cyrilzakka/clinical-trials huggingface dataset:
Evaluation of HCV Viremia Testing Approaches Among PWID in Georgia

This study will evaluate two novel approaches to improve access to Hepatitis C virus (HCV) confirmatory viremia testing. Both approaches are "Harm reduction site-based (HRS)" because HCV viremia testing will be initiated and test results will be provided at the HRSs. These approaches will be compared to the current standard of care (control) in which anti-HCV-positive individuals must travel to a HCV treatment centre for HCV viremia testing. The investigators hypothesize that improving access to viremia testing improves linkage to care and reduces loss to follow-up among those who screen anti-HCV-positive.

A major step in identifying HCV infected individuals in Georgia has already been implemented by providing rapid anti-HCV testing for people who inject drugs (PWID) at HRS. However, access to HCV confirmatory viremia testing remains limited as PWID must be referred to treatment centers for testing.

Two novel approaches to improve access to HCV viremia testing will be evaluated.

In the first approach, participants with a positive anti-HCV test will have blood drawn and HCV RNA test performed at the HRS. Test results will be provided the same day (or the following day if the participant is unable to wait for results) at the HRS.

In the second approach participants with a positive anti-HCV test will have blood drawn at the HRS. The blood will be processed on site and a plasma sample shipped to a central laboratory for viremia testing. Test results will be communicated to the participants by HRS staff at a follow-up visit as soon as the results are available.

In both groups, participants who test positive will be referred to a treatment centre for further assessments and subsequent treatment initiation.

Eligibility Criteria:
1. People who inject drugs attending for care and needle provision at harm reduction sites.

   Inclusion criteria:
   * Any history of injection drug use (IDU)
   * Age ≥18 years
   * Anti-HCV-positive on rapid diagnostic test performed at the HRS
   * Eligible for the Georgia HCV State Program
   * Living in the catchment area served by the HRS
   * No plans to move out of the catchment area during the next 6 months
   * Willing and able to give informed consent

   Exclusion criteria:
   * Tested HCV RNA-positive from April 2015
   * Pregnancy (self-report)
   * Currently on treatment for hepatitis C
   * Unable to provide a blood sample
2. HRS staff involved in HCV testing and care:

   Inclusion criteria
   * Provide HCV services at HRS from screening through linkage to care.
3. Laboratory staff performing HCV viremia testing at the HRSs, Lugar Centre and Treatment centres:

Inclusion criteria:

* Perform HCV viremia testing
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.

As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* HIV viral load \> 1,000 on current antiviral medications
* No resistance to study medications
* Over 18 years of age

Exclusion Criteria:

* Hepatitis B co-infection
* Pregnancy
* Previous therapy with either of the study medications
* Ongoing substance abuse
* Significant history of other physical disease
Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
* Aged 18 at the time of informed consent.
* Must have a relapsing form of MS.
* Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* Progressive form of MS
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
* Female subjects considering becoming pregnant while in the study.
* Female subjects who are currently pregnant or breast-feeding.
* Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol.
* Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.
Effect of TrueTear Corneal Surface Imaging

This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.

Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery

Exclusion Criteria:

* A cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck
* Chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding
* A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the TrueTearTM device
* Pregnancy
* Presence of any ocular disease or condition which in the investigator's opinion would confound the study results
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.

The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.

Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
* Voluntarily consent to participate in the study.
* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
* Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
* Ability to perform all behavioral tests as indicated.

Exclusion Criteria:

* Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
* History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
* History of middle ear or inner ear surgery.
* Current conductive hearing loss or middle ear effusion.
* Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
* Participation in another investigational drug or device study within 30 days prior to study enrollment.
* Female patients who are pregnant or breastfeeding.
Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19

Pilot, randomized and controlled clinical trial for the evaluation of the decrease in the viral load of SARS-CoV-2 in the oropharynx in patients with COVID-19 through the use of mouthwash containing cetylpyridinium chloride (CPC) (0.07%) in mouthwash.

The objective of the clinical trial is to determine the short-term efficacy of cetylpyridinium chloride (CPC) mouthwashes to assess changes in the threshold cycle value of the analysis of the SARS-CoV-2 oropharyngeal saliva sample, in patients diagnosed with COVID-19 and with symptomatology compatible with the disease. A randomized double-blind pilot clinical trial (evaluator and patients) will be developed in patients with a diagnosis of COVID-19 and symptoms of the disease. The experimental group will perform a single rinse with a mouthwash containing Cetylpyridinium Chloride (CPC) while the placebo group will perform the same rinse, but with a harmless liquid that will act as a placebo. The study will be carried out in the Zaragoza III Health Sector, with patients belonging to the Zaragoza II Health Sector, collaborating with the "Seminario" health center and the Lozano Blesa Clinical University Hospital (HCULB). This project will be carried out in accordance with the CONSORT guidelines for clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients older than 18 years and younger than 80 years.
* Patients with a medical indication for a diagnostic test for active infection to SARS-CoV-2
* Patients who present mild symptoms typical of COVID-19 and who have less than three days of evolution
* Patients who have cognitive and motor skills to perform mouthwash correctly.
* Patients who understand and speak Spanish
* Patients who freely give their consent to participate in the study, after a correct understanding of its objectives and procedures.

Exclusion Criteria:

* Patients with hospitalization criteria (moderate or severe symptoms)
* Vulnerable populations such as pregnant, lactating,
* Patients with recent medical diagnosis (≤ 1 month) of pneumonia
* Patients with hyposialia
* Patients with consumption of oral antiseptics (in the form of mouthwash containing CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes with CPC during the last month.
* Patients with cognitive impairment
MAIN-IMAGE Registry

All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.


Eligibility Criteria:
Inclusion Criteria:

patients undergoing pre-intervention optical coherence tomography imaging

Exclusion Criteria:

-
Study on Sintilimab in Stage IV High Risk Neuroblastoma

A phase I observational study on the safety and efficacy of treatment of recurrent stage IV high risk neuroblastoma with Nivolumab


Eligibility Criteria:
Inclusion Criteria:

1. 12 Months to 12 years
2. Histologic verification of stage IV high risk neuroblastoma at relapse following lack of complete response to at least two lines of therapy
3. Fully recovered from the acute toxic effects of all prior anti-cancer treatment
4. At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)
5. At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
6. At least 56 days must have elapsed after transplant or stem cell infusion; patients with prior allogeneic transplants are not eligible
7. Blood counts recovery including White cell count \>= 750/mm\^3 and Platelet count \>= 50,000/mm\^3
8. Creatinine clearance ≥ 50ml/min
9. Liver function: Total bilirubin ≤ 2 mg/dl, Alanine aminotransferase or Aspartate aminotransferase ≤ 2.5 U/dl (or \< 5 in case of liver impairment)
10. Life expectancy of at least 4 months
11. Negative pregnancy test in women of childbearing potential
12. Use of an effective contraceptive method during the whole treatment and
13. up to 3 months after the completion of treatment in males and females
14. Prior informed consent signed

Exclusion Criteria:

1. Patients requiring daily systemic corticosteroids are not eligible; patients must not have received systemic corticosteroids within 7 days of enrollment on study
2. Patients who are currently receiving another investigational drug are not eligible
3. Patients who are currently receiving other anti-cancer agents are not eligible
4. Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody (ANA), rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
5. Patients with \>= grade 2 hypothyroidism due to history of autoimmunity are not eligible; note: hypothyroidism due to previous irradiation on thyroidectomy will not impact eligibility
6. Patients who have an uncontrolled infection are not eligible.
7. Patients with active autoimmune disease. (any autoimmune state requiring medical treatment-including chronic medications)all immune modifying drugs should be stopped at least 7 days prior to enrollment
Glutamine Enriched Total Parenteral Feeding and Proline Metabolism in Severely Burned Patients

Proline is a non-essential amino acid that helps with collagen formation. Collagen is one of the main ingredients of skin, bone, tendons, and connective tissue. It is thought that proline becomes depleted in burn patients because it is being used in greater than normal quantities to help the injured skin and connective tissue heal. If this is true, then the body must look for alternate energy sources as proline becomes depleted.

This study aims to evaluate 1)the metabolic kinetics of the amino acids proline, glutamate, and ornithine and 2) the effects of glutamine supplemented total parenteral nutrition (TPN) on the metabolism of these amino acids.

Proline is a nutritionally dispensable (non-essential) amino acid. Its synthesis and catabolism is via the pathway of ornithine and glutamate. The latter two amino acids serve as immediate precursors for proline, as well as metabolites. Ornithine is one of the intermediates for urea cycle. Glutamate is metabolically connected to tricarboxylic acid (TCA) cycle, the major cycle for energy production.

It is hypothesized that the significantly increased rates of net nitrogen loss and energy "production", as the consequence of the accelerated activities of both the urea and TCA cycles in burn injury "drain" both ornithine and glutamate, thus depleting tissues of the availability of proline. Hence, the de novo synthesis of proline is likely to be affected by the reduced availability of its major precursors: glutamate and ornithine. We further propose that increased supply of glutamine would increase the de novo synthesis of proline and / or spare the loss of proline via its metabolite glutamate. Hence, glutamine will be beneficial to the overall nutritional status of the burn patients.

Eligibility Criteria:
Inclusion Criteria:

Burn patients being treated at MGH Burn Unit with one or more of the following criteria: 1) \>=5% TBSA; 2) inhalation injury; or 3) resting energy expenditure (REE) of \>15% of the predicted Basal Metabolic Rate using the Harris-Benedict equation.

Must be receiving total parenteral nutrition in the course of their treatment.

Exclusion Criteria:

Patients with thyroid disease. Patients who are not hemodynamically stable or show unstable vital signs Patients at the stage of major organ failure, e.g. renal and/or liver failure.
Neuromuscular Electrical Stimulation During Immobilization Due to Ankle Fractures

Rationale: Situations such as fractures of the lower extremity can necessitate a prolonged period of immobilization in otherwise healthy individuals. Long-term immobilization of the lower extremity has shown to cause significant reductions in skeletal muscle mass, already occurring during the early stages of disuse. Accordingly, feasible strategies for attenuating this loss of muscle during disuse need to be pursued. Local neuromuscular electrical stimulation (NMES) offers such a potential strategy but, as yet, remains untested during prolonged muscle disuse in a clinical setting.

Objective: To investigate whether twice daily local (gastrocnemius/soleus) NMES attenuates muscle loss during 2 weeks of unilateral ankle immobilization.

Study design: Randomized, parallel (two groups) study design.

Study population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment.

Intervention: Twice daily neuromuscular electrical stimulation (NMES) or no intervention.

Main study parameters/endpoints: Primary: Calf muscle (gastrocnemius) cross sectional area (CSA) as determined by CT scan. Secondary: type I and II muscle fiber CSA and SC content, intramuscular triglyceride content and mRNA and protein expression of anabolic signaling proteins.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral closed ankle fracture (Weber type A, B or C)
* Aged from 18-65 years
* 18.5 \< BMI \< 30 kg/m2
* Undergoing surgical treatment

Exclusion Criteria:

* Additional fractures beside ankle fracture (e.g. multi-trauma following a car accident)
* Use of oral anticoagulants such as vitamin K-antagonists (e.g. acenocoumarol and fenprocoumon) and direct-acting or new oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban).
* Any family history of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos

Human embryos can be preserved for later transfers by freezing. Traditionally the slow cooling method has been used. About 70% of the embryos remain fully intact after thawing. However, the remaining 30% of the embryos become (partially) damaged, and this freezing damage reduces their chance to implant. Recently an ultra rapid freezing method, called vitrification has been developed. During vitrification no damaging ice crystals are formed and the embryo freezes in a glass like state.

It appears that the freezing damage is reduced when embryos are vitrified. Observational studies in humans indicate that embryos are successfully preserved by vitrification, as indicated by promising pregnancy rates following thawing. However, the effectiveness of vitrification in relation to slow cooling with respect to pregnancy rates has so far not been evaluated by a randomised, controlled trial. The aim of this study is to investigate whether vitrification significantly improves embryo survival and ongoing pregnancy rates when compared to embryos frozen by slow cooling.

time of allocation: following embryo selection

type of embryos: cleavage stage -, morula stage or early blastocyst stage embryo (day3 - day4 after oocyte collection)

cryoprotectants: sucrose, dimethylsulfoxide, ethyleneglycol

vitrification storage device: high security vitrification straws

Eligibility Criteria:
Inclusion Criteria:

* female patient age 35 years or less
* embryos are obtained by in vitro fertilization (IVF) or intra cytoplasmatic spermatozoon injection (ICSI)
* single embryo transfer
* 1rst IVF/ICSI treatment with an embryo transfer
* availability of cryopreservable embryos

Exclusion Criteria:

* female patient age is 36 years or older
* participants of oocyte donation program
* participants of percutaneous spermatozoon aspiration (PESA) program
* couples with a finite source of spermatozoa
* absence of cryopreservable embryos
Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital

In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and fetal outcomes.

Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.

Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.

Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with history of previous caesarean section.
2. Age above 18 years.
3. Gestational age above 28 weeks.
4. U/S signs suggestive of placenta previa accreta.
5. Confirmed diagnosis of Placenta previa accreta spectrum disorder by 3 D U/S, Doppler or MRI if needed.

Exclusion Criteria:

1. Gestational age less 28 weeks.
2. Age less than 18 years.
3. Patients with known bleeding disorders.
4. Multiple pregnancy.
5. Other pathology (fibroid, ....................).
6. Patients with placental separation.