cyrilzakka/clinical-trials huggingface dataset:
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms:

Arm SC: Isatuximab SC + Pd

Arm IV: Isatuximab IV + Pd

Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
* Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).

Exclusion Criteria:

* Primary refractory multiple myeloma participants
* Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
* Prior therapy with pomalidomide
* Participants with inadequate biological tests.
* Significant cardiac dysfunction
* Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
* Concomitant plasma cell leukemia
* Active primary amyloid light -chain amyloidosis
* Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
* Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
* Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis \[JoAS\]) and juvenile psoriatic arthritis (JPsA).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis)
* Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis
* Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator

Exclusion Criteria:

* Participants must not have active or history of inflammatory bowel disease
* Participants must not have active uveitis
* Participants must not have active or latent tuberculosis
* Participants must not have an active infection
* Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis
Efficacy and Safety of Cannabidiol for Gastroparesis and Functional Dyspepsia

Researchers are looking at the effects of a cannabidiol medication on stomach function in people with gastroparesis (a paralyzed stomach) and people with dyspepsia (an upset stomach caused by improper functioning of the stomach's muscles or nerves).


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastroparesis or functional dyspepsia (FD)
* Age 18-70 years
* Patients will be identified from among Mayo Clinic patients.
* Patients will have symptoms consistent with gastroparesis based on a national guideline for gastroparesis (symptoms plus delayed gastric emptying of solids). Patients with Rome IV criteria for postprandial distress syndrome (a subset of functional dyspepsia) will be selected based on gastric emptying of solids which is NOT delayed, in addition to standard FD criteria:

  * Symptoms fulfilled for the last 3 months with onset greater than 6 months before diagnosis:
  * One or more symptoms being bothersome: postprandial fullness, early satiation, epigastric pain or burning
  * Must include one or both of the following at least 3 days per week: bothersome postprandial fullness (i.e., severe enough to impact on usual activities) or bothersome early satiation (i.e., severe enough to prevent finishing a regular-size meal)
  * No evidence of organic, systemic, or metabolic disease to explain the symptoms on routine investigations.
  * Participants will have previously undergone test of gastric emptying of solids using the standardized Mayo Clinic scintigraphic method
* Ability to provide informed consent
* Absence of other diseases (structural or metabolic) which could interfere with interpretation of the study results
* Body mass index of 18-35 kg/m2
* Several medication classes, particularly those affecting gastrointestinal transit or motor functions, will be excluded, including GLP-1 receptor or amylin agonists in patients with diabetes mellitus. Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception, as drug interactions with birth control have not been conducted for secretin PAM) are

Exclusion Criteria:

* Patients with current H. pylori infection will be excluded.
* Pregnancy or lactation
* Rapid metabolizers for CYP3A4 or CYP2C19 \[estimated prevalence of 17% and 18% respectively
* based on literature review will be excluded since this could impact assessment of effects of cannabidiol
* Patients with abnormal baseline liver transaminases (any value above UNL), since up to 3-fold, dose-related elevations of liver transaminases (ALT and/or AST) occur in 13% of treated patients (vs. 1% placebo);
* Hypersensitivity to cannabidiol or any of the ingredients in EPIDIOLEX
* Concomitant use of valproate, central nervous system (CNS) depressants and alcohol, other hepatotoxic drugs
Spondyloarthritis and Nutrition

The food composition and consumption of certain foods could be associated with a higher or lower inflammatory activity of spondyloarthritis and consequently changes in the quality of life of patients. This has been shown in other chronic inflammatory disease.

In order to highlight a profile or nutritional profiles associated with the activity of the disease, we chose to carry out observational pilot study using a qualitative food survey, which will be submitted to all patients with spondyloarthritis. The general demographic data and the data of the disease will be collected by the investigating physician at the same time, as well as possible confounding factors: comorbidities, physical activity, treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who meet the ASAS criteria for axial or peripheral spondyloarthritis
* Patients agreeing to participate and not objecting to the use of their personal data

Exclusion Criteria:

* Presence of Inflammatory bowel disease: Crohn's or RCH diagnosed
* History of bariatric surgery
* Patient subject to a court order, guardianship or trusteeship
* Patient unable to complete questionnaire
Quality of Life After Cervical Ripening

Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.


Eligibility Criteria:
Inclusion Criteria:

- Woman who experienced at least one method of cervical ripening in our hospital

Exclusion Criteria:

- Patient's refusal
Effectiveness of a Mayan Language Social Media Campaign on COVID-19 Vaccine Beliefs in Guatemala

Prior evidence, including formative work supporting the development of this study, suggests there is widespread vaccine hesitancy among Indigenous communities in Guatemala, fueled by mistrust in the health system, lack of official information, and the circulation of myths and misinformation. We will test the effectiveness of a video-based social media campaign that provides a basic overview of the science behind COVID-19 vaccines and addresses prevalent myths and misinformation being shared in target communities. A series of animated videos will be promoted through Facebook Ads and randomized at the individual level across Facebook users throughout the entire country. To investigate the effectiveness of Mayan language content, we are testing three treatment arms - visually identical videos in the 1) Spanish language, 2) K'iche' language, and 3) Kaqchikel language. Our primary outcomes are responses to two attitudinal questions collected via Facebook polling: 1) How safe do you think a COVID-19 vaccine is for people like you? (options: very safe, somewhat safe, barely safe, not safe, don't know); and 2) When you think of most people whose opinion you value, how much would they approve of people getting a COVID-19 vaccine? (options: definitely approve, mostly approve, somewhat approve, not at all approve, don't know). We will measure effects of the three treatment arms across Spanish speakers (including K'iche' and Kaqchikel speakers who also speak Spanish). We will also measure the effectiveness of K'iche vs. Spanish content among K'iche speakers and Kaqchikel vs. Spanish content for Kaqchikel speakers.


Eligibility Criteria:
Inclusion Criteria:

* The intervention will be delivered through the Facebook Ads platform. Intervention content will be promoted to Facebook Users throughout the entire country of Guatemala. K'iche' content will be targeted only in departments where the K'iche' language is primarily spoken. Kaqchikel content will be targeted only in departments where the Kaqchikel language is primarily spoken.

Exclusion Criteria:

* Only adult Facebook users of age 18 will be included. Users under age 18 are excluded.
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity

Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to see. A recent study showed that giving omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need invasive treatments for eye disease. This research trial will give young infants born prematurely n-3 fish oil treatment and look at how this changes factors in the blood that promote disease. Detailed blood studies comparing infants with and without ROP will be performed and the infants will be followed over time to assess their eye development.

Approximately 517,000 infants are born prematurely every year. As low birth weight and premature infants are surviving longer, they are at risk of developing severe retinopathy of prematurity (ROP).

ROP is a disease of the eye affecting prematurely-born babies. It is thought to be caused by disorganized growth of retinal blood vessels which may result in scarring and retinal detachment. ROP can be mild and may resolve spontaneously, but it may lead to blindness in serious cases. ROP is the leading cause of irreversible childhood blindness in the United States. As such, all preterm babies are at risk for ROP, and very low birth weight is an important risk factor.

Researchers have found that increasing omega-3 fatty acids and decreasing omega-6 fatty acids in the diet of mice with eye disease similar to ROP had reduced areas of blood vessel loss and abnormal blood vessel growth. These findings represent new evidence suggesting the possibility that omega-3 fatty acids act as protective factors in diseases that affect retinal blood vessels.

Omega-3 fatty acids make compounds that protect against the growth of abnormal blood vessels by preventing inflammation.

In two European studies, this treatment decreased the risk of needing laser treatment in the eye for ROP. This study has not yet been repeated in the United States. The purpose of this study is to learn how omega-3 fatty acid supplementation in low birth weight infants changes the blood profile of infants receiving this nutritional treatment.

Infants are enrolled in this study shortly after birth and receive IV and/or oral supplementation until they are full term or the retinal blood vessels have completely developed, shortly after term. Once the treatment is over, these infants will continue to be followed for growth and development of their eyes.

Eligibility Criteria:
Inclusion Criteria:

* Infants born less than or equal to 30 weeks gestation or less than 1500 g at birth

Exclusion Criteria:

* Patients with liver disease as tested by liver function tests (LFTs)
* ≤ 500 grams birthweight
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial

Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.


Eligibility Criteria:
Inclusion Criteria:

* 50 to 85 years old
* diagnosis of AMD in both eyes
* must have dry AMD in the study eye
* Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8
* peripheral veins allowing vascular access to establish the extracorporal circuit.

Exclusion Criteria:

* other retinal or choroidal disorders than AMD
* optic nerve disease, glaucoma
* conditions that limit the view of the fundus
* acute bleeding in any eye

General exclusion criteria for the treatment of Rheopheresis:

* anaemia
* haemorrhagic diathesis or coagulopathy
* diabetes
* serious acute or chronic kidney or liver failure
* hypotension systolic \< 100 mmHg
* chronic viral infection (HIV, hepatitis B, C)
* epilepsia, psychosis or dementia
* a malignant disease or any other condition with life expectancy \< 12 months
* known history of alcohol or drug abuse and long term serious nicotine abuse
Changes in Optical Coherence Tomography Leakage Mapping in Diabetic Macular Edema After Conbercept Treatment

Eyes with diabetic macular edema requiring conbercept treatment will be followed up for one month. Before treatment, one week after treatment and one month after treatment, the eyes will be examined by optical coherence tomography (OCT) and optical coherence tomographic angiography (OCTA). The changes of macular edema will be observed and analyzed by OCT leakage mapping software, and the relationship between the changes of macular edema and visual acuity will be analyzed.

1. Research purpose:

   After one month follow-up, we will observe whether OCTleakage mapping can be used as a biomarker to predict the prognosis of DME eyes, and will observe the effect of Conbercept on improving edema and visual acuity of DME eyes.
2. Subjects Number of subjects planned to be recruited: 35

Inclusion criteria:

1. Age ≥ 18
2. Diabetic macular edema eyes treated with conbercept for the first time in 1 week
3. Informed consent of patients and signing of informed consent

Exclusion criteria:

1. High myopia
2. Macular diseases affecting vision
3. Vitreous hemorrhage requiring surgery
4. Patients with anterior segment neovascularization
5. Eye or periocular infection
6. Optic neuropathy and glaucoma
7. Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases
8. Ametropia and cataract surgery
9. In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed
10. Other systemic diseases can not complete follow-up

Eligibility Criteria:
Inclusion Criteria:

1）Age ≥ 18

2) Diabetic macular edema eyes treated with conbercept for the first time in 1 week

3) Informed consent of patients and signing of informed consent

Exclusion Criteria:

1）Myopia ≥ 6.0D

2) Macular diseases affecting vision

3) Vitreous hemorrhage requiring surgery

4) Patients with anterior segment neovascularization

5) Eye or periocular infection

6) Optic neuropathy and glaucoma

7) Periphlebitis, ophthalmic ischemic syndrome, uveitis, coat's disease, FEVR and other retinal diseases

8) Ametropia and cataract surgery

9) In 3 months, in addition to this treatment of conbercept, other anti VEGF treatment, laser treatment or vitreoretinal surgery were performed

10) Other systemic diseases can not complete follow-up
Ispinesib In Combination With Capecitabine In Patients With Solid Tumors

The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
* Bone marrow function: - ANC greater than 1500/mm3.
* Platelet count greater than or equal to 100,000/mm3.
* Hemoglobin greater than 9 g/dL.
* Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
* Total bilirubin greater than 1.5 mg/dL.
* AST/ALT less than 2.5 X upper limit of normal.

Exclusion criteria:

* Females who are pregnant or nursing.
* Pre-existing hemolytic anemia.
* Pre-existing peripheral neuropathy greater than or equal grade 2.
* Known deficiency in dihydropyrimidine dehydrogenase (DSD).
Different Neural Circuit Mechanisms Between Cognitive Therapy and Behavior Therapy for Patients With Panic Disorder: a Dynamic Research

Cognitive behavioral therapy (CBT), which includes cognitive therapy (CT) and behavioral therapy (BT), is the first-line treatment for patients with panic disorder (PD). However, the neural mechanism of CBT is unknown. The exploration of mechanism is of great significance for clinical strategy formulation. This study is proposed on the basis of our early PD and CBT neuroimaging studies, adopt the design of prospective randomized controlled intervention study, set up three time points: before the treatment（week 0）, the initial treatment (week 4th), the plateau treatment (week 28th). With normal subjects as black control and antidepressant therapy as intervention comparison, this study set up CT and BT two intervention groups, respectively collect all the participants'symptomatological, psychological, cognitive function and brain imaging data (3D,DTI, fMRI in resting and tasks states) at week 0, week 4th and week 28th. This study is based on the advanced analysis methods we applied in the early study,including BOLD-fMRI, DTI, topological characteristics analysis of the whole brain network and Granger causality test etc. It is from the point of multiple levels(brain regions, circuits, whole brain), multimodal (structure, function) to comprehensively analysis the role of CT and BT for the function and structure of brain regions, circuits (mood regulating circuit and cognitive control network for emotion processing) and whole brain in patients with PD. Totally, we explore the target area, path and mechanism of CBT for emotion processing neural circuits in patients with PD, and combined with the clinical data we preliminarily explore the imaging biomarkers of different intervention methods which may predict therapeutic effect.


Eligibility Criteria:
Inclusion Criteria:

* meet DSM-5 and Mini-international neuropsychiatric interview (MINI) Chinese version panic disorder diagnosis;
* the age of 20-50 years old;
* Right handedness;
* patients to participate voluntarily, with the consent of their families, signed informed consent book.

Exclusion Criteria:

* neurological diseases or other mental illnesses;
* serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
* treatment by psychotropic medications,psychological treatment, electroconvulsive therapy or physical therapy within 3 months prior to the start of the trial;
* with contraindication for MRI
* pregnancy and lactation.
Phase I Study to Investigate Pharmacokinetics and Safety of BAY73-4506 in Asian (Japanese) Patients With Solid Tumors.

This study is to define the pharmacokinetics and to evaluate the safety of BAY73-4506, 160 mg once daily administered orally as a single agent in Japanese patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese patients \>/= 18 years
* Histologically or cytologically confirmed solid tumors
* ECOG-PS 0 - 1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Uncontrolled hypertension
* Patients with severe renal impairment or on dialysis
* Patients with seizure disorder requiring anticonvulsant medication
* Known or suspected allergy to the investigational agent.