cyrilzakka/clinical-trials huggingface dataset:
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy

The purpose of this study was to determine the efficacy and safety of BCX9930 monotherapy for the treatment of adult participants with PNH not currently receiving complement inhibitor therapy.

This was a randomized, placebo-controlled, double-blind, parallel-group, 2-part study. Parts 1 and 2 was to be conducted in the same participants.

Part 1 of the study was designed to evaluate the efficacy, safety, and tolerability of treatment with oral BCX9930 monotherapy for 12 weeks versus placebo in participants with PNH who were not currently receiving treatment with complement inhibitor therapy. Participants were randomized to receive BCX9930 or placebo under double blind conditions for the 12-week randomized treatment period. The primary efficacy and safety analyses were based on Part 1.

Part 2 of the study was designed to evaluate the long-term safety, tolerability, and effectiveness of open-label BCX9930 monotherapy when administered through Week 52. All participants in Part 2 received BCX9930. Participants who were randomized to BCX9930 monotherapy in Part 1 continued to receive BCX9930 in Part 2. Participants who were randomized to placebo in Part 1 discontinued that therapy at the Week 12 visit and received BCX9930 in Part 2.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years old
* Body weight ≥ 40 kg
* Documented diagnosis of PNH
* No complement inhibitor therapy for ≥ 12 months prior to screening
* Contraindication to or no access to approved (C3 or C5) complement inhibitor therapies
* Documentation of current vaccinations against Neisseria meningitidis and Streptococcus pneumoniae or willingness to start vaccination series
* At screening: PNH clone of ≥ 10%, hemoglobin ≤ 10.5 g/dL and lactate dehydrogenase ≥ 2 × upper limit of normal

Exclusion Criteria:

* Known history of or existing diagnosis of hereditary complement deficiency
* History of hematopoietic cell transplant or solid organ transplant or anticipated candidate for transplantation
* Myocardial infarction or cerebrovascular accident within 30 days prior to screening, or current and uncontrolled clinically significant cardiovascular or cerebrovascular condition
* History of malignancy within 5 years prior to the screening visit
* Active bacterial, viral, or fungal infection or any other serious infection within 14 days prior to screening
* Treatment with anti-thymocyte globulin within 180 days prior to screening
* Initiation of treatment with an erythrocyte or platelet growth factor, or danazol within 28 days prior to screening
* Receiving iron supplementation with an unstable dose in the 28 days prior to screening
Language and Deglutition in Children

The first years of life are considered essential to child development, as there is greater brain growth and formation of more neural connections. Therefore, the stimulation of children in various fields of development becomes relevant to the acquisition of knowledge and skills.

Child development, food and language, particularly in young children in different socioeconomic and cultural, as this is the basis for the growth conditions, socialization and learning.

Eligibility Criteria:
Inclusion Criteria:

* children aged one to three years of chronological age, of both genders, enrolled full-time, ie more than six hours in childcare elected for search

Exclusion Criteria:

* children with minor changes or deviations in child development, who did at least one major meal (lunch or dinner) in the nursery, or other educational institution attended, in addition
Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors

To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.

Newly diagnosed endometrial cancer survivors, who are presenting for their initial consultation with a plan for minimally invasive surgery, will be randomized 1:1 to standard counseling or standard counseling plus asynchronous telemedicine video. The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State-Trait Anxiety Inventory (STAI) questionnaire, assessed before surgery. The secondary outcomes of anxiety following surgery as well as patient satisfaction with counseling type (measured via the Patient Satisfaction Questionnaire (PSQ-18)) before and after surgery will be compared between groups. Both groups will complete questionnaires following their initial consultation (but before surgery) and at their post-operative visit. For the telemedicine group, the duration and frequency of video views will be collected. Participants completing both surveys will receive a survivorship gift bag.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical stage I histologically confirmed endometrial carcinoma, which is clinically confined to the uterus and comprises approximately two-thirds of all endometrial carcinoma cases
2. Patients undergoing planned minimally invasive surgical procedures, such as a minimally invasive technique such as conventional laparoscopy or robotic-assisted laparoscopy, as part of treatment at the Division of Gynecologic Oncology at Carilion Clinic, Roanoke, VA
3. Internet/cellular access at home
4. Ability to read and comprehend materials on questionnaires

Exclusion Criteria:

1 Patients that do not meet the inclusion criteria
Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment

This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.


Eligibility Criteria:
Inclusion Criteria:

* Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
* Patient willing to sign informed consent
* Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria:

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
* Subjects with hypersensitivity to Levemir® or to any of the ingredients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous Urticaria patients

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for inclusion in this study have to fulfill all of the following criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection) and present with active disease as defined by UAS7 ≥12.
  3. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
  4. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.

Exclusion Criteria:

Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria

* Evidence of parasitic infection
* Any other skin diseases than chronic spontaneous urticaria with chronic itching
* Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
* History of anaphylaxis
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to any of the study drugs or its components of similar chemical classes
* Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Pharmacokinetic Interaction Between Ritonavir and Prasugrel in Healthy Volunteers

HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit multiple known risk factors for CVD. Of specific concern is the fact that use of the non nucleosidic reverse transcriptase inhibitors (NNRTI) and/or protease inhibitors (PI) drug classes is associated with dyslipidemia known to increase the risk of coronary heart disease particularly among older subjects with normalized CD4 cell counts and suppressed HIV replication. HIV patients could thus potentially receive anti-aggregant therapy concomitantly with their antiretroviral treatment. Prasugrel is an anti-aggregating agent indicated to prevent the recurrence of ischemic events after coronary arteries stenting. It is a pro-drug mainly metabolized by cytochromes P450 (CYP) 3A and 2B6 and to a lesser extent by CYP2C9 and 2C19. Ritonavir is an anti-protease and CYP3A4 and CYP2B6 inhibitor used in anti-HIV therapy. The aim of the present study is to assess the potential drug-drug interaction between prasugrel and the CYP3A/2B6 inhibitor ritonavir. Ten healthy volunteers will receive prasugrel 10mg alone or after 100mg ritonavir. The effect of ritonavir on prasugrel pharmacokinetics will be assessed. The two sessions will be separated by a one-week "wash out" period. During each session, CYP3A, 2B6, 2C9 and 2C19 activities will be assessed by a micrococktail approach with microdoses of midazolam, bupropion, flurbiprofen and omeprazole. The pharmacokinetics of prasugrel active metabolite will be assessed during the two sessions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged from 18 to 60 years
* BMI between 18 and 25
* Understanding of French language and able to give an inform consent.

Exclusion Criteria:

* smoker
* hypersensitivity to prasugrel or ritonavir or constituents of the tablets - - regular alcohol consumption
* concomitant disease
* intake of any drug or particular food (grapefruit) that can affect or metabolized by the CYP3A, 2C19, 2B6 and 2C9 within 1 month before the study
* pathologies or drugs associated with an increased bleeding risk such as aspirin, non-steroidal anti-inflammatory drugs, steroids and serotonin reuptake inhibitors (in the last 10 days before the start of the study)
* bleeding familial history or antecedent or haemorrhagic disease
* previous gastro-intestinal ulcer or active ulcer
Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1-2x10\^6 cells/kg at one or more occasions dependent on clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Acute graft versus host disease grade 2-4.
* Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

None.
Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms

To determine whether a fall in tear osmolarity precedes improvement in symptoms and signs of dry eye in dry eye patients treated topically with 5% lifitegrast drops for 3 months.

A longitudinal, single-arm, prospective study will recruit up to 30 subjects with moderate to severe dry eye disease. Subjects will be \>18 years of age, diagnosed with moderate to severe dry eye (tear osmolarity \> 320 mOsm/L and Visual Analog Scale (VAS) score \> 40), willing to adhere to twice daily dosing (BID) and follow up visit schedule, have no history of ocular pathology / degeneration / allergy, not on any T-cell modulatory therapy, not have instilled any artificial tears within 2 hours of study visit, and not participating in any concurrent clinical trials. All subjects will complete an informed consent form indicating their voluntary participation in the study.

Study measurements will be made at baseline (first clinic visit), 2-, 6-, and 12-weeks following Lifitegrast therapy and include tear osmolarity (TearLab osmolarity system), VAS questionnaire, slit lamp examination for fluorescein corneal staining, tear break up time (TBUT), and Meibomian gland dysfunction (MGD) grading . At the end of the 3-mo study visit, the subjects will be informed of study completion and exited from the study.

Eligibility Criteria:
Inclusion Criteria:

* Tear Osmolarity \> 320 mOsm/L
* VAS eye dryness \> 40
* No other ocular pathology
* No contact lens wear
* Not currently on T cell modulator
* No change in therapy in last 2 months
* Willingness to adhere to therapy and study visits
* Patients qualified for prescription of lifitegrast drops

Exclusion Criteria:

* Contact lens use
* Eye surgery in Past 6 months
* Use of tear supplements in past 2 hours
4 Repeat Tauopathy Neuroimaging Initiative

The purpose of this study is to evaluate several different tests, including brain imaging, eye movement testing, body fluid samples, measurements of memory and other thinking abilities, and measures of functional independence in the hope that this information can be used to guide diagnosis and treatment of PSP and CBD in the future. Recent advances in our understanding of the biological causes of these diseases offer hope for new treatments. As such treatments are developed, sensitive and specific biological measurements (biomarkers) will be needed to provide precise and direct measures of the state of the brain, which will improve the statistical power of clinical trials. Brain imaging with Magnetic Resonance Imaging (MRI) has previously been used to measure disease-related changes in the brain. The goal of this study is to identify the best methods of analysis (including eye movements, imaging, and behavioral measures) for tracking PSP and CBD over time. In addition, certain biomarkers in the blood and cerebrospinal fluid might also be useful for following these diseases over time. This study will examine the value of blood and CSF biomarkers relative to brain imaging and functional measures.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration
* Must have a reliable study partner who has frequent contact with the subject
* Willing and able to undergo testing procedures

Exclusion Criteria:

* Significant neurological disease other than PSP or CBD
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.


Eligibility Criteria:
Inclusion Criteria:

* Receiving dialysis for 3 months or more before enrollment.
* The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
* Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
* Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion Criteria:

* Uncontrolled hypertension
* Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
* Other hematological disorders
* Upper or lower GI bleed within the prior 6 months
Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population

If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.

The professional practice of firefighting presents risks specific, especially cardiovascular. In the United States 30% of Firefighter deaths are the result of a myocardial infarction that occurred while on duty. Certain occupational tasks expose firefighters to a higher risk of myocardial infarction (high physical load, inhalation of products). There is no recommendation on how to assess cardiovascular risk in French firefighters. In the absence of consensus, the Loire Departmental Fire and Rescue Service has constructed a scale for collecting cardiovascular risk factors (expert working group) to identify firefighters at high cardiovascular risk. A maintenance visit (mandatory every two years until the age of 38 and then once a year) is the best way to assess this cardiovascular risk, with a biological assessment and an electrocardiogram after the age of 40. If cardiovascular risk factors are present and the cardiovascular risk is high, the resting electrocardiogram should be supplemented by an exercise test. An exercise test can directly or indirectly quantify the endurance capacities of firefighters and reveal cardiac abnormalities sometimes absent at rest. Half of all myocardial infarctions occur without any prior symptomatology and remain totally asymptomatic, discovered during routine examinations. If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Any professional or volunteer firefighter with a high cardiovascular risk attached to the Departmental Fire and Rescue Service of the Loire who has carried out an effort test between 2006 and 2014.
* Subject who received informed oral information about the study by telephone and agreed to participate in the study

Exclusion Criteria:

* Subject unable to understand the study
* Subject matter subject to a legal protection measure
Study on Ex-PRESS Implantation Combined With Phacoemulsification in Primary Angle-closure Glaucoma

Primary angle-closure glaucoma (PACG) is common, phacotrabeculectomy is associated with a significant risk of complications.The Ex-PRESS shunt was introduced as a modification to trabeculectomy, with the theoretical advantages of reduced complications.Our purpose is to perform a prospective study to evaluate the clinical outcomes and safety of the Ex-PRESS shunt with cataract surgery for PACG patients coexisting cataract.

The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy mainly for patients with primary open-angle glaucoma.It has been proved to be as effective as trabeculectomy in a series of researches. However the early postoperative complication of Ex-PRESS implantation is less frequent compared with trabeculectomy. Ex-PRESS was designed initially for open angle glaucoma, gradually some scholars used it in refractory postpenetrating keratoplasty glaucoma and in vitrectomized glaucoma,which showed that Ex-PRESS shunt implantation was an effective procedure too. We analyzed the clinical efficacy and safety of combined phacoemulsification and Ex-PRESS implantation for PACG patients with cataract. Data was recorded before surgery and postoperatively at 1 week and 1, 3, 6, 12,18,24,30,36 months，which included intraocular pressure (IOP), best corrected visual acuity (BCVA), number of medications, complications, corneal endothelial cell density and anterior segment optical coherence tomography(AS-OCT). Efficacy was assessed by IOP values and success rates. Complete success was determined by IOP between 5 and 21mmHg without medications.

Eligibility Criteria:
Inclusion Criteria:

* The presence of PACG, angle peripheral anterior synechia (PAS) more than 180 degrees.
* An indication for glaucoma filtering surgery based on uncontrolled IOP or progressive vision field defect despite antiglaucoma medications.
* Mean vision field defect greater than 15dB.
* The presence of a clinically significant decrease of visual acuity as a result of cataract, usually BCVA less than 0.6.

Exclusion Criteria:

* Patients unable to give informed consent.
* Ocular infection or inflammation in the study eye in the 3 months prior to enrollment.
* Intraocular surgery in the study eye in the 3 months prior to enrollment.
Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)

This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.

This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will be collected from all participants at eight timepoints, and clinical data will be collected for 30 days or until discharge/death.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* COVID-19 positive by PCR or assay within 72 hours or less
* Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening

Exclusion Criteria:

* mechanically ventilated
* pregnant
* prisoners
* receiving resuscitation with blood products for hemorrhagic shock
* receiving an investigational therapy for COVID-19
* diagnosed with severe comorbidities
* not expected to survive more than 24 hours
Effects of Sodium Intake on Arterial Stiffness in Black Men and Women

The purpose of this study is to explore the influence of sodium intake on arterial stiffness in African American/Black adults.


Eligibility Criteria:
Inclusion Criteria:

* African American or Black
* Male or Female

Exclusion Criteria:

* pregnancy or within 60 days postpartum
* having taken blood pressure (including diuretics beta-blockers, ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers) or statin medications within the past 3 months
* infection (viral or other) within the past 4 weeks
* having adrenal or endocrine tumors (these could impact BP)
* renal disease defined as a glomerular filtration rate (GFR) of less than 60
* prior myocardial infarction
* known coronary heart disease
* personal history of stroke
* heart failure
* cardiac arrhythmias
* recent chest pain or dyspnea
* current insulin dependence
* currently undergoing chemotherapy or radiation
* identifying as transgender (the focus of this trial is biological sex)
* seated systolic or diastolic blood pressure of more than 149 mm Hg or 99 mm Hg, respectively