cyrilzakka/clinical-trials huggingface dataset:
Analysis of Relevant Influencing Factors of Glycemic Control in Patients With Diabetes

This study aims at the analysis of relevant influencing factors of glycemic control in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-90 years with diabetes and the diagnostic criteria of diabetes is according to the World Health Organization in 1999.

Exclusion Criteria:

Patients with stress hyperglycaemia. Patients with severe systemic disease. Patients treated with systemic glucocorticoids within the last three months. Patients without any records about HbA1c, CGM and SMBG.
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II dose (RP2D) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Diagnosis of R/R MM per IMWG criteria
* For female participants of childbearing potential: agreement to remain abstinent or use contraception
* For male participants: agreement to remain abstinent or use a condom

Exclusion Criteria:

* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
* Prior treatment with elranatamab
* Prior allogeneic stem cell transplantation (SCT)
* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
* Participants with known history of amyloidosis
* History of autoimmune disease
* History of confirmed progressive multifocal leukoencephalopathy
* Peripheral motor polyneuropathy of prespecified grade
* Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Human immunodeficiency virus (HIV) seropositivity
* History of central nervous system (CNS) myeloma disease
* Significant cardiovascular disease
Oral and Topical Tranexamic Acid for the Treatment of Melasma

Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

Tranexamic acid has been used for treating melasma due to its effect on decreasing the activity of tyrosinase and melanogenesis. This 3-arm clinical trial will asess the efficacy and safety of oral and topical tranexamic acid as monotherapy compared with topical hydroquinone for 12 weeks in adults with melasma. One hundred and twenty patients will be recruited in 3 groups of intervention: group I with tranexamic acid at a dose of 250 mg bid orally, group II with 5% topical tranexamic acid bid, group III with 4% topical hydroquinone once daily. The primary outcome will be the percentage of reduction at 12-week period of mMASI and melanin index. The incidence of adverse effects will be reported at weeks 4, 8 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Moderate to severe melasma
* History of multiple topical depigmenting treatments and use of photoprotection, with subjective improvement less than 50% or mMASI \<50% reported by the dermatologist after one year of treatment.

Exclusion Criteria:

* Pregnancy
* Hormonal contraception
* Lactation
* Treatment with hydroquinone or tranexamic acid at the time of the study or in the last 3 months
* Endocrinology diseases
* Hormone replacement therapy
* Family or personal history of one of the following: autoimmune disorders, coagulation disorders, chronic venous insufficiency, heart diseases, retinopathies, kidney disorders
* Mental disability
Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).

A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (ESRD)

The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with ESRD.The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females
2. Age = 30-70 years
3. BMI\&lt; 40 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
4. Normal Glucose Tolerance (HbA1c \&gt; 4.5 % and \&lt; 5.7%) or Type 2 diabetes (HbA1c \&gt;5.7 % and \&lt;10.0%)
5. End Stage Renal Disease (GFR \&lt;15 ml/min/1.73 m 2 or hemodialysis)
6. Subjects are capable of giving informed consent

Exclusion Criteria:

1. Prednisone treatment
2. Beta blocker or any medication that affects sympathetic/parasympathetic activity
3. Known Empagliflozin Excipient Hypersensitivity
4. Liver function enzymes higher more than two times the upper limit
5. Ongoing urinary tract infection
6. history of cancer of any type;
7. cerebrovascular or symptomatic peripheral vascular disease;
8. heart disease class III or IV NYHA;
9. Type 1 Diabetes
10. drug or alcohol abuse;
11. life expectancy \&lt;3 yrs
12. blood pressure \&gt;150/100 mmHg
13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \&gt; 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)
15. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
Observational Study Analyzing RNA Expression Of Endometrial Biopsy Samples From Placebo, Bazedoxifene/Conjugated Estrogens And Raloxifene

This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.

The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible in case of a regulatory inspection of the 303 protocol. Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP) approval, and enrollment could not be met without the inclusion of these subjects. The study was not terminated due to safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
* Has completed 24 months of treatment.
* Was at least 80% compliant with study drug administration.

Exclusion Criteria:

* Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
* Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)
Shocking Therapy for Chronic Pelvic Pain Syndrome

Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis and accounts for approximately 2 million outpatient visits to urology practices in the United States alone. Up to 6% of men in Canada recently experienced at least moderate to severe prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There are a myriad of therapies for prostatitis, some of which work on some of the men but none works for all the men. Recently, a number of centres have been using low energy shock waves applied on the skin to target the prostate and the muscles around the prostate. The initial reports showed a significant reduction in the pain experienced by the men with prostatitis. However, this potentially highly promising therapy has not been widely used at least in part due to a lack of properly designed studies to validate this therapy. The investigators plan a randomized control trial using shock wave therapy on men with prostatitis. The goal is to provide some solid evidence that either shock waves are or are not of clinical benefit.

The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will have a reduction in pain and improved voiding and sexual function following low power transdermal shock wave therapy to the prostate and surrounding pelvic muscles.


Eligibility Criteria:
Inclusion Criteria:

* Exhibit symptoms of pain typical for prostatitis/CPPS
* Have had the symptoms for at least 3 months
* Have no evidence of infection in the urine or expressed prostatic secretions (the seminal plasma may be substituted if expressed prostatic secretions are not available).
* Have failed at least one therapy for CPPS

Exclusion Criteria:

* Suspected or confirmed to have prostate cancer
* Have a coagulation disorders
* Use anticoagulants
* Have thrombosis
* Have used cortisone therapy up to 6 weeks before first treatment
* Are actively trying to conceive
18F-FLT (PET/CT) in Pediatrics With Myeloproliferative Neoplasms

The Main purpose of this project to study the uptake pattern of FLT-PET and it is value in assessing the malignant hematopoiesis in MPN within the pediatric age group, in terms of diagnosis, staging and monitoring response to therapy. As well as, evaluating FLT-PET as a novel non-invasive technique in cases with MPN and its role in comparison to the standard bone marrow biopsy with regard to disease diagnosis, assessment of disease activity, detection of transformation, monitoring of treatment response and grading of fibrosis.Furthermore, we aim to study the association of FLT-PET uptake patterns with different genetic makeup (JAK2, CALR positive, MPL, or Triple negative disease) or allele burden in cases of Pre-PMF with the ability of FLT-PET to differentiate between Pre-PMF and ET.

Although MPNs are diseases of elderly, MPN is diagnosed in younger age groups in a considerable number of cases. Since most of the available data as well as current WHO classification criteria emphases on the "average" MPN patients who range in age between 55 and 65 years. Less consistent data are available in the groups of patients presenting below this median age, such as children and younger adults which we're planning to reveal.


Eligibility Criteria:
Inclusion Criteria:

* Cases fulfilling WHO (World Health Organization) 2016 diagnostic criteria for MPN including: Chronic myeloid leukemia, BCR-ABL1-positive (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product), Chronic neutrophilic leukemia (CNL), Polycythemia vera, Primary myelofibrosis prefibrotic/early stage, Primary myelofibrosis overt fibrotic stage, Essential thrombocythemia, Chronic eosinophilic leukemia, not otherwise specified (NOS) and Myeloproliferative neoplasm, unclassifiable.
* Age between 14 and 18 years old
* Patient accepts to sign inform consent
* ECOG (Eastern Cooperative Oncology Group) performance less than or equal 2

Exclusion Criteria:

* Patient not fulfilling the inclusion criteria.
* Vulnerable groups: pregnant, minors, prisoners will not be included.
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

Hip fractures are a serious public health problem. The current incidence is projected to increase fourfold worldwide by the year 2050. This affliction is obviously linked to the aging of the population and the absence of a systematic prevention of osteoporosis.

This leads to the creation of a minimally invasive, or ever percutaneous, implantable osteosynthesis material which associates :

* the well-known reliability of osteosynthesis using screw-plate with barrel,
* the safety of the fixation with Surfix concept, locking the screws to the plate using lock-screws,
* a modularity thanks to the choice between 3 sizes of barrel,
* the creation of a simple material, easing the operative surgery by minimally invasive approach.

The TRAUMAX answers to all those characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Age \> 18
* with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX

Exclusion Criteria:

* Patient with an acute infection
* Patient with a major osseous deterioration which not allows a correct support of the screws in the bone
* Patient with an ASA score of 4 or 5
* Patient whom the time between the fracture and the surgery could be higher than 8 days
Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)

The main objective of the study is to assess the sensitivity of the salivary cortisol dosage at 23 hours compared to the serum cortisol dosage at 8 am after overnight 1-mg dexamethasone suppression test (Suppression of serum cortisol \<1.8 μg/dL ) as the reference method for the detection of ACIC in obese subjects


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Signed informed consent
* Subjects affiliated with an appropriate social security system
* Body mass index above 30 kg/m2 and
* Pathological waist circumference according to criteria of NCEP ATPIII (men : 94 cm and women : 80 cm)

Exclusion Criteria:

* Pregnancy
* Sepsis
* Recent surgery (less than 30 days)
* Any recent severe acute conditions requiring hospitalisation (less than 30 days)
* Recent use (\< 7 days) of oral steroids, inhaled, dermal, collyrium, infiltration
* Long-term oral corticosteroids
* Nicotinic substitute or per os licorice in 2 weeks before the inclusion
X-MAS Biliary Study With Covered Biliary Stent

The purpose of this study is to provide safety and efficacy data for the X-Suit NIR® Covered Biliary Metallic Stent for subjects with malignant stricture(s) in the biliary tree. The study is designed to support the regulatory requirement of a 510(k) marketing application in the United States.

This is a non-randomized, multi-center, prospective, single arm clinical study of the X-Suit NIR® Covered Biliary Metallic Stent for the palliation of malignant strictures in the biliary tree via endoscopic approach.

Adult males and females (≥ 18 years old), with clinical symptoms of biliary obstruction and inoperable extrahepatic biliary obstruction by any malignant process.

The expected duration of this study is approximately 18 months from the time of first subject enrollment to the time of the last subject's 6-month post stent implantation follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older.
2. Clinical symptoms of biliary obstruction.
3. Presence of inoperable extrahepatic distal biliary obstruction by any malignant process (the subject not being a surgical candidate based on the finding of a pancreatic mass \>2.0cm or a severe medical illness).
4. Subject is willing and able to comply with the study procedures and provide written informed consent to participate in the study.
5. Insured by Social Security (applicable to subjects screened in France).

Exclusion Criteria:

* 1. Participation in an Investigational Study within 90 days prior to date of subject consent.

  2. Perforation of any duct within the biliary tree. 3. Presence of more than one previously implanted plastic stent. 4. Previous plastic stent implantation less than 2 weeks prior to current procedure.

  5. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.

  8. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system.

  10. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.

  11. Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).

  12. Subjects known to be pregnant.

Cholangiographic exclusion criterion:

13. Strictures that cannot be passed by the guide wire or the delivery system.
The HEART Study (Healthy Eating and Recovery Together)

Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.

The long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment.

Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. The intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver App with encouragement, reminders and tips delivered through messaging and peer videos. Participants will complete baseline and 6-week follow-up surveys.

Eligibility Criteria:
Patient Inclusion Criteria:

* 18 years and older
* Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)
* In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months
* Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener

Patient Exclusion Criteria:

* head and neck cancer patients who do not undergo treatment
* Patients who do not read or understand English
* Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
* Patients who do not have a smartphone for use in the study

Caregiver Inclusion Criteria:

* 18 years and older
* Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment

Caregiver Exclusion Criteria:

* Caregivers who do not read or understand English
* Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider
The Causes of Academic Excellence Concentrated in Dormitory

This research will take the sophomore to senior students of Zhejiang University of Traditional Chinese Medicine as the research object to investigate the influence of dormitory atmosphere on the academic performance, scientific research achievements, and competition awards of dormitory members, analyze the path of straightforward-A student dormitory formation, and find out the current Weak links of college students' ideological and political education in dormitory culture construction, and explore how dormitory culture construction can promote the common progress of dormitory members


Eligibility Criteria:
Inclusion Criteria:

* Sophomore-senior students of Zhejiang University of Traditional Chinese Medicine

Exclusion Criteria:

* Non-straight-A student dormitory member
The Effect of Cyclosporin Before Cataract Surgery

To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. 21+ adult men and women
2. Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract
3. Corneal fluorescein staining score (Oxford) is II or less
4. Preoperative MMP-9 positive
5. Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery.
6. Those who have voluntarily written consent to participate in this clinical trial

Exclusion Criteria

1. Those who have used systemic or topical cyclosporine within 4 weeks
2. Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes
3. Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial.
4. Abnormal eyelid function
5. An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status
6. Patients with active eye infections
7. Patients with conflicts with this clinical trial
8. Pregnant and lactating mothers
9. Patients who are determined to be inappropriate by other investigators