cyrilzakka/clinical-trials huggingface dataset:
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus

The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.

Exclusion Criteria:

* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
* Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.
Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)

This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve participants
* Mono-infected participants with chronic HCV GT1
* Non-cirrhotic participants
* Participants with debilitating fatigue (Fatigue Severity Scale \[FSS\] greater than or equal to 4)

Exclusion Criteria:

* Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)
* Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion
* Participants who are wheelchair dependent
Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle

This study aims to analyze the changes in plantar support after the technique of deep dry puncture in the posterior tibial. The data will be analyzed by a baropodometer which will record the possible changes in the footprint. The investigator will perform a pre-intervention measurement and 3 post-intervention measurements (immediately after the intervention, at 24 hours and at 72 hours)


Eligibility Criteria:
Inclusion Criteria:

* presence of myofascial trigger point in the posterior tibialis
* Accept participation in the study (signature of informed consent)
* Do not present any exclusion criteria

Exclusion Criteria:

* Do not present myofascial trigger point in the tibialis posterior.
* Suffering and / or having suffered from lower limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics.
* Not clearly identify the Myofascial trigger point in the tibialis posterior.
* Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
* Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
* Be pregnant.
* Have used analgesics 24 hours before participating in the study.
Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents

Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. AIS causes deviations in the CNS, leading to asymmetry of motor activity and, consequently, an incorrect position of the spine. The progressive deformation of the spine leads to increased asymmetry in body functions. This elevated asymmetry is understood by the nervous system as a norm, which causes children to cease to sense the correct body position that may affect both static and dynamic balance and the foot pressure symmetry of the child, which was not investigated in such cases in any previous studies till now.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic children and adolescents ages 10 to 18 years
* confirmed through X-rays; we focused on patients in growing age.
* adolescent idiopathic scoliosis that has a Cobb angle of 10° to 50°

Exclusion Criteria:

* Neuromuscular etiology (e.g., cerebral palsy, myelomeningocele, muscular dystrophy, spinal muscular atrophy, spina bifida, spinal cord injuries)
* Early-onset idiopathic etiology (infantile \[ages 0 to 3 years\] or juvenile \[ages 4 to 9 years\])
* Congenital etiology (e.g., hemivertebrae, failure of segmentation) Mesenchymal/syndromic etiology (e.g., Marfan syndrome, mucopolysaccharidosis, osteogenesis imperfecta, inflammatory diseases, postoperative)
Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens

This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must sign the informed consent form.
2. The subject must be at least 20 years of age as of the date of evaluation for the study.
3. The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
4. The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
5. The subject must have normal eyes, except ametropia.
6. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
7. The subject must appear able and willing to fill the daily card.

Exclusion Criteria:

1. The subjects who need to use ophthalmic medicine for therapy.
2. The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
3. The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
4. The subjects who have clinically significant tear secretion abnormal.
5. The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer.

The study will determine the prevalence of a secondary rise in PSA \> 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.

This analysis is a subset of the data associated with the active surveillance cohort at Sunnybrook Health Sciences Centre. Approximately 150 subjects within the cohort have received dutasteride therapy from 6 months to 3 years. All subjects have had serial PSAs at regular intervals between 3 to 6 months, and all have had a biopsy performed within 1 to 3 years of initiating dutasteride. The prevalence of a secondary rise in PSA \> 0.5ng/ml will be calculated with the impact of dutasteride therapy on the PSA doubling time. This information will be correlated with baseline PSA value, prostate volume, extent of disease on initial biopsy and baseline PSA kinetics. PSA kinetics will be also correlated with Gleason score upgrading on repeat biopsy. The rate of negative biopsies in men on dutasteride therapy will be compared with a similar group of surveillance subjects not treated with dutasteride.

Eligibility Criteria:
Inclusion Criteria:

* Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to IBD or Gastric Bypass
* Screening Hemoglobin (Hb) ≤ 11g/dL
* Screening Ferritin ≤ 100 ng/mL
* Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study

Exclusion Criteria:

* Hypersensitivity reaction to any component of IV Injectafer or oral iron
* Requires dialysis for treatment of chronic kidney disease (CKD)
* During the 30 day period prior to screening has been treated with IV iron
* No evidence of iron deficiency
* During the 30 day period prior to screening has been treated with a red blood cell transfusion.
* Any non-viral infection
* Known positive hepatitis with evidence of active disease
* Received an investigational drug within 30 days of screening
* Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary
* Alcohol or drug abuse within the past 6 months
* Hemochromatosis or other iron storage disorders
* Pregnant
* Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with the study requirements
A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension

This was a non-interventional, secondary use of data, retrospective, cohort study. The data extracted in this study was used as secondary use of collected patient information in the database, Japan Medical Data Survey (JAMDAS), owned by M3 Inc. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities etc.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date.
2. Sitting systolic blood pressure (sSBP) ≥150 millimeters of mercury (mm Hg) at the index date.
3. At least one prescription of angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), calcium channel blocker (CCB), diuretics, or these SPCs for hypertension at the index date.
4. At least one visit and blood pressure (BP) measurement within 12 weeks from the index date.

Exclusion criteria:

1. Prescription of hypertensive medication including alpha blocker, beta blocker, alpha-beta blocker, aldosterone antagonist, and renin inhibitor within 24 weeks prior to the index date.
2. Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.
3. History of hypotension, hyperkalemia, hypokalemia, or hyponatremia, drug-related or otherwise, or renal failure leading to dialysis, stroke, myocardial infarction, heart failure at the index date or within 24 weeks prior to the index date.
4. History of secondary hypertension (renal parenchymal hypertension, renovascular hypertension \[unilateral or bilateral renal artery stenosis\] coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc.) at any timepoint.
5. Pregnant women at any timepoint.
The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:

Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.

Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care

Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area.

Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care Outcomes: the primary outcomes were the wound surface area measurement, % of wound complete closure and % of days needed for surface area reduction before and after receiving the treatment protocol for two consequetive months, and the secondary outcomes were % of wound cause and location frequencies

Eligibility Criteria:
Inclusion Criteria:

* 1- Diabetic patients with either type I or II 2- Age from 18-60 years old, both sexes 3- Ulcer lasting longer than two months 4- DFU grade 1 or 2 according to Wagner classification. 5- All patients able to walk dependently

Exclusion Criteria:

1. Patients with vascular disease
2. Patients with fixed ankle deformity as Charcot foot or stiffness
3. Patients with any type of osteomyelitis associated with DFU
4. Patients with renal or hepatic failure
5. BMI \< 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; altered population of immune mediators may lengthen the inflammatory process \& decrease oxygenation of subcutaneous adipose tissue which is liable to be infected.
Perioperative Virtual Reality for Pediatric Anesthesia

The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.

The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.

Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 5-12 years
* Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure

Exclusion Criteria:

* Patients with injuries to the head/face that would prohibit wearing of headsets
* Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
* Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
* Patients with a history of or current symptoms of vertigo
* Patients who are blind
* Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
* Patients on whom the VR headset does not fit appropriately
* Non-English speaking patients (due to limited availability of non-English study documents and consents)
Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

This study is being conducted to see how people with Postural tachycardia syndrome (POTS) make sense of the things they see. The information may help doctors to learn more about how the different parts of people's brains communicate.


Eligibility Criteria:
Inclusion Criteria:

* Females 12-21 years old
* Able to communicate and provide consent/assent
* English speaking
* Diagnosed with POTS (POTS will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically)
* Age-matched healthy control subjects: no POTS or other neurological disorders

Exclusion Criteria:

* Inflammatory arthritis, connective tissue or auto-immune disorder
* Any chronic neurological disorder besides POTS
* Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.)
* Neuropathy, central nervous system disorder (e.g., Cerebral palsy, developmental delay, seizure disorder, MS, stroke, etc.)
* Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
* Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
* Current substance or alcohol abuse
* Any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days
* Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
* Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented)
* Chronic use of narcotics for pain
* Claustrophobia or any metal hardware that may interfere with MRI
* Investigators and study staff
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty

In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.


Eligibility Criteria:
Inclusion Criteria:

* adult people (\>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb\>9 g/l).

Exclusion Criteria:

* the presence of pain measured with NRS (NRS\>4)
* rheumatoid arthritis, past surgery
* cancer
* neurological and psychiatric disorders
* dementia with Minimental Test\<24
* pregnancy
* participation in the other clinical studies.
DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

The individual course of chronic kidney disease (CKD) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (eGFR) decline are needed. Recently, urinary dickkopf-3 (DKK3) has been proposed to predict eGFR decline in patients with CKD, independent of presence of albuminuria. The investigators sought to examine the association between changes in DKK3 levels and eGFR decline in patients with heart failure (HF).

The individual course of chronic kidney disease (CKD) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (eGFR) decline are needed. Recently, urinary dickkopf-3 (DKK3) has been identified as an stress-induced, renal tubular epithelia-derived, secreted glycoprotein that induces tubulointerstitial fibrosis. Urinary DKK3 has been found to predict eGFR decline in patients with CKD, independent of presence of albuminuria, but its association with eGFR decline in patients with heart failure (HF) is unknown. The investigators sought to examine the association between changes in DKK3 and eGFR decline in patients with HF.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension

Exclusion Criteria:

* CKD with estimated GFR \<20 ml/min/1.73 m2 (2012 CKD-EPI equation)
* CKD with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload
* active tumor disease
* inflammatory or autoimmune disease requiring systemic immunosuppressive treatment
* clinically apparent infections
* recipients of solid-organ transplants
* anticipated life expectancy of \<12 months
* likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)
* pregnancy or possibility of pregnancy in the next 12 months