cyrilzakka/clinical-trials huggingface dataset:
Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension

Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome.

This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid).

The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and

This study is a multicenter, prospective, population-based cohort study with consecutive inclusion of patients in which the diagnosis of IIH is suspected. This study is carried out in collaboration between the Danish Headache Center, Rigshospitalet-Glostrup, and the Neurological Department at Odense University Hospital.

Patients are eligible for inclusion into the study if:

1. IIH is suspected
2. \> 18 years old and able to provide written informed consent.

At baseline included patients will have:

A.) Medical history B.) Neurological, ophthalmological and general medical examination C.) Relevant neuro-imaging D.) Blood samples and lumbar puncture F.) Evaluation by other specialist, including neuro-psychologists, if appropriate.

Subsequently patients are divided into three sub-groups according to revised Friedmann criteria:

1. Certain IIH or IIH-WOP
2. Suspected, but unconfirmed, IIH
3. IIH ruled out

Patients are followed at a headache center and by neuro-ophthalmologist according to standard clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Able to and willing to provide informed consent
2. More than 18 years of age
3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)

Exclusion Criteria:

1.) Unable to consent (e.g. language, mental retardation).
Flexible URS in Management of Renal Stones in Anomalous Kidney

The urotheliasis is a common problem encountered daily by all urologists worldwide with rates up to 13% in North America, 9% in Europe and 5% in Asia . The urotheliasis is treated by conservation, medical treatment and surgery according to many factors . Anomalies in the kidney happens due to failure in ascending , fusion, rotation or all together, horse-shoe kidney is the most common example , found in one of 400 patients . PCNL and URS are the golden standard method for stone extraction worldwide, since their introduction 1975 by Fernstrom and Johansson \& Arthur Smith respectively in normal kidney .Since the development of the endourological procedures and instrument , continuous updates and upgrades have been applied ,such as enhancing the optical systems ,reducing the diameter, navigation (deflection angles) and stone fragmentation .Stone treatment in anomalous kidney is more demanding, requires more skills and training . The flexible ureterorenoscopy has some problems first the cost but this problem is being now solved by the use of disposable scopes , second the skills it requires , third the possibility of sepsis is higher . To our knowledge most of the studies in the literature are retrospective, carrying some weakness in them. There is no agreed-upon therapeutic method for treatment of stones in anomalous kidney so the investigators will evaluate the role of F-URS in a prospective study.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age above 15 years.
2. Renal and ureteric stones either single or multiple wherever the site and site.
3. Pelvi-uretreic junction obstruction
4. Previous stented ureter.
5. Poorly functioning kidney.
6. Single functioning kidney.
7. Chronic kidney disease patient not on dialysis.
8. Previous operation in this kidney.
9. failed ESWL.

Exclusion Criteria:

1. Not fit for surgery.
2. Uncontrolled bleeding diathesis.
3. Untreated preoperative urinary tract infection (UTI).
4. non function kidney
5. skeletal abnormality
Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.

Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.

Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Diminution of vision due to diabetic macular edema.
* CMT ≥ 250 µ.
* Willing to participate in the study.

Exclusion Criteria:

* Unwilling to participate in the study, 2)
* Ischemic RVO,
* previous laser treatment
* Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
* patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
* Cardiac co-morbidities result in significant hemodynamic changes, 7)Respiratory diseases need treatment with antibiotics,
* Suffering from other chronic diseases as diabetes,
* Patient with allergy from triamcinolone acetonide.
Exercise and Compression for Lymphedema

The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.


Eligibility Criteria:
Inclusion Criteria:

1. Is a female with a history of breast cancer;
2. Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
3. Has visible and palpable unilateral mild to moderate BCRL of at least 200 ml inter-limb volume difference (full limb) or regional lymphedema: defined as a minimal volume difference of 100 ml or 5% in a segment of the arm (e.g. hand and forearm region, elbow and upper arm) after correcting for arm dominance;
4. Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
5. Is in the lymphedema maintenance phase of conservative treatment;
6. Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of pressure);
7. Is agreeable to discontinuing other lymphedema treatments that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week RCT period of the study.
8. Is able to read and understand English.

Exclusion Criteria:

1. Are undergoing or are scheduled to receive chemotherapy or radiotherapy
2. Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease;
3. Has any neurological or cognitive deficit, is pregnant, uses a pacemaker, or has other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
4. Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome

In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence rates ranging from 10% to 40%. This pain can be classified into failure to alleviate baseline pain, pain resulting from complications (e.g., arachnoiditis and epidural adhesions), and pain that ensues several years later as a sequele to alterations in spinal architecture and biomechanics (e.g., adjacent segment discogenic or facetogenic pain) which is called failed back surgery syndrome ( FBSS )

By observing adhesions directly, the lysis of scar tissue can be carried out mechanically using some percutaneous techniques as insertion of catheters as Rac'z catheter (thin in calibre) which will be inserted through the skin under fluoroscopy guidance or using NAVI catheter (large in calibre) either fluoroscopy guided or using thin epiduroscopy. Adhesions can be disintegrated and their evaluation scores may improve.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of lumbar surgery of at least 6 months duration in the past.
* Patients over the 18 years of age.
* History of persistent function-limiting lower extremity pain aggravated by "dural tug" (observed when the patient, sitting on the exam table with legs stretched out, bends forward, bringing on the back pain) with or without low back pain of at least 6 months duration after failure of conventional conservative management in most patients including NSAIDS, muscle relaxants (tizanidine, magnesium sulphate) and pregabalin.
* Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements.

Exclusion Criteria:

* Unstable or heavy opioid use.
* Uncontrolled psychiatric disorders.
* Uncontrolled medical illness.
* Any conditions that could interfere with the interpretation of the outcome assessments.
* Pregnant or lactating women.
* Patients with a history or potential for adverse reaction(s) to local anaesthetics or steroid.
Effect of Physical Therapy Modalities in Osteoarthritis

The purpose of this study was to find the most effective treatment out of both techniques; Dry needling and Kinesio Taping for treating knee osteoarthritis (OA) in terms of pain, strength, and balance

Knee osteoarthritis is also associated with a 50%-60% reduction in maximum quadriceps torque, possibly resulting from disuse atrophy and atherogenic inhibition.

Kinesio taping is a term that comes from the field of kinesiology, because the application of the tape allows the body to move normally, and reacts to fascia via biomechanical or proprioceptive mechanisms. Kinesio tape is an elastic therapeutic tape that finds its application as an adjunct to professional activities in healthcare, rehabilitation, prevention, and sports. In circulatory pathologies, Kinesio tape has the function to promote the drainage of excess fluid, activating a lymphatic drainage response. Kinesio tape promotes better blood circulation and lymph flow in the treated area, and this principle can be used to drain the swelling in trauma and bruises to speed up the process of redistribution of the hematoma. Kinesio tape application decreases the surplus heat via friction reduction resulting in lifting the skin. It also has a good stabilizing effect. Kinesio tape was also used for treating sports and orthopedic injuries, and a variety of musculoskeletal disorders like osteoarthritis. For example, the research of Murray H. has shown an increase in the electromyographic quadriceps muscular activity with Kinesio tape application, applied by patients after ACL repair in the postoperative phase.

Dry is a specific technique for the treatment of functional disorders of the skeleton muscles, fascia, and connective tissue. It can also be used to reduce pain, restore function and reduce structural defects in muscles and joints, the dry needling treatment approaches are based on three models (including models of radiculopathy, spinal sensitization, and myofascial trigger point model). The dry needling technique can be divided into superficial and deep techniques.

Conservative treatment is advocated in patients with mild to moderate osteoarthritis of the knee. Because muscles weakness is associated with pain and physical dysfunction and influences the progression of disease in patients with knee osteoarthritis. Muscle strengthening is a key component in knee osteoarthritis Therefore, local strengthening exercise is prescribed more frequently than general exercise. A growing body of evidence shows that exercise improves knee joint function and decreases symptoms.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with osteoarthritis.

Exclusion Criteria:

* Surgical procedures in the lower extremity in the last 6 months
* neurological disorders
* skin allergy
* patient is under pain medications.
Improving Participation in Universal School Meals (USM)

The purpose of this study is to assess the impact of an implementation strategy on participation in Universal School Meals (USM).

The purpose of this cluster randomized trial is to test the effectiveness of an implementation strategy on implementation and student health outcomes of universal school meals (USM). This will be completed by developing and tailoring of an implementation strategy and testing its effectiveness though a cluster randomized design. Primary implementation outcomes of this trial are acceptability, cost, feasibility, penetration, and sustainability. Secondary student health outcomes are changes in diet quality (district-wide survey for students), food insecurity (USDA 6-item screener), and weight status. Exploratory descriptive models will be run to assess differences between intervention and control schools. To provide evidence for approaches in adolescents at highest risk for poor dietary intake, food security, and obesity risk, racial and ethnic minority adolescents from the School District of Philadelphia will comprise the majority of the sample. The principal investigator has just completed a year-long needs assessment with 8 schools across the district. We will aim to recruit 4 schools to be randomized to 1 of 2 conditions. Recruitment is underway, final recruitment details will be added once randomization is complete. From these schools, we aim to randomize (2 intervention; 2 waitlist comparison) for the development and tailoring of an implementation strategy. At baseline and throughout the 2-year trial period, we aim to collect interview data and surveys, and analyze data on diet quality, food security, and weight status.

Eligibility Criteria:
Inclusion Criteria:

* An elementary/middle or high school within the School District of Philadelphia (SDP) that provides free breakfast and lunch to students
* School is willing to be randomized to either a treatment or waitlist comparison condition
* School has a team of teachers, administration, and food service staff who are willing to complete interviews and surveys for data collection
* School has valid data for student Body Mass Index, meal participation, and food insecurity (parent reported).
* Students currently enrolled in a SDP elementary/middle/high school
* Students willing to participate in an interview and complete surveys
* Students have participated in school meals in the last year.

Exclusion Criteria:

* Charter schools and private schools
* Students not enrolled in school full time; students under 11 years of age.
Mechanisms of Infertility and Hormonal Changes in Patients With Chronic Kidney Disease

Patients with chronic kidney disease (both men and women), especially those with terminal renal failure, manifest infertility. There has been demonstrated several hormonal changes in patients on dialysis. Increased levels of luteinizing hormone (LH) has been seen in men (12). In women the opposite has been reported. The number of spermatocytes is reduced and a disturbance in maturation has been observed.

This project is aimed to study the influence of uremic milieu on fertility in men and women. The hypopituitary/hypothalamus gland axis and hormonal levels will be studied.

Renal elimination of hormones and peptides. By using a human transplantation model the investigators will study changes in hormonal levels before and after a successful transplantation up to 12 months. Hormones: testosterone, SHBG (sex hormone binding globulin), LH (luteinizing hormone), FSH (follicle stimulating hormone), estradiol and inhibin B.

Analysis of sperm quality, concentration, motility, morphology and as well DNA-fragmentation index (DFI) in men with chronic kidney disease. In women the investigators will study the maturation of follicles via vaginal ultrasound. Controls are persons from a study at Dept of Reproductive Medicine.

Eligibility Criteria:
Inclusion Criteria:

* GFR-levels

Exclusion Criteria:

* \> 50 years old
Telemedicine for Patients Suffering From Heart Failure (Danish Telecare North Trial)

There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts.

It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.


Eligibility Criteria:
Inclusion Criteria:

* All heart failure patients that may benefit from telehealthcare.
* Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4.
* Patients must have a permanent residence and be motivated for using telehealthcare. \*Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.

Exclusion Criteria:

* Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
* Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.
* Comorbidity is not an exclusion criterion.
Reducing Fall Risk Post Hip Fracture in Mild Cognitive Impairment

Hip fracture is recognized as one of the most serious consequences of osteoporosis, less than half regain pre-fracture independence. 95% of all hip fractures in older adults are due to falls. Thus, reducing fall risk while restoring function post-hip fracture is critical. Many with fall-related hip fractures have cognitive impairment; cognitive impairment increases the risk of falls. The purpose of this 6-month proof-of-concept randomized controlled trial (RCT) is to assess the efficacy of the home-based Otago Exercise Program (OEP) compared with usual care in reducing fall risk among older adults with mild cognitive impairment (MCI) and a fall-related hip fracture.

Hip fracture is recognized as one of the most serious consequences of osteoporosis, less than half regain pre-fracture independence. 95% of all hip fractures in older adults are due to falls. Thus, reducing fall risk while restoring function post-hip fracture is critical. Many with fall-related hip fractures have cognitive impairment and they are less likely to regain pre-fracture level of function than those without cognitive impairment. Cognitive impairment also increase falls risk. It is currently unknown whether exercise is efficacious in reducing fall risk and promoting function among older adults with mild cognitive impairment (MCI) and a fall-related hip fracture. The purpose of this 6-month proof-of-concept RCT is to assess the efficacy of the home-based Otago Exercise Program (OEP) compared with usual care in reducing fall risk among community-dwelling older adults with MCI and a fall-related hip fracture.

Eligibility Criteria:
Inclusion Criteria: 1) aged 65 or older; 2) sustained a fall-related hip fracture in the last 12 months and have returned home; 3) have preserved general cognition as indicated by a Mini-Mental State Examination (MMSE) score = or \> 20/30; 4) have subjective memory complaints, determined by interview;22 5) score \< 26/30 on the Montreal Cognitive Assessment (MoCA); 6) have an absence of significant functional impairment and no dementia as determined by a physician; 7) are not expected to start, or are stable (i.e., \> 3 months) on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine) during the RCT; 8) are expected to live \> 12 months (based on the geriatricians' expert opinion); 9) can read, write, and speak English with acceptable visual and auditory acuity; 10) are able to walk 3 meters with or without an assistive device; and 1) provide written informed consent.

Exclusion Criteria: 1) diagnosed with or suspected to have (by the geriatrician) a neurodegenerative disease (e.g., Parkinson's disease) or dementia; 2) had a clinical stroke; or 3) have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Chronic Postsurgical Pain: Multivariate Prediction Model

The goal of this observational study is to identify the risk factors of Chronic Postoperative pain (or Chronic Post Surgery Pain - CPSP) three months after surgery and, subsequently. the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery.

The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP.

A comprehensive entry pool was derived from a systematic literature search. Data collection will record parameters at four different time points: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; postoperative period (from the third month after the operation).

The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS (one-dimensional pain scale from 0 to 10) over the past three days and pain localized to the field surgical (or to the area of the lesion) projected into the innervation territory of a nerve located in this area, or referred to a dermatome.

Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients
* Patients undergoing any type of elective surgery

Exclusion Criteria:

* Patients with sensory impairments
* Patients unable to communicate
* Patients with cognitive impairments
* Patients with insufficent knowledge of the language