cyrilzakka/clinical-trials huggingface dataset:
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.


Eligibility Criteria:
Inclusion Criteria:

1. The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
2. Patients who have showed complete response (ALT normalization and HBV DNA \<4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
3. Patients who have showed complete response (ALT normalization and HBV DNA \<4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
4. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
5. Patients with bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.

Exclusion Criteria:

1. Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
2. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
3. Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
5. Patients co-infected with HCV, HDV or HIV.
6. Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.
7. Patients who were pregnant or breast-feeding.
8. Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
9. Patients who were not suitable to the study if judged by an investigator.
Patient Activation in Dialysis

Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Patient activation refers to patients' willingness and ability to make independent actions to manage their health and care and requires knowledge, skill and confidence. This study aims to explore activation levels, using the 13 item PAM-13 survey, of incident dialysis patients at start of dialysis and after 3 months of dialysis.

Eligibility Criteria:
Inclusion Criteria:

-Incident dialysis patients commencing at Satellite Healthcare during study recruitment dates

Exclusion Criteria:

* Age \< 18 years
* Started dialysis more than 3 weeks prior to identification
* Transitioning to dialysis at a participating center from a non-participating center, when that patient has been on dialysis for more than 3 weeks at any center.
* Transitioning to dialysis after kidney transplant failure
* Inability to participate because of cognitive impairment or active psychological condition
Treatment of Acute Asthma in ER With Combination of Systemic Steroids and Inhaled Steroids

We assume that the combination of systemic steroids and inhaled steroid in the first hour of treatment in the ER will decrease the admission rate and improve faster the pulmonary function.

120 patients refferd to the ER due to asthma attack aged 18-60 with PFR \< 60% 0o predicted will participate in the study after giving informed consent.

The usual treatment in the ER is inhalation of Beta 2 short acting and I.V solumedrol 120 mg . The study group will recieve in addition 3 inhalation of Budesonide 1000 microgram each during the first hour.

The controlled group will recieve Nacl 0.9% PFR will be followed 0 30 60 120 min.

Primary end points- PFT improvment and admission rate.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic patients aged 18-60 with PFR \< 60% of predicted

Exclusion Criteria:

* Patients with other chronic diseases
* cardiac renal hepatic etc will be excluded
A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion

Assessing the safety and tolerability of Oxycodone Hydrochloride 50mg/mL in subjects with severe cancer pain.

This is study involving a treatment phase of up to 20 days. During this time patients will receive Oxycodone Hydrochloride 50mg/ml as a subcutaneous infusion. During the treatment phase, safety will be assessed by documentation of type and frequency of spontaneously reported adverse events and adverse events noted after assessment of the infusion site (every 24 hours and when resited). The subjects will be followed up for 7 days to collect information on ongoing AEs/SAEs and any new AEs/SAEs that may have occurred.

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects aged 18 years and above, who have severe cancer pain.
2. Subjects who require a strong opioid by subcutaneous infusion to stabilise and manage their cancer pain effectively.
3. Subjects who give written informed consent to participate in the study.
4. Subjects who agree to their primary care physician being informed of their participation in the study.
5. Subjects who consent to processing of their trial data according to the requirements of the UK Data Protection Act 1998.

Exclusion Criteria

1. Subjects who are pregnant, lactating or in the Investigators opinion are at risk of conceiving and are not using adequate contraception measures.
2. Subjects with known hypersensitivity (allergic reaction) to oxycodone, any other opioids or any of the excipients.
3. Subjects who are planned to receive chemotherapy during the study treatment period or are currently receiving continuous i.v. chemotherapy infusion.
4. Subjects with neutropenia, thrombocytopenia or coagulation disorders.
5. Subjects with any contraindications to oxycodone as outlined in the Investigator Brochure or Summary Product Information sheet for oxycodone.
6. Subjects who are currently participating in another clinical research study involving a new chemical entity.
7. Subjects whom the Investigator believes to be medically unfit to receive the study medication, or unsuitable for any other reason.
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.

Gestational diabetes mellitus (GDM) is the most common complication of pregnancy, with an incidence rate of 10-15% \[1\]. Common risk factors for GDM are increased maternal age and weight and as a consequence of women delaying childbirth and increasing incidence of obesity, there is a corresponding increase in the rate of GDM. GDM is associated with an increased risk of maternal and perinatal short and long-term complications . These include macrosomia, shoulder dystocia, neonatal hypoglycaemia, neonatal hyperbilirubinemia, and perinatal mortality. Maternal complications include higher risks of hypertensive disorders, perineal trauma, and caesarean section. Additionally, both the mothers with GDM and their infants have an increased risk of developing type 2 diabetes mellitus and cardiovascular disease later in life .

Screening and diagnosis of GDM is currently based on an oral glucose tolerance (OGTT), which is carried out at 26-28 weeks' gestation. In addition, an OGTT is carried out at 11-13 weeks in women considered to be at increased risk of GDM based on their demographic characteristics and medical history. Screening and diagnosis of GDM is traditionally delayed until the late second or early third trimester of pregnancy with the rationale that the diabetogenic effects of pregnancy increase with gestation and therefore delayed testing would maximize the detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age ≥ 18 years
* Planned antenatal care at the same centre (i.e. not planning to move before delivery).
* Singleton pregnancy.
* Informed and written consent.

Exclusion Criteria:

* Age \<18 years;
* Multiple pregnancy in current pregnancy;

  * Unconscious or very ill; · Serious mental illness;
  * Learning difficulties;
  * Not fluent in local language and absence of interpreter;
  * Severe congenital anomaly on ultrasound;
  * Pre-existing diabetes mellitus type 1 or 2;
  * Patients undergoing metformin therapy for infertility.
  * Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (\<1 year);
  * Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results;
  * Participating in another intervention study that influences outcomes of this study;
  * Allergy to adhesive materials;
  * Allergy to any of the components of the glucose test:
The Impact of Picture Narrative Format on Print Lung Screening Communication Outcomes

The purpose of this study is to test whether a picture narrative format is more successful, than text with pictures or text alone, in communicating lung screening information (primarily defined by positive attitudes towards the design and increase in knowledge) to people likely to be invited to lung screening where available.

Population screening is key to detecting lung cancer early at a more treatable stage. Uptake of screening should be equitable (i.e., screening benefits all eligible members of the population and does not contribute further to health disparities) and informed (i.e., participants have been involved in the decision to take part and their decision aligns with their values and circumstances). Print decision support materials are the primary mechanism for encouraging engagement with cancer screening and supporting decision making. It is essential that we identify print communication techniques that are effective in informing invitees about lung screening.

The intervention, picture narrative information about lung screening, was previously developed through codesign and prototype testing with people likely to be eligible for lung screening (50 to 75 years old, past or current heavy smokers). Participants will be randomised to one of three groups: Picture narrative format, Text with pictures (control 1) or, Text-only (control 2). This study will assess whether presenting lung screening information in a picture narrative format can improve lung cancer screening knowledge, eligibility self-assessment and attitudes. It will also assess whether perceptions of the information designs can explain any impact of the intervention on these outcomes and whether there are differences across socioeconomic groups.

Eligibility Criteria:
Inclusion Criteria:

* Living in Glasgow
* Willing and able to respond unaided to invitation to participate in the trial and give informed consent.
* Aged between 49 and 75 years

Exclusion Criteria:
Pre-operative Hormonal Treatment for Hormone Receptor Positive Breast Cancer

To investigate prospectively whether short term endocrine treatment can induce molecular changes, predictive for therapy response.

We will perform a randomized, open-label, single-institution study. It will compare the efficacy of three different endocrine treatment regimens (Anastrozole +/- Fulvestrant or Tamoxifen) in changing proliferation-index and inducing apoptosis during a 2-6 week pre-operative treatment period in breast cancer patients. These results will be correlated to gene expression profiles, phosphorylation status of the ER, SNPs in CYP450 sequences, tamoxifen metabolite concentrations, changes in estrogen serum levels and protein expression patterns.

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven invasive adenocarcinoma of the breast
* Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer)
* WHO-performance score 0 or 1
* Written informed consent

Exclusion Criteria:

* Clues of metastatic disease by clinical examination according to most recent NABON guidelines
* Multicentric breast cancer
* Inflammatory breast cancer
* Hormone replacement during the last 12 months
* Other systemic treatment during the waiting time till surgery
* Already planned date for surgery within the next 2 weeks
* Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol
* Patient's refusal to undergo a core biopsy procedure of the primary tumor before the start of treatment

NB: a concomitant malignancy within the last five years is not an exclusion criterium, because survival is not the primary endpoint. Just as prior invasive breast cancer or DCIS within the last 15 years is not an exclusion criterium.

NB: Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during the study.
Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle"

In this study researchers want to gather more information about safety and effectiveness of BAY 2599023 (DTX201), a drug therapy that delivers the human factor VIII gene into the human body by use of a viral vector to treat the disease. By replacing the defective gene with a healthy copy the human body may produce clotting factor on its own. Hemophilia A is a bleeding disorder in which the human body does not have enough clotting factor VIII, a protein that controls bleeding. Researcher want to find the optimal dose of BAY 2599023 (DTX201) so that the body may produce enough clotting factor on its own.


Eligibility Criteria:
Inclusion Criteria:

* Males age 18 years or older.
* Confirmed diagnosis of hemophilia A as evidenced by their medical history with plasma FVIII activity levels \< 1% of normal or at screening.
* Have \>150 exposure days (EDs) to FVIII concentrates (recombinant or plasma-derived).

If on prophylaxis, are required to be willing to stop prophylactic treatment at specified time points throughout the study or If on-demand: should have had \> 4 bleeding events in the last 52 weeks

- Agree to use reliable barrier contraception.

Exclusion Criteria:

* History of allergic reaction to any FVIII product.
* Clinically relevant findings in the physical examination considered critical by the treating physician, including obesity with BMI \> 35 kg/m\*2
* Current evidence of measurable inhibitor against factor VIII, prior history of inhibitors to FVIII protein or clinical history suggestive of inhibitor.
* Evidence of active hepatitis B or C.
* Currently on antiviral therapy for hepatitis B or C.
* Significant underlying liver disease.
* Serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm\*3; HIV+ and stable participants with CD4 count \>200/mm\*3 and undetectable viral load are eligible to enroll.
* Detectable antibodies reactive with AAVhu37capsid.
* Participant with another bleeding disorder that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B).
* Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks.
* Known or suspected hypersensitivity or allergic reaction to trial product(s) or related FVIII products or any component of BAY2599023 (DTX201), or a contraindication to prednisolone
Faith in Action! A Church-Based Navigation Model to Increase Breast Cancer Screening in Korean Women

The purpose of this research is to develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings and evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings in Los Angeles, California. The primary research procedures include trainings and key informant interviews with lay health navigators in faith-based settings followed by a cluster randomized trial to evaluate the intervention.

A parallel cluster randomized trial (CRT) with staggered roll-out will be conducted to evaluate the efficacy of the "Faith in Action!" intervention on breast cancer screening rates among Korean American women. This will involve two blocks of 8 churches each (total 16 churches) randomized to either the intervention or waitlist control.

A train the trainer approach will be used to educate and certify lay health navigators identified by targeted Korean church leaders from selected churches. The trained health navigators will be deployed back to the churches and community settings with tools and resources to deliver cancer education and increase motivation to participate in breast cancer screening through proven approaches such as one-on-one education, small media and workshops.

The research objectives are to:

1. Develop a culturally adapted "Faith in Action!" curriculum to train lay health navigators to provide breast cancer screening navigation to Korean American women within faith-based settings.
2. Evaluate whether the culturally adapted "Faith in Action!" curriculum increases adherence to breast cancer screening guidelines among Korean American women within faith-based settings.

It is hypothesized that the implementation of this culturally adapted cancer screening training curriculum for lay health navigators, built upon the Korean communities' frequent engagement with "expert" schools and deployed among existing networks in the faith-based Korean community, will increase adherence to breast cancer screening guidelines among underserved Korean American women.

Eligibility Criteria:
Inclusion Criteria:

* Korean woman who is 45 years or older
* Does not currently have a breast cancer diagnosis
* Non-adherent to cancer screening (did not receive mammogram in last 2 years based on self-report)
* Prospective or current member of participating Korean Churches
* Willing to participate in study

Exclusion Criteria:

* Does not meet inclusion criteria as described above
Urdu Translation of Wayfinding Questionnaire for Stroke Patients

Descriptive analytical study to translate WQ in Urdu Language. The WQ is in English Language the name of the author of WQ is Van der Ham Et al and firstly introduced in 2013. The reliability of this English tool is 0.70 to 0.80 it has been translated in various Languages i.e Hungarian, Dutch and Chinese and suffering from stroke. But it was not translated in Urdu Language. No such study has been previously conducted in Pakistan region which translates the scale and follows the proper cross-cultural adaptation

For resolving such problem WQ play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. The scale consists of 22 items. All the items dated from 01 to 07 in which stroke patients are accessed. The patients who are taken in the study age from 18 to 65 years. As the WQ is a well-developed measurement scale for accessing navigation in stroke patients. It is meaningful to validate its Urdu version. The translation and cultural adaptation process would start after obtaining approval from the developer of the original WQ. This would be done according to bitten guidelines. The purpose will be to gain uniformity in the translation of both the target Language and source Language. This will involve 5 steps which is forward translation, synthesis 1, back translation, synthesis 2 and pallet testing. The second step would be done according to the Beaton guidelines in which psychometric properties will be measured that is internal consistency, test retest reliability, Discriminant validity, Convergent Validity, Content Validity and Factor analysis

Eligibility Criteria:
Inclusion Criteria:

* Age group 45-65 years
* Male and Female.
* Both ischemic and hemorrhagic stroke
* Patient may have First or Recurrent Stroke.
* Recovery is \> 6 months of First Stroke event
* MMSE score \> 25

Exclusion Criteria:

* Population suffering from Severe Global Aphasia.
* Population suffering from Severe Mobility Problem.
* Any other neurological disease dementia
* Alzheimer's
* Cognitive Decline before Stroke
Study Evaluating Retinal Health Monitoring System Thickness Module

Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).

Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.

Eligibility Criteria:
Inclusion Criteria:

1. Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
2. Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
3. Able to perform self-testing of retinal thickness with the RHMS-RTM after training
4. Able and willing to give informed consent
5. Group 1:

   1. Macula with normal thickness \[central subfield thickness (CST) below 305 microns as measured by SD-OCT\] in at least one eye
   2. Patients with dry AMD are eligible for enrollment into Group 1
   3. No history of wet AMD, DR, or RVO in either eye
6. Group 2 and Group 3 (in at least one or the same eye):

   1. History of center-involving macular edema due to wet AMD (Group 2); or DR or RVO (Group 3)
   2. Macular edema on SD-OCT with CST ≥ 305 microns

Exclusion Criteria:

1. History of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye
2. History of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s)
3. Participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening
4. Refractive error: spherical equivalent of \> 3 diopters of hyperopia or \> 6 diopters of myopia, or \> 2 diopters cylinder in the study eye(s)
5. History of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)