cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Treatment of Diabetic Patients With Foot Ulcers

The purpose of this study, is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.

Project title

"Treatment with oral vitamin D in diabetic patients with chronic foot ulcers on the lower limb; a clinical controlled study of the effect on wound healing".

Abstract

Aims and objectives

The purpose of this study is to determine whether daily supplements of vitamin D improves wound healing in diabetic patients with chronic foot ulcers.

Background

Lifetime risk of developing chronic lower extremity ulcers summarized in type I and type II diabetics is about 25% and the prevalence is approximately 7%. There is often a long term resource consuming disorder where 47% of the diabetic leg and foot ulcers effectively can be treated within 12 months.

In Denmark in 2011 there were more than 300,000 diagnosed type I and type II diabetics, and estimated about 200,000 undiagnosed type II diabetics. Therefore, approximately 35,000 diabetics each year are treated for chronic leg or foot ulcers in the Danish health sector. The treatment of these chronic wounds are associated with significant costs, as well as emotional, physical and financial.

Vitamin D deficiency is a widespread problem, and it is estimated that worldwide there is 1 billion people suffering from vitamin D deficiency. A Danish study from 2012 showed vitamin D deficiency in 52% of adults aged 30 60 years. Vitamin D deficiency is more common in diabetics with chronic foot or leg ulcers, when compared with non diabetics and diabetics without ulcers.

Methods and materials

48 diabetic patients with chronic foot ulcers will be included in the study. The patients will be recruited from the outpatient clinic, department of orthopaedic surgery at Zealand University Hospital, Denmark. The patients will randomly be divided into two groups, respectively treated with vitamin D or placebo.

Expected outcome and perspectives

The investigators expect that this study will show that supplementation with oral vitamin D, will result in a significant effect on wound treatment and healing for a large group of diabetic patients with chronic foot ulcers. This will contribute to a changed procedure in this specific group of patients, leading to measurement of vitamin D status and supplementation with vitamin D if needed.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Diagnosed diabetes.
3. Foot ulcers more than 6 weeks.
4. Informed consent

Exclusion Criteria:

1. Pregnancy
2. Granulomatous diseases such as tuberculosis, sarcoidosis and silicosis
3. Hypercalcemia
4. Supplementation of vitamin D \> 20 μg a day
5. Renal disease
6. Liver disease
7. Osteomyelitis
8. Skin cancer.
9. Epilepsy.
10. High blod pressure (\> 150/100 mmHg).
11. Indication for surgical revision.
The Value of Doppler Study of Central Retinal Artery in Diagnosis of Increased ICP

The purpose of this study is to evaluate the diagnostic value of central retinal artery Doppler study in case of increased intracranial pressure.

In neurocritical care, the detection of raised intracranial pressure (ICP) remains crucial as it is associated with poor outcome . Invasive ventricular devices are the gold standard for continuous and reliable measurement of ICP however their placement could be challenging due to blood coagulation disorder or lack of surgical availability. Moreover, malfunction or obstruction of ventricular catheters has been reported to occur as often as 6%. Recently Julie.et al. revealed in his met analysis that optic nerve sheath diameter (ONSD) has a good level of diagnostic accuracy for detecting intracranial hypertension with a pooled sensitivity of 0.9. The central retinal artery (CRA) is an end artery branch of the internal carotid artery that joins the optic nerve 1cm behind the globe and enters the retina on the optic nerve head . Central retinal artery is located inside the optic nerve sheath, and The optic nerve is part of the central nervous system and the intraorbital subarachnoid space surrounding the optic nerve is subject to the same pressure changes as the intracranial compartment,so we should expect any increase of ICP will compress the central retinal artery exactly the same as basal cerebral arteries. Central retinal artery circulation is low resistance circulation with good diastolic flow and upper limit of resistivity index is 0.7. So, any compression of CRA will decrease the diastolic flow and increase RI. Kamil.et al. studied the blood flow velocity changes in orbital arteries by using Doppler sonography in eight patients with brain death and increased ICP. Peak systolic and end-diastolic velocities and resistive indices of the ophthalmic and central retinal arteries were evaluated. they observed the absence or reversal of end diastolic blood flow in these arteries. If the intracranial pressure is higher than the end-diastolic pressure of the cerebral arteries diastolic flow reversal occurs. If the intracranial pressure exceeds systolic pressure blood flow is entirely ceased with complete and irreversible loss of brain function CRA is a superficial, easy accessible without bony obstacle like transcranial doppler (TCD) and the learning curve of its Doppler study can be very steep, so it could has a big role in management of cases with increased ICP.

Eligibility Criteria:
Inclusion Criteria:

* All Patients with cerebral stroke either ischemic or hemorrhagic
* All Patients with traumatic brain injury including those on mechanical ventilation

Exclusion Criteria:

* Patients with eye trauma
* Patients with either arteritic or non arteritic central retinal artery occlusion
Ultrasound Guidance Vs. Electrical Nerve Stimulation for Infraclavicular Brachial Plexus Block

In an observer-blinded study ultrasound guidance and electrical nerve stimulation will be compared for lateral sagital infraclavicular blocks (LSIB). Block effectiveness, time consumption and patient acceptance will be registered in 80 patients. Ultrasound guidance may cause less discomfort and could be less time consuming than electrical nerve stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Infraclavicular brachial plexus block
* Hand surgery

Exclusion Criteria:

* ASA \> 2
* Block assessment impossible
* Allergy to local anesthetic
Online Wellness Intervention for College Students

We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and a student at a participating university. Access to the internet.

Exclusion Criteria:

* Cannot have participated in a previous version of COMET.
Childhood Asthma and Schooling: The Truth Unveiled

Childhood Asthma and Schooling: The Truth Unveiled.

Children with mild persistent asthma still performed worse than normal healthy children in school. The aim of the study was to evaluate school performance of children with mild persistent asthma in comparison with normal healthy children.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bronchial asthma
* Must be able to swallow tablets

Exclusion Criteria:

* Steroid inhalation or ingestion
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer

It is expected to include 756 patients with colorectal cancer (CRC) who were diagnosed as stage II and underwent radical resection (R0) according to the CSCO colorectal cancer guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from July 2024 to June 2026. The experimental group was treated with Huaier Granule monotherapy, and 378 patients were expected to be included; The control group was treated with capecitabine monotherapy, and 378 cases were expected to be included. Patients in the experimental group began using Huaier granules within 14 days-2 months after surgery. Patients in control group received capecitabine treatment, with one course of treatment every 3 weeks, for a total of 4-6 courses. Patients will be visited every 12 weeks (± 14 days) for the first two years after enrollment, and every 24 weeks (± 14 days) for the third year, until the end of the study, withdrawal from the study for any reason, or death, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, regardless of gender.
* It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ.
* Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment.
* Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery.
* ECOG score 0-2 points.
* According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine.
* Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments.
* Voluntarily join this study and sign an informed consent form.

Exclusion Criteria:

* Low rectal cancer (occurring within 12 centimeters from the anal margin)
* Combining medical history of other malignant tumors.
* Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (only in the experimental group).
* Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan).
* Pregnant or lactating women or planned pregnancy preparation.
* In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual for details).
* Refusal to cooperate with follow-up.
* Other reasons leading to the researcher's belief that it is not suitable to participate in this study.
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Peri-implantitis and Peri-implant Mucositis

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with peri-implantitis/peri-implant mucositis and without any cardiovascular disease.

90 patients: 30 with peri-implantitis, 30 with peri-implant mucositis and 30 healthy controls and without periodontitis history.

All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the peri-implantitis/peri-implant mucositis subjects.

Eligibility Criteria:
PERI-IMPLANTITIS GROUP

Inclusion Criteria:

• Clinically diagnosed with peri-implantitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

PERI-IMPLANT MUCOSITIS GROUP

Inclusion Criteria:

• Clinically diagnosed with peri-implant mucositis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, implant surgery, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

HEALTHY GROUP

Inclusion Criteria:

• Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain

Chronic low back pain (CLBP) afflicts up to 50 million U.S. adults and is a primary cause of disability and reduced quality of life. The prescription of opioids for chronic low back pain (CLBP) has increased substantially within the past decade in the U.S. As noted by the CDC in their recent Guideline (released in March 2016): "Opioids are commonly prescribed for pain. An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses (including acute and chronic pain) receive an opioid prescription. Interestingly, patients scoring very high on measures of psychological distress tend to be systematically excluded from RCTs, even though this subgroup of patients is highly prevalent within the chronic pain population.

This study will provide key information on individual differences in the outcomes of opioid treatment, and its findings should facilitate more effective tailoring of analgesic regimens to individual patient characteristic.

Changes in pain sensitivity will be examined (i.e., OIH) among subgroups of CLBP patients prescribed oral opioid therapy.

Investigators will conduct a moderate-term, double-blind, randomized controlled trial, and use quantitative sensory testing (QST) to evaluate whether changes in pain sensitivity and pain modulation occur as a result of long-term opioid use. Investigators hypothesize that increases in pain sensitivity (i.e., OIH) and maladaptive changes in endogenous pain modulation (i.e., enhanced temporal summation of pain) will occur as a result of long-term opioid use, but that these changes will be observed predominantly among patients with high levels of negative affect and pain-related catastrophizing.

Eligibility Criteria:
Inclusion Criteria:

1. age 25-65
2. CLBP lasting for more than 6 months as the primary complaint
3. typical pain ratings ≥ 4/10 on a visual analogue scale
4. candidate for oral opioid therapy as assessed at the BWH Pain Management Center
5. able to speak and understand English.

Exclusion Criteria:

1. evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures
2. current (i.e., active) substance use disorder (SUD)
3. past history of persistent opioid use (i.e., opioid use for more than 6 months) given that this could affect the biological systems of interest in the present study
4. history of myocardial infarction or other serious cardiovascular condition
5. current peripheral neuropathy
6. current pregnancy, or intention to become pregnant during the study
7. current intrathecal pump.
Relationship Between Serum 1,25-dihydroxy Vitamin D and Markers of Bone Metabolism in Renal Dysfunction Patients

This cross-sectional study was conducted, including those subjects tested for 1,25(OH)2D during Jan 2015-Dec 2021. Estimated glomerular filtration rate (eGFR) was calculated and subjects were classified into chronic kidney disease (CKD) stages. Associations between biochemical marker, calcium, phosphorus, magnesium, alkaline phosphatase, 1,25(OH)2D and CKD stages was determined.


Eligibility Criteria:
Inclusion Criteria:

• Data of serum 1,25(OH)2D available

Exclusion Criteria:

• Serum1,25(OH)2D is not available
The Relation Between Running Patterns and Overuse Injuries in Runners

Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI), however to studies have documented such relationship. Thus, the aim of the study is to investigate the association between running patterns and overuse injuries in runners.

Running patterns are thought to have a major influence on the development of Running Related Injuries (RRI).

Worldwide, running is a sport practiced by many individuals to improve cardio-respiratory function, health and well-being. Although running positively contributes to health, there is also a risk of running related injuries (RRI). At best, the consequence of RRI´s is a periodic absence from physical activity, with the athlete returning to sport within weeks. In the worst case, the injury is a chronic painful condition, causing a sedentary lifestyle without physical activity. This is undesirable since physical inactivity increases the risk of lifestyle diseases and death.

In Denmark it is estimated that 4.500 deaths each year can be attributed directly to inactivity. Furthermore, inactivity leads to reduced quality of life compared to active persons. To avoid people getting a sedentary lifestyle prevention of RRI are necessary.

To define a prevention strategy, one must have knowledge about risk factors and causation. Many risk factors have been proposed. Among these, running patterns and foot type are thought to play a major role in the development of RRI. However, very few firm conclusions can be made based on the existing literature, often because of methodical problems. Consequently, it is suggested to design large scale prospective studies controlling for multiple variables. Furthermore, studies should differentiate between novice, elite and extreme runners. Thus, the study design in this project will take these suggestions into account.

The aim of the study is to investigate the association between running patterns and overuse injuries in runners.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years old
* has a GPS-watch that can measure training data (Garmin Forerunner 205,305 or 405)
* has registered their training (if they have run) for a period of at least three months before the inclusion in the trial
* has an e-mail address

Exclusion Criteria:

* does not wish to keep a training diary
* has not registered training data in the follow-up period
* has had an injury in the leg within the last three months before baseline
* active with another tough sports, cf. American College of Sports Medicine
* psychic condition that does not allow participation
* cannot read or understand Danish
Reha Drive: Capacitive Electrocardiography in Car Seat in Cardiological Patients

In this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.

Increasing number of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to their fitness of driving during cardiac rehabilitation. Little trial data are known, only a position paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience. For judgement and recommendations automotive monitoring via contactless sensors might be helpful. Therefore while "driving" in a simulator distinct heart circulation situations will be created. Vital signs will be measured via long term electrocardiography (ECG) in comparison to contactless capacitive ECG (cECG) measurements via embedded sensors in the car seat as well as heart rate and breathing rate measurements via camera.

Eligibility Criteria:
Inclusion Criteria:

* cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery)
* rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

* dementia
* lack of language ability
* pregnancy
* implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)
Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period
* Women who have read and signed the Informed Consent Form
* Women with an intact uterus
* One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities.
* Blood estradiol concentration of 30 pg/ml or less .

Exclusion Criteria:

* Women who have not signed the Informed consent Form
* Women who had a known or suspected history of breast carcinoma
* Estrogen dependent neoplasia. Women with a known, past or suspected Estrogen-dependent malignant tumours such as endometrial or ovarian cancer
* Positive or suspicious mammogram results
* Any systemic malignant disease
* Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months
* Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause
* Vaginal infection requiring treatment
* Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria
* Any serious disease or chronic condition that could interfere with study compliance
* History of thrombolytic disorders
* Use of vaginal contraceptives (DIU, vaginal ring...)
* Participation in another clinical trial in the last three months.
99mTc-anti-TNF-alpha Scintigraphy in the Evaluation of Inflammatory Processes Activity

Rheumatoid and psoriatic arthritis patients benefit from anti-TNF-α therapy, once it is effective in reducing joint and skin manifestations in 60-70% of patients with inflammatory articular joint and skin diseases. Thus, identifying the presence and amount of TNF-α in the joint or skin in these patients may help in guiding the course of treatment more efficiently. The investigators research group has developed a novel approach to label anti-TNF-α with technetium-99m. Here the investigators compare the results obtained with scintigraphy and MRI in rheumatoid and psoriatic arthritis. The 99mTc-anti-TNF-α scintigraphy might recognize the molecule involved in the inflammatory process and provide crucial information to help physicians taking decisions about the drugs to be used based on biological evidence and which are cost-effective and appropriate for the treatment of choice. It allows direct identification of the monoclonal antibody anti-TNF-α in the articular joints and skin while it also ensures that the drug has reached its therapeutic target. It also allows correlation between the presence of the drug and clinical responses.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis (RA) patients must have 1 joint with edema.
* Inflammatory lumbalgia
* ankylosing spondylitis
* Psoriatic arthritis with active disease and skin lesion

Exclusion Criteria:

* Patients that do not return to scintigraphy
* Pregnancy, Lactation, active infection, severe concomitant disease and medication allergy history