cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children.

SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs.

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.

Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Recommended:

* PCP prophylaxis.

Allowed:

* Immunoglobulin.
* Erythropoietin, G-CSF, and GM-CSF.
* Corticosteroids.
* Ethionamide or isoniazid for TB if no alternative is available.
* Pyridoxine (up to 50 mg/day) as vitamin supplement.

Patients must have:

* Symptomatic HIV infection.
* No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).
* Consent of parent or guardian.

NOTE:

* Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.

Prior Medication:

Allowed:

* Maternal immunomodulator or antiretroviral therapy (including during pregnancy).
* Antiretroviral therapy prior to 2 months.
* Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current grade 3 or worse neuropathy / lower motor neuropathy.
* Other grade 3 or worse clinical or laboratory toxicities.
* Known intolerance to either AZT or d4T.

Concurrent Medication:

Excluded:

* Chemotherapy for active malignancy.

Patients with the following prior conditions are excluded:

* History of grade 3 or worse neuropathy/lower motor neuropathy.

Prior Medication:

Excluded:

* More than 6 weeks of prior antiretroviral or immunomodulator therapy.
* Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.
QLESP Block in Hip Surgery

Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization. Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent

Exclusion Criteria:

* 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure
Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma

The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.


Eligibility Criteria:
Key Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma with measurable disease
* Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
* Eastern Cooperative Oncology Group Performance Status of 0 - 2
* Last treatment for multiple myeloma not within 21 days prior to study treatment initiation
* Bone marrow transplant not within 3 months prior to study treatment initiation
* Required baseline hematology and chemistry parameters.

Key Exclusion Criteria:

* Clinically significant cardiac disease (New York Heart Association Class III or IV)
* Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (\>450 msec) after electrolytes have been corrected on baseline electrocardiogram
* Malabsorption syndrome or uncontrolled gastrointestinal toxicities
* Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
* Clinically significant pleural effusion in the previous 12 months or current ascites
* Clinically significant coagulation or platelet function disorder
* Intolerance to dasatinib and/or bortezomib
* Acute diffuse infiltrative pulmonary disease
* Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.
Tumor Budding in Patients With Colorectal Cancer Under Different MMR Status

This study investigates the ability of tumor budding to identify prognosis in different MMR states and different levels of tumor lymphocyte infiltration. Tumor budding is usually defined as an isolated single cancer cell or a cluster of up to four cancer cells located at the front of an infiltrating tumor.

As a component of the tumor microenvironment, tumor budding is associated with the epidermal mesenchymal transition of tumor cells and may predict disease progression and poor survival. The current assessment of tumor budding levels is mainly based on the ITBCC grading system. The dMMR phenotype of colorectal cancer is associated with the generation of non-self-recognizing neoantigens by the immune system, with tumor-associated extensive inflammatory cell infiltration, and often the dMMR phenotype of colorectal cancer has a lower level of outgrowth, possibly with the generation of local immune responses capable of eradicating tumor budding cells. The prognostic value of the conventional tumor budding grading system has been validated mainly in stage I and II colorectal cancers and does not consider the effect of MMR status on tumor budding. This retrospective study is designed to investigate whether the high grade of tumor budding under high immune response status implies immune escape of tumor cells and brings worse survival outcome, establish a more independent risk grading system to maximize the prognostic value of tumor budding in dMMR phenotype of colorectal cancer in combination with tumor-infiltrating lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed colorectal adenocarcinoma cancer pathologically
2. Underwent primary surgery
3. With records for tumor budding staining
4. Willing and able to provide written informed consent for participation in this study
5. Non-complicated primary tumor (complete obstruction, perforation, bleeding)

Exclusion Criteria:

1. With distant metastases at the time of initial diagnosis
2. Without a complete pathological date
3. Hereditary colorectal cancer
4. Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer
Resistant Starch on Glycemic Response in Older Adults

The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.

To measure the blood glucose response, we collected blood samples before eating and 15, 30, 45, 60, 90 and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy (not diagnosed with disease)
* Over 60 years of age

Exclusion Criteria:

* Diagnosed with diabetes or other metabolic disorder
* Allergies to wheat
* Non-smokers
An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

The overall aim of the investigation is to investigate the effect of repeated reuse of intermittent urinary catheters and to observe the impact of switch from single use to multiple reuse catheters.

Throughout the investigation, the impact of switch from single use to multiple reuse catheters will be observed and compared with respect to health-related quality of life (HR-QoL), satisfaction, perception, and preference in female and male catheter-users, who use clean intermittent catheterization (CIC) for bladder management.

Furthermore, the investigation intends to identify microbial contamination of reused catheters and compare proportions to a control single use catheter.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age and has full legal capacity
2. Signed informed consent form
3. Use clean intermittent catheterization to the greatest extent possible (at least three times daily) for at least the last 1 month prior to inclusion
4. Ability (assessed by the investigator) and willingness to participate in a 4-week study period with at least three catheterizations a day using the investigational test product
5. Self-catheterize using a single use hydrophilic coated catheter for at least 1 month prior to inclusion

Exclusion Criteria:

1. Participation in any other clinical intervention study during this investigation
2. Previous participation in this investigation
3. Any known allergies towards ingredients in the investigational device
4. Symptoms of UTI at time of inclusion, as judged by the investigator
5. Antibiotic treatment within 2 weeks prior to the Baseline visit (V1)
6. Pregnancy
7. Breastfeeding
Bisphosphonates Use After Total Joint Arthroplasty

Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.

Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

Exclusion Criteria:

1. Patients with total joint arthroplasty before the index date,
2. Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
3. Patients who were lost to follow-up
4. Patients \< 40 years old
National Stigma Survey About Mental Illness, Intellectual Disability and Homelessness in Spain

This project is framed within the "Complutense University of Madrid (UCM)-Group 5 Against Stigma Chair", of the Faculty of Psychology. The main objective of the Chair is to fight the stigma that affects people with mental disorders, disabilities, vulnerability or extreme social exclusion. For this purpose, the Chair is developing research studies, training programs, cultural activities and awareness campaigns, proof of this is the recent publication of the Guide to good practices against stigma, which, although it takes as a reference to the people with a diagnosis of mental disorder, it is expected to be generalizable to other groups.

Stigma is associated with the condition of being different, and affects any person belonging to a minority or vulnerable group, being one of the main obstacles to full participation in different social, political and cultural institutions. The fight against stigma is included in important international treaties, such as the United Nations Convention on the Rights of Persons with Disabilities or the European recommendations regarding the fight against social exclusion of people with mental health problems.

This study will focus on three groups of special social sensitivity, with clear stigmatizing conditions: people with mental health problems, people in a homeless situation and people with intellectual disabilities.

The primary aim of this research is to describe the stigma faced by people corresponding to three highly vulnerable population groups: people with mental health problems, homeless people and people with intellectual disabilities.

From this general aim, four different specific goals are derived: 1) To delve into the experience of stigma of these groups, from first person; 2) To develop a quantitative assessment instrument that captures the current needs and experiences of people from these groups; 3) To describe and compare the social stigma of these three groups in a representative Spanish sample; 4) To address, from a gender perspective, possible differences in terms of the variables explored in the populations under study.

Eligibility Criteria:
Inclusion Criteria:

* People aged 18 and over from general population.
* Any gender.

Exclusion Criteria:

* People under 18 years old.
Impact of Cognitive Rehab and Physical Activity on Cognition in Patients With Metastatic Brain Tumors Undergoing RT

To determine the feasibility of processes and instruments with an overarching purpose to guide the design of a larger study. To determine the feasibility of individuals with metastatic brain tumor(s) to engage in physical activity(PA) and cognitive rehabilitation (CR) as in an outpatient therapy setting.

Rolling recruitment for the study. Participants will be randomized into one of three treatment arms. All treatment arms will undergo physical \& cognitive testing prior to whole-brain radiation therapy (WBRT)/stereotactic radiosurgery (SRS). Arm 3 will receive cognitive rehabilitation intervention sessions prior to, and concurrent with, WBRT/SRS. Approximately 14 days following WBRT/SRS: all arms will undergo physical and cognitive testing, and: Arm 1 will begin physical activity intervention. Arm 2 will begin physical activity intervention and cognitive intervention. Arm 3 will continue with cognitive intervention and begin physical activity intervention. All Arms will undergo physical and cognitive testing approximately 2.5 months post WBRT/SRS.

Eligibility Criteria:
Inclusion Criteria:

* A potential subject must meet all of the following inclusion criteria to be eligible to participate in the study:
* Ability to understand and the willingness to provide written informed consent
* 18 years of age and older
* Diagnosed with one or more metastatic brain tumor(s)
* Medical treatment plan includes whole-brain radiation therapy and / or sterotactic radiosurgery

Exclusion Criteria:

* A potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.
* Diagnosis of dementia or unable to grant their own informed consent
* Prisoner or patient in custody
* Patient on psychiatric hold
* Physically unable to participate in the study
* The opinion of the treating physician determines it is not medically safe to participate in the study
* Pre-registration screen of cognition is "severe" or lower.
Ability of Carotid Sonography and Inferior Vena Cava Sonography for the Prediction of Post-induction Hypotension in Hypertensive Patients

Hypertensive patients have more hemodynamic instability during general anesthesia than do patients with NORMOTENSION. In this study, the investigators evaluated the usefulness of carotid ultrasound and inferior vena cervical ultrasound for predicting hypotension after induction of anesthesia in patients with hypertension.

Carotid and venous ultrasonography is performed in a comfortable state. Corrected blood flow after carotid ultrasound and carotid artery blood flow rate were measured.

After inferior vena cava sonography, using the embedded software, the collapsibility Index by measuring the largest and smallest diameter during the respiratory cycle will be obtained.

After confirming baseline blood pressure and pulse rate, propofol 2 mg / kg is administered and remifentanil is maintained at 4.0 ng / mL using the Target Control System (TCI).

Following the administration of rocuronium 1.0-1.2 mg / kg, and 1 minute and 30 seconds after BIS 60 or less, endotracheal intubation is performed using video laryngoscope.

Blood pressure and heart rate are measured at prior to induction, 1 minute after the induction, immediately after intubation, and at 1, 3, 5, 7 and 10 minutes after intubation.

Post-induction hypotension after anesthesia induction is considered as a decrease of 20% or more of the pre-anesthesia blood pressure or a mean arterial blood pressure of less than 60 mmHg.

In the event of hypotension in accordance with the above definition, repeated administration of ephedrine 4 mg or phenylephrine 50 mcg is used.

Eligibility Criteria:
Inclusion Criteria:

* 1) 19-80 years old hypertensive patients with ASA class I-III
* 2) Scheduled surgery under general anesthesia

Exclusion Criteria:

* 1) Emergency operation
* 2) Reoperation
* 3) Patients with history of heart failure (unstable angina, congestive heart failure, coronary artery disease)
* 4) Patients under 40 % of Ejection faction
* 5) Patients with history of valvular heart failure
* 6) Patients with history of peripheral arterial occlusive disease
* 7) Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
* 8) Pregnancy patients
* 9) Patients who cannot read the consent form (examples: Illiterate, foreigner)
* 10) Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
* 11) Patients who withdraw the consent
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression

The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable suppressed viremia and no prior virologic failures.

This is a randomised (1:1), multicentre, comparative, parallel-group, prospective, open label, non-inferiority controlled clinical trial.

Enrolled patients, taking an ATV/r based HAART and with stable HIV-RNA \< 50c/ml (24 weeks), will be randomized to:

* continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs (according to the specific dosing schedule) as backbone (HAART arm) with ATV/r
* or simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy (Monotherapy arm) with ATV/r The study follow up will be 96 weeks after randomization and primary objective will be evaluated at week 48.

Patients will be followed every 4 weeks for the first 16 weeks, and then every 8 weeks until week 48, then every 12 weeks until week 96 or discontinuation ; at each visit the following evaluations will be performed:

* clinical assessment.
* routine laboratory tests (hematological tests and hematochemistry) including creatinine, phosphorus, calcium, alkaline phosphatase, gammaGT; urine analysis, lipid profile, level of HIV-RNA and CD4 cell counts.

During follow-up, at randomization, week 48, week 96 or discontinuation, patients will additionally undergo:

* Fat redistribution evaluation by DEXA (dual-energy X-ray absorptiometry
* Vertebral and femoral bone mineral density evaluation by DEXA.
* ECG;
* Glicate haemoglobin.
* Adherence assessment (questionnaire and/or pills counts).
* Neurocognitive evaluation \[HIV-associated neurocognitive disorders (HANDs) evaluated by validated neuropsychological tests\].

In case of viral rebound (defined as 2 consecutive measurement of HIV-RNA \> 50 c/ml) patients will be immediately contacted in order to perform genotypic tests. Furthermore a plasma PK analysis will also be performed. Any patients with virological rebound will be selected for a reintensification therapy with NRTIs and if not suppressed after 12 weeks they will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected patients
* age \> 18 years
* On treatment with ATV/r plus 2 NRTIs for at least 48 weeks
* Virological suppression (HIV-RNA\<50 c/ml) by at least 24 weeks with ATV/r plus 2 NRTIs
* No virologic failure after the initiation of the first antiretroviral therapy. Previous treatment changes due to toxicity or treatment simplifications will be permitted only if occurred with documented virological suppression.
* CD4 cells nadir \>100 cells/µL
* PPI and H2-receptor antagonists as follows: the proton-pump inhibitors should not be used; if H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg BID should not be exceeded.

Exclusion Criteria:

* Pregnancy and breast feeding women
* AIDS defining events
* Evidence of active HBV infection (HBsAg positive)
* Previous virological failure
* History of resistance to ATV
* Use of contraindicated medications
The Turkish Deglutition Handicap Index

The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.

The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of the instrument will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between The Turkish Deglutition Handicap Index and Turkish Eating Assessment Tool.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate
* Having swallowing problems

Exclusion Criteria:

* Being under the age of 20 years, and above the age of 60 years
* Not willing to participate
* Having no swallowing problems