cyrilzakka/clinical-trials huggingface dataset:
Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .

Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. 20-65 years-old
2. pain lasting \>3 months
3. Painful arc between 40° to 120° in abduction
4. positive Neer and Hawkins-Kennedy tests
5. positive Empty can test
6. pain in daily living activities
7. Bursa thickness more than 2mm in ultrasound
8. Rotator cuff tendinopathy

Exclusion Criteria:

1. history of significant shoulder trauma
2. history of surgery, fracture, or dislocation
3. adhesive capsulitis
4. full thickness rotator cuff tear
5. a long head of bicep tendon tear
6. Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)
7. previous shoulder steroid injection in one month
8. had any rheumatologic, systemic, or neurologic disorders
9. patients taking regular systemic NSAIDs or steroids
10. pregnant or breastfeeding mothers
11. malignancy
Effects of Nordic Walking in Water on Cerebrovascular Function and Cognitive Impairment in Elderly With Type 2 Diabetes

Nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.
* Participants had Montreal Cognitive Assessment - Thai (MoCa-T) scores between 18 24 points.
* Participants had time up \& go test between 8 - 15 seconds

Exclusion Criteria:

* Participants were excluded if they dropped out or completed less than 80% of the training schedule
Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCT

The usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy.

Although it has not been evaluated prospectively, the usual treatment for obstructive airway disease (OAD) after allogeneic hematopoietic stem cell transplantation (AHSCT) , which is related to graft versus host disease (GVHD), consists of intensification of systemic immunosuppressive therapy. However, this treatment has a limited efficacy and is associated with a significant number of serious adverse effects, particularly infectious. Alternative treatments are therefore necessary.We have retrospectively reported clinical and functional improvement in patients with OAD following AHSCT treated with inhaled budesonide/formoterol combination.These encouraging results need to be confirmed by the present randomised, prospective double-blind trial. This study is therefore designed to evaluate the efficacy of budesonide/formoterol versus placebo in patients with moderate to severe OAD, not requiring initiation or intensification of systemic immunosuppressive therapy for extra thoracic GVHD.

Inclusion criteria modified according to amendment of 02/11/2009

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years.
* Previous normal PFTs available.
* Absence of extrathoracic GVH disease justifying initiation or intensification of systemic immunosuppressive therapy.
* Respiratory signs present for less than 6 months.
* AHSCT recipients who have developed moderate to severe bronchiolitis obliterans, defined by reduction of FEV1/VC below the 5th percentile of predicted normal or \< 80% of predicted, with FEV1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist. AHSCT recipients with FEV1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist and TLC ≥ 80% of predicted.
* Respiratory symptoms related to obstructive lung disease present for at least 6 months.
* Negative respiratory microbiology work-up.
* Informed consent signed by the patient or both parents of a minor.

Exclusion Criteria:

* Extrathoracic graft versus host reaction justifying initiation or intensification of systemic immunosuppressive therapy.
* Use of inhaled bronchodilator and/or corticosteroid therapy at the time of inclusion.
* Known intolerance to inhaled bronchodilators and/or corticosteroids and/or lactose.
* Personal or donor history of asthma.
* Active smoking
* FEV1 \< 40% of predicted normal or ≥ 80% of predicted normal or PO2 \< 50 mmHg.
* Documented respiratory tract infection.
* Pregnancy.
* Absence of effective contraception during the trial.
* Not covered by French national health insurance.
A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT)

The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively.

This is a multi-center, retrospective and prospective registry study on the use of the Valeda® PBM system as a treatment for visual improvement in participants with dry AMD. The target is at least 25 participants/site in up to 20 participating sites in Europe.

Participants will or will have received nine non-invasive, short treatments over three to four weeks starting at Baseline (BL), with up to five additional rounds of treatment every four to six months, or as determined by the Investigator.

Standard visual outcome measurements collected will include visual acuity (either ETDRS BCVA or LogMAR) prior to and following treatment. OCT and Fundus Autofluorescence (FAF) imaging of the retina should be taken at screening, and after each round of treatment. As this is a registry study, missing

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator
2. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
3. Informed of the nature of this study and has provided written, informed consent (participants enrolled retrospectively will need to be contacted and sign an informed consent form prior to their data being used).

Exclusion Criteria:

1. Signs of active, inactive or history of exudative macular neovascularization (MNV)
2. History or active accumulation of intra and subretinal fluid of any cause (e.g., diabetic macular oedema, central serous retinopathy, cystoid macular oedema)
3. Use of any photosensitizing agent (e.g. topicals, injectables) activated by the Valeda Light Deliver System within 30 days prior to treatment without consulting participant's physician
4. Has any known photosensitivity to yellow light, red light, or near infrared radiation (NIR), or has a history of light activated CNS disorders (e.g. epilepsy, migraine)
5. In the opinion of the Investigator, is unlikely to comply with the study protocol or has a history or current evidence of any condition that, in the opinion of the investigator, might interfere with the participant's involvement in the trial, or is not in the best interest of the participant.
Study of Brain Cools Device in Patients Resuscitated From Cardiac Arrest

This submission is a pilot in which the new IQool Warming System device will be used to maintain the temperature of adult patients in cardiac arrest within a range of within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The IQool Warming System has received a 510 K Clearance by the FDA.

Subjects will receive temperature management using the IQool. This is an FDA approved device. Managing temperature is part of standard care for this population and surface cooling is commonly employed.

The following phases will be conducted as standard of care, and will be reviewed for this study:

Induction phase: When a subject is included in the study, the IQool will be connected to the patient and activated. The induction period will continue until the patient has reached the upper limit of the target temperature range (defined as 0.5°C above the target temperature).

Maintenance phase: Set target temperature will be maintained for 24 hours. The maintenance phase begins when the subject temperature is within 0.5°C of goal temperature. The maintenance phase is completed 24 hours after first reaching below the upper limit of the target temperature range.

Rewarming phase: After 24 hours of maintenance, gradual rewarming at 0.25 °C/h will commence. When the subject reaches 37°C the TTM period is completed and the IQool will continue to provide fever control.

Post TTM fever control: The subject will be kept at a body temperature of 37°C until 72 hours after the cardiac arrest or earlier if the subject regains consciousness.

Eligibility Criteria:
Inclusion Criteria:

* In- or out-of-hospital cardiac arrest of all initial rhythms
* Adult patients (18 years of age and older)
* Unconscious on admission to hospital, defined as not following commands
* Indication for targeted temperature management

Exclusion Criteria:

* Pregnancy
* Prisoner
* Active do not resuscitate order
* Any patient not expected to survive 72 hours
* Skin infection
* Skin wound affecting site of temperature exchange pads
Glioma: Biomolecular Aspects

Main limitations in Glioma studies are due to the wide heterogeneity and genetic instability of the tumor and to the fact that the molecular informations are static, i.e. obtained on the tumor at its onset. Instead, spontaneous or therapy-induced variations are difficult to evaluate and they would need further sampling of the tumor throughout the clinical history. Currently these data are more and more routinely used not only for diagnostics but also in the clinical management of the patient.

Furthermore, microenvironment study is becoming increasingly important. It is also important correlate morpho-functional pathway and brain Magnetic Resonance.

Therefore, the main goal of the study is to correlate the data obtained with morphological (site, signal intensity, margins, behavior after contrast medium infusion, mismatch between T2 and FLAIR sequences) and non-morphological MR imaging through a radiomic approach and Diffusion and Perfusion study, with molecular data relating to the IDH mutation, MGMT gene promoter methylation, 1p/19q co-deletion and EGFRvIII expression.

Furthermore, it is proposed to carry out a correlation between the radiological data and the mutations found in the NGS panel.


Eligibility Criteria:
Inclusion Criteria:

* glioma diagnosis
* have performed morphological brain MRI or not with contrast medium before surgery
* informed consent form

Exclusion Criteria:

* Patients without Magnetic Resonance were excluded
Vertical Distance Between Medial and Lateral Malleolus in Normal Population

Determine variation in vertical distance between the medial and lateral malleolus in the normal population subjected to X-rays for any other causes than ankle fracture Determine the effect of weight bearing on this variation

There is gap of knowledge about determination of vertical distance between medial and lateral malleolus Our research will cover this gap of knowledge ,so our research question will be what is the normal variation of vertical distance between medial and lateral malleolus Fractures of ankle are common injuries,approximately 2% of the general population will sustain an ankle fracture during their life time .many can be successfully treated non operatively However,for those injuries that require surgical intervention ,restoration of the anatomy is the main principle The importance of anatomic restoration of the fibula ,specially in preserving normal length has been appreciated by several authors Data will be obtained from measuring the vertical distance between lateral and medial malleolus in AP view of ankle in traumatic non ankle fractured people in standing and non standing position

Eligibility Criteria:
Inclusion Criteria:

* non ankle fractured people Non arthritic ankle Age more than 18 years old Non diabetic people Normal ankle X-rays as determined by tibiocrural angle and tibiofibular overlap

Exclusion Criteria:

* people with fracture ankle (United \&non United) Arthritic ankle Diabetic people Abnormal ankle X-rays
The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being

The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is:

Does a 2-week contemplative nature intervention improve spiritual well-being?

Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality.

Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes.

Participants in the active control condition will walk for 30 minutes without further instruction.


Eligibility Criteria:
Inclusion Criteria:

* is 18 years or older;
* has access to a nearby natural environment for walking and sitting activities such as a forest, park, or walking area;
* possesses the physical ability to walk for half an hour;
* has access to a computer or tablet with a stable internet connection and an email address;
* is willing to commit half an hour to engage in nature walks 10 times over 14 days.

Exclusion Criteria:

- NA.
Effect of Walnuts on Sperm Parameters and Male Fertility

The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men seeking care for infertility will beneficially affect sperm parameters and fertility. The investigators will compare the walnut intervention to the commonly suggested recommendation of adding an OTC multivitamin supplement to the diet.

Purpose: The investigators are testing the hypothesis that two ounces of whole-shelled walnuts/day added to the diet of men with oligo- astheno- or teratospermia will beneficially affect sperm parameters. The investigators found in a previous study (Robbins et al. 2012, Biology of Reproduction 87(4):101, 1-8.) that walnuts added to a Western diet improved sperm parameters in healthy, young men of unknown fertility and the most improvement occurred in participants with poor sperm parameters at baseline. The investigators now test the walnut dietary intervention in a fertility clinic population known to have poor sperm parameters. The investigators will compare the walnut intervention to the usual care suggestion of adding an OTC multivitamin supplement to the diet. Neither walnuts nor the OTC multivitamin have been tested for efficacy in this fertility clinic population previously.

Methods: A randomized, parallel two-group, dietary intervention trial with single-blind masking of outcome assessors will be conducted with up to 140 men who present for fertility work-up with semen parameters below the 25th centile for count, and 10th centile for motility and/or morphology according to the WHO 5th Edition, Laboratory Manual for the Processing and Examining of Human Semen, 2010. Repeated measures at baseline and 12 weeks include: semen analyses (primary outcome), blood fatty acid/ nutrient profiles (secondary outcomes); IPAQ physical activity questionnaire and IIEF index of erectile function (potential modifiers or confounders). Dietary intake will be assessed throughout using 24-hour ASA dietary recall x 5 and fertility assessed by questionnaire at one year post enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Sperm concentration \< or = to 41 million per ml
* Sperm motility \< or = to 40%
* Normal sperm morphology forms \< or = to 5.5%
* Patients of Howard H. Kim, MD seen at the Male Reproductive Medicine and Microsurgery Clinic, Cedars-Sinai Medical Center, Los Angeles, California
* Have eaten walnuts throughout life without adverse reaction

Exclusion Criteria:

* Allergy to walnuts or tree nuts
* Food allergy
* Known genetic cause of infertility
* Known anatomical cause of infertility
* History of seizure disorder
Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery

This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.

PRIMARY OBJECTIVE:

I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary dissection in breast cancer patients.

OUTLINE:

Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =\< 3 mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.

After completion of study, patients are followed up within 6-22 days post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cT0-4, N1 breast cancer
* Axillary lymph node metastasis with pathologic confirmation by needle biopsy
* Clip placed in the sampled axillary lymph node before completing chemotherapy
* Received neoadjuvant chemotherapy prior to surgical resection
* Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection \[SLND\])
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* Distant metastases
* Inflammatory breast cancer
* Prior surgical axillary procedure including SLND or axillary node excision
* Prior history of breast cancer in the ipsilateral breast
* History of lymphoma
* The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed
* Previous radiation to the breast or axilla
* Pacemaker of other implantable device in the chest wall
Evaluation of Sores Treatment by Oxygenotherapy

Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day.

The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* accepted to participate
* Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface

Exclusion Criteria:

* infected ulcers
* necrosed ulcers
* Arterial ulcers requiring a revascularisation.
* Ulcers whose surface is superior in 10x10 cm.
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

Background:

- Orthopedic procedures are common in the United States. These include joint replacement and spine surgeries. Researchers want to study data about these procedures over time. They want to see if treatment has gotten better. They also want to find ways to change the care that people get before and after they have these procedures. These changes may lower the risk of problems people can have during and after treatment. They may also improve people s results.

Objectives:

- To study a series of questions about surgery, medicine, treatments, and outcomes for orthopedic procedures.

Eligibility:

- Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015.

Design:

* Researchers will look at data for people ages 20-100.
* No new participants will be used in this study.
* The study will last 6 years.

Major orthopedic procedures, including total joint replacement and spine surgeries, are among the most common procedures in the population. Learning about how often these surgeries are performed can give indications of whether the treatment of arthritis and other musculoskeletal conditions has been improving over time. Learning about the complications associated with these surgeries can give indications about ways to alter the care of patients before and after surgeries that may decrease the risk of complications and improve patient outcomes. We will analyze Medicare and Medicaid data from 1999 to 2015 to examine a series of questions, including whether the use of joint replacement surgery has changed over time among patients with rheumatoid arthritis and ankylosing spondylitis, to see if rheumatoid arthritis medications are associated with some types of surgical complications, to see if anticoagulation medication after joint replacement is associated with the risk of complications, to see if regional differences in surgery rates can be explained by differences in patient characteristics, and to determine the surgical treatment for hip fractures that is associated with the fewest long-term complications. From the Framingham Heart Study Cohort, we will study the changes in the incidence of hip fractures and the risk factors for osteoporosis over time.

Eligibility Criteria:
* Subjects will be either Medicare or Medicaid beneficiaries with available claims from 1999 to 2015. For projects requiring detailed medication information, inclusion will be limited to those with Part D claims from 2006 to 2015. Eligibility for each project will be based on claims for the appropriate disease (e.g. RA) or procedure (e.g. hip arthroplasty).

Medicare beneficiaries will be excluded (or censored) if they do not have both Part A and Part B coverage, or enrolled in Medicare Advantage plans (Part C), as detailed claims for these beneficiaries are not available. We will also exclude dual-eligible (Medicare and Medicaid recipients) as these subjects have distinct clinical conditions (e.g. blindness) that distinguishes them from most Medicare beneficiaries. There will be no exclusions based on gender, race, ethnicity, or cognitive impairment.