cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)


Eligibility Criteria:
For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Note: Subjects \> 16 are eligible for enrollment at selected centers

Inclusion Criteria:

* Potential subjects must have active lupus nephritis
* Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
* Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
* Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
* There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:

  * Worsening of lupus nephritis OR
  * UPCR ≥ 3 at Screening OR
  * Active urine sediment OR
  * Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis

Inclusion Criteria for the Long-Term Extension Period:

* Signed Written Informed Consent
* Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment

Exclusion Criteria:

* Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
* Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
* Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
* Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible
Myofunctional Therapy in Facial Palsy

Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.

Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.

Eligibility Criteria:
Inclusion Criteria:

* facial paralysis with more than 2 years elapsed since the onset of symptoms
* surgically treated for reanimation at least 12 months before
* static and/or dynamic facial asymmetry causing aesthetic concern

Exclusion Criteria:

* spastic paralysis
* serious systemic or neuromuscular diseases
* cognition impairment
* pregnant women
Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients

The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant recipients with proteinuria compared to normoalbuminuric transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* One Group of kidney transplant recipients with ACR\< 30mg/g
* One Group of kidney transplant recipients with ACR \>300mg/g

Exclusion Criteria:

* Treatment with amiloride, spironolactone, aldosterone- or analogs or tranexamsyre
* Pregnancy
* Clinically relevant organic or systemic disease including malignancy
* eGFR or creatinin-clearance \< 30ml/min
* hyperkalemia (s-potassium \> 5,0mmol/l)
Expectant Management of Ectopic Pregnancy

The aim of this study is to assess the efficacy and safety of expectant management in the treatment of tubal ectopic pregnancy and identification of different factors that can be used to predict its success.


Eligibility Criteria:
Inclusion Criteria:

- all women who underwent expectant management as the first line of management offered after optimal counseling during the period from January 1, 2016 to December 31, 2020.

1. Hemodynamically stable with confirmed diagnosis of ectopic pregnancy on ultrasound scan.
2. No significant pelvic pain.
3. No hemoperitoneum.
4. No fetal heart in the ectopic pregnancy.
5. HCG level \<5000 IU/L.
6. Expectant management was the first line of management offered to the patient after optimal counseling.

Exclusion Criteria:

1. all women with non tubal ectopic pregnancy
2. all women with tubal ectopic pregnancy that recieved medical or surgical treatment as 1st line treatment
68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for Biopsy Guidance in Patients With Suspected Prostate Cancer

The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.

Exploratory Objective:

* Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy
* Correlation of 68Ga RM2 and Gleason score at biopsy

Eligibility Criteria:
Inclusion Criteria:

* Suspected prostate cancer
* Planned prostate biopsy
* Able to provide written consent
* Karnofsky performance status of 50 (or ECOG/WHO equivalent)

Exclusion Criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Metallic implants (contraindicated for MRI)
Negotiation Training for Caregiver Communication in AD

The purpose of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience.

The goal of this study is to design a Negotiation and Dispute Resolution (NDR) training intervention to improve communication and address resolution of conflicts that family caregivers of patients with cognitive impairment and/or Alzheimer's Disease (AD) frequently experience. Specifically this study will:

Aim 1: Employ a caregiver (user)-centered design approach to modify and tailor a negotiations and dispute resolution (NDR) training intervention to support communication skills of family caregivers of adults with AD.

Aim 2: Utilizing Multiphase Optimization Strategy (MOST), conduct a randomized controlled trial of the NDR intervention that targets better communication between caregivers and health teams to determine the feasibility of delivering the intervention, and derive estimates of the effect of 3 intervention components on changes in patient-centered outcomes at post-intervention and follow-up.

Exploratory Aim 3: Explore if intervention components (lectures/exercises) interact to change communication between caregivers and health care teams at post-intervention and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Speak/read English;
* Currently provide care-giving support (e.g. emotional, social, physical, task-related) to an adult over the age of 65;
* Currently provide care-giving support at least 1 hour per week (e.g. may include grocery shopping, scheduling appointments, and transportation);
* Currently involved in any decision-making related to the healthcare and support of this adult over the age of 65;
* Score \>2 on the 8-item Informant Interview to Differentiate Aging and Dementia (AD8);
* Access to and the ability to use the internet to complete a series of online activities; and
* Have a valid email address or the willingness to create one to access during the study

Exclusion Criteria:

* Less than 21 years old
* Unable to speak and read English
Prevalence and Severity of Colour Vision Deficiency Among Turkish Children

To evaluate the usability of the Colour Assessment and Diagnosis (CAD) test in children. To determine the prevalence of colour vision deficiency (CVD) among Turkish children, to identify the class of deficiency and to quanify severity of loss.


Eligibility Criteria:
Inclusion Criteria: children with aged 6-16 years, who attended the ophthalmology department at the Istanbul Medipol University -

Exclusion Criteria:Children with known or current evidence of ocular pathology (other than refractive errors), with history of long term use of medication, previous ocular surgery and those with chronic systemic diseases were excluded from the study

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Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.


Eligibility Criteria:
Inclusion Criteria:

* Age more than or equal to 18 and less than or equal to 40
* BMI more than or equal to 18 and less than or equal to 35
* Diagnosis of PCOS according to Rotterdam criteria
* Normal gynaecological ultrasound \< 6 months before inclusion
* Signed informed consent form
* Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage

Exclusion Criteria:

* Recurrent implantation failure
* Recurrent miscarriage
* Presence of adenomyosis
* Untreated intrauterine pathology
* rAFS (revised American Fertility Society) Grade III or IV endometriosis
* Hydrosalpinx
* In vitro maturation (IVM)
* Untreated autoimmune disorders
* (History of) malignancy
* Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past
* Pre-implantation genetic testing (PGT)
Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
* Patients must have previously untreated locally advanced or metastatic NSCLC
* EGFR activating mutation (exon 19 deletion, L858R) is required
* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

* Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
* Patients with wild-type EGFR
* Any other investigational agents are not permitted
* Any evidence of interstitial lung disease
Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, the control preparation.


Eligibility Criteria:
Inclusion Criteria:

1. Age: Women in 30\~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
2. Patients with a disorder in autoimmune system
3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.
5. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
6. Patients with a malignant tumor
7. Women in pregnancy or lactation
8. Hepatitis carriers or VDRL/HIV positive patients
9. Those with a hypersensitivity to the investigational medical device of this study
10. Other persons including those considered as difficult to perform this study by the principal investigator
Effect of Food on the Pharmacokinetics of Meloxicam in Healthy Volunteers

Study to investigate dose-proportionality over the dosage range 7.5 mg to 22.5 mg, and to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects as determined by results of screening
* Age range from 21 to 50 years
* Broca index +/- 20%
* Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG and laboratory value) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than ten half-lives of the respective drug prior to administration
* Use of any drugs which might influence the results of the trial (≤ one week prior to administration or during trial)
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range or clinical relevance
* History of haemorrhagic diatheses
* History of gastrointestinal ulcer, perforation or bleeding
* History of bronchial asthma

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. sterilisation, intrauterine pessary, oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactating
Prevalence of Depression and Anxiety Among Breast Cancer Patients

Depression and anxiety in patients with breast cancer is serious comorbidity that affects the quality of life for patients, and their survival rates as they have poorer health outcomes. Furthermore, patients' high psychological burden is linked to higher healthcare costs. The investigation of the depression and anxiety symptoms prevalence among newly diagnosed breast cancer patients will help to navigate the health policy adjustment and psycho-social support system requirements. This study aims to investigate the prevalence of depression and anxiety symptoms among newly diagnosed breast cancer patients in Almaty, Kazakhstan, and associated risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Female adults with confirmed diagnosis of breast cancer within the 6 months study enrollment
* TNM stage I-IV
* Russian or Kazakh language proficiency
* Ability to provide informed consent

Exclusion Criteria:

* Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
* Current active suicidal ideation
* Referral to palliative care
Efficacy Evaluation and Influencing Factors of Argon Laser Peripheral Iridoplasty in Acute Angle Closure Glaucoma

To investigate the changes of angle structure and intraocular pressure after argon laser peripheral iridoplasty in patients with acute angle closure glaucoma patients whose intraocular pressure could not be controlled by drug therapy during the major attack period.

To evaluate intraocular pressure and anterior segment optical coherence tomography measurement parameters at baseline and each follow-up. Each patient was followed up for 6 weeks for 9 times. Visit 1st was baseline examination, visit 2nd was 1 hour after argon laser peripheral iridoplasty treatment, visit 3rd was 2 hours after argon laser peripheral iridoplasty treatment, visit 4th was 1 week after argon laser peripheral iridoplasty treatment, visit 5th was 2 week after argon laser peripheral iridoplasty treatment, and visit 6th was 1 month after argon laser peripheral iridoplasty treatment, visit 7th was 6 week after argon laser peripheral iridoplasty treatment.

Eligibility Criteria:
Inclusion Criteria:

* One eye had an acute attack, which could not be relieved by medication, and the intraocular pressure was more than 21mmhg;
* The patients were 40 to 80 years old, regardless of gender;
* Patients are able and willing to comply with the research guidance and may complete all visits required by the research;
* Informed consent has been signed.

Exclusion Criteria:

* History of ocular trauma;
* Any previous intraocular surgery;
* Secondary glaucoma was diagnosed, including uveitis, neovascular glaucoma, glaucoma with elevated superior scleral venous pressure, lens dissolution glaucoma, glaucoma caused by lens dislocation, lens cortical glaucoma, pigmented glaucoma, etc;
* The patient's history indicated that he had severe dysfunction of heart, lung, liver and kidney;
* Women in pregnancy, lactation or planned pregnancy;
* The researchers believe that the patient's condition may put the patient at a significant risk, may confuse the results of the study, or may significantly interfere with the patient's participation in the study.
Risk Factors of Ascending Aortic Atheromatous

Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated.

Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma

Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover.

Five standard epiaortic views will be collected. Epiaortic clips will be review and determine about atheroma by two qualified echocardiographers. Atheroma more than third grade will defined to significant. Potential risk factors of atheroma will be gather from medical record

To assess the relationship between risk factors and atheroma a univariate analysis was performed using an unpaired t-test and a Chi-square test.

For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Schedule to cardiac surgery with sternotomy

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm
Universal CAR-T Cell Therapy for Refractory Lupus Nephritis

This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years; both genders eligible.
* Subjects diagnosed with lupus nephritis.
* Previous treatment outcomes were unsatisfactory.
* Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
* NIH Activity Index \> 2 and elevated chronicity index.
* Urine protein: creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.
* Receiving hormones with or without antimalarials.
* SLEDAI-2K score ≥ 6.
* Antinuclear antibody positive, and/or anti-ds-DNA antibody positive, and/or anti-Smith antibody positive.
* Positive expression of CD19 on B cells in peripheral blood.
* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
* Provides written informed consent.

Exclusion Criteria:

* History of solid organ transplantation.
* Malignant tumor within the last two years.
* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
* Primary immunodeficiency (congenital or acquired).
* Severe cardiac disease.
* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
* Allergic constitution or a history of severe allergies.
* Pregnant or breastfeeding women.
Virtual Reality in Laryngology

The purpose of this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of care counterparts because the VR environment will distract them from their procedure.

This is a prospective randomized controlled trial, comparing patients' pain and anxiety experience while wearing a VR headset and receiving standard analgesia during In-office aerodigestive procedures (IOAEP) to patients' experience receiving standard analgesia only during IOAEP.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 or older)
* Patients scheduled for IOAEP, including laryngeal biopsies, percutaneous injection laryngoplasty, KTP ablation of hemorrhagic polyps and respiratory papilloma, and transnasal esophagoscopy (TNE), and esophageal manometry.

Exclusion Criteria:

* Patients under 18 years of age
* Patients unable to consent
* Non-English-speaking patients
* Patients who have undergone prior IOAEP
* Patients who have used any psychotropic or analgesic medication within the last 24 hours due to the possible confounding effect on pain or anxiety perception
* Patients with motion sickness or uncorrected visual impairment (legal blindness)
* Patients with past medical history of seizures or visual abnormalities