cyrilzakka/clinical-trials huggingface dataset:
Greek Physicians Perceptions Regarding Generics Prescribing in Glaucoma

This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics prescription in glaucoma by means of a structured questionnaire.

The following dimensions will be recorded

1. Overall physician's empathy regarding generics in glaucoma
2. Physician's prescribing habits regarding generics in glaucoma
3. Physician's perceptions regarding generics cost-effectiveness in glaucoma
4. Physician's perceptions regarding adequacy of Greek regulatory authorities (generic market in glaucoma)
5. Physician's perceptions regarding adequacy of European regulatory authorities (generic market in glaucoma)

Eligibility Criteria:
Inclusion Criteria:

Licensed Registration to Greek Ophthalmology Council

Exclusion Criteria:

-
Mycological Comparative Study on Maxillary Dentures of Two Different Materials

Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the candida species


Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
* The edentulous ridges should be covered by firm healthy mucosa.
* Angle class I maxillomandibular relation.
* Healthy and cooperative patient

Exclusion Criteria:

* Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
* Previous history of radiotherapy or chemotherapy.
* Any skeletal problem dictates surgical intervention
Molecular Analysis and Treatment Options of SCLC

Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.

Ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.

In summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of SCLC
* 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Histologically proven diagnosis of non-SCLC
Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
* Patients of both genders, aged 18-65 years old being at the first episode
* Patients with chronic Bipolar Disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality

Exclusion Criteria:

* Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®).

Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

The investigated vaccine is an inactivated, adjuvanted and preservative-free hepatitis A vaccine. Each dose contained 250 U HAV antigen in 0.5 milliliter.

Total 400 subjects were enrolled and assigned into four groups, each receiving one of the three lots of Healive® or an established control vaccine at month 0 and 6. Anti-HAV titers were determined at month 1, 6 and 7. Anti-HAV titer over 20 mIU/ml is defined as seroprotection.

After the full immunization schedule, written informed consents were obtained from subjects who would like to participate in the follow-up study. Blood samples of these subjects were collected at month 18, 30, 42, 54, 66, 112,138 after the first injection to evaluate the seroconversion rates (SCRs) and geometric mean concentrations (GMCs) of antibody against hepatitis A virus. Serological results of the follow-up study were then used to explore suitable statistical model for predicting the persistence of hepatitis A vaccine-induced antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Health children from 1 to 10 years
* Not participate in any other trial during the course of the trial
* Informed consent

Exclusion Criteria:

* Any history of allergic reactions or convulsions following vaccination
* Other known or planned vaccination within 1 month prior to the study and during the study period
* Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
* Presence of any congenital abnormality, upgrowth obstacle
* Any history/suspicion/presence of neurology and Lunacy
* Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
* Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
* Abnormal ALT
* Positive markers for anti-HAV and HBV（HBsAg）infection
* Presence of fever at the time of vaccination, i.e. body temperature (by mouth) \> 37.0 centigrade.
Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study

Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to established treatment consisting of psychotherapy. Patients often go years with this debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of patients will drop out of treatment because of psychological burden and overactivation. A novel ketogenic diet treatment could amend established treatment, and potentially upregulate the threshold for exciting neurons in dysfunctional brain regions, mediated through various mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to psychological treatment without getting overactivated and unable to process trauma. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with PTSD for four weeks.

The study aims to include 10 PTSD patients. If a participant drops out of the study, or if the study is otherwise terminated for a participant, another patient will be recruited until 10 have completed the study. The primary objectives of this feasibility study are to investigate if it is possbile to carry out a ketogenic diet therapy for patients with PTSD for 4 weeks, and systematically gain insight in all challenges relating to these objectives. The participants will follow a ketogenic diet for 4 weeks, and they are asked to self report daily on results from finger pricking blood measurements (glucose and betahydroxybutyrate (BHB)) to establish they are in a ketogenic state and are compliant to diet. Participants will also report food intake and side effects daily to be evaluated by the principal investigator. Participants are further asked to specify and elaborate on which adverse effects or other reasons as to why it is challenging to follow the study diet and/or procedures. The study lacks in power to statistically evaluate if ketosis has any effect on PTSD symptoms, however this secondary objective will be preliminary evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-65 years
* Diagnosed with posttraumatic stress disorder (PTSD)
* Understand and speak Scandinavian language

Exclusion Criteria:

* Body Mass Index \< 18
* Metabolic disorders contraindicating a ketogenic diet
* Dysregulated Diabetes Mellitus
* Medicated for elevated triglycerides
* Pancreas, kidney or liver disorders
LEGION Hinge Safety and Efficacy Study

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.

Eligibility Criteria:
Inclusion Criteria:

* Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
* Subject has a failed primary or revision knee replacement
* Subject is 18-80 years of age
* Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
* Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
* Subject is willing to sign and date an IRB/EC-approved consent form
* Subject plans to be available through the five (5) year postoperative follow-up
* If of child bearing potential, Subject reports she is not pregnant nor plans to become pregnant during the study
* Subject agrees to follow the study protocol

Exclusion Criteria:

* Subject is receiving the study device as a primary knee replacement
* Subject has presence of malignant tumor, metastatic, or neoplastic disease
* Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
* Subject is pregnant or plans to become pregnant during the course of the study
* Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
* Subject has known (Subject reported) metal hypersensitivity
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in this study
* Subject has BMI\>45
* Subject is participating in any other pharmaceutical, biologic, or medical device clinical investigation or has been treated with an investigational product in the past 30 days
* Subject is facing current or impending incarceration
* Subject is not a good candidate for the study based on Investigator opinion
Evaluation of Efficacy and Safety of Milsaperidone As Adjunctive Therapy in Patients with Major Depressive Disorder

The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient 18 to 65 years of age, inclusive;
* Meets DSM-5-TR criteria for MDD
* Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ)

Exclusion Criteria:

* Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD
* Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD that is a primary diagnosis
* Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment
Sayana Press UK Self-Injection Study

A one-year evaluation of Sayana Press self injection in women of reproductive age in the United Kingdom (UK).


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 to 45 years of age who are willing to attempt Sayana Press self-injection at home;
* women who are likely to be successful on a DMPA self-injection program, based on the opinion of the investigator;
* not planning to move out of the area for at least 12 months;
* willing to be contacted by the clinical staff at work or at home;
* evidence of a personally signed and dated Informed Consent Document (ICD) indicating that the subject has been informed of all pertinent aspects of the study;
* subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures

Exclusion Criteria:

* a pre-existing medical condition that would interfere with participation in the study or pose a risk to the subject, including hypersensitivity to MPA or any constituents of Sayana Press;
* known or suspected malignancy of genital organs;
* known or suspected malignancy of the breast;
* history of cerebrovascular disease
* metabolic bone disease
* a contraindication to DMPA (UK Medical Eligibility Criteria Category 3 or 4) such as:
* Multiple risk factors for cardiovascular disease (e.g. older age, smoking, diabetes, obesity, hypertension)
* current and history of ischaemic heart disease;
* stroke (history of cerebrovascular accident, including transient ischaemic attack);
* unexplained vaginal bleeding;
* current or history of breast cancer;
* diabetic nephropathy, neuropathy, retinopathy or other diabetic vascular disease;
* severe (decompensated) liver cirrhosis;
* hepatocellular adenoma;
* hepatoma;
* Systemic Lupus Erythematosus (positive or unknown antiphospholipid antibodies; severe thrombocytopenia;
* subjects who are investigational centre staff members directly involved in the conduct of the study and their family members, centre staff members otherwise supervised by the investigator, or subjects who are Pfizer employees involved in the conduct of the study;
* participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation;
* patients who plan to get pregnant within two years of study;
* breastfeeding and pregnant subjects;
* other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
Immunobiology of Cancer

To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.

BACKGROUND

We have previously demonstrated that tumor-specific T cells could be identified in \>50% of patients with metastatic melanoma and these cells appeared to be rendered anergic in vivo \[Nature Medicine 5:677, 1999\]. Recently we discovered that there is a signaling defect in the Interferon (IFN) pathway in immune cells from melanoma patients \[PLOS Medicine 4:897 2007\]. Interestingly, preliminary studies are showing the same defect in immune cells from breast cancer patients (unpublished). We would like to expand our research to all types of cancer to determine whether these phenomena occur in different cancer types.

OBJECTIVES

Our primary objective is to determine whether there is an IFN signaling defect in different types of cancers and to determine what is causing this defect.

The second objective is to determine whether these PBMCs are rendered anergic.

INVESTIGATIONAL PLAN

The study population will consist of patients who have been diagnosed with cancer, regardless of sex or ethnicity. Blood will be collected during the subjects regularly scheduled laboratory appointment and peripheral blood mononuclear cells (PBMCs) will be isolated for research purposes. These PBMCs will undergo studies, i.e. phosflow, qPCR, proliferation, survival, etc., to determine immune responses for T cells (CD4 and CD8), B cells (CD19), natural killer cells (CD16), and possibly monocytes (CD14).

Eligibility Criteria:
Inclusion Criteria:Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over. Exclusion Criteria:Participants who have an autoimmune disorder and/or are under the age of 18 years.
Mobile Apps Enhancing Acupressure Therapy Compliance and Efficacy for Asthenopia

The goal of this clinical trial is to learn if a mobile application works to improve adherence to acupressure therapy in asthenopia. It will also learn about the efficacy of acupressure as a therapy for asthenopia. The main questions it aims to answer are:

-Does a mobile application have a role to improve therapy compliance and efficacy of self-guided acupressure in asthenopia?

Researchers will compare users of a mobile app to non-users of a mobile app to see if a mobile app works to improve adherence to acupressure therapy in asthenopia

Participants will:

* Do acupressure 2 times every day for 4 weeks
* Filling in the absence link has been after doing acupressure every day
* Fill out the link regarding the condition of asthenopia once per week

This is a clinical trial study to evaluate the role of a mobile application in therapy compliance and acupressure efficacy in asthenopia sufferers. Participants are 60 males/females aged 18-64 years. They will be divided into 2 groups: (1) Acupressure mobile app users and (2) Non-acupressure mobile app users. Acupressure is scheduled 2 times every day for 4 weeks. Therapy compliance will be assessed from the absence link that participants fill out every day, while therapy efficacy will be assessed once per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Using a smartphone with the Android platform.
* Work or use digital gadgets for at least 4 hours a day.
* Suffering from asthenopia as indicated by a CVS-Q score ≥ 6.
* Can be contacted with the WhatsApp application.
* Willing to take part in this research until completion and agree to informed consent.

Exclusion Criteria:

* There are tumors, wounds or skin infections in the eye area.
Probiotics and Early Microbial Contact in Preterm Neonates

Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly reduces overall mortality and risk of necrotizing enterocolitis, a devastating inflammatory intestinal disease. The investigators have previously demonstrated that administering probiotics to the lactating mother enhances the immunoprotective properties of breast milk. Despite the promising data, the optimal probiotic intervention is yet to be established. The mechanisms by which probiotics exert their effects remain largely unknown.

This research project is based on the notion that modulation of early microbial contact by probiotics may provide a safe and effective means to improve the health of preterm infants. In particular, the investigators hypothesize that the protective potential of probiotics may be enhanced via breast milk by administering probiotics to the lactating mother. All of the potentially beneficial effects of probiotic bacteria are strain-specific and therefore preliminary laboratory and clinical research with regard to different physiological targets of probiotic intervention should be carried out to guide the design of large-scale clinical trials aiming show clinical efficacy and establish clinical practice. The purpose of this research project is to identify targets for probiotic therapy in premature neonates and to provide insight into the optimal probiotic strains and administration protocol the clinical efficacy of which will subsequently be tested in a randomized controlled trial.

The specific aims of the project are:

1. To determine the effect of maternal consumption of probiotics during lactation on immunomodulatory properties of breast milk in mothers of premature infants. Concentrations of immunomodulatory factors and microbiological properties of breast milk will be measured.
2. To investigate the impact of different probiotic administration protocols on gut microbiota composition in preterm infants. In particular, the issue whether maternal probiotic consumption instead or in addition to probiotics administered to the infant is effective will be elucidated. Different potential probiotic strains will be assessed.
3. To elucidate the impact probiotic bacteria administered to the lactating mother and/or directly to the infant on gut immunophysiology in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* premature infant born at \<35 weeks gestational age

Exclusion Criteria:

* severe asphyxia
* significant anomalies