past 6 months
* No cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26)
* Able to understand and follow verbal instructions
* No facial palsy or only mild facial palsy without limitation of labial occlusion
* Able to complete all loaded breathing tests on both stable and unstable surfaces included in this study

Exclusion Criteria:

* Acute myocardial infarction or acute heart failure
* Acute pain in any part of the body
* History of chronic respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough, and sputum retention)
* Presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedures
Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: I. Assess the safety of motexafin gadolinium and cranial irradiation, in terms of dose-limiting toxicity and clinically significant adverse events, in patients with newly diagnosed glioblastoma multiforme. II. Evaluate the pharmacokinetics of this regimen in these patients. III. Determine the survival of patients treated with this regimen. IV. Assess the activities of daily living and neurological status of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 30 minutes on days 1-5 of weeks 1 and 2, and on days 1, 3, and 5 of weeks 3-6. Patients undergo cranial irradiation on days 1-5 of weeks 1-6. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo a neurological examination and an activities of daily living questionnaire at baseline, week 10, and during follow-up visits. Patients are followed at weeks 10 and 16 and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Grade IV astrocytoma Located supratentorially At least 2 weeks and no more than 4 weeks since prior surgery for GBM No recurrent disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: HIV negative No history of porphyria No glucose-6-phosphate dehydrogenase deficiency No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior antineoplastic agent for GBM No concurrent chemotherapy during and for 2 weeks after study No other concurrent antineoplastic investigational agent Endocrine therapy: Prior and concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy to the brain Surgery: See Disease Characteristics Other: Concurrent anticonvulsants allowed Other concurrent cancer therapy allowed if medically necessary
Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery

This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.


Eligibility Criteria:
Inclusion Criteria:

* 36 weeks gestation
* 3 months corrected age
* appropriate for gestational age (AGA)
* admitted for surgical correction of congenital heart defects (single ventricle, tetralogy of Fallot, truncus and complex biventricular repairs)
* enteral nutrition at 30 kcal/kilogram/day

Exclusion Criteria:

* 5 minute Apgar score of 4
* major congenital defect other than heart defect
* presence of significant neonatal morbidity (intraventricular hemorrhage (IVH) grade 3 or greater, necrotizing enterocolitis (NEC) and surgical abdomen)
* any metabolic disorder
* any endocrine disorder
* medications which alter eicosanoid metabolism including indomethacin, acetylsalicylate (with exception of steroids which will be analyzed independently)
Non Invasive Brain Stimulation for PTSD

This study is designed to identify changes in the brain that underlie symptoms of combat-related PTSD using brain imaging (fMRI). Then, the investigators will administer mild electrical stimulation to the side of the head (using a method called tDCS) in an attempt to reduce the symptoms of PTSD.

Being involved in combat is a horrific experience that substantially increases the risk of developing posttraumatic stress disorder (PTSD). Although several effective treatments have been identified for PTSD a substantial number of patients (up to 50%) continue to experience symptoms. The field of neuroscience has revealed that patients with PTSD demonstrate altered functioning within, and interactions between, several brain regions; findings that are consistent with animal models of chronic stress. Despite this evidence, existing treatments are generally not designed using this neuroanatomical knowledge. The central premise of the proposed study is that neuroscientifically-based information can be used to develop more precise and effective treatments. Transcranial direct current stimulation (tDCS) will be used in an attempt to "correct" the dysfunctional brain regions (and communication between these regions), with the expectation that this modulation will result in symptom improvement.

The primary goals of the study are to verify the maladaptive brain networks and then establish evidence that tDCS modulates these networks. Subsequent studies, performed during the later study years, will examine dose-response relationships and synergistic effects of tDCS and existing treatments. Outcome will be assessed using a multi-method approach that includes functional connectivity using resting-state functional magnetic resonance imaging data, neuropsychological tests, and self-report measures of emotional functioning. The combined results will provide vital methodological, mechanistic, and practical information necessary for a formal clinical trial of tDCS in PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Combat Veteran - both Veterans with and without PTSD will be included at different points in this study
* Right-handed
* Between the ages 18-88
* Stable on medications for a minimum of 2 weeks

Exclusion Criteria:

1. a history of neurological disease (e.g., dementia, epilepsy, stroke, moderate - severe traumatic brain injury)
2. "severe" Axis I diagnoses (e.g., bipolar disorder, schizophrenia)
3. presence of Axis II disorders
4. current alcohol or drug abuse/dependence (in the past 8 weeks)
5. participants will also be excluded if they are not MRI compatible (assessed using the guidelines of the American College of Radiology)
6. Imminent risk of harm to self or others
7. history of HIV or sickle cell anemia, as these can cause neuropsychological issues .
Social Inequalities in the Participation and Activity in Children and Adolescents With Hodgkin-lymphoma

Purpose of this study is to determine the influence of social factors on participation and activity among children and adolescents aged 10-18 years with hodgkin-lymphoma. Furthermore personal and treatment-related factors and their impact on participation will be explored.

Hodgkin-lymphoma is a rare malignancy among children and adolescents (about 140 each year in Germany) which is highly curable. Beside this therapeutic success, a lot of therapy-related long-term problems arise (e.g. fertility disorders, thyroid diseases, secondary malignancies). While most of the studies focused on mental and physical impairments, little attention has been drawn to social dimensions of health. Due to the disease and the requirements of the therapy, participation of children with hodgkin-lymphoma can be impaired acutely or chronically. This can be of serious consequences, because participation in daily life is an important component of the development of children and adolescents. To determine the influence of social, personal and treatment-related factors on participation, all patients who were actual treated in the international therapy study EuroNet-PHL-C2 in all of Germany (N ≈ 700) and their parents will be interviewed. Statistical analyses will be done using descriptive and multivariate methods taking account of treatment-related issues (e.g. stage of disease, chemotherapy, radiotherapy, progression/relapse).

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed primary diagnosis of classical Hodgkin's Lymphoma
* 10-18 years
* written informed consent of the patient and/or the patient's parents or guardian according to national laws

Exclusion Criteria:

* other (simultaneous) malignancies
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients

The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine characteristics that can be linked to poor clinical outcome and to examine the hypothesis that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization, cardiovascular and all-cause mortality.

Background: High prevalence of hepatitis C virus (HCV) infection is noticed in Yun-Lin, Chiayi area in Taiwan. Patients with maintenance hemodialysis (MHD) in this area have the highest risk for HCV infection. Understanding the natural history of HCV and its association with inflammation, nutrition and outcomes in dialysis patients may provide more information for anti-HCV management strategies in dialysis and other patient populations.

Objective: We hypothesize that HCV infected MHD patients have distinct metabolic, and inflammatory characteristics that can be linked to adverse conditions and increased higher morbidity and mortality.

Design: A cross-sectional study is conducted in one regional teaching hospital with its medical alliance dialysis clinics. A cohort of 200 MHD patients including 70 HCV subjects are recruited. Basic data and dialysis characteristics are collected. Metabolic syndrome (MS) is defined according to International Diabetes Federation (IDF) consensus 2005. Insulin resistance (IR) is defined by HOMA index. Comorbidity is rated by Charlson Comorbidity Score. Malnutrition-inflammation score (MIS) is used to rate the severity of malnutrition-inflammation complex syndrome (MICS). Nutritional and appetite status are evaluated by appetite and diet assessment tool (ADAT) and anthropometric evaluation. Inflammatory status is measured by biomarkers such as serum concentrations of C-reactive protein, tumor necrosis factor-α, interleukin-1β, interleukin-6, adiponectin, leptin and plasminogen activator inhibitor-1. Ankle-brachial index (ABI)test is used to predict the severity of peripheral arterial occlusive disease (PAOD). We use Beck's depression inventory to assess depression status and apply SF36, WHOQOL and EQ-5D questionnaires to assess health-related quality of life (HRQOL). Outcome evaluations are based on mortality and hospitalizations followed prospectively for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* The main inclusion criteria were those outpatients who were undergoing MHD for at least 8 weeks, were 18 years or older, and who signed the written consent form.

Exclusion Criteria:

* Patients with a clinical or laboratory evidence of active infectious diseases in the last 1 month before inclusion in the study, or life expectancy of less than 6 months, for example, because of a metastatic malignancy or terminal HIV disease, were excluded.
Information, Motivation, Behavioral Skills Model on Urinary Incontinence and Quality of Life in Men

Multiple studies have shown that education based on the IMB model is effective at bringing about health-related behavior change. The IMB model was found to be effective in developing healthy behaviors aimed at maintaining heart health, providing behavior to prevent smoking addiction, diabetes management, correct nutrition in iron deficiency anemia, and using condoms to prevent HIV. There are no studies in the literature regarding the adaptation of the IMB model to behavioral therapy in patients with OAB or urinary incontinence. To address this, there we aimed to investigate the effect of the IMB model on urinary incontinence and quality of life in men with OAB.

This study aimed to investigate the effect of the Information, Motivation, Behavioral Skills Model (IMB) on urinary incontinence and quality of life in men with overactive bladder.

This is a single-center, parallel-group, open-label, randomized controlled clinical trial.

This study was conducted between February 2018 and February 2019, with a total of 60 male patients admitted to the urology clinic of a training and research hospital. Patients over the age of 18, male, and with overactive bladder were included in the study.

Participants were randomized into two equal groups: the intervention group (n=30) and control group (n=30). Structured bladder training with the IMB model was applied to the intervention group. This model was not applied to the control group. The primary outcome was the mean score change over the severity of incontinence measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). The other outcomes were measured by the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7), and Urinary Incontinence Information Rating scores. All outcome measures were evaluated before and 6 months after the training. Bladder training with IMB model was found to be effective at ameliorating urinary incontinence and improving quality of life in patients with an overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

* Male patient
* Over 18 years old
* Overactive Bladder
* Urge urinary incontinence
* Voluntarily agreed to participate in the research

Exclusion Criteria:

* Benign prostatic hyperplasia
* Prostate cancer
* Congenital urinary anomalies
* Neurological or spinal cord injury,
* Diabetes mellitus
* Hypertension
* A mental disability
* Receive medical treatment for incontinence
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.

OUTLINE: This is a multi-center study.

Sample Collection:

* Tumor sample
* Serum sample

Treatment Regimen:

* All registered patients must be planning treatment with lonafarnib

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
* Age \> 18 years.
* Planned treatment with lonafarnib for metastatic breast cancer.
* Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study.

Exclusion Criteria:

* Planned treatment with any other treatment regimen