cyrilzakka/clinical-trials huggingface dataset:
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent prior to initiation of any study-specific activities/procedures
* Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01)
* Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study
* Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies)
* Subject has known sensitivity to any of the products or components to be administered during dosing
* Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study
* Subject is receiving dialysis prescription dialysate calcium concentration \< 2.25 mEq/L
* Subject is pregnant or nursing
Anticaries Potential and Fluorosis Risk From Different Fluoride Toothpastes

Fluoride toothpaste has been associated not only with declining dental caries prevalence but also with an increase in dental fluorosis. In the balance of benefits/risks of fluoride toothpaste use, the purpose of this study is to evaluate the availability of fluoride concentration in the mouth (biofilm fuild), as an indicator of fluoride benefits (anticaries effect), and the fluoride concentration in urine, as an indicator of fluoride absorption from ingested toothpastes (with potential to cause dental fluorosis), in a sample of young Brazilian children using toothpaste formulations representative of those available and most used by this age-group.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Good oral health
App-based Diabetes Management and Community-based Interventions

Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years and above
* Having been diagnosed with type 2 diabetes mellitus
* Having most recent HbA1c ≥ 6.5%
* Physically able to exercise
* Able to read, write, and converse in English
* Able to comply with study procedures

Exclusion Criteria:

* Requiring assistance with basic activities of daily living (BADL)
* Have planned major operation or surgical procedure within 6 months from the time of recruitment
* Current pregnant or lactating
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily

The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.

Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
* Are age 16 or older (consent of a parent or guardian required if under 18).
* Agree to practice abstinence or use barrier methods of birth control (such as condoms).
* Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
* Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
* Have changed their medications in the last 2 weeks.
* Are allergic to IDV, RTV, d4T, or 3TC.
* Have used certain medications (see the technical summary for more detail).
* Are pregnant or breast-feeding.
Integrated Positron Emission Tomography - Computed Tomography (PET-CT) in Patients With Pancreatic Cancer

In suspecting pancreatic cancer, dynamic phase pancreatic CT is the most effective tool in diagnosis and staging. In addition, magnetic resolution image, endoscopic ultrasonography, endoscopic retrograde pancreatography, angiography can be performed.

After introduction of functional image, PET has been suggested in the role of diagnosis and staging of pancreatic cancer. Furthermore, recently fused images of PET and CT were available.

In this study, the researchers evaluate the role of integrated PET-CT in patients with pancreatic cancer and analysis the cost-effectiveness of the integrated PET-CT.

Compared to dynamic phase pancreatic CT, integrated PET-CT will be evaluated for sensitivity, specificity and accuracy of diagnosing and staging pancreatic cancer while the gold standard for pancratic cancer is operative specimen. If the operation can't be performed, EUS-FNA of the pancreatic mass or lymph node and additional imaging modality will be preferred to laparotomy.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic mass suspicious of pancreatic cancer
* No comorbidity, expected life expectancy less than 6 months
* Consent this study in letter

Exclusion Criteria:

* Refuse diagnostic and staging work-up
Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making

The purpose of this study is to try and improve the way that patients with colon cancer understand and cope with their illness and give them tools for talking with their loved ones and family about their illness.

Dignity Therapy is a well tolerated structured interview that helps patients reflect on who they are, what is most important to them and what lessons they have learned through life. For patients not receiving chemotherapy, Dignity Therapy gave patients more hope, more meaning in their life, and helped their families. Researchers at Northwestern University would like to see if it has the same effect in patients getting chemotherapy. We will also see if the Dignity Therapy changes patient's understanding of their disease and their medical preferences.

All study procedures will take place when participants come for a scheduled doctor's visit or to receive chemotherapy. At the first visit participants will answer a questionnaire taking approximately 15-30 minutes. Participants will then have a Dignity Therapy Session approximately 1-2 weeks later. A second Dignity Therapy Session will be scheduled again in another 1-2 weeks. Each study Dignity Therapy Session will take approximately an hour. One to two weeks later a repeat questionnaire will be filled out. Finally, a third and final questionnaire will be complete 4 weeks later.

Eligibility Criteria:
* Participants must be currently receiving treatment for stage IV colorectal cancer.
* Participants must have experience disease progression after their first course of treatment and are being considered for second course of treatment or have already started their second course of treatment.
* Participants must be 18 years old or older.
* All participants must have given signed, informed consent prior to registration on study.
* Participants must speak English.
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.


Eligibility Criteria:
Main inclusion criteria, patient with:

* malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
* newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
* ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling.

Main exclusion criteria:

* Current acute or chronic use of methadone
* History of an neoplasm or an ongoing gastrointestinal-related issue
* Signs or symptoms of gastrointestinal obstruction
* History of prolonged neutropenia or thrombocytopenia with clinical sequelae.
* Patients currently receiving the first cycle of chemotherapy
Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria:

for both groups (glaucoma study group and control group): men and women of at least 50 years of age

for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria:

for both groups (glaucoma study group and control group):

* less then 18 years of age
* any pathology of the central retina
* any optic nerve disorder other then glaucoma
* retinal vascular disorder

for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma

for the control group: any diagnosis of glaucoma
Analytical Impact of the Transport of Pathological Biological Material by Drone

The Hospital Group of Territory Somme Littoral Sud, through its biology sector and in partnership with the company DELIVRONE, aims to engage in the experiment of transporting biological samples by means of a drone platform. Transport by air will be between the CHAM, the Abbeville Hospital and the CHU Amiens-Picardie by flying as much as possible over the waterways via the Somme. With a flight speed of around 100km/h at an altitude between 80 and 120 m, drones will be able to connect sites in less than an hour by transporting packages between 2 and 3 kg. Powered by propellers connected to rechargeable batteries, these drones do not emit CO2. This type of transport has not been validated in France by measuring the analytical impact of transport constraints for medical biology, and has never been evaluated according to the criteria of ISO 15189 standard allowing the certification of medical biology laboratories. Validation steps of this transportation method are therefore necessary on pathological samples prior to routine use. The aim of the project is to verify the absence of analytical impact of the transport of pathological biological samples by drone under defined flight conditions, according to the ISO15189 norm.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Amiens-Picardie University Hospital and having benefited from medical biology examinations including the parameters of interest
* according to the usual management modalities and without additional sampling
* at the time of the test period

Exclusion Criteria:

* Refusal to participate in the study
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject
* Age 18 to 55 years, inclusive
* In good health with no history of major medical conditions
* A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2

Exclusion Criteria:

* Pregnant or nursing females
* Acute or chronic medical illness
* Abnormal lung function
* Positive for human immunodeficiency virus (HIV), active hepatitis A, B or C test
* Nose or nasopharynx abnormalities
* Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug
Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.

This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* 1. patients voluntarily enrolled in the study and signed an informed consent form; 2. aged 18-80 years (including 18 and 80 years), male; 3. diagnosed with prostate adenocarcinoma by pathology or cytology; 4. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score 0-1. 5. patients who have undergone radical prostatectomy (RP) and pelvic lymph node dissection (PLND) without non-regional lymph node metastasis, bone metastasis, or metastasis to other sites (e.g., visceral metastasis) as confirmed by conventional imaging (bone imaging, CT, or MRI) or PSMA PET/CT 6. have positive postoperative pathologic lymph nodes (pN1); 7. with their consent and have signed an informed consent form.

Exclusion Criteria:

* Patients will not be enrolled if they have any of the following:

  1. have histologic features of neuroendocrine differentiation or small cell carcinoma;
  2. have received prior treatment for prostate cancer: postoperative systemic therapy including ADT for \>3 months, conventional endocrine therapy (e.g., flutamide, bicalutamide) for \>3 months, novel endocrine therapy (e.g., dalotamide, abiraterone, abatacept, enzalutamide), chemotherapy (e.g., docetaxel), immunotherapy, and targeted therapies
  3. Inability to tolerate Darotamine or ADT treatment;
  4. persons who are allergic or have a known history of allergy to darotarolimide or ADT;
  5. other conditions that the investigator considers inappropriate for inclusion.
A Gene Therapy Study for Hemophilia B

A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with Hemophilia B.

Hemophilia B, or Christmas disease, is a genetic bleeding disorder resulting in the lack of ability to produce blood-clotting factor IX (FIX). Individuals with hemophilia B suffer repeated bleeding events, which can cause chronic joint disease and sometimes leads to death due to the inability for blood to clot efficiently. This chronic joint disease can have significant physical, psychosocial, and quality-of-life effects, including financial burden. The current treatment is intravenous infusion of FIX protein products, either prophylactically or in response to bleeding.

The approach being tested in this study uses a novel recombinant adeno-associated virus (AAV), which in nature causes no disease, to deliver the human factor IX (hFIX) gene to the liver cells where FIX is normally made. Recent data of a gene therapy study showed preliminary encouraging results with the approach of using an AAV vector carrying the factor IX gene. This study will seek to determine the safety and kinetics of a single IV infusion of SPK-9001 (a novel AAV vector carrying a high specific activity factor IX variant).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent and comply with requirements of the study
* Males ≥18 y.o. with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous factor IX)
* Received ≥50 exposure days to factor IX products
* A minimum average of 4 bleeding events per year requiring episodic treatment of factor IX infusions or prophylactic factor IX infusions
* No measurable factor IX inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor IX protein
* Agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences

Exclusion Criteria:

* Evidence of active hepatitis B or C
* Currently on antiviral therapy for hepatitis B or C
* Have significant underlying liver disease
* Have serological evidence\* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (\* subjects who are HIV+ and stable with CD4 count \>200/mm3 and undetectable viral load are eligible to enroll)
* Neutralizing antibodies reactive with AAV-Spark100 above and/or below a defined titre
* Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational drug within the last 12 weeks
* Unable or unwilling to comply with study assessments
TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months

Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.

Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.

This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA \> 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .

Eligibility Criteria:
Inclusion criteria:

1. Male or female patients, aged 18 to 70 years, including 18 and 70 years old;
2. Patients with poor response to tenofovir for 12 months did not obtained HBeAg seroconversionPatients with poor response to tenofovir for 12 months who didn't obtain HBeAg seroconversion choosed to continue taking tenofovir or take tenofovir combined with Tbl for 12months;
3. Persons were willing to sign informed consent and comply with medication regimen and follow-up.

Exclusion Criteria:

1. Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
2. In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
3. With malignant tumors (including hepatocellular carcinoma);
4. Concomitant with other liver diseases, such as alcoholic liver disease, autoimmune disease, or other systemic diseases involving the liver, such as hemochromatosis, Alpha-1 antitrypsin deficiency, or Wilson disease;
5. During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;

There are any other factors that the researcher thinks are not suitable for inclusion in the study, or that may affect the patient's participation or completion of the study.