cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)

This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB.

The overall study period is of 24 months which includes telephonic follow-up of the baseline COVID-19negative patients at 2 weeks and of all participants at 2 months.

Adult patient with presumptive TB will be screened for inclusion at 4 geographically diverse participating centres in high TB burden countries. This will be the first large scale evaluation on prospectively collected fresh samples.

Telephonic follow-up visits at 2 weeks (for baseline COVID-19 negative patients) and 2 months (for all participants) after enrolment will help overcome the challenges of using MRS only. Follow-up will be conducted telephonically two weeks post-enrolment for participants who tested negative for COVID-19at enrolment to determine any change in status -this is intended to account for participants who may have tested 'early' for COVID-19at enrolment (false negative) but subsequently developed symptoms or tested COVID-19positive. Similarly, investigators will conduct a telephonic follow-up two months post-enrolment among all participants to determine if: 1) participants diagnosed with confirmed TB at enrolment were linked to treatment; and 2) assess if any new TB diagnoses were made.

This multi-center study will evaluate the performance of the Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex test using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB and collect alternative tongue swab samples for further research use. The data gathered from this study, will form part of the dossier to be submitted to WHO (world health organization) for review.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years); and
* Able to provide written informed consent in their chosen language; and
* Self-report at least one or more symptoms suggestive of pulmonary TB\*; and
* Willing to return for a day 2 visit
* Willing to provide oral swab samples for biobanking \* cough ≥2 weeks, fever, night sweats or unintended weight-loss

Exclusion Criteria:

* Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
* Any anti-TB treatment within 60 days prior to enrolment (not current episode)
* Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
* Unable to provide all study samples before starting the 3rddose of anti-TB treatment.
IL2 Imaging in Renal Transplantation

After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 (\[18F\]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between \[18F\]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection


Eligibility Criteria:
Inclusion Criteria:

* Female or male aged between 18 and 80 years.
* Renal Transplant recipients
* The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
* All patients will have a clinical indication for renal biopsy.

Exclusion Criteria:

* Patients with multiple-organ transplants.
* Female patients who are pregnant or unwilling to use adequate contraception during the study.
* Claustrophobia
* Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.
Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications

Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Recalled for second stage screening due to microcalcifications on the mammogram
2. Renal function is within normal limits
3. No known allergies to contrast
4. Able to give informed consent

Exclusion Criteria:

1. Known allergy to contrast
2. Renal impairment
3. Unable to provide informed consent
4. Having radioactive iodine treatment for hyperthyroidism
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus continuous dosing of ribociclib vs. letrozole plus intermittent dosing (3-weeks-on/1-week-off) of ribociclib.

The difference in clinical, pathologic and radiologic response as well as Pre-operative Endocrine Prognostic Index (PEPI) scores across the three treatments arms will be examined. Subjects will also be followed for 5 years post-treatment to determine if ribociclib in combination with letrozole for 24 weeks results in improved 5 year Relapse Free Survival (RFS) compared to letrozole alone.

Eligibility Criteria:
Key Inclusion Criteria:

* Pathologically confirmed invasive breast cancer by core needle biopsy
* Female subjects, age ≥ 18 years
* Only postmenopausal women will be eligible.
* Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-2
* Invasive breast cancer must be ER+ in ≥66 % of the cells or ER Allred score 6-8
* Invasive breast cancer must be HER2 negative.
* Clinical Stage II or III (by clinical measurement and/or breast imaging)

Key Exclusion Criteria:

* Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
* Current use of other investigational agents
* Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
* An excisional biopsy of this breast cancer
* Surgical axillary staging procedure prior to study entry
* Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
* Clinical or radiographic evidence of metastatic disease
* Clinically significant, uncontrolled heart disease
* Herbal preparations/medications as listed in Appendix B of the protocol
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.

Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.

Aim 2: To assess Veteran acceptability and usability of the COAST platform.

Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* A Veteran receiving care at VA Pittsburgh Healthcare System
* Active sedative-hypnotic medication use \>14 days/month for \>=3 months
* A desire to reduce or stop using sedative-hypnotic medications
* Access to a mobile device with internet

Exclusion Criteria:

* A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression)
* A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)
* High risk of suicide
* An active substance use disorder in past 6 months
Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB) are well established techniques for the acquisition of tissue to classify a number of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic, lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available modality used to obtain cytological samples for analysis. The major shortcoming of this technique is the lack of a histological tissue core.

In recent years attention has turned to optimizing needle design to improve sample quality. New needles have been developed which aim to obtain a core of tissue with preserved architecture.

These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston Scientific, Marlborough, MA, United States).

Currently there are a paucity of studies comparing the performance of these needles, and only two of these are prospective randomized controlled trials. Real world performance of these needles has seldom been reported, with only one RCT including non-pancreatic masses in their analysis.

The investigators hypothesize that second generation needles have equivalent or better diagnostic performance than the prior first-generation needle.

To test this, the investigators aim to conduct a prospective randomized controlled study comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic, subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include a retrospective control arm of consecutive cases using the first-generation Reverse-bevel needle.

The investigatora aim to assess the diagnostic yield of each needle, as well as number of needle passes used, and specimen quality.


Eligibility Criteria:
Inclusion Criteria:

* Any solid tissue biopsy performed at the time of endoscopic ultrasound

Exclusion Criteria:

* Fluid samples were excluded.
* Cases where biopsy was not deemed necessary by the proceduralist based on endosonographic findings
* Cases where biopsy was deemed unsafe
Pre-approval Single-patient Expanded Access for Talazoparib (PF-06944076)

Provide pre-approval single-patient Expanded Access (Compassionate Use) of talazoparib for patients with metastatic castration-resistant prostate cancer.

In Expanded Access, treating physicians are the Sponsors..

Expanded Access requests from treating physicians may be submitted at www.pfizercares.com; availability will depend on location/country.

Eligibility Criteria:
Talazoparib is not intended for monotherapy. Talazoparib is intended for combination use with enzalutamide in first-line metastatic (M1) Castration-Resistant Prostate Cancer (mCRPC) only. Must be a newly diagnosed mCRPC patient who has not yet received 1st line therapy (1st generation Androgen Receptor (AR)-inhibitors do not count). Must have not received 2nd generation AR-inhibitors (enzalutamide, apalutamide, darolutamide), a Poly \[ADP-ribose\] polymerase (PARP)-inhibitor, cyclophosphamide, or mitoxantrone as prior treatments in any prostate cancer disease setting. Previous abiraterone and/or docetaxel for hormone-sensitive disease (CSPC) is allowed (patient eligible). Patients with identified need for use of potent P-glycoprotein (P-gp) inducer drugs within 7 days of onset/under duration of talazoparib plus enzalutamide treatment are at risk of drug-drug interactions (DDIs) and are therefore ineligible. Additional eligibility criteria may be required.
Metabolic Effects of Betaine Supplementation

Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine levels to diabetes and cardiovascular disease. Small human studies suggest benefit for non-alcoholic liver disease. In this study we will determine if administration of betaine improves metabolic measures, liver fat and/or endothelial function in humans with glucose intolerance who are overweight.

This study is a single site, prospective, randomized (1:1), double masked, placebo controlled trial to assess metabolic effects of betaine compared to placebo on glycemia and insulin sensitivity, liver fat and endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* 1) Men and women aged 21-65 years old;
* 2) Dysglycemia/prediabetes is defined as impaired fasting glucose (≥100 mg/dl), impaired glucose tolerance (2 hour post 75 g oral glucose load 140-200 mg/dl) or HbA1c 5.7-6.5%);
* 3) overweight to grade 3 obesity (BMI 25 to 45 kg/m2).

Exclusion Criteria:

* 1) cystathionine beta-synthase (CBS deficiency);
* 2) Presence of liver disease other than NAFLD;
* 3) Use of medications causing steatosis;
* 4) Known alcohol consumption ≥ 2 drink per day;
* 5) Use of medications known to cause insulin resistance;
* 6) Use of weight loss drugs (or program) within 3 months of screening;
* 7) Treatment with any experimental drug within the past 6 months;
* 8) Subjects must be willing to abstain from use of phosphodiesterase type 5 (PDE-5) inhibitors;
* 9) Pregnancy or lactation, and women of child bearing potential must use adequate contraception;
* 10) Surgery within 30 days of screening;
* 11) Heart disease defined as New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months;
* 12) Uncontrolled hypertension;
* 13) eGFR \<60; 14) History of acquired immune deficiency syndrome;
* 15) History of malignancy within 5 years;
* 16) Hemoglobin \<12 g/dL (males), \<10 g/dL (females);
* 17) Triglycerides (TG) \>500 mg/dL;
* 18) Poor mental function or any other reason to expect patient difficulty in complying with study requirements;
* 19) Metal clips or implants that preclude magnetic resonance imaging.
Effectiveness of Written Dietary Advice on Lipoproteins - a Pragmatic Randomized Controlled Trial

This study investigates the effect of detailed, written dietary advice for improving blood lipids, in a primary care setting. n=222 participants will be randomized to Active Intervention or Control Group. After 3 weeks' intervention, participants will receive written feedback on the effect on their blood lipids. After 6 months, another blood sample is drawn and participants will receive further written feedback.

The Active Intervention Group will receive detailed dietary advice based on current evidence for food choices that improve LDL cholesterol levels. The information will contain motivational strategies, e.g. "It's great that you want to improve your blood lipids! What are your three main reasons that you want to improve your blood lipids? What food choices suit you? How low can you go?" Participants will receive a table of ten suggested healthy food choices and be instructed to mark for each day a certain food change has been made.

The Control Group will receive similar advice and motivational strategies, with the one difference being the dietary advice, that will focus on Triglycerides instead of LDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Listed patient at Svärdsjö Primary Health Care Centre
* Willing to reduce blood lipids

Exclusion Criteria:

* Drugs affecting blood lipids (statins, ezetimibe, fibrates, PCSK9-inhibitors, neuroleptic drugs, cortisone, amiodarone, estrogen, progesterone, testosterone, cyclosporin, tacrolimus, loop diuretics, protease inhibitors and anti-convulsants; whereas beta blockers, thiazide diuretics, and SGLT2-inhibitors are allowed under established medication
* Current malignant disease
* Extreme diet
* Abnormal metabolism e.g. uncontrolled hypothyroidism
* Dementia
* Unability to comprehend written information in Swedish
* Other participant from same household
* Current employment on Svärdsjö Primary Health Care Centre
New Technologies as a Tool for Health Promotion in Schoolchildren of Compulsory Secondary Education

The rapid development of new technologies could be one of the causes that has favored changes in the lifestyle habits of young people. Research carried out to date shows that new technologies could be useful in increasing levels of physical activity and motivation to practice sports. However, these studies have major limitations that make it difficult to generalize the results.

The objectives of the present project are: 1) to determine the influence of the use of new technologies on the levels of sports practice and the physical and psychological health of adolescents; 2) to analyze the effects of a physical-sports activity program that integrates new technologies through mobile applications related to physical exercise on the level of physical activity and the physical and psychological health of adolescents; and 3) to analyze the adherence that this type of program generates in the medium term in adolescents as a function of age and gender.

The project will be divided into two phases. In the first phase, 500 students from the centers of Compulsory Secondary Education will be included, who will undergo physical tests, questionnaires related to sports practice and physical and psychological health, and an anthropometric assessment. In the second phase, an intervention will be carried out with four experimental groups and a control group. The four experimental groups will use different technological applications outside school hours for 12 weeks. Participants will keep a weekly record of physical activity and pre-, post and re-test measurements will be taken to evaluate the efficacy of the sports technology applications in increasing and maintaining physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Be a student of compulsory secondary education
* Not present any disease or surgical operation that would prevent the performance of the physical tests or the follow-up of the established intervention.
* Complete the questionnaires provided and carry out the established tests in their entirety
* Have access to any mobile device that allows access to the technological sports applications used in the intervention.

Exclusion Criteria:

* Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety
* Failure to complete scheduled intervention activities.
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)

This study is designed to assess the effect of a single dose of MK-8527 on the single-dose pharmacokinetics (PK) and the safety and tolerability of levonorgestrel/ethinyl estradiol (LNG/EE) in healthy adult postmenopausal or ovariectomized female participants.


Eligibility Criteria:
Inclusion Criteria:

* is in good overall health
* assigned female at birth

Exclusion Criteria:

* has a history of clinically significant endocrine, GI, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
* has a history of cancer (malignancy)