cyrilzakka/clinical-trials huggingface dataset:
Peru Decentralized HIV Care

The purpose of this study is to understand the processes by which HIV care is decentralized, an evidence-informed strategy to improve retention in HIV care, in Peru. Decentralization of HIV services has not been evaluated using experimental designs and urban decentralization studies of HIV are uncommon, so this study will lend important insights for future decentralization efforts in Peru and other countries.

Aim 1: Using the Delphi method, to create guidelines to identify: 1) criteria for transferring patients between hub and spoke and for initiating treatment in primary health clinics (PHCs); and 2) the most important quality health indicators (QHIs) needed to be assessed at PHCs to improve Retention in Care (RIC) and Viral Suppression (VS).

Aim 2: To identify the barriers and facilitators to decentralized HIV care from patients and clinicians in Secondary Health Centers (SHCs) and PHCs in Peru, where HIV is concentrated in key populations and treated primarily in SHCs. Findings will guide a hub and spoke decentralized care model to facilitate decentralized HIV care.

Aim 3: Using a step-wedge design with 4 hub/spokes (4 SHCs + 165 PHCs), the investigators will conduct a Type 2 hybrid implementation trial using to assess the extent to which decentralized services are adopted and scaled-up in PHCs over 24 months of observation using NIATx (Network for the Improvement of Addiction Treatment) combined with ECHO (Extension for Community Healthcare Outcomes)-like tele-education to develop and enhance a Hub and Spoke model. The implementation outcomes will include the proportionate increase of People with HIV (PWH): a) treated in PHCs; b) retained in care; and 3) achieving VS. Adoption by PHCs to accept PWH, fidelity to NIATx and ECHO, and concordance with decentralization guidelines will also be assessed.

The focus of this registration is Aim 3.

Eligibility Criteria:
Inclusion Criteria for Aim 3:

Survey of PHC and SHC Clinicians (N=330):

* Currently employed at a PHC or SHC that is participating in the study. Provide consent for participation.

Continuing Professional Development (N=825):

* Currently employed as a nurse or physician who fulfilled the ECHO training requirements

Survey of PHC Leadership (N=165):

* Currently serving as the leader of a PHC.
The Role of Circulating CircRNAs and MicroRNAs in Acute Lung Injury

Efforts to identify circulating factors that predict severity of acute lung injury/acute respiratory distress syndrome（ALI/ARDS）patients is unrevealing. The primary purpose of this study is to verify circRNAs and microRNAs might be potential novel ALI/ARDS biomarkers and could play roles in pathogenesis of ALI/ARDS.

Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause of morbidity and mortality characterized by alveolar epithelial and endothelial injury. Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to identify circulating factors that predict severity of ALI/ARDS patients have been unrevealing.

Circular RNAs (circRNAs) are a novel class of endogenous non-coding RNA with a covalently continuous closed-loop structure. Compared with traditional linear RNAs, circRNAs are more stable and resistant to RNase R due to the absence of 5' caps and 3' tails, which show clear advantages in acting as novel molecular biomarkers for many diseases. In addition, many studies have reported that circRNAs can bind to microRNAs (miRNAs), acting as "miRNA sponges" which are named competitive endogenous RNAs (ceRNAs), and can regulate gene expression at the transcriptional or post-transcriptional level. Evidence indicates that circRNAs play important roles in cancers and other diseases such as tuberculosis and intervertebral disc degeneration. As no published research has studied the expression and role of circRNAs in the pathology and pathogenesis of ALI/ARDS, the investigators aimed to validate the aberrant expression of circRNAs in ALI/ARDS and explore the potential pathological mechanism in which circRNAs are involved.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ALI/ARDS
* Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.

Exclusion Criteria:

* Patients who have chronic lung disease before enrollment.
* Patients who have severe organ dysfunction, autoimmune diseases and tumor.
* Women who are pregnant or breast-feeding.
* Patients who, in the opinion of the Investigator, have any other medical condition which renders the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
* Patients participating in or planning to enroll in another clinical trial during the time of the study.
Oral Supplementation With Selenium in Patients With Mild Thyroid Orbitopathy

Background: The activity of thyroid orbitopathy can be evaluated with CAS (Clinical Activity Score) based on 7 inflammatory signs. Selenium acts as an oxide-reducing agent in thioredoxin-reductase, and as an anti-inflammatory agent by reducing the hydroxy peroxide intermediates on the cyclo-oxygenase pathways. Increased oxidative stress has been observed in Graves' disease and therefore, by incorporating an antioxidant such as selenium in patients with mild thyroid ophthalmopathy, inflammatory activity could be reduced or inactivated.

General Objective: To determine the clinical differences between patients with mild thyroid orbitopathy who were administered oral supplementation with selenium and patients who were administered oral placebo.

This is a simple controlled clinical trial. In which 66 eyes of 33 patients were studied. Fifteen patients were assigned to the placebo group and 18 to the Selenium group. We randomized into two groups the patients with mild clinical activity according to CAS score. Group A took placebo pills twice a day which consisted in 100µg of starch, and Group B took a pill of Selenium 100 µg twice a day. All the subjects tool the pills during six months. Patients of both groups where examined and evaluated with CAS score before and after the first, third and sixth month of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active mild thyroid orbitopathy according to CAS scale.
* Older than 18 years of age.

Exclusion Criteria:

* Patients with mild thyroid orbitopathy undergoing treatment with corticosteroids.
* Active smokers
* Patients allergic to Selenium
* Follow-up shorter than 6 months
Emotion Regulation Individual Therapy for Adolescents With NSSI - An Open Pilot Study

The primary aim is to investigate the effectiveness of Emotion Regulation Individual Therapy for Adolescents (ERITA) who self-harm.


Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of NSSI as defined by DSM-5 Section 3
* \< 1 NSSI episode during the past month
* at least one parent needs to commit to participate in the parent program

Exclusion Criteria:

* bipolar disorder I or primary psychosis
* severe suicidal ideation
* ongoing substance dependence
* Insertion/withdrawal of psychopharmacological substances within two months prior to the treatment
* other acute primary axis I diagnosis (e.g. anorexia nervosa) that demand treatment in first hand
* current life circumstances that would hinder the treatment (i.e. ongoing domestic abuse)
* insufficient Swedish language skills
* Cocurrent treatment with Mentalization based therapy (MBT) or Dialectical behavioral therapy (DBT)
Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS

Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.

Individuals with MS cannot perform self-care in many areas due to the problems they encounter during their daily life activities, and they need an individual who will take care of them and a lifelong care.

Eligibility Criteria:
Inclusion Criteria

* Chronic low back pain he is 18-60 years old
* No verbal communication barrier
* Complaining of pain for more than three months
* Volunteering of participants Exclusion Criteria
* Absence of cognitive impairment (delirium, dementia, amnesia)
* Exercise contraindications (uncontrolled medical conditions)
* Caring for individuals with an unclear diagnosis of MS
* Disagreeing with the measurements to be made or providing incomplete answers
* Previous spinal surgery
* Spinal and joint disorders other than lumbar disc herniation
Double-Lumen Tube With or Without a Carinal Hook

Most teams use a left double-lumen tube. The double-lumen tube is available with or without a carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large in Europe and quite unknown in US. The literature is poor, containing only few case reports.

The purpose of this research is to compare the two types of left double-lumen tube.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for lung surgery requiring one-lung ventilation

Exclusion Criteria:

* pregnancy
* ASA class 4
* prevision of difficult intubation or of pulmonary aspiration
Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients

There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood pressure across the range of blood pressures from normal to elevated. Information about this relationship is inadequate in part because of the rarity of individuals with subclinical vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active treatment in the investigators' hospital. The clinical implications of widespread hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the investigators will measure vitamin levels and blood pressure in clinically stable acutely hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital for at least 7 more days. The investigators will examine for an inverse relationship between baseline vitamin level and blood pressure across the range of blood pressures. Consenting patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will be considered sufficient for analysis. The hypothesis is that either treatment will reduce blood pressure in patients whose baseline systolic blood pressure is 110 or more; the investigators will also examine whether the reduction in blood pressure with treatment is proportional to the increase in the circulating vitamin level with treatment.


Eligibility Criteria:
Inclusion Criteria:

* Competent to grant informed consent
* Anticipated to remain in hospital at least 7 days after enrollment

Exclusion Criteria:

* End-stage renal disease on renal replacement therapy
* Critical illness
* Judged unstable clinical status at the time of enrollment
Steroids After Laser Trabeculoplasty for Glaucoma

The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of glaucoma
* clinician has determined that SLT laser is indicated
* IOP currently \>18 and was ever \>21 in the past (e.g. prior to treatment)

Exclusion Criteria:

* prior history of uveitis
* prior glaucoma surgery including glaucoma laser surgery
* pregnant or 3 months post-partum
An Evaluation of the Effectiveness of Dual Focus Soft Contact Lenses in Slowing Mypoia Progression

The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.

Eligibility Criteria:
Inclusion Criteria:

* Be between 8 and 12 years of age inclusive.
* Best-corrected visual acuity by manifest refraction of +0.10 logMAR.
* Spherical Equivalent Refractive Error between -0.75 and -4.00 D
* inclusive astigmatism: \< -0.75 D and anisometropia: \< 1.00 D
* Possess wearable and visually functional eyeglasses.
* Agree to wear the assigned contact lenses for a minimum of 10 hours per day, - at least 6 days per week, for the duration of the 3 year study.

Exclusion Criteria:

* Subject has previously or currently wears contact lenses or rigid gas permeable contact lenses, including orthokeratology lenses.
* Subject is currently or within 30 days prior to this study has been an active participant in another clinical study.
* Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine or ANY other myopia control treatment.
* Regular use of ocular medications (prescription or over-the-counter), artificial tears, or wetting agents.
* Current use of systemic medications which may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
* A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.
* Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
* Any ocular, systemic or neuro-developmental conditions that could influence refractive development.
3D Laparoscopy Versus 2D Laparoscopy

* To compare surgical and oncological outcomes in patients underwent to colorectal resection with 3D vs 2D laparoscopic technique.
* To evaluate the visual overload in surgeons using 3D laparoscopic technique.

3 Dimensional (3D) Camera system is a new technique introduced into laparoscopic surgery field, adding the depth perception. Even if in the first 2000' the old 3D camera had negative results in terms of quality of images, thanks to technological progress the new 3D systems have reached high quality.

This new technology has been widely tested in pelvic trainer, not yet in live surgery. Moreover effects on surgeons visual work load are unknown.

Aim of the present study is to evaluate the potential superiority of 3D laparoscopic technique on 2D one in terms on postoperative complications and oncological radicality (in case of neoplastic disease).

Secondary aim is to study the possible major visual stress on surgeons brain caused by 3D camera rather than 2D videos.

ENROLLMENT All patients affected by neoplastic or inflammatory colorectal disease are enrolled in the study.

Preoperative, intraoperative e postoperative data are collected dividing all the patients according the camera system used during the operation: 2D group vs 3D group.

Preoperative data: sex, age, date of birth, id, date of admission, past medical history Intraoperative data: date of surgery, pathology, site of pathology, type of surgery and duration, intraoperative blood loss, other intraoperative problems, loop ileostomy, colostomy, drain positioning, intensive care unit admission Postoperative data (at 30th postoperative day): complications according to Dindo-Clavien scale (Dindo-Clavien classification of surgical complications), type of complications, transfusion, reoperation, other treatments, histology specimen report.

At the end of every operation, the 1st surgeon has to fill in the NASA (The National Aeronautics and Space Administration) task load index and the Simulator Sickness questionnaire.

Number of participants: 350 Years necessary: 2

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer with or without preoperative radio e chemiotherapy
* inflammatory bowel disease affected colon and rectum that need surgery

Exclusion Criteria:

* patients under 18 years
Usability of the PreView PHP for Home Use in Intermediate AMD Patients

To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye
* Age ≥65 years
* VA with habitual correction better than 20/60 in the study eye
* Ability to speak, read and understand instructions in English or Hebrew
* Qualified to use the device by health care professional

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
* Any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)
The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary Incontinence

The aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.

Pad testing is an important method to evaluate the severity of women with stress urinary incontinence (SUI). The investigators had proved the superiority of the infusion of the strong desire amount while using 20-minute pad test for detecting SUI. However, a considerable volume of urine may be produced by natural diuresis during the course of 20-minute pad test with strong-desire amount infusion, and may cause bladder overdistension, more urine leakage and overestimate the severity of SUI. Thus, the aim of this study is to estimate of the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.

The investigators will review the clinical data of patients who receiving urodynamic studies in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014. STATA 11.0 software will be used for statistical analysis.

The investigators will get the mean values of diuresis, and the factors affecting the amount of diuresis. Besides, the investigators can get the influence of diuresis on the accuracy of 20-minute pad test as a role of estimating the severity of SUI. The above data should be important for further refinement of 20-minute pad test.

Eligibility Criteria:
Inclusion Criteria:

* More than 20-year-old woman who with stress urinary incontinence (SUI).
* We will review the clinical data, urodynamics, pad weight and bladder diary of patients who receiving urodynamic studies and 20-minute pad test in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014.

Exclusion Criteria:

* \< 20 year old female
Prostate Core Needle Biopsy

Prostate tissue biopsy is performed with either transrectal or transperineal approach. These two methods are usually based on tissue sampling with an ultrasound-guided core needle biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial technique or with a coaxial technique. In conventional transperineal technique, biopsy needle is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be placed over the perineum; then, the direction of the biopsy can be changed by tilting the coaxial needle. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in transperineal prostate biopsy.


Eligibility Criteria:
Inclusion Criteria:

* an elevated prostate-specific antigen (PSA) level
* suspicious digital rectal examination

Exclusion Criteria:

* a history of prostate cancer
* clinical findings of acute or chronic prostate inflammation
* a history of urogenital procedures
Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity

The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation.

* both gender
* only adults
* Medical intensive care patients.

We are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation.

We are measuring transesophageal presssures to estimate ideal PEEP and evaluate hemodynamic parameters.

Eligibility Criteria:
Inclusion Criteria:

* both gender
* morbid obesity
* hemodynamically stable

Exclusion Criteria:

* pregnant patients
* cirrhotic patients with esophageal varicose
Botulinum Toxins Intralesional Injection for Scar Pain

Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.

After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
2. The scar size is larger than 10 cm2
3. Immunocompromised status
4. Systemic infection status
5. Allergic to Botulinum toxin type A or steroids