cyrilzakka/clinical-trials huggingface dataset:
Comparison of Nexavar/Placebo as Maintenance Therapy for Patients With Advanced Ovarian or Primary Peritoneal Cancer

Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) stage (67) III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-6 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment.
* Normal serum CA125 (cancer-associated tumor marker) level within 7 days of first dose of sorafenib.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* All scans used to document complete response must be done within 30 days prior to randomization.
* Patients must be able to swallow and retain oral medication.

Exclusion Criteria:

* Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard Computed tomography (CT) or magnetic resonance imaging (MRI).
* Prior local radiotherapy, neoadjuvant chemotherapy or intraperitoneal chemotherapy.
* Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
* Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
Clinical Trial Assessing the GNbAC1 in Patients With Onset of Type 1 Diabetes Within 4 Years

The monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous Multiple Sclerosis associated RetroVirus (MSRV), which could play a critical role in different autoimmune disorders, notably type 1 diabetes (T1D).

This study is a multicentre study evaluating for the first time the safety and efficacy of GNbAC1 in T1D subjects for a first bouble-blind period of 20 weeks followed by an optional open-label period of 24 weeks. The primary objective of the study is to assess the safety and tolerability of six consecutive 4-weekly doses of GNbAC1 in subjects with T1D. Secondary objectives are to determine the pharmacodynamic response to GNbAC1 on biomarkers of T1D.


Eligibility Criteria:
Main Inclusion Criteria:

* Subjects diagnosed with type 1 diabetes in the 4 years prior to signed informed consent;
* Peak stimulated C-peptide of ≥0.2 nmol/L during a mixed meal tolerance test performed during the Screening period;
* 18 to 55 years of age (both inclusive);
* Body weight \>40 to ≤100 kg;
* Subjects positive for at least one diabetes-associated autoantibody (insulin, glutaminic-acid-decarboxylase-65 \[GAD-65\], tyrosine phosphatase-related antigen 2 \[IA-2\], ZnT8 or islet-cell antibody \[ICA\]).

Main Exclusion Criteria:

* Subjects with type 2 diabetes;
* Pregnant and nursing women.
Influence of Dexmedetomidine on a Closed-Loop Anesthesia System

The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* male patients scheduled for a general anesthesia

Exclusion Criteria:

* age lower than 18 years
* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* expected bleeding surgical procedure,
* simultaneous general and loco-regional anesthesia,
* severe hepatic insufficiency.
Evaluation of Age-Related Skin Changes

This trial is a knowledge study utilizing skin measurement probes that are non-invasive instruments, with negligible risks for the subjects. No product will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian subjects with Fitzpatrick skin type II or III.
* Subject agreeing to complete all study required procedures.
* Subject having given freely and expressly her informed consent.

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject in a social or sanitary establishment.
* Subject participating to another research on human beings or being in an exclusion period for a previous study.
* Subject who underwent tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, liposuction of the thigh, or other ablative procedures) in the face or thigh within 12 months before study entry or was planning to undergo any such treatment during the study.
* Subject who underwent treatment with botulinum toxins in the face or neck within 6 months of study entry or was planning to undergo such treatment during the study.
* Subject who ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or thigh, or was planning to be implanted with any of these products at any time during the study.
* Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face or thigh that could interfere with measurements.
* Subject having changed, started or stopped any hormonal treatment or any treatment likely to have an impact on skin condition (over-the-counter or prescription, oral or topical, or anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.
Improving Birth Outcomes in Bangladesh

Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh.

Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant.

A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with their first or second child (in case of death of the first or second child during pregnancy or within two years of birth, the mother will be eligible during her third pregnancy);
* In possession of a valid NID (or a NID application acknowledgement).
* Meeting the eligibility criteria of the Government of Bangladesh' Mother and Child Benefit Programme (MCBP)
MRI - Guided Adaptive RadioTHerapy for Dysphagia in Head and Neck Cancer

Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow better visualization of tumor and organs at risk during patient positioning and daily treatment finally repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old;
2. I-IVb stage oral cancer, hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer confirmed by histopathology or cytology (AJCC 8th edition);
3. Receiving radical synchronous radiotherapy and chemotherapy;
4. According to the RECIST version 1.1 evaluation criteria, at least one measurable lesion is present;
5. ECOG PS score 0-1;
6. Hematology indicators are basically normal: white blood cell count ≥ 4 × 109/L； Absolute neutrophil count ≥ 1.5 × 109/L； Platelets ≥ 100 × 109/L； Hemoglobin ≥ 90g/L; Kidney function is basically normal: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CrCl)\>60 mL/min (using Cockcroft Fault formula): Female CrCl=(140 age) × Body weight (kg) × 0.85 / (72 × Scr mg/dl)； Male CrCl=(140 age) × Body weight (kg) × 1.00 / (72 × Scr mg/dl) Liver function is basically normal: serum total bilirubin ≤ 1.5 × ULN； Cereal grass transaminase (AST) ≤ 2.5 × ULN； Glutamate transaminase (ALT) ≤ 2.5 × ULN；
7. Having sufficient cognitive ability to complete the questionnaire survey;
8. Able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

1. There is evidence of swallowing dysfunction (unrelated to HNSCC);
2. Patients who have previously received radiotherapy for the head and neck region;
3. Recurrent or metastatic patients;
4. Involvement of posterior pharyngeal wall, posterior ring, and posterior pharyngeal lymph nodes;
5. Previous tumor resection surgery or major head and neck surgery (excluding biopsy/tonsillectomy);
6. Previous tracheotomy;
7. Participated in other interventional clinical trials within 30 days prior to screening;
8. Individuals with a history of other malignant tumors (excluding cured skin basal cell carcinoma)
9. There are concurrent diseases with poor control (such as heart failure, severe lung disease, severe liver disease, mental illness, etc.);
10. Individuals who are allergic to the use of drugs or their components in this protocol;
11. Pregnant (confirmed by blood or urine HCG testing) or lactating women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment;
12. Researchers believe that it is not suitable to participate in this study;
13. Those who are unwilling to participate in this study or unable to sign an informed consent form;
Improving Employment and Reducing Recidivism Among Prison Offenders Via Virtual Interview Training Tool (MICHR)

The goal is to conduct a feasibility effectiveness RCT of Virtual Interview Training (VIT) by comparing employment and recidivism outcomes of offenders (25 years and older) receiving vocational services as usual (SAU) plus VIT (SAU+VIT) with the outcomes of offenders receiving only services as usual (SAU-only).

The plan calls for participants to include offenders who are at moderate to high risk for reoffending (with an emphasis on violent-crime reoffending) who are currently enrolled in a Vocational Village Prison Setting with the Michigan Department of Corrections.

More than 600,000 ex-offenders re-enter the community from prison each year and 50% of them recidivate within 12 months of release. Employment significantly reduces the risk of recidivism for ex-offenders, and as such, is a critical target for intervention. However, evidence-based employment services are rarely delivered in prisons. Moreover, employment services that are available do not include evidence-based job interview training. Virtual Reality Job Interview Training (VR-JIT) is an evidence-based tool that was developed and evaluated with funding from the National Institute of Mental Health. However, VR-JIT has a feature to practice discussing a prior conviction during a job interview that has not yet been evaluated. Given that an ex-offender's job interview outcome may depend on discussing their prior conviction, we are partnering with the Michigan Department of Corrections (MDOC) to evaluate if delivering VR-JIT within their Vocational Village program can improve employment and reduce recidivism among offenders after their release from prison. Thus, there are two goals for this pilot study. We will evaluate the preliminary effectiveness of whether VR-JIT added to Vocational Village services-as-usual improves outcomes (interview skills, employment, recidivism) for offenders after their release from prison (at a 6-month follow-up visit). These preliminary data will support a proposal to a federal agency for a fully-powered randomized controlled trial to evaluate the effectiveness of VR-JIT with prison settings.

Eligibility Criteria:
Inclusion Criteria:

* 25 years or older
* Identified as at moderate to high risk for reoffending with violent crimes (determined at the time of enrollment in the Vocational Village via the COMPAS Risk Assessment Classification Instrument \[60\])
* Within three months of their earliest release date
* Actively enrolled in a Vocational Village
* Have at least a 6th grade reading comprehension

Exclusion Criteria:

* Has uncorrected hearing or visual problem that prevents him or her from using the training
* Has a medical illness that compromises their cognition (for example, moderate to severe traumatic brain injury).
Dextenza in Pterygium Surgery

DEXTENZA for the treatment of post-surgical pain and inflammation compared to standard of care topical prednisolone acetate 1% in patients who undergo pterygium surgery (excision of pterygium with conjunctival autograft)

In patients who undergo pterygium surgery, eyes will be consecutively assigned to receive either DEXTENZA or topical prednisolone acetate 1%.15 eyes will receive a Dextenza insertion into both the upper and lower puncta at the time of surgery, followed by at postoperative month 1 visit institution of topical prednisolone acetate 1% bid x 2 weeks then qd x 2 weeks then discontinued. 15 eyes will receive starting on postoperative day 1 topical prednisolone acetate 1% q2 hours x 2 weeks then qid for 2 weeks then bid for 2 weeks then qd for 2 weeks then discontinued.

Eligibility Criteria:
Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Age of at least 18 years with primary pterygia

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

* Glaucoma
* Ocular hypertension
* Prior conjunctival surgery
* Other uncontrolled ocular disease
* Ocular surgery in either eye within 3 months
* Use of eye drops other than postoperative medications and artificial tears
Multimodal Ultrasound and Focal Liver Lesions (FLLs)

Background and aim: FLLs are common findings in abdominal ultrasound and differential diagnosis between benign and malignant lesions is often challenging, especially in patients with chronic liver diseases. The diagnostic role of CEUS has already been defined by international guidelines when lesions show a typical pattern for hepatocellular carcinoma whereas in case of non-typical contrast enhanced patterns radiologic imaging or liver biopsy are still needed. However, these techniques are more invasive and expensive than ultrasound. Therefore, the aim of this study is to identify D-CEUS and SWE quantitative parameters useful for characterizing FLLs.

Study design: Prospective, observational, single-center study Methods: 50 consecutive adult patients with focal liver lesions detectable with B-mode ultrasound will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. Exclusion criteria will be liver failure, hearth failure, previous locoregional or systemic treatments for FLLs (e.g. ablation, chemoembolization, alcoholization, chemotherapy), known allergy to ultrasound contrast agents. After obtaining informed consent and identifying the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE and, subsequently, to computed tomography/magnetic resonance/biopsy according to international guidelines and current clinical practice. The average, maximum, minimum and standard deviation value of lesion elasticity in KPa will be calculated using SWE. Three consecutive SWE acquisitions will be performed both for the lesion and for the liver parenchyma and the average value of the three measurements will be considered. The CEUS will allow the construction of signal intensity curves as a function of time in a specific area of interest drawn manually. From these curves a series of quantitative parameters related to the flow and volume of blood will be extrapolated and in particular: peak intensity, PI (in Arbitrary Units, AU); time to peak, TP ( in seconds); area under the time curve, AUC (in AU); slope of the wash-in curve, Pw (in AU per second); average transit time, MTT (in seconds). In addition, the personal, clinical and laboratory data necessary to determine the hepatological scores of disease severity such as MELD and Child-Pugh will be collected. The study has an expected duration of one year.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* adult patients (more than 18 years old)
* focal liver lesions detectable with B-mode ultrasound

Exclusion Criteria:

* liver failure,
* hearth failure,
* previous locoregional or systemic treatments for FLLs (e.g. ablation, chemoembolization, alcoholization, chemotherapy),
* known allergy to ultrasound contrast agents
* pregnancy
* lactation
Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus

This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients able to provide voluntary consent.
* Severe tinnitus in one ear that began no more than ten years ago.
* Ear to be treated must be deaf or have profound hearing loss.
* Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
* Subject must have intact cochlear nerve on the ear to be treated.
* Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.

Exclusion Criteria:

* Current diagnosis of bilateral tinnitus.
* Current diagnosis or history of pancreatitis.
* Females that are pregnant or lactating.
* Use of investigational drugs within the previous 30 days.
* History of drug dependency or other substance abuse.
Autologous Bone Marrow Derived Mesenchymal Stromal Cells (BM-MSCs) in Patients With Chronic Kidney Disease (CKD)

This study was designed to provide confirmation of safety of mesenchymal stem cells (MSCs) therapy in chronic kidney disease (CKD).

We will assess the 18-month safety and potential efficacy of autologous MSCs as a therapy for CKD. A total of 10 patients with CKD IV injection of high doses 2×106/kg of autologous MSCs t, which will be derived from biopsies of their bone marrow. Assessments will be performed at 1, 3, 6, 12 and 18 months after cell injection. Changes in Glomerular Filtration Rate (GFR) were evaluated by scan isotope.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* CKD symptoms
* CKD confirmed with serum and urine analysis and GFR 25-60 mL/min/1.73 m2
* Patient's age between 25 - 60 years
* Ability to understand and willingness to sign consent from

Exclusion Criteria:

* Pregnant or lactating
* Basis disease such as diabetes, malignancy and autoimmune
* Unable to follow post-operative exercise regimen or return for evaluations
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic atrial fibrillation
* Atrial fibrillation documented by ECG
* Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion Criteria:

* Systolic blood pressure \<100 mmHg
* Heart rate \<50 bpm
* Temperature \>38°C
* QT or QTcB \>440 ms
* QRS \>140 ms
* Paced atrial or ventricular rhythm on ECG
* Serum potassium \<3.5 meq/L
* History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
* History of amiodarone in last 6 months.
* Clinical evidence of acute coronary syndrome
* Acute pulmonary edema or embolism
* Hyperthyroidism
* Acute pericarditis
* History of failed electrical cardioversion at any time
* History of torsades des pointes
* History of familial long QT interval syndrome
* History of ventricular tachycardia requiring drug or device therapy
* History of NYHA Heart Failure Class 3 or 4.
Optimized Cardioprotection Therapy in Obese Subjects With AMI

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With acute myocardial infarction (AMI) Who Have Undergone Percutaneous Coronary Intervention (PCI).

Adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. Adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. Adipokines may contribute to reduce scar formation and improve cardiac function in acute myocardial infarction (AMI). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with AMI symptom onset within the prior 12 hours. However, our previous work showed that obese patients may benefit more from PCI. Thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with acute myocardial infarction (AMI) who have undergone PCI.

Eligibility Criteria:
Inclusion Criteria:

age between 20 and 70 years old STEMI and NSTMI according to the WHO definition PCI \<12 hours from the onset of symptoms

Exclusion Criteria:

previous myocardial infarction (MI) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system NYHA functional class IV heart failure at baseline severe renal, lung and liver disease cancer