cyrilzakka/clinical-trials huggingface dataset:
Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With IPF

The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure the severity of cough, breathlessness, and changes in cough and disease-related quality of life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have been used in other types of disease, but have not all been tested and validated in patients with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related QOL questionnaire scores will correlate with physiologic markers of IPF severity and worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are important to assess the benefit of investigational drugs under development to treat patients with IPF.

This study in patients with IPF will determine the validity, responsiveness, and reliability of two cough measures (the Leicester Cough Questionnaire (LCQ), as well as Visual Analogue Scales (VASs) for cough severity and distress; one dyspnea measure (the Baseline and Transition Dyspnea Index (BDI/TDI); and two health-related quality of life (HRQL) measures (the obstructive lung disease-specific Saint George's Respiratory Questionnaire (SGRQ) and the IPF-specific 'A Tool to Assess QOL in IPF' (ATAQ-IPF). Both the SGRQ and ATAQ include cough questions. Study participants will complete all questionnaires at baseline, 6, 12, and 18 months at the time of their usual clinic visits. Physiologic data will be collected at the same time of these visits including pulmonary function testing, exercise oxygen saturation, and changes in medications and health status. Changes in cough, dyspnea and QOL scores will be correlated with concurrent changes in physiologic markers of IPF severity. If a study participant has an acute worsening of their IPF, or undergoes lung transplantation, study questionnaires may be given at these additional timepoints when possible.

Eligibility Criteria:
Inclusion Criteria:

* Completion of informed consent.
* Adults over the age of 18.
* Diagnosis of IPF per ATS guidelines.
* Clinically stable at the time of enrollment defined as no antibiotics within the past month, with the exception of those patients currently listed for Lung Transplantation.
* No changes in immunosuppressive regimens (if applicable) over past month.

Exclusion Criteria:

* Inability to understand or complete paper and pencil questionnaires.
* Patient not planning to return to Stanford for clinic visits.
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study.

This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1, Day 15, and Day 85.

Eligibility Criteria:
* Inclusion Criteria

  1. Male or non-pregnant female who previously participated in and completed two vaccinations in the V-122 Study.
  2. Women of childbearing potential and men must agree to practice medically effective contraception during study period.
  3. Able to understand the content and possible risks of informed consent and willing to sign the Informed Consent Form (ICF).
  4. Able to understand and agrees to comply with all study procedures and be available for all study visits.
  5. Ear temperature ≤ 38.0°C.
  6. At screening visit, at least 6 months after first vaccination in the V-122 study.
* Exclusion Criteria

  1. Female who is pregnant or positive in pregnancy test at screening visit.
  2. Female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination.
  3. Any acute illness, as determined by the study investigator 3 days before booster vaccination.
  4. Prior administration of attenuated, nucleic acid (mRNA or DNA) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination.
  5. Prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination.
  6. Any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study.
  7. Previous exposure to SARS-CoV-2 or receipt of an investigational or EUA vaccine product for the prevention of COVID-19, MERS or SARS except UB-612.
  8. Subjects who take part in another clinical study, other than V-122 study, within 12 weeks prior to the day of informed consent.
  9. Prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination.
  10. Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.
Impact of Video Discharge Instructions on Heart Failure Patient's Knowledge

With improve care of patients with heart failure, many patients are living longer. Care for these patients is now not only focused on mortality but also on the quality of life. Patient knowledge about heart failure and their overall compliance with the necessary lifestyle changes will lead to an improved quality of life. Discovering alternative ways to improve patient knowledge is key to long term survival. This studies objective is to assess the overall impact of video discharge instructions as compared to paper discharge instructions on Heart Failure Knowledge among an under-served patient population.

In this study, we will randomized patients admitted to the hospital with heart failure exacerbation to receive either paper or video discharge instructions within a day prior to discharge. The video and paper instructions will have the same content. The patients will take a pre-test and post-test and the change in scores among the patients who received the video and paper discharge instructions will be compared. Other points of interest include participant satisfactions with discharge instruction, followup at post hospital appointment and 30-day readmission.

Data to be collected includes:

1. Medial history of the patient
2. Educational background
3. Social Status
4. Patients Health Measurement: Self Efficacy for managing medications and Treatment Management, Informational Support

Eligibility Criteria:
Inclusion Criteria:

* hospital admission with a diagnosis of Heart Failure (HF)- Heart failure with reduced ejection fraction or heart failure with preserved Ejection fraction
* planned discharge from hospital to home setting
* able to read and write English
* Acceptable to answer Questionnaire and to receive a call at the end of the study

Exclusion Criteria:

* Planned discharge to long term acute care
* Patients with unstable housing
* imprisoned patients
* patients who are pregnant
* illiteracy (defined as inability to write or read) and non-native speakers of English
* impaired cognition
* impaired vision
* Patients with End Stage Renal Disease(ESRD)
* Cancer patients
Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section

postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality . Tranexamic acid is used in many studies in management of PPH in combination with ecobolics. this study aims to evaluate the possible value of the use of tranexamic acid in prevention of postpartum hemorrhage .


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 28 weeks or more.
* Chronic Hypertension.
* Preeclapmsia -Eclampsia.
* Multiple pregnancy.
* Uterine Liomyomas.
* Polyhydraminos.
* Fetal macrosomia.
* Associated Thrombocytopenia
* History of postpartum hemorrhage.

Exclusion Criteria:

* Patients with rheumatic heart disease.
* Patients with history Cardiac Valve Replacement.
* Current or past history of DVT.
* Women on any anticoagulant therapy.
* Sensitivity to tranexamic acid
* Pregnancies with any abnormally implanted or located placenta.
Analyzing the Pharmacodynamic Substances and the Effects of Xingnaojing for Mild-to-Severe Acute Ischemic Stroke

The main purposes of this trial are to analyze the pharmacodynamic substances and the effects of Xingnaojing for mild-to-severe acute ischemic stroke.

Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. In order to further clarify the main pharmacodynamic substances of Xingnaojing in the treatment of acute ischemic stroke, this study intends to carry out a non-randomized, open-label, controlled clinical trial. The primary hypothesis is that , compared with the control group, Xingnaojing will produce serial changes in plasma metabolites at baseline (pre-dose) and 7 days, as well as urine metabolites at baseline (pre-dose), 6 days, 7 days and 8 days. The serial changes may be the potential support to explain the intervention effect of Xingnaojing. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute ischemic stroke；
* Symptom onset within 24 hours；
* 40 ≤ age ≤ 80 years;
* 4 ≤ NIHSS ≤ 25；
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Planned or already receiving intravenous thrombolysis or endovascular treatment;
* Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
* Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
* Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
* Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);
* Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
* Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)
* Other conditions that render outcomes or follow-up unlikely to be assessed;
* Known to be pregnant or breastfeeding;
* Use any drugs containing traditional Chinese medicine within 1 week before enrollment;
* Currently receiving an investigational drug.
Screening for Occult Malignancy in Idiopathic Venous Thromboembolism

Prospective controlled randomized study. Aim of this study is to assess the feasibility and sensitivity of CT scanning of the thorax, abdomen and pelvis for the detection of occult cancer in patients with idiopathic venous thromboembolism. Patients presenting with acute idiopathic venous thromboembolism, free from already known cancer and in whom a routine battery screening has excluded the presence of cancer, are randomized to receive either a CT scanning of the thorax, abdomen and pelvis (completed by mammography if not already performed in the past year, and by gastroscopy and/or colonoscopy in patients with positive hemoccult) or a diagnostic programme freely decided by attending physicians. Patients of either group in whom the search for cancer is negative are followed-up for two years to register the development of clinically symptomatic malignant disease. The rate of cancer detection and that of cancer development are compared between the two study groups.


Eligibility Criteria:
Inclusion Criteria:

* idiopathic venous thromboembolism

Exclusion Criteria:

* cancer already known or shown by routine battery tests
* previous venous thromboembolism
* geographic inaccessibility for long-term follow-up
* allergy to contrast medium
* refusal of informed consensus
Uric Acid and the Endothelium in CKD

This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease

The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:

1) Allopurinol therapy and 2) Placebo.

Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
* Elevated uric acid levels
* Age range: more than 18 years old
* Ability to give informed consent
* Albumin \> 3.0 g/dL
* BMI \< 40 kg/m2

Exclusion Criteria:

* Life expectancy \< 1.0 years
* Expected to undergo living related kidney transplant in 6 months
* Pregnant, breast feeding, or unwilling to use adequate birth control
* History of severe liver disease
* History of severe congestive heart failure
* History of hospitalizations within 3 months
* Active infection, on antibiotics
* History of Warfarin Use or other medications that are contraindicated with allopurinol
* Uncontrolled hypertension
* History of acute gout on Allopurinol
* History of adverse reaction to Allopurinol
* Immunosuppressive therapy within the last 1 yr
Rapamycin+Estradiol- vs. Rapamycin-Eluting Stents to Reduce Restenosis (ISAR-PEACE)

The purpose of this study is to evaluate whether adding estradiol to rapamycin better prevents coronary artery reblockage after drug-eluting stent implantation.

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neontimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence or absence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of permanent polymers in DESs, which have a proinflammatory and prothrombogenic potential, and sometimes may induce a hypersensitivity reaction. On the other hand, lack of or delayed reendothelialization is considered an important factor for development of coronary reblockage. Estradiol has been shown to promote rapid reendothelialization of the stent and to reduce the restenosis after PCI. This trial will compare the anti-restenotic efficacy of the polymer-free rapamycin plus 17β estradiolvalerat -eluting stent with that of the polymer-free rapamycin-eluting stent in patients with coronary artery disease. The ISAR stent is a rough surface stainless steel stent which allows coating without the need of polymer (PF ISAR stent) in the cath lab.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

* Target lesion located in the left main trunk or bypass graft.
* In-stent restenosis.
* Acute ST-elevation myocardial infarction.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: aspirin, clopidogrel, rapamycin, estradiol, stainless steel.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies

This study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).

This study is a pilot randomised controlled trial (RCT) comparing adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA) with a treatment as usual control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 15) and at follow-up (week 23).

Eligibility Criteria:
Inclusion Criteria:

* Parents or caregivers who identify as having a child under the age of 18 with a food allergy
* The allergy has been diagnosed by a qualified physician (e.g. GP or allergy specialist)
* Mean score of \>=2 on the FAQL-PB, indicating they are at least 'somewhat limited/troubled' by their child's allergy (Cohen et al., 2004).
* Resident in the United Kingdom
* Have access to email, a PC/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing

Exclusion Criteria:

* They had consulted on the design and content of the intervention or study
* They have already participated in a substantial mindfulness-based course
* They are currently engaged or are planning to engage with another psychological intervention during the course of the study
* They currently engage in regular mindfulness-based practice
* They do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice
* They have scores \>19 on PHQ-8 (indicating 'severe' depressive symptom severity; Kroenke et al., 2009) or \>15 on GAD (indicating 'severe' level of anxiety; Spitzer et al., 2006)
* They have a problem with alcohol or recreational drug misuse
* They have experienced thoughts about harming themselves or others in the last 12 months
* They have been given a diagnosis of psychosis
* They are currently experiencing high levels of distress and/or currently feeling particularly fragile
* They have experienced a bereavement of someone close to them in the last year or are continuing to experience continuing grief in relation to losing someone further back in time
* They have had traumatic experiences that they continue to be troubled by (including, but not limited to, receiving diagnosis of post-traumatic stress disorder)
* They experience significant difficulty being in a group with other people.

NB: for further details re the FAQL-PB and PHQ-8, please see the outcome measures section.
Intragastric pH and Bismuth Effect for H. Pylori Eradication

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan, there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric cancer development is known to follow a multistate process from non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection plays the key role of this carcinogenic process. Although H. pylori eradication would result in a marked gastric cancer reduction, treatment success using standard regimens has become more difficult in recent years, and increased antibiotic resistance is considered the most important reason for decreased treatment efficacy. As no specific new medications have been introduced in recent years, novel treatment regimens have been created using different combinations, durations and sequences of available medications. The addition of bismuth improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori to bismuth has not been reported. Bismuth absorption is not required for efficacy in H. pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth with responsible for rapid destruction of H. pylori within the stomach remain unclear. Knowledge of the mechanism of action of bismuth compounds against H. pylori would be beneficial in the development of improved treatment regimens in this era of declining eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of H. pylori in specimen through electron microscopy after bismuth therapy and provide insight into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H. pylori therapeutic strategies.


Eligibility Criteria:
Inclusion criteria

1. Age 20-69
2. Confirmed H. pylori infection by urea breath test or previous histology
3. Scheduled endoscopy
4. Mentally competent to be able to understand the consent form for individuals equal to or older than 20
5. Able to communicate with study staff for individuals equal to or older than 20
6. Without history of gastric cancer Exclusion criteria

1.History of gastric cancer

Deferral criteria:

1. Having received antibiotic treatment in the previous 15 days
2. Need of time to decide participation