cyrilzakka/clinical-trials huggingface dataset:
A Real-world Study of Imraldi® Use

The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU).

The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events.


Eligibility Criteria:
Inclusion Criteria:

* Initiation on Imraldi® therapy after 18th October 2018, as part of routine treatment immediately after transitioning from at least 16 weeks' treatment with originator adalimumab (Humira®)
* Availability of at least one Baseline disease score (i.e. within 16 weeks prior or up to 6 weeks post-initiation of Imraldi®)
* Should provide informed consent to participate in the study

Exclusion Criteria:

- Unlikely to attend for regular clinic visits for the duration of study follow-up, in the opinion of the Investigator
A Sham Controlled Study of the Effects of Ultrasonic Shockwaves as a Treatment for Chronic Pelvic Pain

Introduction:

Chronic pelvic pain with unknown pathology is a condition that affects both men and women. the condition is defined as pelvic pain lasting for a minimum of 6 months without any known etiology eg. cancer, infection or inherent anatomical abnormalities. Low intensity extracorporeal shockwave therapy (LIESWT) enables the practitioner to deliver a small amount of energy approximately 5 cm under the skin of the patient without damaging the skin. This have been shown to increase blood flow and accelerate healing which could also be beneficial in chronic pelvic pain patients.The purpose of this study is to investigate the effects of LIESWT on chronic pelvic pain.

Methods:

All patients will be treated at the Birthe Bonde clinic, in Copenhagen, Denmark.

The investigators anticipate to include 100 chronic pelvic pain patients in the study.

included patients will be randomized into two groups: active treatment or sham treatment.

All patients will be required to provide a urine sample and a semen sample prior to final inclusion. Samples will be analyzed for microbial growth. Furthermore, patients will undergo a digital rectal exploration and finally all patients is required to provide an informed consent in order to be included in the study.

A Storz Doulith SD1 T-Top (CE1275) will be used to generate shockwaves. Patients will receive the treatment once a week until their symptoms have seized or for a maximum of 6 times. Each treatment consists of 3000 shockwaves applied to the perineum with a energy density of 0.25-0.40 millijoule(mJ)/mm2 and a frequency of 3 hz.

Participants will fill out a questionnaire one week before the treatment, one week, four weeks, and twelve weeks after the last treatment.

Possible gains from this study:

The investigators hope to provide further evidence for this treatment and consequently be able to offer the treatment as an alternative to the very limited array of treatments existing for this group of patients today.

Ethics, funding, and publication:

The study is performed in compliance with the Helsinki declaration. External funding have been applied for but not yet received. Participants will be informed of sources of external funding. The result of the study will be published as soon as possible, preferably in a peer-reviewed international journal.


Eligibility Criteria:
Inclusion Criteria:

* pelvic pain with a duration of more than 6 months
* be able to read and understand the study information

Exclusion Criteria:

* known etiology for pelvic pain eg. cancer, infection, inherent abnormalities.
* diagnosed with hemophilia
* receiving anti thrombotic therapy other than hearth magnyl
* diagnosed with thrombocytosis
* active cancer
* treated with IV glucocorticoids within the last 6 months
* disease in the rectal area
* abnormal digital rectal exploration
* bacteriospermia
Dipole Density Mapping in Supraventricular Tachycardia

Use of dipole density mapping to identify activation in complex supraventricular tachycardias.

The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows:

NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, \& Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI)

All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.

Eligibility Criteria:
Inclusion Criteria

1. Be aged 18-75 years
2. Be scheduled for ablation of an SVT due to the arrhythmia being recurrent, poorly tolerated, and /or unable to be controlled with antiarrhythmic drugs.
3. Be able and willing to give informed consent

Exclusion Criteria

1. Have any of the following:

   * implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped
   * permanent pacemaker or ICD leads in the chamber being mapped
   * hypercoagulopathy or an inability to tolerate anticoagulation during the procedure
   * Stents in the area of the pulmonary veins (Study CL-SVT-004 ONLY)
2. MI within the prior two (2) months
3. Cardiac surgery within the prior three (3) months
4. Intracardiac thrombus
5. Clinically significant tricuspid and/or mitral valve regurgitation or stenosis
6. Cerebral ischemic event (including TIA) in the prior six (6) months
7. Pregnant or nursing
8. Currently enrolled in another clinical investigation
9. Have a contraindication for transfemoral venous access (Study CL-SVT-004 ONLY)
10. Have a contraindication for transseptal left atrial access (for patients with left atrial arrhythmias) (Study CL-SVT-004 ONLY)
11. Life expectancy of less than one (1) year (Study CL-SVT-004 ONLY)
12. Any health condition that, in the Investigator's opinion, would not allow the application of the investigational device (Study CL-AF-004 ONLY)

NOTE: The additional exclusion criteria for CL-SVT-004 were not expected to alter or bias the patient selection for study enrollment. While these criteria would have been assumed by other investigators as a standard of care for safe enrollment in a clinical study, the German EC approval required the additional statements.
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females

The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.


Eligibility Criteria:
Inclusion Criteria:

* 9-30 healthy female able to provide legal identification.
* Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
* Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.

Exclusion Criteria:

* Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
* History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
* History of severe allergic reaction that required medical intervention.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
* Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
* Fever prior to vaccination (auxiliary temperature ≥37.3 °C).
* Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.
* Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.
* Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
* Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.
* According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients.

This study is a prospective single-arm clinical study. 37 patients with right colon cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction are planned to be included in the study. The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The primary endpoint is the postoperative complications of this type of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that NOSES could reduce postoperative complications. In addition, operating time, intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven colon carcinoma;
2. Imaging diagnosis of T1-3 colon cancer;
3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
4. Maximal tumor diameter ≤5 cm;
5. Body mass index (BMI) ≤30 kg/m2;
6. Written informed consent;

Exclusion Criteria:

1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;
Studying Tumor Tissue Samples to Learn More About DNA Changes and Response in Patients With Breast Cancer Treated With Bevacizumab on Clinical Trial ECOG-2100

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This laboratory study is examining tumor tissue samples from patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100 to learn more about DNA changes and response in these patients.

OBJECTIVES:

Primary

* Assess the effect of known variant polymorphisms (with functionally important associations) of the vascular endothelial growth factor (VEGF) gene on outcome (time to progression) in patients with breast cancer treated with bevacizumab on clinical trial ECOG-2100.

Secondary

* Assess the effect of known variant polymorphisms (with functionally important associations) of the VEGF receptor-2 (KDR) gene on outcome (time to progression) in these patients.
* Assess the effect of known variant polymorphisms of these genes on efficacy (objective response rate and survival) in these patients.
* Assess the effect of known variant polymorphisms of these genes on toxicity outcome in these patients.
* Assess the effect of VEGF polymorphisms on VEGF expression by immunohistochemical staining (a known prognostic marker).
* Assess the effect of KDR polymorphisms on KDR expression by immunohistochemical staining.

OUTLINE: This is a multicenter study.

Tissue and genomic DNA samples from paraffin-embedded primary tumor are examined using standard polymerase chain reaction (PCR) restriction fragment-length polymorphisms, immunohistochemistry, allele-specific PCR, and/or Taqman-based assays. Vascular endothelial growth factor (VEGF) and VEGF receptor-2 (KDR) expression and polymorphisms are assessed.

PROJECTED ACCRUAL: A total of 500 specimens will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the breast
* Enrolled on clinical trial ECOG-2100 and received treatment with bevacizumab
* Paraffin-embedded tumor samples available
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of LY3127804 in Participants With COVID-19

A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants who are hospitalized with pneumonia and presumed or confirmed COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Are hospitalized with pneumonia, and presumed or confirmed COVID-19
* Are able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed)

Exclusion Criteria:

* Female participants must not be pregnant and/or lactating
* Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent mandatory ventilation (IMV), or are ineligible for IMV
* Have any concurrent serious medical condition (for example dialysis) or concomitant medication that would preclude participation in the study
* Are moribund irrespective of the provision of treatments
* Have a known history or show evidence of human immunodeficiency virus (HIV) and/or hepatitis
* Have recently undergone major surgery or central venous access device placement
* Have a significant bleeding disorder or active vasculitis
* Have experienced a thromboembolic event
* Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac arrhythmia
* Have a serious, nonhealing wound, peptic ulcer, or bone fracture
* Have liver cirrhosis
* Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins
* Have a history of hypertensive crisis or hypertensive encephalopathy or current, poorly controlled hypertension
Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand

International and national guideline for chronic hepatitis B (HBV) infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. In Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital.

Recently, many of simplified scoring system (TREAT-B score, WHO (World Health Organization)-simplified score and REACH-B score) were developed for assessment of antiviral initiation.

This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.

According to WHO Global health sector strategy on viral hepatitis 2016- 2021, WHO aim to global eliminate HBV infection within 2030. Main strategies for achievement are effective prevention and treatment.

International and national guideline for HBV infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. Thus, HBV viral load and liver elastography are required for indication assessment. In low-to-middle income country such as Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital.

Recently, many of simplified scoring system (TREAT-B score, WHO-simplified score and REACH-B score) were developed for assessment of antiviral initiation.

This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021
* Age \> 18 years

Exclusion Criteria:

* Treatment experience chronic hepatitis B infection patients
* HIV co-infection
* HCV (hepatitis C) co-infection
* concomitant HCC (hepatocellular carcinoma)
* Pregnancy
* Incomplete data
Emotional Attention Bias Modification and Targeted Memory Reactivation in Alcohol Use Disorder

Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification.

This protocol uses TMR during REM sleep to strengthen associative memories generated by emotional attention bias modification (EABM), an effective treatment for controlling craving levels in patients with Alcohol Use Disorder (AUD). EABM involves exposure to negative emotional words (e.g., frustrated, inferior) associated with alcohol-related cues and positive emotional words (e.g., successful, confident) associated with healthy lifestyle cues. The goal is to reduce alcohol-related cue positive emotional attention bias (EABs). In EABM training, alcohol-related cues and healthy activity (e.g., exercising, reading, playing musical instruments) images are always paired with negative words and positive words, respectively. The TMR group receives the EABM protocol with auditory cue feedback (sound S1-Alcohol; sound S2-Healthy Life); the control group receives the EABM protocol without auditory cue feedback. All patients will perform EABM every evening and will be exposed to sounds S1 and S2 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the EAB and craving levels of AUD will be conducted before and after (with a 2-week follow-up). The investigators hypothesize that patients treated with EABM and who are exposed during REM sleep to a sound that had previously been associated with the new negative memory of alcohol and the positive memory of a healthy lifestyle (TMR group) will have more reduced EAB and craving levels compared to participants exposed to the same, but non-associated, sound during REM sleep (control group).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years; Meets the diagnostic criteria for Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013); Alcohol withdrawal period of less than 6 months; Normal vision and hearing, or corrected to normal; Agrees to participate in the study and is able to cooperate to complete the experiment.

Exclusion Criteria:

* Acute alcohol withdrawal period: Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score ≥ 9; History of organic brain diseases or brain trauma; History of seizures, other neuropsychiatric disorders, or family history of psychiatric disorders; Presence of substance abuse/addiction other than alcohol (excluding nicotine addiction).
Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.


Eligibility Criteria:
Inclusion Criteria:

Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation.

Exclusion Criteria:

* Surgery is scheduled in less than 12 weeks.
* Paralytic or completely immobilized patient, condition making physical training impractical.
* Cognitive disability making participation impossible.
* Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults

Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in HIV-infected population are few. The present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (Gardasil®) in HIV-infected female and male adolescents and young adults.


Eligibility Criteria:
Inclusion Criteria:

* For both HIV-infected and healthy subjects:

  * Subjects aged 13-27 years, females and males
  * Written informed consent from parent or guardian if applicable (age\<18 years)
* For HIV-infected subjects:

  * HIV-positive
  * Asymptomatic subjects (generalized lymphadenopathy is accepted)
  * Lymphocyte CD4+ count \> or equal to 350 cells/mm3
* For subjects receiving HAART:

  * Good compliance to therapy
  * At least two suppressed viral loads HIV-RNA (\<37copies/ml9 during 6 months prior to enrollment.

Exclusion Criteria:

* For female subjects (both HIV-infected and healthy)
* Pregnancy or breastfeeding
* Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.
* For both females and males (HIV-infected and healthy):
* Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.
* History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.
* Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
* Acute infection requiring therapy or fever at time of enrollment
* Chronic autoimmune or oncologic disease receiving chemotherapy
* Concomitant therapies (other than HAART):
* Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.
* Use of investigational agents within 4 weeks prior to study enrollment.
* Current drug or alcohol use or dependence.
* Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.