cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months
* Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
* Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
* Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 6 months after the last dose of investigational product

Inclusion Criteria for Transition-Extension Period:

* Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study
* In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period

Exclusion Criteria:

* Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
* Have a known hypersensitivity to human immunoglobulin proteins or other components of Remicade or SB2
* Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
* Have a current diagnosis of active tuberculosis
* Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
* Have any of the following conditions

  1. Other inflammatory or rheumatic diseases.
  2. History of any malignancy within the previous 5 years prior to Screening
  3. History of lymphoproliferative disease including lymphoma.
  4. History of congestive heart failure
  5. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
  6. History of demyelinating disorders.

Exclusion Criteria for Transition-Extension Period:

* Have been withdrawn from the SB2-G31-RA study for any reason
* Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.

The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 4 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.

Eligibility Criteria:
Recipient Inclusion Criteria

* Participants ≥ 40 years old
* On the deceased donor kidney waitlist at Johns Hopkins Hospital
* Awaiting a first or second kidney transplant
* No available living kidney donors
* On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a glomerular filtration rate \<15 ml/min for ≥ past 90 days
* HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
* Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 80%

Recipient Exclusion Criteria

* Plan to receive a multi-organ transplant
* Plan to receive a dual kidney transplant (including en bloc)
* Prior solid organ transplant
* Participating in another study that involves an intervention or investigational product
* Plan to receive a blood type incompatible kidney
* History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
* Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
* Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?

The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. The main question is to determine the number of participants who can successfully be re-fit into DT1 CL, by utilizing a cldeq-8 questionnaire as well as an investigator developed questionnaire to gauge comfort and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.
2. Participants will be required to have worn Oasys MAX 1-day CLs for at least 3 months in the past year and currently wearing these CLs.
3. All participants will be required to have a CLDEQ-8 score \<12 while wearing their habitual CLs (Oasys MAX 1-days) and to indicate that they are satisfied with Oasys MAX 1-day CLs (Yes/No).
4. Participants will be required to be able to wear DT1 Sphere CLs (astigmatism \< 0.75D OD/OS).
5. Participants will be required to wear the study CLs for ≥12 hours with no overnight wear
6. Participants will be required to use digital devices at least 8 hours/day.
7. Participants will be required to provide a glasses prescription that is less than 3 years old.

   -

Exclusion Criteria:

* 1. Have presbyopia and/or need a reading add as determined during their initial manifest refraction.

  2. Have worn DT1 in the past for more than 1 week. 3. Are past rigid CL wearers. 4. Have a history of being diagnosed with dry eye or ocular allergies. 5. Have known systemic health conditions that are thought to alter tear film physiology.

  6. Have corrected acuity 1 line or more worse vision recorded at Visit 2 (compared to the Visit 1 findings) with their optimized Oasys MAX 1-day lenses.

  7. Have a history of viral eye disease. 8. Have a history of ocular surgery. 9. Have a history of severe ocular trauma. 10. Have a history of corneal dystrophies or degenerations. 11. Have active ocular infection or inflammation. 12. Are currently using isotretinoin-derivatives or ocular medications. 13. Are pregnant or breast feeding
Nutritional Needs and Intake on Clinical Outcomes in Mechanically Ventilated Critically Ill Elderly Patients

The purposes of this study were to investigate the caloric requirement and clinical outcomes in mechanically ventilated critically ill elderly patients and identify those at high nutritional risk who require high protein formula intervention.

The elderly population is rapidly increasing, but studies on calorie requirement in critically ill elderly patients are few, and indirect calorimetry (IC) is not available in every intensive care unit (ICU). The aim of this study was to compare IC and Harris-Benedict (HB) predictive equation in different BMI (body mass index) groups. And to investigate whether the nutrition intake from EN (enteral nutrition) and PN (parenteral nutrition) created a better clinical outcome than EN alone in HNR (high nutritional risk) mechanically ventilated critically ill elderly patients.Inclusion criteria were: age ≧65 years old, APACHE Π score ≧15, mechanical ventilation ≧48 hours and on NG tube feeding. Nutritional risk was screened by mNUTRIC and GNRI. Indirect calorimetry and HB equation were used to assess energy requirements. Patients were randomized 1:1 to two tube feeding regimens: general formula and high protein formula (1.5\~2.0 gm/kg BW). Nutritional intake from EN, the type and amount of intravenous nutrition within 7 days, tolerance to feeding, MVD (Mechanical Ventilation Day), newly diagnosed VAP (Ventilator Associated Pneumonia), ICU and hospital LOS (Length of Stay) and date of death were recorded. We used SAS version 9.4 for statistical analysis. Statistically significance was set at α=0.05.

Eligibility Criteria:
Inclusion Criteria:

* APACHE Π score ≧ 15
* ≧ 65 years
* on mechanical ventilation ≧48 hours
* received EN

Exclusion Criteria:

* Use of total parenteral nutrition
* Fasting \>5 days
* Brain death
* Terminal cancer
Disposable Versus Reusable DrApes and Gowns for Green OperatiNg Theatres

Multicentre non-inferiority cluster randomised trial testing Disposable versus Reusable drApes and Gowns for green OperatiNg theatres. A pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.

Background: The World Health Organisation makes no recommendation for the use of disposable or reusable surgical drapes and gowns due to a lack of effectiveness evidence. Since disposable versions are likely to have higher financial and carbon costs, they are only justifiable if they can be proven to significantly reduce surgical site infections (SSIs).

Aim: This randomised controlled trial will assess whether reusable surgical drapes and gowns are non-inferior in reducing SSI compared to disposable drapes and gowns in patients undergoing surgery.

Design: Pragmatic 1:1 international multi-centre non-inferiority cluster randomised controlled trial, with an internal pilot. Clusters are individual hospitals.

Intervention: Reusable surgical drapes and gowns.

Comparator: Disposable (single-use) surgical drapes and gowns.

Sample size: The control group SSI event rate is estimated to be 12.5% based on previous literature. To determine whether reusable drapes and gowns are non-inferior to disposable drapes and gowns with a non-inferiority margin of 2.5% would require a total of 26,800 participants from 134 clusters, with an average of 200 participants per cluster, assuming 90% power, 2.5% one-sided alpha, intraclass correlation of 0.01 and 5% participant loss to follow up.

Eligibility Criteria:
Inclusion criteria:

* Patients with at least one incision that is ≥5cm in adults and ≥3cm in children aged under 16 years. This can include both open and minimally-invasive surgery providing at least one incision meets this criteria.
* Patients with a clean-contaminated, contaminated, or dirty surgical wound. Definitions of contamination are given in Table 2.
* Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) surgery.
* Any operative indication (including caesarean section).
* Patients aged 10 or over.

Exclusion criteria

* Adults with an incision \<5 cm and incision \<3cm in children aged under 16 years.
* Patients undergoing procedures with a clean surgical wound only.
The Use of Deep Inspiration Breath Hold and Prone Irradiation to Decrease Cardiac Radiation Exposure

This study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose.

This study aims to discover more about radiation techniques for people treated for left-sided breast cancer that minimizes exposure to the heart, as noted by mean heart dose. Both prone (lying face down) radiation and Deep Inspiration Breath Hold (DIBH) are more labor-intensive and usually require longer treatment times for patients than traditional supine (lying face up) free-breathing radiation treatments. Thus, identifying people that benefit most from these techniques can better utilize resources. This study compares supine and prone positioning, with or without DIBH, to further assess which positioning technique will achieve the lowest cardiac radiation doses.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a pathologically proven diagnosis of left-sided invasive breast cancer or ductal carcinoma in situ receiving breast/chestwall irradiation +/- regional nodal irradiation, or a right-sided invasive ductal cancer status post-mastectomy or lumpectomy who will be receiving breast/chest wall and nodal irradiation.
* Patients must have undergone breast conserving surgery (i.e. lumpectomy, partial mastectomy) or mastectomy prior to enrollment.
* Patients must be 18 years of age or older.
* Study entry must be prior to CT simulation.
* Per Medical College of Wisconsin Department of Radiation Oncology Standard of Care, women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable forms of contraception during radiation therapy. Patients under age 50 with a uterus and ovaries must have a negative serum pregnancy test within one week of planned CT simulation per Radiation Oncology Departmental guidelines prior to CT simulation.
* Patients must provide study specific informed consent prior to study entry.
* Patients must be able to hold their breath long enough to undergo CT simulation in DIBH (ten to fifteen seconds). The patient should also affirm they can lie in the prone position. This will be determined by the treating radiation oncologist, as per current standard of care.

Exclusion Criteria:

* Patients who are unable to hold their breath long enough to undergo CT simulation in DIBH. While this may affect patients with chronic obstructive pulmonary disease (COPD) and/or other respiratory conditions, the presence of these comorbidities alone will not exclude patients from enrollment so long as they can maintain breath hold long enough to perform DIBH.
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study

Primary objective:

To assess the efficacy of the stents (sinus-Obliquus stent for the common iliac vein, the sinus-XL Flex stent or sinus-Venous stent for the external iliac and common femoral veins) by evaluating different gradations of patency rates, patient's rating of disease severity and quality of life in patients with post-thrombotic syndrome and concomitant common iliac vein compression.

Secondary objective:

To assess long-term safety of venous stenting


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults aged ≥18 years
2. Post-thrombotic syndrome (Villalta score \>4 points) due to iliac vein thrombosis with or without femoral deep vein thrombosis
3. Evidence of venous stenosis in common iliac vein \>50% confirmed by venography (CT or MRI) or intravascular ultrasound (IVUS)
4. Use of sinus-Obliquus stent for unilateral common iliac vein stenosis
5. If stent extension is required either sinus-XL Flex or sinus-Venous stents must have been used for stenoses \>50% confirmed by venography (CT or MRI) or IVUS in external iliac and common femoral veins

Exclusion Criteria:

1. Pregnancy, breast-feeding or birth-giving during the last 30 days
2. Life expectancy \<6 months
3. Iliofemoral DVT less than 3 months ago
4. Permanently immobile patient (wheelchair user or bed-ridden patient)
5. Allergy to Nitinol
6. Patient's target vessel(s) has/have been stented before
7. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
8. Patients in custody by juridical or official order
Diagnostic Accuracy of Dual-energy CT

The study will include 20 people with hand OA awaiting surgery in the fingers. Participants will undergo dual-energy CT, cone-beam CT, ultrasound, clinical examination, blood sampling and questionnaires. Images will be analysed for the presence of joint-associated crystal including monosodium urate, calcium pyrophosphate and calcium hydroxyapatite. Material obtained during surgery will be used for crystal verification and calculation of diagnostic accuracy of dual-energy CT and cone-beam CT.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Informed consent obtained.
3. Patients with hand OA as defined by the American College of Rheumatology Classification Criteria for hand OA:

   * Hand pain, aching or stiffness

And 3 or 4 of the following features:

* Hard tissue enlargement of ≥2 of the 10 selected joints\*.
* Hard tissue enlargement of ≥2 of the 10 DIP joints.
* Fewer than 3 swollen MCP joints.
* Deformity of at least 1 of 10 selected joints\*. \*The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands.

Exclusion Criteria:

1. Known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, gout, psoriatic arthritis, psoriasis, inflammatory bowel disease), or other joint diseases (haemochromatosis)
2. Positive anti-cyclic citrullinated peptide (\>10 kU/L)
3. Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
4. Foreign material/metallic implants at the area of interest will be excluded to avoid artefacts on CBCT \[68\].
5. Other diseases in the area - e.g. skin disease, known previous fracture in the joint of interest.
6. Participation in experimental device or experimental drug study 3 months prior to enrolment.
7. Pregnancy or breast-feeding.
8. Previous septic arthritis at the target joint.
9. Previous surgical procedures at the target joint.
10. Injection into the target joint within 3 months prior to enrolment.
11. Inability to speak and read Danish fluently.
12. Treatment with Colchicine within the last 30 days.
13. Treatment with systemic steroids ≥7.5 mg prednisolone within the last 30 days.
14. Lack of sample obtained for reference standard, i.e. unable to obtain either synovial fluid, joint lavage fluid, joint biopsy or excite joint.
15. Any other condition that in the opinion of the investigator may interfere with study participation.

There will be no restriction on sex or Kellgren-Lawrence (KL) grading.
Fasting Predictors of OGTT and MMTT Response

1. To develop a database containing matched information from dynamic tests of postprandial glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and clinical information related to diabetes risk obtain through subject interview.
2. To use the database to identify fasting biomarkers and associated algorithms to best predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical information such as current medication use.


Eligibility Criteria:
Inclusion Criteria:

* Weight \>95

Exclusion Criteria:

* Prior diagnosis of Diabetes
Is Family Screening Improved by Genetic Testing of Familial Hypercholesterolemia

To test the hypothesis that in patients with a clinical diagnosis of familial hypercholesterolemia (FH), genetic testing and identification of a causative mutation might enhance the success of family-based cascade screening.

To examine the impact of genetic testing on the efficiency of cascade screening for FH, patients with suspected FH or a clinical diagnosis of FH have been randomized to genetic testing or standard of care with lipid testing alone. After systematic encouragement of family enrollment, as a primary endpoint, the compared the number of probands with relatives enrolled in each group one year after results were returned to probands. The secondary endpoints examined include the number of relatives enrolled within 52 weeks of the genetic counseling call and the number of relatives diagnosed with FH through the study. Exploratory subgroup analyses were conducted stratifying the cohort by randomization/genetic test result. Further exploratory analyses compared probands' perceptions about high cholesterol diagnosis at baseline and at 20 weeks from enrollment

Eligibility Criteria:
Inclusion Criteria:

* For probands, inclusion criteria are as follows:

  1. LDL cholesterol \> 220 mg/dL or a previous clinical diagnosis of FH
  2. Aged 18 years or older
  3. Ability to provide informed consent
  4. Willingness/ability to contact a minimum of 2 biological relatives about the study

Exclusion Criteria:

* For family members of probands, inclusion criteria are as follows:

  1. Willingness to participate in the study
  2. Age 10 or older
  3. Ability to give informed consent/assent