cyrilzakka/clinical-trials huggingface dataset:
Lifestyle and Dietary Pattern in Relation to Precursor Lesions of Colorectal Cancer and Cardiometabolic Diseases

The association between lifestyle and dietary patterns with precursor lesions of colorectal cancer and cardiometabolic diseases is still unclear. This study is conducted in Jinhua, a city with a high prevalence of colorectal cancer in China, to assess the relationship between lifestyle and dietary factors with precursor lesions of colorectal cancer and cardiometabolic diseases.

Investigations of lifestyle and dietary factors in relation to precursor lesions of colorectal cancer and cardiometabolic diseases are limited in China. The investigators aim to collect the basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors and so on, to assess the associations between lifestyle and dietary factors with precursor lesions of colorectal cancer and cardiometabolic diseases. This large cohort - the Lanxi Pre-colorectal Cancer Cohort (LP3C) also included several subcohorts consisting of patients with CVD, diabetes, hypertension, metabolic syndrome, obese/overweight or fatty liver disease. Results from this study will be valuable for colorectal cancer and cardiometabolic disease prevention in China.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥45 and ≤74 years old
* Subject has complete data on diet and follow-up time

Exclusion Criteria:

* Colorectal cancer
* Severe intestines problems
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age at time of enrollment.
* Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:

  1. At least 1 symptom of either dyspnea, orthopnea, or edema.
  2. At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
* Be willing to comply with protocol-specified instructions
* Able to understand and grant informed consent.

Exclusion Criteria:

* Inability to give informed consent.
* Systolic BP \< 90 mmHg
* Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.
* Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L
* Known adverse reaction to metolazone
* Inability to take oral medications
* Severe Aortic Stenosis (AVA \< 0.8cm³)
* History of Hypertrophic Obstructive Cardiomyopathy.
* Metastatic Carcinoma
* Severe Chronic Obstructive Pulmonary Disease (COPD), FEV \< 1L
* Severe dyspnea requiring prolonged CPAP or intubation
* Moderate/Severe Dementia
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening

Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms for this increased risk in women are not well-understood. QTc interval duration has been shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the QTc interval response to drugs that may cause TdP is greater during the menses and ovulation phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and lesser during the luteal phase, during which serum progesterone concentrations are highest. Additional evidence from our laboratory suggests that progesterone may be protective against TdP. Specific Aim 1: Establish the influence of oral progesterone administration as a preventive method by which to diminish the degree of drug-induced QT interval prolongation in women. Working hypothesis: Oral progesterone administration effectively attenuates enhanced drug-induced QT interval response in women. To test this hypothesis, progesterone or placebo will be administered in a crossover fashion to women during the menses phase of the menstrual cycle. QTc interval response to low-dose ibutilide, a drug known to lengthen the QT interval, will be assessed. The primary endpoint will be individually-corrected QT interval (QTcI) response to ibutilide, in the presence and absence of progesterone, which will be assessed by: 1) Effect on maximum change in QTcI, and 2) Area under the QTcI interval-time curves (AUEC). At the conclusion of this study, we will have established that oral progesterone administration is a safe and effective method of attenuating drug-induced QT interval prolongation.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21-40 years
* Premenopausal

Exclusion Criteria:

Serum potassium ,\< 3.6 meq/l

* Serum magnesium \< 1.8 mg/dl
* Serum hemoglobin \< 9.0 mg/dl
* Serum hematocrit \< 26%
* Hypertension
* Coronary artery disease
* Heart failure
* Liver disease
* Kidney disease
* Serum creatinine \> 1.5 mg/dl
* Taking hormone contraceptives
* Baseline Bazett's correct QTc interval \> 450 ms
* Family history of long-QT syndrome, arrhythmias, sudden cardiac death
* Concomitant use of any QT prolonging drug
* Pregnancy
* weight \< 45 kg
* Unwillingness to use non-hormonal forms of birth control during the study period
Behavioral Science Aspects of Rapid Test Acceptance

The relevance of this research to public health is to make it possible to test for hepatitis C and syphilis at point of care so that people will receive their results immediately instead of requiring people to wait for at least a week to get their test results. This research will make rapid tests for HIV available that can detect HIV infection earlier and are more accurate than current tests available in the United States.

This application addresses "Studies to improve access and utilization of HIV counseling and testing" for "HIV/AIDS and AIDS-related co-infections" such as "hepatitis C virus (HCV), other sexually transmitted infections (STIs)" that are part of PA-07-307 Drug Abuse Aspects of HIV/AIDS. The only rapid tests that are approved for use in the US currently are for HIV infection. Tests for other conditions such as hepatitis C (HCV) and syphilis are in use in other countries. In response to an Opportunity that the CDC published in the Federal Register, there are now candidate rapid test kits for HCV and syphilis available for experimental use in the US. Different combinations of rapid and standard tests will be offered to participants in a four-arm trial to assess which tests are accepted by the participants. Only a minority of clients at CBRS who have been offered the rapid test for HIV have accepted it. Those who chose rapid HIV tests were more likely to be male, educated, gay, young and White. They were less likely to be Black, or injection drug users. The proposed study has the potential to have a significant impact upon screening for HIV, syphilis, and HCV. Rapid tests have the potential to increase the receipt of test results, particularly among groups that are less likely to return for their results using traditional testing. The candidate tests are designed for Point of Care (either oral fluid and/or whole blood), and thus will require real-time testing, so the trial will be able to evaluate both the accuracy of the tests in settings of intended use and their acceptability to potential clients in real-world situations.

Eligibility Criteria:
Inclusion Criteria:

* Over 17 years old
* Mentally stable
* Sober
* Able to understand English or Spanish
* At least one good vein for phlebotomy
* Member of Behavioral Risk Group
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m\^2) and weight \>= 40 kg at screening
* Documented physician-diagnosed asthma
* On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
* Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted
* Evidence of uncontrolled asthma
* Use of contraceptive measures

Exclusion Criteria:

* Diagnosis of mimics of asthma
* Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
* Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
* Recent history of smoking
* History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, have an impact on the study results
* Asthma exacerbation within 4 weeks prior to screening
* Intubation for respiratory failure due to asthma within 12 months prior to screening
* Comorbid conditions that may interfere with evaluation of investigational medicinal product
* Known sensitivity to any of the active substances or their excipients to be administered during dosing
* Positive pregnancy test
Comparison of Traditional Cataract Surgery and Traditional Surgery Combined Triamcinolone Staining

Previously, the investigators have developed a surgical technique to reduce inflammatory response after congenital cataract surgery. This prospective, randomized controlled study aims to compare the prognosis of traditional cataract surgery with traditional surgery combined triamcinolone staining of the anterior vitreous in treating congenital cataracts.

Surgical technique for congenital cataract is now more and more mature, but many young patients still have obvious postoperative inflammatory response, which might cause visual axial opacification, posterior synechiae and secondary glaucoma. Triamcinolone is used in intraocular injection for its anti-inflammatory effect However, the application of Triamcinolone was reported to be associated with high intraocular pressure. It is necessary to evaluate the safety and effectiveness of using triamcinolone in congenital cataract surgery.

In this randomized clinical trial, children with equal degree of congenital cataract in both eyesare enrolled. Patients receive cataract surgery on both eyes on the same day. For each patient, one eye is randomly assigned to undergo traditional surgical procedure, while the fellow eye is undergoing new surgical procedure. The traditional surgical procedure include anterior continuous curvilinear capsulorhexis (ACCC), irrigation/aspiration (I/A), posterior continuous curvilinear capsulorhexis (PCCC), and anterior vitrectomy(A-VIT). Primary intraocular lens implantation (IOL) is performed in children older than age of two. The new surgical procedure is to combine triamcinolone staining of the anterior vitreous on the basis of the traditional surgical procedure. Investigators then compare the incidence of high intraocular pressure, visual axis opacification, uveitis, iris/pupil abnormality, and macular edema between two groups

Eligibility Criteria:
Inclusion Criteria:

1. Age between 3 months and 13 years
2. Uncomplicated bilateral same degree of congenital cataract (≥ 3 mm central dense opacity)
3. Informed consent signed by a parent or legal guardian

Exclusion Criteria:

1. Intraocular pressure \>21 mmHg
2. Preterm birth (\<28 weeks)
3. Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma, microcornea, persistent hyperplastic primary vitreous) or systemic disease (congenital heart disease, ischemic encephalopathy)
4. History of ocular trauma
5. Previous intraocular surgery
A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19

A Phase 2 Study to Evaluate the Efficacy and Safety of QLS1128 Orally in Symptomatic Participants With Mild to Moderate COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between ages of 18-80 years.
2. Confirmed SARS-CoV-2 infection as determined by RT-PCR or antigen test in any specimen collected within 48 hours prior to randomization，first diagnosis of this infection within 72 hours prior to the randomization.
3. Initial onset of the COVID-19-related symptoms/signs within 48 hours prior to the randomization，and at least 1 of the COVID-19-related symptoms/signs (Cough,Shortness of breath or difficulty breathing,fever,Chills,Body pain or muscle pain,Diarrhea,Nausea,Vomiting，Headache，Sore throat，Stuffy or runny nose)present on the day of randomization.

Exclusion Criteria:

1. Previous treatment with QLS1128 sustained-release tablets or other 3CL protease inhibitors failed.
2. Has received local approved anti-SARS-CoV-2 drugs within 7 days before screening or plan to receive them during the study period (e.g. paxlovid, azvudine, etc.)
3. Has received monoclonal antibody against SARS-CoV-2 virus within 1 year prior to screening.
4. Has received or expect to receive convalescent plasma therapy for COVID-19 patients during the trial.
5. Has received any CYP3A4/2C8 strong inducer within 28 days prior to screening or plan to receive any CYP3A4/2C8 strong inducer during the study period.
6. A known history of active liver disease , including acute/chronic hepatitis B, hepatitis C, cirrhosis, or acute liver failure.
7. Allergic or have contraindications to test drugs or test drug excipients.
Assessment of Early Healing Period of Dental Implants

This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Systemically healthy
* Need for implant treatment in unilaterally edentulous posterior mandible
* Sufficient interocclusal space for implant and restoration placement
* At least four months passed since tooth extraction
* Alveolar bone height adequate for implant placement, with a minimum width of 6 mm, and without risking anatomical structures
* Plaque and bleeding scores of less than 15% in the entire mouth
* Presence of opposing teeth in occlusion
* Written informed consent obtained, including permission for the use of data for research purposes

Exclusion Criteria:

* Poor oral hygiene
* Uncontrolled periodontal disease
* Pregnancy or lactation at any stage of the study
* Uncontrolled diabetes
* Patients with suppressed immune systems
* History of radiotherapy to the head and neck region
* Diseases or medications affecting bone metabolism
* Smoking more than 10 cigarettes per day
* Bone augmentation performed before or concurrently with the implant
* Failure to achieve primary stability with the implant
Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy

This study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women gestational age less than 36 weeks with heartburn

Exclusion Criteria:

* Having medical disease that contraindicated to use study drug
* Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel
VR Mind and VR Mind+ Intervention

The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator \[protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)\]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.

Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).

Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
* Signing informed consent
* Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated

Exclusion Criteria:

* occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
* psychosis,
* bipolar disorder,
* mental retardation
* pregnancy,
* drug addiction,
* alcohol addiction,
* psychoactive substances addiction,
* participating in the experimental session while intoxicated
* (current) neurological treatment of chronic disease of central nervous system,
* epilepsy,
* paroxysmal vertigo,
* presence of suicidal thoughts, tendencies or attempts,
* participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
* current CBT treatment for Social Anxiety Disorder
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4

The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start.

Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support.

Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole.

The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline.

The Duration of Treatment can be up to 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
2. Minimum age of 18 years
3. Patients in cardiogenic shock
4. Cardiogenic shock is defined as:

   1. Systolic blood pressure \< 90 mmHg for at least 30 min
   2. Inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmHg
   3. Clinical signs of heart insufficiency with pulmonary congestion
5. Signs of end organ hypoperfusion with at least one of the following criteria:

   1. Cold, damp skin or extremities
   2. Oliguria (≤ 30 mL/h)
6. Serum lactate \> 3.0 mmol/L

Exclusion Criteria:

1. In case of female patients: pregnancy or lactation period
2. Participation in an interventional clinical study during the preceding 30 days
3. Previous participation in the same study
4. Age \> 85 years
5. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 30 min
6. No flow time \> 5 min
7. Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
8. Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
9. Fever (Body temperature \> 38.0 °C) or other evidence of sepsis
10. Onset of cardiogenic shock \> 6 h before enrolment
11. Lactate \> 16 mmol/L
12. Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
13. Contra-indications for anticoagulation
14. Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD
Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff

The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.

The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.

Eligibility Criteria:
Inclusion Criteria:

* Willing to undergo eye examination
* Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

Exclusion Criteria:

* Known pre-existing severe eye disease, such as glaucoma
* Prior lens surgery
* Known hypersensitivity to the mydriatic agents
* Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator