cyrilzakka/clinical-trials huggingface dataset:
To Establish a Molecular Typing System for Early Diagnosis of Lung Cancer

This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the feasibility of the development of early lung cancer screening and diagnosis of molecular classification system, improve its early screening early detection accuracy and efficiency, Improve the survival status of lung cancer high-risk population. At the same time, this project combined AI analysis technology of LDCT image results with ctDNA methylation detection, so as to overcome false negatives caused by the deficiency of ctDNA methylation detection technology in sensitivity, specificity, stability and flux, and correct false positive results that may be caused by AI analysis technology of LDCT image results. The combination of the two can avoid missed diagnosis and over - examination and over - treatment.

1. All patients underwent low-dose CT pulmonary nodule AI detection and peripheral blood ctDNA methylation detection at baseline
2. Follow-up plan: Low-risk and medium-risk nodules and some high-risk nodules (5-10mm) were followed up. 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. The high-risk nodules over 10mm were evaluated by the expert group and the patients were informed by biopsy or surgical resection. Histopathological diagnosis was made and compared with ctDNA methylation results to analyze the sensitivity and specificity of ctDNA methylation markers of lung cancer.
3. Endpoint: Tissue samples were pathologically diagnosed as benign or malignant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pulmonary nodules confirmed by chest CT are not limited to single nodules;
2. Nodule diameter 5-30mm
3. Nodules include solid, semi-solid and ground glass nodules;
4. Age 18-75, no gender limitation;
5. The newly diagnosed patients did not receive surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related interventions;
6. Sign informed consent.

Exclusion Criteria:

1. Patients with diagnosed lung cancer and extrapulmonary malignant tumor;
2. Pulmonary sarcoidosis, pulmonary vasculitis, pulmonary tuberculosis;
3. Patients with poor compliance are expected to be unable to complete follow-up according to the study protocol;
4. Major trauma requiring blood transfusion occurred within one week before enrollment;
5. Pregnant and lactation patients.
The BIFSORB Pilot Study II

The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.

Methods:

The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.

Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.

At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.

The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina pectoris
* Stabilized non-ST elevation myocardial infarction
* Silent angina pectoris
* Age \> 18 years
* De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
* All Medina classes except Medina x.x.1.
* Diameter of side branch ≥ 2.5 mm
* Side branch diameter stenosis less than 50%
* Signed informed consent

Exclusion Criteria:

* ST-elevation infarction within 48 hours
* Expected survival \< 1 year
* Severe heart failure (NYHA≥III)
* S-creatinine \> 120 µmol/L or GFR \< 0.45 mL/min per 1.73 m2
* Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
* Unable to cover main vessel lesion with one stent
* Severe tortuosity
* Severe calcification
A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.

The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
* Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
* For women who can have children, a negative urine pregnancy test at the Day 1 visit.

Exclusion Criteria:

* Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.
* Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany \& Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 \& 3). No new subjects will be enrolled in these follow-up phases of the study.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
* Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
* Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria:

* Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
Measurment of GFR by Nasal Sensors

to measure kidney function by measuring blood creatinine and to compare it to the measurment of GFR by Nanotechnology


Eligibility Criteria:
Inclusion Criteria:

adults between 18-70 yrs

Exclusion Criteria:

subject under 18
Avonex PEN Satisfaction and Patients Experience Clinical Trial

This is an open-label, multicenter, survey-based study to determine subject satisfaction with using the single-use autoinjector for the delivery of AVONEX PS. Enrollment will consist of 200 subjects in a single cohort who have been prescribed AVONEX PEN in accord with its Product Monograph. All subjects must be experienced AVONEX PS users (i.e., using it for at least 12 weeks without any support person to help with the injections administered in the vastus lateralis) and enrolled in MS AllianceTM program (hereinafter, MS Alliance). The clinic nurse investigator will instruct the patient on the correct method of using AVONEX PEN and the first injection with Autoinjector, using the subject's own supply, will be completed in the clinic, with the clinic nurse investigator present. All further injections of AVONEX PEN will be self-administered at home. The subjects will complete the first set of questionnaires, including Subject Satisfaction Questionnaire, Ease of Use Grading Scale and the Autoinjector Instructions Grading Scale, within 10 minutes after the first injection at the clinic, and will be given another set of questionnaires to be completed at home within 10 minutes following the last study injection 2 months later, provided the subjects still continue to self-administer their AVONEX PEN. The first set of questionnaires will be left with the clinic nurse investigator to be sent to the CRO by fax or e-mail, while the second set will need to be mailed to the CRO by study subjects using the provided self-addressed, postage-paid envelope.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent. If required by local law, candidates must also authorize the release and use of Protected Health Information (PHI)
* Must be 18 to 65 years old, inclusive, at the time of informed consent
* Must be on AVONEX PS for at least 12 consecutive weeks
* Must be self-injecting AVONEX PS at the vastus lateralis site without any help, with or without use of Personal Injector
* Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance
* Must be able to physically demonstrate use of the Autoinjector device and be able to self-administer the injections
* Must be able to understand and comply with the protocol

Exclusion Criteria:

* Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding
* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment
Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects.

Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. BMI over 30 and eligible for sleeve gastrectomy
2. Mentally capable for consent
3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug

Exclusion Criteria:

1. Gastrointestinal illness impairing absorption
2. renal failure (glomerular filtration rate\<45)
3. liver cirrhosis
4. heart failure (New York Heart Association class III or IV)
Narrow Band Imaging in Flexible Cystocopy

Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources.

First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted.

A total number of 896 patients is planned to be included.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC

Exclusion Criteria:

* Patients not fullfilling the above
Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency

Double blind randomized controlled parallel pilot trial of Quercetin vs placebo oral administration in 24 postmenopausal women. The study team will conduct a feasibility pilot in preparation for a larger efficacy trial that will test the protective effects of quercetin against cardiac and skeletal muscle dysfunction and changes in structure induced by estrogen loss and potential mechanistic pathways in post-menopausal women at risk of heart failure with preserved ejection fraction (HFPEF).

Participants receive either oral Quercetin 1000 g/day or placebo for 20 weeks. Quercetin levels, biomarkers, ultrasounds (heart and muscle), functional assessments will be measured on enrollment and after the intervention. The study coordinator will contact participants weekly to monitor safety and ensure compliance. All quercetin administration will be supervised by Claudia L Campos, MD, Associate Professor of Internal Medicine, Medical Director Internal Medicine clinic.

Eligibility Criteria:
Inclusion Criteria:

* Female, postmenopausal, aged 60 to 74
* Stated willingness to comply with all study procedures and availability for the duration of the study
* High risk of Heart failure with preserved ejection fraction (HFPEF) using web-based Primary Care Physician-HF risk tool (Khan S, et al.10-Year Risk Equations for Incident Heart Failure in the General Population. Information used for calculation include: age, gender, race, hypertension treatment (yes or no), fasting glucose value, smoking status, body mass index, systolic BP, diabetes treatment (yes or no), total cholesterol, HDL cholesterol, and electrocardiogram QRS duration. Prospective participant's with scores \>= 10% will be included.
* Electrocardiogram (EKG) on medical record

Exclusion Criteria:

* History of congestive heart failure or use of loop diuretics
* Recent myocardial infarction (MI), stroke, angina, or atrial fibrillation (in the past 6 months), either self-reported and or in the electronic medical record.
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Significant renal insufficiency requiring dialysis or estimated glomerular filtration rate (eGFR) \< 15 mL/min
* Liver disease
* Psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder
* Participants reporting extreme energy intakes \>3500 or \<500 kcal/day
* Plans to leave area within the study period
* Refuses informed consent
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years of age
* Patients who have qualitative olfactory distortion
* Etiology of qualitative olfactory distortion is due to upper respiratory infection
* Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir)
* Quantitative score ≥ 8 on the QOD.
* At least 6 months of parosmia but less than 24 months
* Patients can have been previously treated with oral and topical steroids but this is not a requirement
* Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care)
* Be able to read and understand English
* Be able and willing to provide Informed Consent

Exclusion Criteria:

* Patients \< 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft
* Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss \> 24 months
* Patients with bleeding disorders or on blood thinners such as coumadin and plavix
Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors

Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75, male or female;
2. Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;
3. Expected survival ³ 8 weeks and able to receive long-term follow-up;
4. Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;
5. First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group);
6. Voluntarily signing an informed consent form.

Exclusion Criteria:

1. Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer;
2. history of psychiatric illness prior to the diagnosis of the tumor
3. patients who resist treatment
4. patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;
5. patients who are pregnant or have a pregnancy plan;
6. patients who, in the judgment of the investigator, are not suitable for inclusion in this study.
Watermelon/UBIQuinone Study

The objective of the proposed pilot trial is to determine the feasibility and safety of increasing watermelon consumption, with or without coenzyme Q supplementation in patients after kidney transplantation on kidney function and urinary protein excretion.

While many observational studies have examined the effects of consuming watermelon in patients without chronic kidney disease, there have been few studies on the consumption of a diet high in watermelon as a means of improving kidney function or reducing protein in the urine. Coenzyme Q is also recognized as a supplement that has benefits for heart health and has anti-oxidative effects, but whether it could be used to improve kidney function or reduce protein in the urine has not been thoroughly examined, especially in the kidney transplant population. The objective of the proposed pilot trial is to determine the feasibility and safety of increasing watermelon consumption, with or without coenzyme Q supplementation in patients after kidney transplantation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Received a kidney transplant in the last four weeks
* History of dialysis dependency prior to kidney transplant
* Able to provide informed consent
* Not currently consuming a high-watermelon diet or taking co-enzyme Q10
* Not underweight (body mass index \<19 kg/m2)
* Not enrolled in any other interventional trial
* Planning to return for follow-up at UCSF (or willing to return for study visits)

Exclusion Criteria:

* \< 18 years of age at the time of transplant
* Preemptive transplantation
* Unable to provide informed consent
Digital Treatment of Irritable Bowel Syndrome (IBS)

The aim of this work is to identify whether the digital treatment program Mage-tarmskolen has an effect on patients with IBS. Our secondary objectives is to address multiple aspects of digital treatmtent success of the different modules. The patients will be randomized to one of four arms and will be delivered different kinds of digital treatment. All patients will have access to ask questions to a registered dietitian. Primary end point is the proportion of patients with treatment success in the low FODMAP, behavioral therapy or both groups, versus the patient education group (sham). Treatment effect is defined as an improvement of 50 points or more on the IBS severity scoring system at 3 months after treatment start compared to the score before treatment.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosed with IBS in the primary or secondary healthcare service.

* Patients aged 18-70 years with IBS defined by the Rome IV criteria: Recurrent abdominal pain, on average at least 1 day per week during the previous 3 months, that is associated with two or more of the following: i) Defecation, either increased pain or pain relief, ii) Change in stool frequency, iii) Change in stool form (appearance)
* All participants \>50 years: Colonoscopy within the last 5 years prior to study entry excluding other pathology
* Bank-ID and access to tablet, PC or smart phone.
* No known presence of: symptomatic endometriosis, Diabetes type 1 and 2, Malignant disease (excluding basalioma),
* No history of: severe psychiatric disorder, alcohol or drug abuse, inflammatory bowel disease, microscopic colitis, diverticulitis or ileus, major abdominal surgery (except appendectomy, cholecystectomy, caesarean section, and hysterectomy)
* No "red flags'' indicating severe undiagnosed disease: Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding), Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 6 months without knowing the reason, or blood in stool
* Not pregnant
* Ability to comply with protocol requirements