cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

Pharmacokinetic, bioequivalence study


Eligibility Criteria:
Inclusion Criteria:

* The subject has given written, informed consent and is available for the entire study.
* Histologically or cytologically confirmed diagnosis of breast cancer;
* Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
* Age 18 years or more

Exclusion Criteria:

* Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
* Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
* Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
* Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
[18F]-DPA-714 PET/CT (Positron Emission Tomography/Computerized Tomography) in Triple Negative Breast Cancers

This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and \[18F\]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

The purpose of this study is to evaluate the correlation of inflammation assessed by M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and \[18F\] DPA-714 PET imaging by using qualitative and image texture analysis in patients with triple negative breast cancer.

Patients receive pre-therapeutic diffusion-weighted breast MRI (Magnetic resonance imaging) and 18FDG (fluorodeoxyglucose) PET/CT (Positron Emission Tomography/Computerized Tomography) scan within 30 days before enrollment.

\[18F\] DPA-714 PET/CT scan is performed before surgery. About 3 MBq/Kg of \[18F\] DPA-714 are injected intravenously, two acquisition sequences are performed following injection and 60 minutes after injection in order to evaluate early and late tumor uptake of \[18F\] DPA-714.

Surgery is scheduled after \[18F\] DPA-714 PET/CT scan. Tissue samples from breast surgery are used to assess M1 and M2 macrophages expression and to perform tumor molecular subtyping by Immunohistochemical analysis. Tumor Autoradiography with the TSPO (18 kDa Translocator Protein) ligand \[18F\]DPA-714 will be also assessed on tumor tissue.

A blood sample is performed before \[18F\] DPA-714 PET/CT scan in order to assess the genotyping of TSPO (18 kDa Translocator Protein) gene.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Triple negative primary breast cancer based on immunohistochemical results as follows:

  * Estrogen receptor \< 10%
  * And Progesterone receptors \< 10%
  * And HER2 (Human Epidermal Growth Factor Receptor-2) not amplified or not overexpressed
* Patient with a primary tumor eligible for primary surgery
* Performance Status equal to 0 or 1
* Fertile patients must use effective contraception
* Patient must be affiliated to a Social Health Insurance
* Written informed consent

Exclusion Criteria:

* Patient with No triple negative breast cancer
* Patient with inflammatory breast cancer
* Patient with metastatic breast cancer
* Patient receiving cancer treatments such as chemotherapy, immunotherapy, biologic response modifiers, hormonal therapy, and radiotherapy BEFORE the biopsy and PET scans are performed
* Treated diabetes with fasting blood glucose \> 10 mmol/L
* Patient who received antibiotics and/or steroidal and/or non-steroidal anti-inflammatory drugs within 30 days PRIOR to \[18F\]-DPA-714 PET scan
* Contraindication to MRI (implants or metallic prosthesis, severe claustrophobia, pacemaker ...)
* Patient deprived of liberty, under a measure of safeguard of justice, under guardianship or under the authority of a guardian
* Pregnant or nursing patient
* Agitation; impossibility of lying motionless for at least 1 hour, or known claustrophobia
Effects of Rosuvastatin on Aortic Stenosis Progression

The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec
* Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines
* Baseline triglyceride levels must be within target level for the risk categories

Exclusion Criteria:

* Very mild AS defined by peak Doppler AS velocity \<2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception.
* Severe AS defined by peak Doppler AS velocity \> 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
* Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio \>0.45; Patients with diabetes or with a fasting blood sugar level \> 7.0 mmol/L (must be confirmed with one repeat assay within 14 days).
* Significant concomitant mitral valve disease, defined by \> moderate mitral regurgitation (MR) or mitral valve area (MVA)\< 1.5 cm2; A very high risk of CAD (10 year risk \> 30%), according to the Canadian Guidelines.
QoL Assessment in Traditional Glaucoma Surgery and MIGS.

Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).

Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.

Eligibility Criteria:
Inclusion Criteria:

patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:

* all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
* patients not tolerating antiglaucoma medications,
* patients with poor compliance
* progression in visual field

Exclusion Criteria:

* active inflammatory disease
* pregnancy
* mental disease or emotional instability
* general steroid therapy
* inability to fill in the questionnaire
A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients

The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppression medication adherence among adolescent kidney transplant recipients. The investigators aim to test this by recruiting adolescent (ages 14-21) kidney transplant recipients to use an mHealth application to record themselves taking their immunosuppression medications, and tracking medication adherence over time. The study population will be approximately 50 adolescent kidney transplant recipients at the Johns Hopkins Hospital.

In kidney transplant recipients, non-adherence to immunosuppressant medications post-transplant has been associated with a range of negative implications, including increased healthcare utilization, rejection of the graft, kidney loss, and death. Specifically, adolescents and young adults are the most at risk populations for experiencing death-censored graft loss and medication non-adherence. Previous studies have reported rates of non-adherence in this population ranging from 50-70%, and even minor deviations in immunosuppressant medication adherence have been shown to have negative effects. The use of mobile health (mHealth) technology could prove useful in aiding transplant recipients to stay adherent to their medical regimen.

We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to perform a pilot trial examining the rates of medication adherence in adolescent kidney transplant recipients who use a novel mHealth system, and to understand the acceptability/satisfaction with using this technology.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents (14-21 years old)
* Have received a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria:

* Non-English speaking
* International
Low-intensity Exercise in Metabolic Syndrome

People with metabolic syndrome (MetS) are characterized by a lower quality of life in terms of reduced vital activity, emotional state, and social functioning. Therefore, the investigator's aim was to determine the impact of low-intensity exercise and psychoeducation on depression symptoms and self-perceived stress in women with MetS.

Metabolic syndrome (MetS) is currently one of the major threats to health in highly developed societies. A recent study has demonstrated that depression may be significantly associated with MetS in people aged 60 years or over. The more components of MetS that are evident in the individual, the more depressive symptoms this individual is likely to exhibit.

MetS treatment is essentially founded on implementing lifestyle changes which involve regular physical activity and healthy dietary habits. Systematically undertaking exercise has a beneficial influence on health, particularly on cardiovascular system functions as well as the quality of life and depression status in middle-aged and older women with MetS.

Previous work has shown moderate or high intensity exercise to be optimal for the treatment of MetS. Nevertheless, many patients with MetS have hypertension and obesity. Therefore, for safety reasons, the patient's condition during intensive group exercises should be constantly monitored by a physician or specialized equipment, which generates costs and may limit the availability of this type of intervention.

Hence, the investigator's aim was to determine the impact of 12 weeks of low-intensity exercise, combined with psychoeducation, on the severity of depression symptoms and self-perceived stress in women with MetS.

Eligibility Criteria:
Inclusion Criteria:

The presence of Metabolic Syndrome diagnosed using the International Diabetes Federation-recommended criteria (2006):

* "mandatory" central obesity (defined as waist circumference ≥ 80 cm in females),

and any two of the following:

* raised triglycerides (\>150 mg/dL),
* reduced HDL cholesterol (50 mg/dL in females),
* elevated blood pressure (BP; systolic BP \> 130 or diastolic BP \> 85 mm Hg) ,
* increased fasting plasma glucose (\>100 mg/dL),

Exclusion Criteria:

* disturbed cognitive functions (Mini-Mental State Examination \> 23),
* the inability to move independently or a motor disability precluding exercise,
* serious neurological or orthopaedic conditions (e.g., advanced Parkinson's disease, severe stroke consequences),
* attending fewer than 13 intervention sessions.
The Effect of Local Cold Application and ShotBlocker Use in Subcutaneous Injection on Injection Pain and Patient Satisfaction

The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection.

The research was conducted as a single-blind, randomized controlled, experimental study to determine the effect of ShotBlocker and local cold application on pain and patient satisfaction in subcutaneous heparin injection. The research was conducted with 208 patients hospitalized in the Cardiology and Internal Medicine clinics at Izmir Atatürk Training and Research Hospital between April 2022 and April 2024. Patients were assigned to four groups: ShotBlocker (n=52), ShotBlocker placebo (n=52), local cold application (n=52) and control (n=52) groups using the randomization algorithm.

A ShotBlocker was placed on the arm of the patients in the ShotBlocker group during the injection, and the injection was performed from the part where the opening was located by lightly pressing with the fingertips throughout the injection. During the injection, the back side of the ShotBlocker was placed on the arm of the patients in the ShotBlocker placebo group and the injection was performed by gently pressing with the fingertips throughout the injection. Local cold application was applied to the arm of the patients in the local cold application group for five minutes using a cold pack, and then the injection was performed. Patients in the control group were injected with a routine subcutaneous injection procedure. In all groups, the injection took 30 seconds and was performed by researcher. At the first minute after the injection, the patients were evaluated about the pain they felt during the injection and their satisfaction with the injection by a different reseacher. Data were collected by face-to-face interview technique using an informed consent form, individual identification form, visual analog scale and visual patient satisfaction scale. Ethics committee permission, institutional permission and written permission from the patients were obtained for the implementation of the research. Number, percentage, median, mean, and standard deviation, Mann Whitney U test, Kolmogorov-Smirnov test, Kruskal Wallis H test, Bonferroni and chi-square test were used in the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* Enoxaparin sodium 1x1 0.6 ml. SC treatment
* Over 18 years of age
* No vision or hearing problems
* No scar tissue, incision, lipodystrophy or infection at the injection site

Exclusion Criteria:

* Underwent mastectomy
* Not being voluntering
The Rhode Island Prescription and Illicit Drug Study

This study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (PWUD), who are 18-65 years old at the time of enrollment. The investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. Results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. This is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(Krieger et al., 2018)

The investigators will assess the efficacy of the RAPIDS intervention on preventing overdose among PWUD. Participants will be randomized 1:1 to receive the RAPIDS intervention or the attention-matched control condition. Experimental arm participants will receive the RAPIDS intervention, which includes education about the dangers of illicitly manufactured fentanyl (IMF), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training. All participants will attend additional study visits at months 1,2,3,6, and 12. The primary endpoint will be the rate of self-reported overdose over the follow-up period. Secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases.

The primary aims of this study are to: 1) Assess the efficacy of the RAPIDS intervention in reducing rates of overdose among people who use drugs; 2) Examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) Explore whether there is heterogeneity of treatment effect related to key participant characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Reside in Rhode Island
* Are able to complete interviews in English
* Are able to provide informed consent
* Self-report past 30 day heroin, illicit stimulants, counterfeit prescription pills, or injection drugs

Exclusion Criteria:

* Participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription
Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa

The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;
* Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;
* Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;

Exclusion Criteria:

* Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.
18F-FDG PET/CT in the Diagnosis of Tuberculous Pericarditis

A total of 11 patients confirmed with tuberculous pericarditis were enrolled in this study to analyze the diagnostic value of 18F-FDG PET/CT for tuberculous pericarditis.

A total of 11 patients with tuberculous pericarditis, who underwent 18F-FDG PET/CT from January 2015 to February 2022 in the affiliated hospital of Jiangnan university were retrospectively reviewed in this study to analyze the diagnostic value of 18F-FDG PET/CT in tuberculous pericarditis.

Eligibility Criteria:
Inclusion Criteria:

patients confirmed as tuberculous pericarditis through follow-up.

Exclusion Criteria:

patients confirmed as other pericarditis through follow-up.
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders

This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.

Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders
* Negative pregnancy test in females of childbearing age

Exclusion Criteria:

* Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy
* Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia
* Current treatment with heparin
* Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium
* Current or anticipated corticosteroid use
* History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding
* Those on warfarin or any anticoagulant
* Current treatment with lithium or asthma medication
* Individuals with pre-existing liver, cardiac, or kidney disease