cyrilzakka/clinical-trials huggingface dataset:
A Study of ASKG712 in Patients With Diabetic Macular Edema

This multicenter, non-randomized, open-label, multiple-dose-escalation and dose-expansion study will investigate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 following intravitreal administration in patients with diabetic macular edema (DME).

The Part 1 of study is a multicenter, open-label, sequentially, multiple-dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME. Patients will be sequentially enrolled into four different dose-level cohorts following accelerated titration combined with the traditional "3+3" design.

The Part 2 of study is a multicenter, open-label, sequentially, dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ASKG712 in patients with DME.

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
2. Hemoglobin A1c of less than or equal to 12%
3. For women of childbearing potential: agreement to use acceptable contraceptive methods during the treatment period and for at least 90 days after the final dose of study treatment
4. Ability and willingness to undertake all scheduled visits and assessments
5. Macular thickening secondary to DME involving the center of the fovea
6. Decreased visual acuity attributable primarily to DME

Exclusion Criteria:

1. History of allergy or current allergic response to ASKG712 or fluorescein
2. Diseases that affect intravenous injection and venous blood sampling
3. Uncontrolled blood pressure
4. Systemic autoimmune diseases
5. Previous anti-VEGF drug treatment
6. Currently pregnant or breastfeeding, or intend to become pregnant during the study
7. Any uncontrolled clinical disorders
8. Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
9. History of intraocular or periocular corticosteroid treatment in the study eye
10. Uncontrolled previous or current glaucoma in the study eye
11. Previous intraocular operations in the study eye
12. Active intraocular or periocular infection or active intraocular inflammation in the study eye
13. History of uveitis in either eye
14. Other protocol-specified inclusion/exclusion criteria may apply
FimasaRtan-basEd BP Targets After Drug SwitcHing

The recent hypertension clinical practice guidelines published by American College of Cardiology (ACC) and American Heart Association (AHA) reduced the target BP to 130/80 mmHg, indicating the needs for more aggressive efforts in hypertension treatment. However, studies in Koreans must be preceded before applying such new overseas guidelines; thus, this study has been designed to establish clinical materials reflecting treatment setting in Korea. In this study, patients with uncontrolled hypertension whose antihypertensive regimens are changed to ARB-based therapy (ARB monotherapy or ARB-containing combination therapy) will be followed to assess the treatment trend, treatment effect, and risk of cardiovascular disease.

This study will be performed in patients with blood pressure (BP) uncontrolled by existing antihypertensive drugs (including ARB) among hypertensive patients visiting outpatient clinic of medical institutions in Korea. The study enrollment number will be assigned to the subjects who provide a written consent to the use of personal information and meet the inclusion/exclusion criteria. Follow-up will be conducted for 12 weeks in total and prespecified study related data will be collected in the case report form.

Eligibility Criteria:
Inclusion Criteria:

* Provided written consent to the use of personal information after receiving the explanation of the objective, methodology, etc. of this clinical study
* Male or female adults ≥ 19 years who are diagnosed with essential hypertension
* Receiving outpatient treatment at the time of study enrollment
* Patients with hypertension uncontrolled by existing antihypertensive drugs (including ARB) whose antihypertensive regimens decided and scheduled to be changed to ARB monotherapy or ARB-containing combination therapy (the result of the arm with a higher mean BP \[systolic BP preferred\] when measured twice with at least a 2-minute interval in both arms at the medical office on the study enrollment date, will become the reference)

  * Definition of uncontrolled hypertension: Target BP (SBP \<140 mmHg and DBP \<90 mmHg) not achieved even after the treatment using the existing antihypertensive drugs for 4 weeks or longer

Exclusion Criteria:

* Patients who were hospitalized or are scheduled to be hospitalized 4 weeks before or after the study enrollment date
* Patients with suspected or confirmed secondary hypertension
* Pregnant or breast-feeding women
* Patients who received investigational product within 12 weeks or are scheduled to participate in another clinical study while participating in this study
* Patients who are determined inappropriate for participating in the study by investigators for other reasons
AUgmented REality for the Visually Impaired - Part 1

The main objective of this study is to quantify vision parameters in subjects with concentric visual field constriction, and this in relation to the display on virtual reality goggles. More specifically:

* The maximum brightness value for visual comfort (THRESHOLD_MAX)
* The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
* The speed of light change adaptation in the range \[THRESHOLD_MAX-THRESHOLD_MIN\] and \[THRESHOLD_MIN-THRESHOLD_MAX\].

Secondary objectives are to:

A. Quantifying the device parameters "RV glasses + camera" depending on visual acuity and the visual field of each subject:

* Optimal extent of the visual field provided by the device "RV glasses + camera".

B. Measuring the effectiveness of different image processing algorithms used in the development of the software part of this technical assist device:

* Capture and display HDR images (High Dynamic Range)
* Color adjustment.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The subject is suffering from retinitis pigmentosa or glaucoma with concentric visual field constriction and presents with:
* An acuity in the better eye superior or equal to 1/10 in near vision,
* A binocular field of between 1° and 30°,
* A good central fixation, absence of central scotoma,
* Motor capability for using a computer keyboard with one hand.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Subjects with (or evolving toward) a multiple sensory disability, or one including cognitive disorders
Impact of Pharmacist-led Educational Intervention on Pneumococcal Vaccination Rates in Cancer Patients

According to the World Health Organization (WHO), immunization; is defined as making a person immune or resistant to an infectious disease by applying a vaccine (1). The primary indicator of an effective immunization is that adequate vaccination rates have been achieved. The risk of cancer and chronic diseases increases with advancing age, which increases the importance of immunization in adults.

Cancer patients, one of the patient groups for whom adult immunization is a priority and crucial, are subjected to immunosuppressive medications, making them vulnerable to infections. In cancer patients, infections are severe, antimicrobial treatments are sometimes insufficient, leading to morbidity and mortality. One of these infections is pneumococcal disease caused by Streptococcus pneumonia, with high morbidity and mortality in cancer patients. Invasive pneumococcal disease is seen 23-48 times more frequently in cancer patients compared to healthy individuals. In many countries worldwide, the 13-valent pneumococcal conjugate vaccine and the 23-valent polysaccharide pneumococcal vaccine, both developed to prevent pneumonia caused by Streptococcus pneumonia, are successfully used in childhood vaccination programs within the framework of WHO's immunization policies. However, in Turkey, like in the rest of the world, the required adult immunization rates have not been achieved yet. Immunization rates among cancer patients, one of the patient groups for whom adult vaccination is required, remain below the targeted levels. Pharmacists, one of the health professionals, have significant contributions to increasing vaccination rates in adults. According to studies, pharmacists can help raise immunization rates by providing education and information. In Turkey, no study has been conducted to assess the impact of vaccination education on cancer patients' attitudes and actions about the pneumococcal vaccine. This study aimed to determine the impact of pharmacist-led pneumonia and pneumococcal vaccine education on cancer patients' vaccination attitudes, knowledge, and vaccination rates.


Eligibility Criteria:
Inclusion Criteria:The study will involve patients who have all of the following features simultaneously.

* patients who visit medical oncology outpatient clinics,
* patients who are over 18 years old,
* patients who have been diagnosed with cancer for less than two years,
* patients who are in remission stage (as determined by a medical oncologist),
* patients who have never had the pneumococcal vaccine.

Exclusion Criteria:

* patients who could not communicate in Turkish,
* patients who were illiterate,
* patients who had visual/auditory/cognitive impairments,
* patients who had previously received a pneumococcal vaccine recommendation,
* patients who did not know their pneumococcal immunization status
* patients who want to leave the study
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
* Biopsy confirmed active lupus nephritis.
* Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
* Autoantibody-positive.

Key Exclusion Criteria:

* Pregnant or nursing.
* On dialysis within the past year.
* Treatment with belimumab within the past year .
* Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
* Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
* Severe active central nervous system (CNS) lupus.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy

To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).

There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically clear invasive breast cancer between 2003 and 2018;
* Female,18-75 years old;
* Measurable metastatic lesion according to RECIST 1.1 evaluation criteria;
* The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines;
* First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD));
* After the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks;
* Patients' Karnofsky performance status (KPS) scores were ≥70.

Exclusion Criteria:

* Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
Microbiome and Metabolomics Profiling in Children With OSA

Objectives: Obstructive sleep apnoea (OSA) exhibits variable susceptibility to end-organ morbidities. Previous studies suggest that physiological sequelae in individuals with OSA promote changes in microbiome, which also interact with metabolic and inflammatory mediators. Therefore, microbiome and metabolomic profiling could potentially reveal the pathological processes underlying OSA. The primary objectives of our study are 1)To investigate the differences in the composition of nasal and stool microbiome between children with OSA and non-OSA controls; 2)To investigate the differences in the urine metabolomic profiles between children with OSA and non-OSA controls.

Hypothesis to be tested: The microbiome composition and urine metabolomic profiles are different between children with OSA and non-OSA controls. Changes in microbiome composition are associated with specific urine metabolomic and inflammatory profiles in children with OSA.

Design and subjects: A prospective case-control study. Chinese children aged 6-11 years old with habitual snoring and polysomnography (PSG) confirmed OSA will be recruited as cases. Non-OSA healthy children will be recruited as controls. All subjects will undergo evaluation including questionnaires, anthropometric measurements, PSG, blood, urine, nasal and stool sampling.

Primary outcome measures: Microbiome and metabolomic profiles in children with OSA compared to non-OSA controls.

Analysis: Comparisons of the microbiome and metabolomic profiles between OSA children and controls. Correlations of microbiome and metabolomic profiles with inflammatory biomarkers and PSG measurements will be evaluated by regression analysis.

Expected results: This study will provide novel data regarding microbiome and metabolomic profiles, and their relationship with inflammatory biomarkers in children with OSA.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-11 years old

Exclusion Criteria:

* Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities, structural or congenital heart disease, use of medications or therapy that could affect immunity such as systemic corticosteroids, chemotherapy, radiation therapy, intravenous immunoglobulins.
Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol

This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.

Eligibility Criteria:
Inclusion Criteria:

* De Novo, single Kidney recipient
* At least 1 HLA mismatch

Exclusion Criteria:

* Recipient of multiple organs
* prior transplant recipient
* Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
* PRA \>10%
* Hepatitis B surface antigen positive
* Hepatitis C antibody positive
* HIV positive
Efficacy of Dry Needling Treatment in Myofascial Pain Syndrome

The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.

64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.

Objective: The aim of this study is to investigate the short and long-term effects of dry-needling of participants with trigger points in the upper trapezius muscle.

Methods: 64 participants who diagnosed with myofascial pain syndrome will be included in the study. All participants will have trigger points in the upper trapezius muscles. They are randomised into two groups: dry needling (n=32) and exercise group (n=32). Ultrasonographic evaluation of trigger points (diameter, circumference and area), pain intensity and neck disability will be evaluated as primary outcome. Active cervical range of motion will be evaluated as secondary outcome.

All treatments will be applied by an investigator and a different blinded investigator will evaluated all participants. Numerical Rating Scale will be used for evaluating pain intensity and Neck Disability Index will be used for evaluating neck disability.

Dry-needling treatment will be applied once a week for three weeks. Servical stretching exercises are given to all participants. (20 repetitions in one session and 2 sessions in a day, three days a week.)

All participants will be evaluated before treatment, after treatment (at 3rd week) and at 3 month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* trigger points in the upper trapezius muscle
* 18-45 years old
* no treatment in three months for myofascial pain syndrome (MPS)
* accept to participate treatment program

Exclusion Criteria:

* already treated in 3 months for MPS
* below 18 years and above 45 years old
* no acceptance to participate the trial
Prototyping a Device for Automating Stool and Urine Output Tracking

The purpose of this study is to test an electronic apparatus for measuring stool and urine output in an accurate and easy way. Participants will have one in-person or virtual visit with the study team prior to starting the study events. Participants that enroll in this study will have the freedom to choose when to begin and stop using the toilet apparatus when it is available for human testing. This apparatus will be located in a private bathroom in either the CIEMAS building or MSRB III Building.


Eligibility Criteria:
Inclusion Criteria:

* people who are able to use the private bathroom at no risk to themselves in the CIEMAS building (B508) or the bathroom located in room 4002, 4th floor of MSRB3.
* students or employees at Duke University since card access is required for our MSRB3 bathroom.
* people who spend most of their time in these buildings so we can assure the use of the toilet.
* If the recruitment number is slow, enrollment will include people from the closest buildings.

Exclusion Criteria:

* People who use wheelchairs or other mobility devices won't be able to enroll, since at this moment the bathroom is not compliant with the requirements on The Americans with Disabilities Act (ADA) of 1990.
Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty

A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.


Eligibility Criteria:
Inclusion Criteria:

* Varus knee; degrees of extra articular deformity \< 15°; Knee Osteoarthritis; Straight limited \< 30°; range of knee flexion \> 90°; No hip abnormalities

Exclusion Criteria:

* Valgus knee; degrees of extra articular deformity \> 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery
Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential Hypertension

Study to assess the effect of Telmisartan on diastolic and systolic blood pressure and to establish the effect on patient's quality of life scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage I essential Hypertension (diastolic blood pressure 90-99 mmHg, and/or systolic blood pressure 140-159 mmHg)
* Signed informed consent form

Exclusion Criteria:

- Females of childbearing potential