cyrilzakka/clinical-trials huggingface dataset:
Number of Previous Cesarean Sections on the Results of Angiogenic Factors.

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit.

Although the usefulness of angiogenic factors in these scenarios is known, little is known about the effects that other conditions might have on their serum levels, mainly those that have an effect on trophoblastic invasion, the process that initiates implantation of the pregnancy in the endometrium. The purpose of the present study is to assess the effect that a history of uterine surgery, such as caesarean section, might have on angiogenic factor scores in subjects with no history of a hypertensive disorder of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* 36 weeks of gestation or more
* Singleton pregnancy
* Previous cesarean section (case)

Exclusion Criteria:

* Vasculitis
* Twin pregnancy
* Chronic endometritis
* Smoking
* Lupus
* Renal failure
* Liver disease
* Thrombocytopenia
Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology

Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.

It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice.

Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).

Eligibility Criteria:
Inclusion Criteria:

* Age: adult patients ≥ 18 years of age;
* signed ECMO informed consent;
* femur vein VA-ECMO treatment;
* agreed to establish VA-ECMO side branch cycle;
* informed consent to this study.

Exclusion Criteria:

* a completely closed double lower limb venously before surgery;
* amputee
Growth Hormones and Cells in Human Milk Depending on Gestational Age

Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.

Neurotrophins (epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF)) as well as amount of cells, especially positive for sex-determining transformer protein (TRA)-1-81 and stage-specific embryonic antigen (SSEA)-4, are planned to be quantified in human breast milk of extremely preterm newborns as well as term newborns at different stages of lactation.

Eligibility Criteria:
Inclusion Criteria:

* the newborn infant is being fed with own mothers milk

Exclusion Criteria:

* low amount of breast milk
Strong People Strength Training Study

The Strong People Strength Training study aims to assess whether a community-based progressive strength training program can improve risk factors for diabetes and heart disease in older rural adults.

This study aims to evaluate the effects of a twice weekly, 12-week progressive strength training program, Strong People Strength Training, on cardiometabolic risk factors in a pragmatic, community-based randomized intervention trial among rural men and women 50 and older. We hypothesize that individuals randomized to the intervention group will demonstrate statistically significant and clinically meaningful improvements in cardiometabolic risk factors as well as physical function, quality of life, and physical activity compared to those randomized to the delayed intervention control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 or older
* Willing and able to get health care provider (HCP) authorization if required (PAR-Q answered yes to any question or 70 and older)

Exclusion Criteria:

* Strength trained in last 12 months
* Previous enrollment in Strong People
* Enrolled or planning to enroll in lifestyle program
* Cognitive impairment
* Unable to obtain physician authorization
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .

The primary outcome variables for this study are subjective comfort and lens preference.

The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .

The primary outcome variables for this study are subjective comfort and lens preference.

Eligibility Criteria:
Inclusion Criteria:

* Healthy full-time wearers of spherical daily disposable contact lenses
* Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS
* Visual acuity corrected to at least 20/30 with spherical contact lens

Exclusion Criteria:

* Participating in another clinical trial
* Vision not correctable to 20/30 with lens powers listed above
Pharmacogenetic Effect on the Pharmacodynamics of Glibenclamide

Glibenclamide is metabolized by the hepatic enzyme P450 CYP2C9 to less active form. Polymorphism of this enzyme demonstrated clinical significance when examined on other drugs from the sulfonylurea drug family, to whom Glibenclamide is included.

The investigators assumption is that patients with less active alleles of the enzyme may show lower dose requirements of the drug for glycemic control, when compared to patients homozygotes to wild-type alleles.


Eligibility Criteria:
Inclusion Criteria:

* Tx with metformin and glibenclamide

Exclusion Criteria:

* Tx which affecting the P450 2C9 action
* Renal failure
Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites

To determine the absorption, metabolism and excretion of BIA 9-1067.

Monocentre, open, non-placebo-controlled, single-group, single-dose study

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male subjects, 40-55 years of age.
* Sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: BP: 100 - 160 mmHg systolic, 50 - 95 mmHg diastolic and pulse rate: 50 - 100 bpm. Blood pressure and pulse were to be measured after 3 minutes resting in a sitting position.
* Subject body mass index was to be between 18 and 28 kg/m2
* Normal 12-lead ECG
* Ability to communicate well with the investigator and comply with the requirements of the entire study.
* The subject had given his written informed consent to participate in the study.

Exclusion Criteria:

* History of serious adverse reactions or hypersensitivity to any drug.
* Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
* History of alcohol or drug abuse in the last 5 years.
* Abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study.
* Need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug.
* Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested.
* Loss of 500 mL blood or more during the 3 month period before the study, e.g., as a donor.
* Existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract.
* Symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration.
* History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
* Positive results from the HIV serology.
* Clinically significant abnormal laboratory values (as determined by the Principal Investigator) at the screening evaluation, however, liver parameters (SGPT, SGOT) values must be within the normal range.
* Positive results of the drug screening.
* Known hypersensitivity to BIA 9-1067.
* Heavy smokers, i.e., more than 10 cigarettes per day
* Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation)
* Subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.
DPBRN Prevalence of Questionable Occlusal Caries Lesions

The purpose of this study was to investigate the process involved when making decisions about the diagnosis and treatment of questionable lesions, as well as determine if there is any association between lesions progression (or depth, if opened) and clinical characteristics and baseline risk assessment.

The term"questionable" is defined as a tooth with no cavitation (no continuity break in the enamel) and no radiographic radiolucencies, but the presence of caries is suspected due to roughness, surface opacities, or staining. The characteristics of these lesions and the patient's baseline caries risk were examined.

There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Eligibility Criteria:
Inclusion Criteria:

* patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts.

Exclusion Criteria:

* patients under 6 years old
* patients 6 years old and older who do not have a questionable lesion
Colorado Adult Joint Assessment Scale (CAJAS) Validation

To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male, 18 to 50 years of age
* Diagnosis of moderate to severe hemophilia A (documented \<1-2% Factor VIII Concentration \[FVIII:C\])
* Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study

Exclusion Criteria:

* Routine need for wheelchair or routine need for two canes or crutches
* Diagnosis of another bleeding disorder such as von Willebrand Disease
* Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)
A Blood and Tissue Sample Collection Study of Patients Who Have Inflammatory Bowel Disease, Who Have Been Treated With Adalimumab and Who Developed Hepatosplenic T-Cell Lymphoma

To collect and store blood and biopsy samples obtained from CD or UC patients exposed to adalimumab and diagnosed with Hepatosplenic T-cell Lymphoma (HSTCL), for the purpose of identifying potential biomarkers and genetic mutations in patients who have developed HSTCL.

A study to bank samples for future evaluation to identify genetic mutations and other biomarkers that predispose inflammatory bowel disease (IBD) patients to developing Hepatosplenic T-cell Lymphoma (HSTCL).

Eligibility Criteria:
Inclusion Criteria:

* Male or female who has received a single dose of HUMIRA prior to a confirmed diagnosis of HSTCL.
* Confirmed diagnosis of CD or UC as documented by a Gastroenterologist or physician who diagnosed the CD or UC.
* Confirmed diagnosis of HSTCL as determined by a biopsy performed on a specimen taken from the patient.
* Patients 18 years old and older must voluntarily sign and date an IRB/EC approved Informed Consent Form. For patients younger than 18 years old, a parent or legal guardian is required to voluntarily sign and date an IRB/EC approved Informed Consent Form. Pediatric patients will be included in all discussions if possible, in order to obtain their assent.

Exclusion Criteria:

* Male or female who has not received at least a single dose of adalimumab prior to a confirmed diagnosis of HSTCL.
* Unconfirmed diagnosis of HSTCL, CD or UC, respectively.
* The patient or the patient's HCP is unwilling to participate in this study.
* The parents or legal guardians (in the case of patients younger than 18 years of age), who are unable and/or unwilling to consent to the patient's participation in this study.
User Evaluation of BGM VGM77

Performance Evaluation by the User of the Blood Glucose Monitoring System VGM77Compliant with DIN EN ISO 15197:2015


Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015
Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

HCC patients with tumors \>5 cm in diameter, regardless of involvement in the intrahepatic and extrahepatic portal branches participated in the study. Patients were randomized allocated in liver transplantation (LT) only group and LT plus ADV-TK therapy group. All patients received orthotopic liver transplantation; in the LT plus ADV-TK group, ADV-TK therapy was delivered to patients twice.


Eligibility Criteria:
Inclusion Criteria:

* 18～70 years of age (Male and Female).
* Clinical diagnosis of advanced hepatocellular carcinoma who could accept liver transplantation
* Patients who had unresectable HCC \>5 cm and no metastasis in lungs and bones were eligible to participate in this study. Tumor involvement in the intrahepatic and extrahepatic portal branches was not considered to be an exclusion criterion.
* No prior chemotherapy, radiation therapy, targeted therapy or other kind of biological treatment within 4 weeks.
* Provide written informed consent

Exclusion Criteria:

* Metastasis in lungs and bones
* Invasion in main vescular.
* Contraindications of liver transplantation
* Contraindications of operation of other organ system
* Hypersensitivity to adenovirus, GCV or similar drugs
* Accept clinical trials of other drugs
* Immunological deficit
* Active pregnancy
* Unable or unwilling to sign informed consents
Safety and Efficacy of Talampanel in Glioblastoma Multiforme

The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age
* Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
* Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
* Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
* Patients must have a Karnofsky performance of at least 60% or more.

Exclusion Criteria:

* Patients with serious concurrent infection or medical illness.
* Patients receiving concurrent chemotherapeutics or investigational agents.
HealthcAre sUppoRt fOr Remote HIV pAtients

Adherence to antiretroviral therapy (ART) is crucial for treatment success in HIV+ patients. This study proposes the use of a smartphone application, specifically developed for this project, to monitor ART adherence and assess quality of life among HIV+ patients. The aim is to optimize long-term disease management through the early identification of comorbidities and clinical complications

Since the first cases were reported more than 35 years ago, 78 million people have been infected with HIV and 35 million have died from AIDS-related illnesses.

Currently, the availability of TARV regimens associated with good tolerability and high levels of efficacy make it necessary to turn attention toward new standards of efficacy indicative of patients' mental and physical well-being. Indeed, health-related quality of life (HRQoL) is becoming increasingly preponderant as a therapeutic outcome. Despite TARV-related viroimmunologic success, people living with HIV (PLWH) continue to have lower HRQoL than the general population. Indeed, much evidence confirms the impact on quality of life not only of therapeutic treatments but also of social and relationship issues and comorbidities. Improving HRQoL is now, therefore, a primary goal for the care and support of PLWH.

Evaluations of new treatments and interventions to improve care, therefore, require the measurement, in addition to clinical endpoints, of HRQoL using valid and reliable instruments. Therefore, the importance of PROs (Patient Reported Outcomes), which represent the description of the patient's own reported state of health, without any interpretation by clinicians or health care personnel, emerges in this area. In this way, the patient is directly involved in his or her own process of care.

Adherence to TARV is essential for successful treatment and improved quality of life. Unfortunately, non-adherence to treatment is a common problem among HIV-infected patients.

The Covid-19 emergence has significantly revolutionized the health care system leading to the implementation of new modes of care, including the use of technological tools to ensure remote medical care.

The present study, targeting HIV-infected patients undergoing virological suppression, aims to use a smartphone application to facilitate continuity of care remotely, promoting adherence to therapy and thus the effectiveness of TARV, assessing the patient's quality of life and identifying possible comorbidities or other critical clinical

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HIV-infected patients
* HIV plasma RNA values \< 50 copies/mL
* Patients referred to the HIV outpatient clinic at the SC Infectious Diseases of the Azienda Alexandria Hospital
* Patients on a stable antiretroviral regimen for at least 6 months
* Patients who have the ability to download the application under study
* Patients who have signed the informed consent

Exclusion Criteria:

* Newly diagnosed patients
HPV Vaccine Reminders - SEARCH II Study

This RCT will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.

Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.

Eligibility Criteria:
Inclusion Criteria:

* Be a parenting adult of an adolescent girl aged 10-14 years
* Reside in Kampala and/or the surrounding districts
* Speak English or Luganda
* Have a cell phone with text messaging capability
* Must have ability to consent

Exclusion Criteria:

* Parenting adult speaks other language than English or Luganda only
* Parenting adult already enrolled in the study for another child
* Participation in previous HPV vaccine reminder study
FCH PET/MRI Parathyroid Localization

A prospective trial comparing the accuracy of \[F-18\]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Biochemically proven primary hyperparathyroidism
* Indication for parathyroidectomy as per institutional guidelines

Exclusion Criteria:

* Contraindication for MRI as per current institutional guidelines.
* Contraindication for Gadolinium injection as per current institutional guidelines.
* Renal failure
* Inability to lie supine for at least 45 minutes.
* Any participant who is pregnant or breastfeeding.
* Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism)
* Familial HPT syndromes
* Participant currently being treated with any cytotoxic chemotherapy