cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Age 18-65 years old.
* HBsAg positive \>6 months.
* ALT \>= 2 ULN \>6 months.
* HDV RNA positive serology.
* Serum antibody to hepatitis delta antigen of IgG and IgM class.
* Knodell score HAI \>= 6 and F \>= 0; positive test for intrahepatic Delta antigen in liver biopsy.
* Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
* Participants must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
* Participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

Exclusion Criteria:

* Age \<18 and \>65.
* Concomitant HCV and/or HIV infection.
* Actual liver failure (total serum bilirubin \>2.5 x normal, prolonged prothrombin time \>3 sec, serum albumin \<3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
* Toxic or autoimmune hepatitis (ANA titers \> 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
* Women who are pregnant or nursing.
* Leukopenia (\<2500/mm\^3), neutropenia (\<1000/mm\^3), hemoglobin \<10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
* Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
* Depression and/or psychiatric disorders.
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.

This is a study of the efficacy and safety of MTG201 given by intratumoral injection to patients with malignant pleural mesothelioma who have failed front line chemotherapy. Patients will also receive IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.

MTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic pleural mesothelioma
* Failed one prior treatment regimen including cisplatin-based chemotherapy
* Eastern cooperative oncology group (ECOG) performance status; 0,1
* Adequate organ function
* Measurable disease per RECIST

Exclusion Criteria:

* Candidate for surgical resection
* has active autoimmune disease, primary or acquired immunodeficiency
* significant cardiovascular disease
* has active interstitial lung disease
* has active infection or HIV, hepatitis B or C
* previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy
* other clinical significant disorder that could affect conduct of study
Increasing the Uptake of Advanced Directives in SingHealth Polyclinics

An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. Despite the AMD act being passed in Singapore Parliament in 1996, uptake remains low among the population. Several intervention studies have shown that education and communication can be effective in promoting end-of-life discussion and planning. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.

An Advanced Medical Directive (AMD) is a legal document in Singapore that allows one to inform their medical practitioner that they do not want any life-sustaining treatment should they become unconscious and terminally ill where death is imminent. It may be completed by any person, of sound mind, aged 21 years and above.The AMD Act was passed in the Singapore Parliament in May 1996.

A cross-sectional, community-based study surveyed 1200 selected households in Singapore. Only 37.9% of the sample population had heard of the AMD prior to the study, though when approached, 60.6% were willing to sign an AMD. As of 2017, less than 25,000 people (0.45%) in Singapore have opted to sign an AMD.

Past studies have shown that end of life discussions reduce stress, anxiety, and depression in surviving relatives. A local study in 2010 revealed a 33% patient-surrogate discrepancy in end-of-life decision making.

There are a lack of intervention studies regarding AMD in Singapore. In this study, we aim to compare the effectiveness of counselling sessions together with pamphlets, versus pamphlets alone, versus current care, in increasing the completion rates of the AMD in the Singapore Polyclinic setting.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40
* Patient who seeks medical consultation at Singhealth Polyclinics (Bedok, Marine Parade, Outram, Tampines)

Exclusion Criteria:

* History of dementia
* History of depression
* Known diagnosis of terminal illness
* Signed Advanced Medical Directive/Advanced Care Plan previously
Neurocognitive Function After Therapy of OSAS

Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. A comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. The "Apnea-hypopnea index" (AHI) defined as events per hour, gives information about the severity of the disease. The American Academy of Sleep Medicine Task Force" defined that more than 5 episodes per hour is strongly suspect for an OSAS disease. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. The prevalence rise with age and about 20% of the population is suspect to a sleep disorder. However about 1-5% of male and about 0,5-2% of female aged adults are affected. Main reason is obesity. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. It is notable that the long-term mortality is comparable in both medical treatment options. However, a comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

Eligibility Criteria:
Inclusion Criteria:

\* Patients within 30 to 70 years of age both gender.

Exclusion Criteria:

* Patients under 30 years of age or older than 70 years of age.
* Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy.
* Preexisting neurological, neuropsychological medication.
* Preexisting neuromuscular diseases.
* Alcohol - and drug abuse.
* Postoperative complications, pain and time shifts within the test protocol.
Neural Bases of Cognitive Rehabilitation for Brain Injury

Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.

Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed.

We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU).

GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention.

Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are \> 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).

Exclusion Criteria:

* Severely apathetic/abulic
* aphasic
* or other reasons for patients being unable or unwilling to participate with the training tasks
* severe cognitive dysfunction
* history of neurodevelopmental abnormalities
* ongoing illicit drug or alcohol abuse (AUDIT\>8)
* severe depression as measured by Beck Depression Inventory (\>29)
* severe PTSD precluding participation in research activities (such as group training or MRI scanning)
* There will be no restriction in regard to gender, race and socioeconomic status.
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum

A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum


Eligibility Criteria:
Main Inclusion Criteria:

1. 18 years or older at the time of signing the informed consent.
2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer, Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case of PARACELSUS score \< 10, additional justification shall be provided by the investigator to support clinical diagnosis of ulcerative PG.
3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of ≥ 5 cm 2 at screening and baseline

   * circulated by intact skin
   * evaluable by at least 2-dimensional measurement

Main Exclusion Criteria:

1. Patients with target ulcers exceeding 80 cm 2 .
2. Patients with target ulcer in transplanted skin.
3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).
4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start of treatment with IMP).
5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start of treatment with IMP).
6. Any active infection requiring systemic antibiotic or other systemic treatment or suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of treatment with IMP).
7. Patients received any systemic medical treatment for PG within 4 weeks prior to baseline
8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks prior to baseline (i.e., start of treatment with IMP), except existing biologic or immunomodulatory therapy used for an underlying disease (other than PG at a stable therapy with no dose adjustments for at least two maintenance doses prior to screening this is allowed to be continued.
9. Patients receiving corticosteroids treatment for PG of more than 10 mg/day of prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment with IMP).
Prognostic Value of The Age, Creatinine, and Ejection Fraction Score for Non-infarct-related Chronic Total Occlusion Revascularization After Primary Percutaneous Intervention in Acute ST-elevation Myocardial Infarction Patients: A Retrospective Study

The age, creatinine, and ejection fraction (ACEF) score has been used to evaluate the clinical prognostic to patients who underwent PCI. However, it is not known if ACEF score could evaluate the prognostic of recanalization of non-infarct-related coronary arteries (non-IRA) chronic total occlusions (CTO) in patients who successful underwent primary PCI. The objectivity of current study was to assess the prognostic value of ACEF score in acute ST-segment elevation myocardial infarction (STEMI) patients with non-IRA CTO after successful primary PCI.


Eligibility Criteria:
Among the 2952 patients with STEMI successful treatment by PCI, 395 patients (13.4%) had a non-IRA CTO lesion. 18 patients were excluded from current study as they death within 7 days (n=6) or were not to follow-up (n=7). Due to unavailability of ejection fraction or renal function before CTO-PCI, ACEF score could not be calculated in 5 patients. The remaining 377 patients (95.4%) were finally analyzed in the study. 279 patients performed a staged CTO-PCI attempt(ranging 7-28 days) and was successful in 221 of them. Due to low possibility of PCI success or patients refused to perform PCI, 98 patients did not undergo the PCI attempt. The patients were then divided into successful CTO-PCI group (221 patients) and failed/ non-attempted CTO-PCI group (156 patients).

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Preserving Fertility After Colorectal Cancer Study

The PREFACE Study is a prospective, longitudinal cohort study of reproductive health and clinical outcomes among individuals diagnosed with colorectal cancer between age 18 to 49 years.

The Preserving Fertility After Colorectal Cancer (PREFACE) Study comprehensively investigates fertility, sexual health and clinical outcomes along the cancer care continuum among individuals diagnosed with colorectal cancer between age 18 to 49 years.

Patients are recruited prior to colorectal cancer therapy \[baseline\] and followed for up to 36 months after completion of first-course therapy (or 45 months after diagnosis for patients on maintenance therapy). Study timepoints are defined at: (i) completion of first-course treatment (or 9 months after diagnosis for patients on maintenance therapy \[treatment\]); (ii) and at 9, 18 and 36 month intervals thereafter \[surveillance\]. This cohort is enriched by a robust collection of biospecimens and data.

Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of colorectal cancer
* Age 18 to 49 years at colorectal cancer diagnosis
* Diagnosed by and/or consulting with a physician participating in the PREFACE Study
* No prior history of colorectal cancer and/or colorectal cancer treatment
* Mentally and physically able to consent and participate in the study

Exclusion Criteria:

* Women who are pregnant at the time of colorectal cancer diagnosis
* Prisoners
* Unable to provide informed consent
* Unable to read, write, or complete questionnaires in English
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
2. Mentally competent to understand the nature, the scope and the consequences of the study
3. Able and willing to give written informed consent prior to study entry
4. Available for all the visits scheduled in the study
5. in good health as determined by:

   1. Medical history related to the previous six months,
   2. Physical examination,
   3. Clinical judgment of the investigator.

Exclusion Criteria:

1. Unwilling or unable to give written informed consent to participate in the study
2. Currently experiencing an acute infectious disease
3. Any serious disease such as, for example:

   1. Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
   2. Autoimmune disease (including rheumatoid arthritis)
   3. Advanced arteriosclerotic disease or complicated diabetes mellitus
   4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
   5. Acute or progressive hepatic disease
   6. Acute or progressive renal disease
   7. Congestive heart failure
4. Surgery planned during the study period
5. Bleeding diathesis
6. History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
7. Known or suspected impairment/alteration of immune function resulting from:

   1. Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
   2. Receipt of immunostimulants
   3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study
   4. High risk for developing an immunocompromising disease
8. History of drug or alcohol abuse
9. Laboratory confirmed influenza disease in the past 6 months
10. Received influenza vaccine within the past 6 months
11. Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
12. Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
13. Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
14. Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
15. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial

The purpose of this multicentre prospective trial is to determine the incidence and risk factors for surgical wound infections. Also the investigators will evaluate consequences of wound infections to the patients, and extra costs caused by wound infections.


Eligibility Criteria:
Inclusion Criteria:

* non-emergency infrarenal aortic or lower limb arterial surgery

Exclusion Criteria:

* patient's refusal to participate
The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis

Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.

The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.

However, the definite effect of intra-articular PRF for osteoarthritis from current published studies are insufficiently proved because of small patient numbers and lack of placebo-controlled design. The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30-75 year-old
* Clear consciousness
* No receive steroid injection, hyaluronic acid, platelet rich plasma in past 6 months
* The pain (VAS) more than 4
* Symptom duration at least 6 months

Exclusion Criteria:

* Cancer
* Joint contracture
* Coagulopathy
* Pregnancy
* Status of Pacemaker
* Inflammation status
* Operative history of treated joint