cyrilzakka/clinical-trials huggingface dataset:
Influences on HIV Infected Subjects' Willingness to Participate in Research and Ability to Give Informed Consent

This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.

This protocol seeks to better understand the various factors which influence an HIV infected individual's decision to participate in clinical research, and especially how the offer of payment influences the decision to participate and understanding of the risks, benefits and purpose of the research. Subjects will be HIV infected individuals participating in or being screened for participation in intramural HIV studies being conducted by the NIAID, CCMD, and NCI. Willing subjects will be recruited from studies that offer payment and comparable studies that do not pay. The primary methodology is an interview via a survey schedule. Use of the interview schedule will be preceded by a focus group of about 7-10 individuals and pretesting of the survey instrument. Paid and unpaid subjects will be compared with respect to motivations, understanding, willingness to withdraw, and sociodemographics.

Eligibility Criteria:
Those HIV seropositive subjects participating in or being screened for participation in selected NIAID or NCI intramural HIV studies will be eligible for participation in this study.

Eligible subjects are those willing and able to provide their own informed consent.

No subjects that are unable to speak English or are unable or unwilling to communicate with investigators for any reason.
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.


Eligibility Criteria:
Inclusion Criteria:

All Participants

* For a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. Females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose
* Non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period Participants with ESRD on HD
* Maintained on a stable regimen of HD within 3 months prior to first dosing Participants with Severe Renal Impairment
* Estimated glomerular filtration rate (eGFR) at screening is \< 30 mL/min/1.73m\^2 Healthy Controls
* Participant is within ± 10 years of the mean age and within 10% of the mean body mass index of severe renal impairment participants
* eGFR at screening is \>=80 mL/min/1.73m\^2

Exclusion Criteria:

All Participants

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable
* History or presence of alcoholism and drug abuse within the past 6 months
* Female participants who are pregnant or lactating
* Regular user of any medication (including over the counter) that would significantly alter GFR
* Donation of blood or significant blood loss within 56 days prior to the first dose of study medication(s)
* Plasma donation within 7 days prior to the first dose of study medication(s)
* A renal transplant or nephrectomy Participants with ESRD or Severe Renal Impairment
* Rapidly fluctuating renal function
Addressing Low-Income Families' Basic Social Needs at Pediatric Visits

This research project is aimed to address low-income families' basic social needs (housing, food, employment, education, childcare, utilities) within the context of pediatric primary care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive impact of a similar intervention on pediatric residents' screening and referral to community agencies. This study will specifically test whether a further strengthened intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal enrollment in community resources and receipt of eligible benefits. In addition, we will measure the intervention's impact on maternal well-being, and compliance with well-child care (WCC) visits.

The project will take place at eight community health centers in the Greater Boston Area. The centers will be randomized to either an intervention or control site. Mothers who bring their infant in for a WCC visit from birth to 6 months will be eligible. They will be followed until their child is one year of age. Study subjects will complete two self-administered surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9 months old). Pediatric providers will also be subjects; and will fill out a demographic questionnaire at the time of enrollment.

The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers.

Families attending the control health centers will receive standard of care. Enrolled mothers will be offered the intervention at the end of the 12-month follow-up interview. When follow-up data collection is complete, the PI will offer the control sites the opportunity to implement the BNS protocol.


Eligibility Criteria:
Inclusion Criteria:

* Mothers (18 yrs or older) who bring their infant between the ages of birth and 6 months for a well-child care visit
* Medical providers who provide care to pediatric patients at the participating community health centers

Exclusion Criteria:

* Foster parent
* Mothers who anticipate changing their infant's site for care
* Mothers who are non-English or non-Spanish speaking
* Infants with hx of prematurity (born before 32 weeks)
* Infants with chronic cardiac or respiratory diseases
* Previously enrolled mother
Telomere and Telomerase

Researchers hope to determine if the DNA is shortened in your body and determine if there is an increase in the protein that shortens DNA called telomerase.

A telomere is a region of repetitive DNA at the end of chromosomes, which protects the end of the chromosome from destruction. Telomeres can be viewed as the tips on the ends of shoelaces that keep them from unraveling. Telomeres compensate for incomplete semi-conservative DNA replication at chromosomal ends. In absence of a reparative process, DNA sequences would be lost in every replicative phase until they reached a critical level, at which point cell division would stop.

Loss of telomeres leads to chromosome end-to-end fusion, chromosome re-arrangements, and genome instability.

Telomerase is a "ribonucleoprotein complex" composed of a protein component and an RNA primer sequence which acts to protect the terminal ends of chromosomes. Telomerase is the natural enzyme which promotes telomere repair. It is however not active in most cells. It certainly is active though in stem cells, germ cells, hair follicles and in 90 percent of cancer cells. Telomerase functions by adding bases to the ends of the telomeres. As a result of this telomerase activity, these cells seem to possess a kind of immortality.

Progressive shortening or attrition of telomere length with consequent genomic instability leading to cancer has been described in various hematological malignancies including acute and chronic myeloid leukemia.

Reduced telomere length has been documented in patients with the progressive BM failure syndrome called Dyskeratosis Congenita. Abnormalities in these patients include skin pigmentation, nail dystrophy and leukoplakia. Mutations in the telomere maintenance mechanism have been implicated in the pathogenesis of this heterogeneous condition.

Myelodysplastic syndrome is an acquired clonal stem cell disorder characterized by in-effective hematopoiesis, increased intra-medullary apoptosis and peripheral cytopenia. A number of such patients will eventually develop worsening cytopenia evolving into acute myeloid leukemia. A number of studies have investigated telomerase activity and telomere length in patients with MDS and AML. Telomere shortening was significantly more pronounced in patients with cytogenetic alterations as compared to patients with normal karyotypes.

Genomic instability develops with progressive telomere shortening. The Telomere attrition related genome instability is a stress that leads to up-regulation of specified DNA damage foci. These telomere-associated DNA damage points are often called as Telomere Dysfunction-Induced Focus (TIF).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced Myelodysplastic Syndrome (MDS) or acute myeloid leukemia
* must be 18 years of age
* must be able to give written informed consent
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis

Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).


Eligibility Criteria:
Inclusion Criteria:

* patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
* Caucasian
* written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)

Exclusion Criteria:

* active endocarditis
* history suggestive for inherited oe acquired bleeding disorder
* concomitant coronary heart disease
* agents impairing platelet function up to 14 days before surgery
* Pregnancy
* inherited platelet function
* known intolerance against HAEMATE HS
* previous thromboembolic complications
* Hepatitis B, C or HIV infection
* previous chemotherapy
* emergency surgery within the last 7 days
* weight \< 50 kg and \> 100 kg
Vitamin D Supplementation Study

Patients with colorectal cancer will be recruited to undergo vitamin D supplementation in the peri-operative period. Vitamin D levels (25OHD) will be measured to assess response to supplementation.

Patients with a new diagnosis of colorectal cancer will be recruited from colorectal outpatient clinics after confirmation of eligibility. Potential participants will be identified by their healthcare team comprising of clinical nurse specialist or surgeon and co-enrolment with portfolio studies including ALLEGRO and Prepare-ABC will be permitted. Patients undergoing neo-adjuvant therapy, already established on supplementary Vitamin D or with contra-indications to vitamin D supplementation will be excluded. After informed consent participants will undergo blood sampling at baseline (for 25OHD level and DNA) and given 3200IU cholecalciferol (Fultium) per day to take until the time of surgery (median time from pre-operative clinic 4 weeks). Further blood sampling will be performed on the day of surgery, in the early post-operative period (1-2 days, 3-5 days, 6-9 days) and at the first post-operative clinic appointment. Where possible surplus serum from clinically indicated blood tests will be collected to assay 25OHD and reduce need to additional venesection.

Eligibility Criteria:
Inclusion criteria -

* All participants will be aged 16 years or over.
* Participants must be resident in the United Kingdom.
* Undergoing bowel cancer surgery

Exclusion criteria

* Patients who may be at increased risk from Vitamin D supplementation including:
* Kidney disease
* High levels of calcium in the blood
* Atherosclerosis
* Sarcoidosis
* Histoplasmosis
* Over-active parathyroid gland (hyperparathyroidism)
* Lymphoma
* Currently taking thiazide diuretics, digoxin or other cardiac glycosides
* Known allergy to nuts (as peanut oil contained within vitamin D preparations)
* Female subjects of child bearing age who are not taking effective contraception during the period of the trial
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis

This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).


Eligibility Criteria:
Inclusion Criteria:

* Be aged 18 and older
* Be capable of giving informed consent themselves and are able and willing to participate in the study
* Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
* Patients that regularly brush their teeth twice a day

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients taking long-term anti-microbial or anti-inflammatory drugs
* Patients unable or unwilling to provide informed consent
* Self-reported use of tobacco products
* Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
* Less than 26 teeth in the mouth
* Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
* Periodontitis as indicated periodontal pockets greater than 5 millimeters on more than one site
* Inability to comply with assigned treatment regimen
Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.

This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age one month and older
* Weight greater than or equal to 3 kg
* The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

* Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
* Decision-impaired adult on behalf of a pediatric patient who is unable to assent
* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
* Subjects deemed not suitable for the study at the discretion of the investigator
* Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty

This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.

Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.

Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.

Eligibility Criteria:
Inclusion Criteria:

1. Adult participants of at least 18 years of age
2. Undergoing a primary, unilateral, total knee arthroplasty
3. Planned single-injection adductor canal nerve block
4. Weight \> 50 kg (to minimize the risk of local anesthetic toxicity)

Exclusion Criteria:

1. chronic opioid or tramadol use: daily oxycodone equivalents \> 20 mg for \> 4 weeks
2. neuro-muscular deficit of the surgical limb
3. moderate pain (NRS \> 3) in an anatomic location other than the surgical site
4. planned hospital admission following surgery
5. history of opioid misuse
6. those who lack capacity to complete informed consent
7. inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
8. incarceration
9. pregnancy
10. allergy to amide local anesthetics
A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and safety profile comparing to propofol.

This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 18-60 years；
* intending to undergo diagnostic upper GI endoscopy
* American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；
* 18 kg/m²\<BMI(Body Mass Index)\<30 kg/m².

Exclusion Criteria:

* Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator;
* one or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.);
* history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine hypnotics;
* history of severe cardiovascular disease;
* cerebral disease or mental disorder;
* allergic to drugs used in the study;
* pregnant women or those in lactation period
EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects

To investigate the associations bewteen the sedation level and the airway adverse effects by using the EEG, Airmod breath sound monitor and the capnography.

Deep sedation is mandatory for many invasive procedures such as the digestive endoscopy, bronchoscopy and cystoscopy. However, deep sedation may induce respiratory adverse effects including airway obstruction, hypoventilation and apnea. These respiratory adverse effects, which may occur in more than 20% of high-risk groups (eg, children, the elderly, and patients with sleep apnea), hence, are the major concerns of the anesthetic care. However, It is difficult for clinicians to objectively quantify the sedation level and find the associations of inadequate sedation level and the occurrence of respiratory adverse effects.

Airway obstruction and respiratory rate decline during deep sedation are conventionally monitored by using capnography(EtCO2 waveform). However, previous studies have tracheal breath sound monitoring can achieve better detection accuracy than the capnography. The novel Airmod smart breathing monitor has the functions of breath sound recording, anti-noise signal processing, event recording and respiratory rate analysis and research. Through the continuous breath sound recording, airway adverse effects during sedation may be detected, and these breathing spectrogram can be presented for image analysis. This is helpful for researcher to identify associations between airway adverse effect and the sedation level.

The state-of-art anesthetic depth is determined by using the electroencephalogram (EEG). Both EEG raw data or the EEG spectrogram graphs may be used for quantify the sedation level with respiratory adverse effects. Accordingly, this study aims to investigate the associations between the sedation level and the airway adverse effects by using the EEG monitor, Airmod breath sound monitor and the capnography.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing procedural sedation with expected produre time longer than 30 minutes

* Pediatric group: age 4-8 year-old
* Geriatric group: age\>= 65 year-old

Exclusion Criteria:

* Preoperative active brain conditions (dementia, Parkinsonism, seizure)
* A history of nasal or oral tumor