cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Individualized Rituximab in Maintaining Remission of Moderate and Severe Systemic Lupus Erythematosus

Several clinical studies have shown that rituximab is safe and effective for the induction of remission in moderate to severe systemic lupus erythematosus, and has been recommended by several guidelines for the induction of remission in refractory lupus with important organ involvement. However, there are few studies on the use of rituximab in the long-term maintenance and remission of the disease. There is no recognized scheme for the dose, interval and course of treatment of the drug. In this study, patients with moderate and severe systemic lupus erythematosus who achieved remission after standardized treatment were randomly divided into two groups at 1:1 and followed up every 3 months for 24 months. The basic situation and disease activity score of each subject were recorded. The recurrence rate of each observation group was calculated, the influencing factors of disease recurrence were analyzed, and a more reasonable drug use scheme was explored.


Eligibility Criteria:
Inclusion Criteria:

1. Age, 18-65 years old, weight ≥ 40 kg, sex unlimited.
2. Clearly diagnosed with systemic lupus erythematosus.
3. There was at least one BILAG B or above score in the kidney, blood system and nervous system.
4. After standardized treatment with high dose glucocorticoid combined with immunosuppressants such as CTX,MMF or RTX, complete or partial remission of the disease was achieved (up to 1 BILAG B score, and at least 1 BILAG A or BILAG B score less than before).
5. Glucocorticoid: prednisone or the equivalent of prednisone less than or equal to 20 mg daily dose, and can be increased or decreased within 20 mg during the study.
6. Subjects are willing to participate in this study and sign informed consent voluntarily.
7. Prospective subjects agreed to use effective contraception throughout the study period.

Exclusion Criteria:

1. Abnormal liver function: ALT or AST \>2ULN，or ALP or TBil \>1.5ULN
2. Severe cardiopulmonary disease;
3. Severe blood system disease
4. Patient with malignant tumor;
5. Concurrent infection：Subjects were hospitalized for infection or treated with parenteral antibiotics within 30 days before random; Hepatitis B surface antigen positive or active hepatitis, not treated with hepatitis B antivirus; T-SPOT positive or active tuberculosis, not treated with antituberculous therapy; Any positive in HCV-Ab, HIV-Ab, or TPPA ;
6. Pregnant patients or patients with recent fertility requirements;
7. Received cyclophosphamide treatment within 30 days before random;
8. For any other reason, the investigator believes that it is inappropriate to participate in the trial.
Low-dose Iron Supplementation and Markers of Iron Status Among Non-anemic, Iron-deficient Women

Healthy premenopausal women that are iron-deficient without anemia will receive a low-dose iron dietary supplement. The investigators seek to determine if the low-dose iron dietary supplement will restore iron levels to normal range with fewer side effects than typically experienced at higher doses of iron supplementation.

The primary purpose of this clinical trial is to evaluate the impact of a low-dose iron dietary supplement on markers of iron status among a sample of premenopausal women that are iron-deficient without anemia. This study will also assess the incidence of mild adverse events (constipation, nausea, etc.) that are relatively common with other over the counter iron dietary supplements and that the investigators hypothesize will be reduced with this lower-dose formulation.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal
2. Iron deficient without anemia (serum ferritin concentration \< 20 ug/L and a hemoglobin concentration \> 120 g/L)
3. Agree to continue with current diet and any dietary supplements
4. Able to understand and write English
5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

1. Daily supplementation of another iron supplement (other than multivitamin) currently or within past 2 weeks
2. Pregnant or breastfeeding females
3. History of alcohol, drug, or medication abuse
4. Known allergies to any substance in the study product
5. Donated blood in the past month or plan to do so at any time during the 8-week trial
6. Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis)
7. Taking medication that my interfere with the absorption of iron
8. Current tobacco smoker
The Effect of Morning Versus Evening Administration on The Pharmacokinetics and Pharmacodynamics of Empagliflozin

An Open-label, One way, Two period Comparative study To Determine The effect of Morning Versus Evening administration of Empagliflozin 10mg on Its Pharmacokinetics And Pharmacodynamics in Healthy Adults

Sixteen(16) healthy subjects will receive a single oral dose of Empagliflozin at the evening(Period I) and after a seven days washout period, the same 16 subjects will receive a single oral dose of Empagliflozin at the morning(Period II).

In both Periods(I and II), blood samples will be collected from each volunteer ethylene diamine tetra-acetic acid(KEDTA) containing tubes prior to drug administration then samples will be obtained at 0.33, 0.67, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 48 hours(h) after drug administration.

These samples will be centrifuged and the plasma harvested and stored at -80°C until assay.

Urine samples will be collected over the first 24h after oral administration of the drug with sampling being at the following intervals: 0 to 4h, 4 to 8h, 8-12h, 12 to 24hr.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18-45 years at screening.
* Subject has a Body Mass Index of 18 to 35 kg/m2.
* Subject are non smokers or moderate smokers(not more than 5 cigarettes per day)
* Subject is willing to participate and give their final written consent prior to the commencement of the study procedures
* Subject is in good age-appropriate health condition as established by medical history, physical examination, and results of biochemistry, hematology and urine analysis testing within 4 weeks prior to study.
* Subject has a normal blood pressure and pulse rate, according to the reference normal ranges

Exclusion Criteria:

* Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
* Subjects who have taken any medication two weeks preceding of the trial starting date.
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
* Gastrointestinal diseases.
* Renal diseases.
* Cardiovascular diseases specially transient ischemic attacks and cardiac dysrhythmia .
* Pancreatic disease including diabetes.
* Hepatic diseases as hepatic failure, cirrhosis, galactose intolerance, fructose intolerance, glycogen storage diseases
* Hematological disease or pulmonary disease
* Abnormal laboratory values.
* Subjects who have donated blood or who have been involved in a drug study within 6 weeks preceding the start of the study.
* Positive HIV test.
* History of or current abuse of drugs, alcohol or solvents.
* Endocrine disorders as Pheochromocytoma, Addison disease, glucagon deficiency, carcinomas, extra-hepatic tumors
* Autoimmune disorders as Graves disease
* (Central nervous system (CNS) disorders
A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19

According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide inhalation could eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild COVID-19 (NEWS scoring system 0-4)
* Patient within 7 days from symptom onset or Patient within 48 hous after laboratory diagnosis (SARS-CoV-2 RT-PCR)

Exclusion Criteria:

* Hypoxia (SaO2 \<95%)
* Unable to take oral medication
* Unable to use inhaler
* Pregnancy or breast feeding
* Immunocompromising conditions
* Moderate/severe renal dysfunction : creatinine clearance (CCL) \< 30 mL/min
* Moderate/severe liver dysfunction: AST or ALT \> 5 times upper normal limit
* Asthma or chronic obstructive lung disease
Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies

Oncology patients require numerous invasive procedures throughout their disease process including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health care providers. One of the biggest concerns for health care providers is to improve patient comfort. The goal of this study was to reduce pain during BMBs.

Specific aims of the study were to determine if there is a difference in patients' perceived pain during injection of the pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered to patient's receiving bone marrow biopsies.

A double blind, experimental crossover design was used to examine the difference in pain levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48 patients was enrolled into the study. Patients served as their own control. The site of first biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual analogue scale (VAS) was used to measure pain.

All data has been collected, are currently under analysis, and results will be completed in August 2006. Differences in groups will be examined using a paired t-test. A demographic questionnaire was used to gather select demographic variables. Correlative studies will be done to examine the relationship between the patient's perceived pain scores and several exploratory variables. Results of this study may change the current type of anesthetic used pre-BMBs thus improving patient comfort.


Eligibility Criteria:
Inclusion Criteria:

* Any newly diagnosed patient at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute whose Hematologist or Oncologist has ordered them to undergo a bilateral bone marrow biopsy for diagnostic and /or treatment purposes.
* 18 years of age or older.

Exclusion Criteria:

* Pregnant or Lactating women.
* Patients with allergies to local anesthetics.
* Patients requiring a unilateral bone marrow biopsy.
* Patients that cannot lie flat in either the supine or prone position.
* Patients that have used any of the following: narcotics, non-narcotic analgesia or an anti-anxiolytic medication on the same calendar day as the scheduled procedure. These medications will not be given to the participant at any time before or during the procedure.
* Patients on long-acting narcotic medication.
* Patients with neuropathy in the posterior iliac crest area
* Patients with a platelet count less than 20,000.
* Patients who are cognitively impaired or unable to self-report pain using the VAS.
* Patients with known bone metastasis.
Endometrioma Related Reduced Ovarian Reserve

Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.

The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age
* Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.

Exclusion Criteria:

* Menstrual cycle irregularity
* Polycystic ovarian syndrome
* Women who were pregnant or contemplating pregnancy in the next six months
* History of ovarian surgery
* Using medication which could affect ovarian function during six months before recruitment
* Indication for surgical excision
Effect of an Educational Nail Biopsy Video on Pre-operative Anxiety, Health Literacy, and Patient Satisfaction

The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures.


Eligibility Criteria:
Inclusion Criteria:

* All patients recommended to receive a nail biopsy procedure in our specialty nail clinic.

Exclusion Criteria:

* Age less than 18
Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.

Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmed diagnosis of Stage IV NSCLC according to 2009 the seventh edition of TNM staging of lung tumors.
* No disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment.
* Brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases.
* ECOG score 0-1

Exclusion Criteria:

* First-line chemotherapy other than combination treatment of gemcitabine plus cisplatin
* Other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment.
* Active infection
* Inadequate liver and renal function.
* Serious concomitant systemic disorder incompatible with the study.
* Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence)
* Presence of the pregnancy
Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns

The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.

The specific aims of the proposed research are to:

2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and

2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.

These aims will be examined by characterizing:

* glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
* glucose variability, as measured by the AGP inter-quartile range; and
* glucose stability, as measured by change in the AGP median curve.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the ISL unit at Melrose Institute
* Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)

  1. For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
  2. For ED/only group: Diagnosis of an eating disorder AND no history/diagnosis of type 1 or type 2 diabetes.
* Female.
* At least 14 years of age.
* Able to provide informed consent.

  1. If the potential participant's age is at least 18 years she must be able to provide informed consent.
  2. If the potential participant is less than 18 years she must have a parent or guardian able and willing to provide written informed consent on the participant's behalf. In addition, the participant must be willing to sign a consent on her own behalf.
* Participants must be able and willing to utilize the CGM system and perform required calibrations using self-monitored blood glucose.

Exclusion Criteria:

* Male.
* Age \< 14 years.
* History of self-injurious behavior that the senior clinician feels precludes participation.
* Unable to understand the study protocol.
* Unwilling to follow the study protocol.
* Participation in any competing research study.
* Planned ISL admission for \<4 days.
* Pregnant.
* Not able to communicate in English.
* Regular use of acetaminophen or acetaminophen containing medications and not able to modify their medication to a non-acetaminophen based medication.
A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children

Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

Eligibility Criteria:
Inclusion Criteria:

* At the time of signing the informed consent form, the subject's age must be ≥6 years and \<10 years (6-9.99 years);
* Both eyes are not myopic (SE\>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D\< SE under cycloplegia ≤+0.75D); \[spherical equivalent (SE)=Sph+Cyl/2\]
* Astigmatism ≤1.00D in each eye;
* Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
* Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
* Be in good general health;
* Be able to actively cooperate with the intervention plan and ophthalmological examination;
* Normal binocular vision
* At least one parent with SER ≤-3.00 D

Exclusion Criteria:

* Incapable of expressing consent
* All categories of persons particularly protected by law
* Subject in another study which might have an influence on vision or interfere with study assessment.
* Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
* History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
* Those who are allergic cycloplegic drugs;
* Other reasons that the investigator considers inappropriate for inclusion in the study.
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers

This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.

The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law
* All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
* History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
* History of severe allergic or anaphylactic reactions
* Known history of or positive test result for Human Immunodeficiency Virus (HIV)
* Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
* Female subjects who are pregnant or currently breastfeeding