cyrilzakka/clinical-trials huggingface dataset:
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months

To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months

The secondary objectives of PENTA15 were:

To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir

To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months)

To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine


Eligibility Criteria:
Inclusion Criteria:

* Infants and children with confirmed presence of HIV-1 infection
* Infants and children aged 3 to \<36 months
* Parents/guardians able and willing to give written, informed consent
* Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.
* HIV-1 RNA viral load either;

  * suppressed HIV-1 RNA viral load (i.e. \<400 copies/ml)
  * non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen
* Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.

Exclusion Criteria:

* Intercurrent illness
* Receiving concomitant therapy except prophylactic antibiotics
* Abnormal renal or liver function (grade 3 or above)
Screening for Studies on Inherited Eye Diseases

This screening protocol is designed to help recruit patients for National Eye Institute (NEI) studies on inherited eye diseases. Patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program.

Candidates will undergo a medical history, physical examination, eye examination and blood test. The eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. Specialized tests will be done only if needed to determine eligibility for a specific study in NEI's Ophthalmic Genetics Clinic. These include routine laboratory tests, non-invasive imaging, questionnaires and other standard tests, as well as specialized tests and procedures where needed, including genetic testing. Photographs of the eye may be taken. Patients will be asked questions about family history, especially relating to eye disease or cataracts, and a family tree will be drawn. A blood sample will also be drawn.

When the screening is completed, patients will be informed of their options to participate in a study. Patients who are ineligible for a current study will be informed of alternative treatments or options. No treatment is offered under this protocol.

This protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible, and wish to participate in NEI clinical research studies.

Each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the NEI ongoing studies. The screening evaluation will include past and current medical histories, and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risk and will be described in more detail in section III: "Study Procedures". Once the screening process is completed and their eligibility is assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician.

Eligibility Criteria:
* INCLUSION CRITERIA:

Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study.

The subjects source for this study will be from referrals by medical practitioners in the private sector, clinics, hospitals, medical institutions, and the Occupational Medical Services at the National Institutes of Health
Early Prediction of Sepsis

In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient (age ≥18 years).
2. Patient is admitted to the ICU during the recruitment period of the trial.

Exclusion Criteria:

1. Patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days.
2. Patient is known to be pregnant.
3. Death is deemed imminent and inevitable, at the investigator's discretion.
4. Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision
5. Patient has previously been enrolled in this trial.
Postoperative Management of Groin Flaps for Vascular Coverage

This is a randomized controlled trial designed to analyze the impact of bedrest duration on return to functional independence at discharge following sartorius flap for coverage of vascular reconstruction in the groin.

This is a pilot prospective study with the purpose of evaluating the impact of bedrest duration on outcomes of groin muscle flaps used for groin coverage in patients undergoing open, infrainguinal vascular surgery. The investigators plan to target all patients undergoing groin muscle flaps for vascular groin coverage at UCSF.

All patients undergoing groin flaps will be block randomized into two cohorts: Cohort 1 - one day of bedrest (mobilize on post-op day 2) versus Cohort 2 - 5 days of bedrest (mobilize on post-op day 6).

The investigators perform approximately 50 infrainguinal muscle flaps per year. They aim to enroll 30 patients (15 per cohort).

Outcome measures include: surgical complication rates (including wound and lymphatic complications, readmissions, and reoperations), physical function, hospital length of stay, venous thromboembolism (VTE), and rates of discharge to a skilled nursing facility. The investigators will also examine the impact of bedrest on patient reported outcomes one month following surgery. Patient outcomes will be followed for 3 months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing muscle flaps following infrainguinal, open vascular surgery. Patients must be ambulatory at baseline. Patients must be able to provide informed consent.

Exclusion Criteria:

* Patients who are unable to provide informed consent. Patients are non-ambulatory at baseline. Patients' clinical status is not amenable towards early ambulation. Enrollment is at the discretion of the vascular and plastic surgeons.
* Bilateral sartorius flaps
Breast Cancer Implementation Science Study With Educational Intervention

A study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adverse effects for HER2+/HER2 low breast cancer patients on or about to start on HER2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (AE) management and patient-clinician communications.


Eligibility Criteria:
Inclusion Criteria, PATIENT participant group:

* ≥ 18 years of age
* Confirmed diagnosis of HER2+ or HER2 low breast cancer who are receiving or are about to receive HER2-targeted antibody drug conjugates (ADCs)
* Patient must be able to sign informed consent and be willing to participate in and comply with protocol requirements (3 visits \[can be virtual\], entry of survey information, access training, subset: 2 interviews and focus group) \[All Virtual\]
* Patient must be able to read, speak, and understand English
* Access to or ability to 1) enter information on computer or iPad into HIPAA-compliant Intelligent Dashboard online database; and 2) access training on computer or iPad

Inclusion Criteria, CLINICIAN participant group:

* Clinician agrees to see their own patients at study visits (baseline, interim time point, and end of study) in order to reduce inter-clinician variability that can affect result findings (observe effect of clinician's education on their patients' learning.)
* Clinician is a physician, NP, physician assistant, nurse, or pharmacist who works with patients with HER2-positive or HER2-low breast cancer.
* Clinician must be willing to participate in and comply with protocol requirements and provide informed consent (per IRB requirements), including availability for interviews (3), case role plays (3), patient visits (3/patient), and training
* Clinician agrees to access virtual online training videos: SDM, simulation case role play, management of adverse events for patients receiving HER2-targeted ADCs for HER2-positive or HER2-low breast cancer

Exclusion Criteria, PATIENT participant group:

* History of noncompliance
* Inability to make required "office visits" (in-person or virtual)
* Inability to participate in training
* Non-ambulatory
* Limiting comorbidities (eg. psychiatric diagnosis; significant cognitive impairment limiting ability to fulfill protocol requirements)
* Pregnant patients
* No internet and computer access

Exclusion Criteria, CLINICIAN participant group:

• Inability to participate in required virtual visits, training, assessments, and other protocol requirements.
Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels

Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.

Vitamin D has shown multiple health benefits specifically in regards to bone healing. To the investigators knowledge there are currently no protocols for Vitamin D supplementation in the Orthopedic community for patients recovering from fractures. The investigators study will monitor 3 different groups of volunteers taking various Vitamin D regimens and how participants blood serum 25(OH)D3 levels are effected throughout a 3 month period. The 3 groups will include: 1) 100,000 units D2 once on day one, 2) 100,000 units D2 taken once a week x 12 weeks, 3) 50,000 units D2 x 10 days, then 2000 units D3 taken daily for the remainder of the study period. There will be 15-20 volunteers randomly assigned to each of the 3 groups. The investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. From these results the investigators will determine which protocol most effectively raises and maintains vitamin D levels in the volunteers through this 3 month period. The investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. The investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin D supplementation in patients recovering from fractures.

Eligibility Criteria:
Inclusion Criteria:

* Low Vitamin D level

Exclusion Criteria:

* Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.
Effect of Virtual Reality on Preoperative Anxiety

The aim of this study was to determine the effect of virtual reality (VR) on the preoperative anxietyof patients undergoing colorectal surgery.

The sample of this study consisted of 86 patients in experimental and control groups. The experimental group received VR application in the preoperative period for 10 minutes. Anxiety level was assessed with the Anxiety Specific to Surgery Questionnaire (ASSQ) and measured with physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application.

Eligibility Criteria:
Inclusion Criteria:The study included

* conscious,
* orientated and cooperated patients who could speak and understand Turkish,
* who had no psychiatric diseases,
* who were 18 years old and older,
* who were scheduled for elective colorectal surgery for the first time,
* who did not take any sedative drugs before surgery, and
* who gave written and oral permission to participate in the study

Exclusion Criteria:n The study excluded

* had language problems,
* underwent emergency surgery,
* were over 65 years of age and
* refused to participate in the study.
Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment

Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.


Eligibility Criteria:
Inclusion Criteria:

1. Cytological or histological diagnosis of SCLC, NSCLC or melanoma
2. Patients age \>/= 18 years old
3. Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated
4. If a biopsy is proposed, lesion lust be easily accessible
5. Signed informed consent

Exclusion Criteria:

1. Patients unable to follow the protocol
2. Consent refusal
Multi-canceR Early-detection Test in Asymptomatic Individuals (PREVENT)

PREVENT is a prospective, multicenter, interventional study evaluating the performance of the OverC multi-cancer detection blood test in asymptomatic individuals with cancer risk.

Participants will receive the OverC multi-cancer detection blood test along with standard-of-care screening, whose results will be returned to health care providers and participants. The diagnostic procedures will be guided firstly by the OverC multi-cancer detection blood test and then by the standard-of-care screening. The number, cancer types, and cancer clinical stage of cancer patients diagnosed via the OverC multi-cancer detection blood test will be recorded.

The study will enroll approximately 12,500 participants as defined by eligibility criteria with an anticipated enrollment period of approximately 9 months at up to 30 clinical sites within China. Participants will be actively followed for approximately 5 years from the date of their enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to provide a written informed consent form
* Participants must not have received any colonoscopy, abdominal MRI/CT, low-dose CT, or chest CT within 5 years before signing the informed consent form
* Participants must be able to provide blood samples for study tests
* Participants must be between 40 and 75 years old

Exclusion Criteria:

* Individuals who have an acute infection or inflammation within 14 days prior to recruitment
* Individuals with cancer-associated clinical symptoms or suspected of cancer
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
* Recipient of blood transfusion within 7 days prior to recruitment
* Individuals who have pure ground-glass opacity
* Unable to provide blood samples for the multi-cancer early detection blood test
* Individuals who are unable to tolerate standard-of-care cancer screening tests or have contraindications of standard-of-care cancer screening tests
* Individuals who have taken medication with anti-tumor effects within 30 days prior to recruitment
* Individuals who have received or are undergoing curative cancer treatment within three years prior to recruitment
* Individuals with hemorrhagic diseases
* Individuals with autoimmune diseases
* Individuals who are pregnant or lactating
* Individuals who have severe comorbidities that are not suitable for participating in the trial judged by researchers
Pharmacist's Influence on Breast Cancer Patient Quality of Life

The purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. Croatian randomized controlled trial. Targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23 questionnaire result from the baseline to after 3 week cycle.


Eligibility Criteria:
Inclusion Criteria:

* Early breast cancer
* First adjuvant chemotherapy
* Chemotherapy protocol: anthracycline x 4

Exclusion Criteria:

* Cardiovascular comorbidities
* Regular nausea or vomiting during six months before enrollment
* Unable to answer the quality of life questionnaire on their own
Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

The purpose of this study is to determine if untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of diabetes
* Be 18 years of age or older
* Be able to speak, read and understand English and understand the Informed Consent document.
* Be willing to complete study procedures

Exclusion Criteria:

* Pregnancy
* Infections or skin disorders at the puncture site (at the discretion of the site professional staff).
* Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
* A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
* Previously participated in a blood glucose monitoring study using Contour TS system or use the Contour TS for personal use when monitoring blood glucose.
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.

20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms

: ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.

Eligibility Criteria:
Inclusion Criteria:

* All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection

Exclusion Criteria:

* Mixed AMR and T cell rejection
* do not sign the consent
The Effect of Eye Mask and Earplugs on Sleep Quality and Delirium in Coronary Artery Bypass Graft Patients: a Randomized Controlled Study

Coronary artery bypass grafting is the most commonly performed surgical procedure among cardiovascular diseases. Nursing care for patients undergoing cardiac surgery involves a process that includes preoperative preparation and subsequent close monitoring of neurological, cardiac, respiratory, vascular status, kidney function, and pain. Sleep disturbances are observed after cardiac surgery. Sleep plays a critical role in the body's maintenance, repair, and renewal processes. Improved sleep can reduce patient agitation and decrease the risk of delirium. The presence of delirium leads to increased care requirements and prolonged hospital stays, which in turn raises hospital costs. Enhancing sleep quality and preventing delirium after surgery have positive effects on clinical patient outcomes. This study is designed to determine the effects of using eye masks and/or earplugs on sleep quality and delirium in patients undergoing coronary artery bypass grafting during nighttime sleep. This research is a randomized controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

-Patients who voluntarily agree to participate in the study

* Those who have undergone coronary artery bypass graft surgery
* Those between the ages of 18-79
* Those who are cooperative and oriented
* Those who are literate
* Those who speak Turkish
* Those whose initial delirium scale score (Nu-DECS) is less than 2
* Those whose Glasgow coma scale score is \>13 will be included in the study.

Exclusion Criteria:

* • Patients diagnosed with sleep disorders,

  * Those using sleeping pills,
  * Those who have a habit of using an eye patch while sleeping,
  * Those who were not transferred to the clinic on the first day after surgery and whose treatment continues in the intensive care unit,
  * Those who develop complications and/or need to be re-operated,
  * Those who need treatment other than routine treatment,
  * Patients with hearing or vision problems will be excluded.