cyrilzakka/clinical-trials huggingface dataset:
Ankle Injuries, Imaging and Prevention Program Effectiveness in New Army Recruits

Infantry recruits will undergo a musculoskeletal examination to assess tendon, muscle, proprioception, agility, and joint status. Afterward, an exercise intervention program will be implemented, followed by a concluding evaluation.

Purpose: To evaluate ankle injuries in new infantry recruits, including their characteristics, association with imaging and functional measures, and the effectiveness of a preventive exercise program.

Methods: 650 new male infantry soldiers aged 18-23 will be recruited to participate in the study at the beginning of their military training. At the beginning and the end of the training (after approximately six months), the soldiers will be assessed for the following: 1. Demographics (height, weight, leg length, BMI calculation), 2. Proprioception ability (Active Movement Extent Discrimination Apparatus AMEDA), 3. Dynamic balance (Y-Balance Test YBT), 4. Leg muscle strength (bilateral heel rise test), 5. Hip strength (hand-held dynamometer), 6. Ankle agility (hexagon agility hop test), 7. Ankle stability (Anterior Drawer Test, musculoskeletal ultrasound for the Anterior Talofibular Ligament), 8. Achilles tendon structure (Ultrasound tissue Characterization UTC), 9. Aerobic ability (3000 meters run, will be recorded by the fitness instructors at the training base). In addition, the soldiers will fill out a previous ankle sprains questionnaire, pre-induction physical activity questionnaire, the Cumberland Ankle Instability Tool (CAIT) for ankle perceived instability, and the Ankle Fear Avoidance Beliefs Questionnaire (ankle-FABQ).

The soldiers will perform a constructed ankle sprain prevention program for five minutes every day during the six-month length of the study. Every 1-2 weeks, the researcher will arrive at the training base to monitor ankle injuries. Those who are diagnosed with a sprain will undergo ultrasound evaluations, which will be performed every few weeks.

Eligibility Criteria:
Inclusion Criteria:

* soldiers ages 18-22

Exclusion Criteria:

* knows disease of the bones
* before orthopedic surgery
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies

To investigate the relationship between the integrity of the white matter, including the corticospinal tracts and the corpus callosum, with the recovery of lower extremity function in patients with cerebral stroke at the subacute and chronic stages.

Recent studies have provided strong evidence that motor recovery after adult ischemic stroke is a function of neural plasticity. Up to date, it remains largely unknown as to the relationship between the integrity of the subcortical white matter with the lower extremity function recovery. Given the fact that the white matter is more resistant to ischemia after acute stroke than the gray matter (Falcao et al., 2004) and that the intensity of white matter in stroke has been found to be much greater in many brain areas in stroke than in healthy controls (Wen et al., 2004), it is of interest to study how the integrity of the subcortical white matter, primarily the corticospinal tracts and the corpus callosum, contributes to the recovery of lower extremity function in subacute and chronic stroke with lesions involving different areas of the brain.

Eligibility Criteria:
Inclusion Criteria:

* between 30 to 80 years old
* diagnosis of the first-time onset of stroke as confirmed by imaging studies
* within 30 days post onset University Hospital
* brain lesions mainly involving either the cortical primary motor cortex (M1) area or confined to the subcortical (M1 spared)
* No neurological or orthopedic problems which would affect their lower extremity function
* no contraindications for MRI studies

Exclusion Criteria:

* medically unstable
* unable to communicate with the experimenters
Arterial Stiffness and Complication Risk in Type 2 Diabetes

Background

The prevalence and incidence of type 2 diabetes is increasing globally. A common complication of diabetes is the disease of the blood vessels, vascular diseases, which can cause disorders like myocardial infarction, stroke and kidney failure. Methods to detect early subclinical stages of macro-vascular disease are not yet available in a clinical setting.

Hypothesis

Arterial stiffness, an easy accessible vascular parameter, may provide additional prognostic information when evaluating risk profile for patients with diabetes type 2.

Aim

The aim of the project is to investigate the association between arterial stiffness and the occurrence and development of vascular complications in patients with type 2 diabetes. Specifically we want to investigate:

1. in a cross-sectional study, the association between arterial stiffness and subclinical atherosclerotic changes in the coronary arteries assessed by computed tomography (CT) and
2. in a longitudinal study, the predictive value of arterial stiffness on the development of subclinical cerebrovascular changes assessed by magnetic resonance imaging (MRI) and nephropathy assessed by urine analysis.

Methods

The study population consists of 100 patients with newly diagnosed type 2 diabetes and 100 age- and sex matched controls. The study participants were enrolled between 2008-2011 and extensively characterized i.a. with arterial stiffness (pulse wave velocity), MRI (white matter lesions and cerebral infarctions) and urine analysis (albuminuria). In this study we will enrol the same patients in a 5 year follow-up study in order to repeat above mentioned measurements. Furthermore, CT is used to investigate the coronary plaque burden of the participants (Agatston Score and Segment Involvement Score).

Results and Perspective

This project adds new insight into arterial stiffness as a predictor of the progression of micro- and macrovascular complications in patients with type 2 diabetes, and can potentially improve risk stratification and early strategies of intervention in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diabetes, type 2, diagnosed within 5 years from baseline (cases)

Exclusion Criteria:

* Non-diagnosed diabetes (healthy controls)
* Acute or chronic infectious diseases
* Kidney failure (requiring dialysis)
* Pregnancy/breastfeeding
* Prior or concomitant cancer disease
* Contraindication for MRI (claustrophobia, magnetic implants or bodyweight above 120kg)
* Contraindication for CT (estimated glomerular filtration rate \< 50 ml/min, Body Mass Index \> 35 kg/m2, heart arrhythmia, heart failure, aorta stenosis, contraindications for beta blockage or nitroglycerin or failure to cooperate)
CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer

CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven SCC or adenocarcinoma of esophagus .
2. Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
4. Age ≧ 18 ys
5. KPS ≧ 60%
6. Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .

Exclusion Criteria:

1. Invasion to surrounding organ ( T4 disease ) .
2. Distant metastasis , except M1a disease .
3. Patients who refuse operation .
Pre-myeloid Cancer and Bone Marrow Failure Clinic Study

This clinical trial tests next generation sequencing (NGS) for the detection of precursor features of pre-myeloid cancers and bone marrow failure syndromes. NGS is a procedure that looks at relevant cancer associated genes and what they do. Finding genetic markers for pre-malignant conditions may help identify patients who are at risk of pre-myeloid cancers and bone marrow failure syndromes and lead to earlier intervention.

PRIMARY OBJECTIVES:

I. To use genomics and functional translational studies to diagnose, prognosticate and potentially offer therapeutic directives for patients with precursor features of myeloid neoplasms (myelodysplastic syndrome \[MDS\], myeloproliferative neoplasms \[MPN\], MDS/MPN overlap syndrome) and germline predisposition/bone marrow failure states, who do not meet the criteria for the diagnosis of these cancers as of yet.

II. To identify patients with precursor myeloid malignancies and bone marrow failure syndromes.

III. To examine the utility of NGS methods for discovery of targets or pathways involved in precursor features of myeloid cancer and bone marrow failure.

IV. To use clinomics/genomics to better understand pathobiology and risk of disease progression.

V. To help better understand the implications of variants of unknown significance using computational biology and functional studies.

VI. To utilize normal, age and sex matched controls to validate genetic and epigenetic testing carried out under this protocol (essential for accurate data analysis).

VII. To assess frailty in patients with clonal hematopoiesis in order to validate genetic and epigenetic testing completed under this protocol as objective assessments of frailty and aging in comparison to standard of care frailty and geriatric assessments.

OUTLINE:

Participants may undergo blood sample collection, a bone marrow biopsy, a skin punch biopsy, hair follicle collection, a buccal swab, and/or saliva collection for NGS analysis on study. Patients may additionally undergo clinical assessment and may receive genetic counseling on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic cytopenias of unclear significance (ICUS)
* Patients with clonal hematopoiesis of indeterminate significance (clonal hematopoiesis of indeterminate potential \[CHIP\]), including the recently described CHIP syndrome called VEXAS (vacuoles, E1 ubiquitin ligase, X chromosomal, autoimmune and somatic)
* Patients with clonal cytopenias of undetermined significance (CCUS)
* Marrow failure syndromes with myeloid malignancy predisposition - telomere dysfunction, chromosomal breakage disorders
* Germ line inherited syndromes with risk for malignant transformation - GATA2, CEBPA, ETV-6, RUNX1, JAK2, PF6, etc.
* Low risk MDS (idiopathic dysplasia of unclear significance)
* Family member of a patient with one of the above conditions
* Patient at high risk or suspected of developing one of the above conditions

Exclusion Criteria:

* Patients under 18 years of age
4-aminopyridine Treatment for Nerve Injury

To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.

Eligibility Criteria:
Inclusion Criteria

* Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP)
* Prostate-Specific Antigen (PSA) levels less than 15 ng/ml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed
* Ages 45-75
* An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
* Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery
* Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery
* Willingness to participate and able to provide informed consent

Exclusion Criteria

* Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins
* Neo-adjuvant therapy prior to NSRP
* History of recurrent prostate cancer
* History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder
* History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater)
* History of known hypersensitivity to 4AP
* Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery
* Renal impairment based on calculated GFR (GFR\<60 mL/min)
* Use of any other aminopyridine medications for any other indication
Serum Cytokine Values in Patients With Granulomatous Mastitis

Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying etiologies, including infectious and non-infectious causes. Etiological reasons were examined in various studies, but neither etiology nor definite criteria for diagnosis were found. Our aim in this study is to examine the role of cytokines in differentiating the etiology of granulomatous mastitis and using it as a prognostic marker.

Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying aetiology, including infectious and non-infectious causes. This disease can clinically and radiographically mimic breast cancer, which can pose a diagnostic challenge as well as concern during evaluation. A nonspecific inflammatory response, 'granuloma' is defined as necrosis or infiltration of other inflammatory leukocytes, with or without mononuclear phagocyte collection. It is thought to be caused by infectious agents or foreign substances that activate the immune system, leading to granuloma formation. Some of the known inflammatory etiologies of granulomatous mastitis are autoimmune diseases such as tuberculosis (most commonly caused by Mycobacterium tuberculosis), sarcoidosis, fungal infection and granulomatosis with polyangiitis and giant cell arteritis. These diseases cannot be distinguished clinically, pathologically, and radiographically from idiopathic granulomatous mastitis.In this study, we aimed to investigate IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels in patients with granulomatous mastitis and to evaluate the differences in cytokine levels and its usability as a predictive marker in diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with granulomatous mastitis

Exclusion Criteria:

* Cancer Patients
* Patients with known immunodeficiency
* Pregnancy
* Patient diagnosed with tuberculosis
Impact of a Rehabilitation Programme for Mothers With Breast Cancer and Their Children

About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together" focuses on these special family needs. This waiting-control-group study examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.

About 1/3 of newly diagnosed breast cancer patients are mothers of children who still live at home. They face additional challenges and stress, their children are also affected by the mother's illness. The oncological rehabilitation programme "getting better together", administered by the Rexrodt von Fircks Foundation and the Clinic Ostseedeich in Groemitz, Germany, focuses on these special family needs. This waiting-control-group-study, designed and executed at the Philipps University Marburg Medical Center, Department of Child and Adolescent Psychiatry, examines the effectiveness of the intervention by accompanying the patients and their children over the course of a year and assessing their quality of life and psychological health.

The primary outcome measure for mothers is the health related quality of life as assessed by the EORTC QLQ-C30 and BR-23; children's adaptation is assessed with the ILK (Inventory for the Assessment of Quality of Life of Children and Adolescents) as well as the Strengths and Difficulties Questionnaire (SDQ)

Eligibility Criteria:
Inclusion Criteria:

* participants of the rehabilitation programme "getting better together"
* mothers of children up to the age of 16
* have been diagnosed with and treated for breast cancer for the first time in their lives
* chemotherapy or radiation therapy ended no less than 6 weeks ago

Exclusion Criteria:

* metastases
A Clinical Feedback System in Ostomy Care

Background: Living with an ostomy can be challenging and adapting to life with an ostomy can be particularly complex, with regard to both the physical and psychosocial aspects. Follow-up with a stoma care nurse is usually performed after surgery to support the adaptation process. In this project, we describe a new model of ostomy care, where a clinical feedback system (CFS) is implemented in order to improve the adaption process of patients with an ostomy. We also present a plan for evaluating patients experience with the CFS and their clinical outcomes.

Methods: We include patients who had recently performed colostomy, ileostomy, or urostomy surgery. The intervention includes self-reported measures for adaptation to life with an ostomy and health-related quality of life (HRQoL), as well as patient experiences and satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings. Patient experiences and satisfaction with care will be measured with the Generic Short Patient Experiences Questionnaire. Adaptation to the life with ostomy will be measured with the Ostomy Adjustment Scale, and HRQoL with the Short Form 36.

Discussion: This study presents a novel approach that could lead to improved consultation, more patient involvement, and better adaptation to life with an ostomy.

The study protocol is avaliable on request, and will also be published in a open acsess peer-reviewed journal.

Eligibility Criteria:
Inclusion criteria:

* \>18 years of age
* Living with a colostomy, ileostomy, or urostomy for a minimum of 3 months
* Being able to read and write Norwegian

Exclusion criteria:

* \< The 3 weeks follow-up after surgery are not included
* Patients who have their ostomy removed \<12 months after surgery
Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet

This project examines sleep (e.g. prevalence of obstructive sleep apnea(OSA)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. In addition, the effect of treatment with a mandibular advancement device (MAD) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

Sleep is very important for children's growth, development and learning. The anatomy and size of the airway and position of the jaw can affect children's sleep. Children with large overjet due to a posterior position of the mandible have smaller airways compared to children with neutral occlusion. Reduced dimensions of the upper airways may increase the risk of impaired sleep quality and the sleep related breathing disorder obstructive sleep apnoea (OSA), which causes symptoms e.g. failure to thrive, irritability, behavioural disorders, fatigue, which affects the children's growth, development, and learning negatively.

Children with large overjet due to mandibular retrognathia in Denmark are offered orthodontic treatment in municipal dental care and are in most cases treated with a mandibular advancement device (MAD) keeping the mandible in a forward position relative to the maxilla. MADs are also used to treat adults with mild-moderate obstructive sleep apnoea while they sleep. This can reduce the number of apnoea periods by up to 75% as well as preventing daytime sleepiness.

No previous study have examined sleep, upper airway, jaw function, well-being and quality of life in children with large overjet before, during and after MAD treatment compared to a control group with normal occlusion.

Eligibility Criteria:
Inclusion Criteria:

Overjet group:

* Horizontal maxillary overjet ≥ 6 mm and need of orthodontic treatment according to the Danish procedure for screening the child population for malocclusion involving health risk.
* Informed consent from parent(s)/guardian(s)

Control group:

* Neutral occlusion
* No history of orthodontic treatment
* Informed consent from parent(s)/guardian(s)

Exclusion Criteria:

* Known general and/or craniofacial syndromes/diseases
* Known sleep disorders, included bruxism during sleep
* Chronic respiratory diseases and asthma6/12
* Adenoid vegetations, hypertrophic tonsils and significantly reduces airflow through the nose (mouth breather), which need primary treatment.
* Dysfunction of masticatory muscles and temporomandibular joint, which need primary treatment.
The Impact of Renin-angiotensin System on Brain Activation During Hypoglycaemia in Healthy Men, a PET Study

The purpose of this study is to evaluate the cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS).The renin-angiotensin system is a hormone system which is involved in the regulation of the blood pressure. Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively

The purpose of this study is to evaluate the regional cerebral blood flow in subjects with high and low activity in the renin-angiotensin system (RAS). Earlier studies have shown that high RAS activity is associated with a more pronounced cognitive impairment during hypoglycaemia compared to low RAS activity in both type 1 diabetic patients and healthy volunteers. We intend to examine brain activity by oxygen-15 labelled water-PET scanning during hypoglycaemia in response to cognitive function testing in 20 healthy male volunteers with high and low RAS activity, respectively.

Eligibility Criteria:
Inclusion Criteria:Male Age 18-40 years Right-handed In good general health based on history High/low RAS activity (high ACE activity, A-allele for angiotensin II receptor (subtype 2) and high plasma angiotensinogen, or low ACE activity, low plasma angiotensinogen and not carrier of the A-allele for angiotensin II receptor (subtype 2)).

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Exclusion Criteria:

Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year

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