cyrilzakka/clinical-trials huggingface dataset:
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed ovarian, fallopian tubal, primary peritoneal cancer
* Patients suspected of metastatic lymph nodes in the cardiophrenic, internal mammary, and/or supraclavicular lymph node by CT (size larger than 5mm)
* Patients clinically diagnosed FIGO stage IVB ovarian, fallopian tubal, primary peritoneal cancer
* Patients underwent debulking surgery (primary debulking surgery or interval debulking surgery) at Seoul National University Hospital from January 2010 to January 2020
* Patients age 18-90

Exclusion Criteria:

* Borderline or benign ovarian disease
* Patient didn't undergo debulking surgery
* Non-epithelial ovarian cancer
Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health

The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.

The goal of this 5 year project is to promote HIV testing and improve HIV-related risk behaviors (e.g. condom use, substance use before sex, regular Sexually Transmitted Infection (STI) testing) via population-sensitive and population-specific HIV prevention videos that are appealing, evidence-based, scalable, and sustainable to the target population. Formative research was conducted in Phase I (Year 1-2), to pre-test the questionnaire and gather in-depth data (via focus groups, intercept interviews, and individual structured interviews) to inform intervention development. Phase 2 of the project involved developing, delivering, and subsequently evaluating the efficacy of peer-driven EE HIV prevention messaging to broader social networks via a social media platform, with the platform contingent on formative data. An HIV education video series, "The Beat HIVe", was produced and served as intervention materials for the quasi-experimental research project. Respondent Driven Sampling (RDS) was used to access and use the social networks of high-risk youths as channel and agents for change. RDS is a recent innovative adaptation of chain-referral network sampling that provides peer-driven access to hard-to-reach subpopulations while reducing sampling biases associated with conventional snowball sampling.

Eligibility Criteria:
Inclusion Criteria:

African American young adults Aged 18-25 Living in the Birmingham USA Competent to give informed consent

Exclusion Criteria:

Obvious psychosis, dementia, inability to hear. Plan to move within the next 6 months
Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?

This study aims to optimize the dosing of cefazolin, ceftazidime, and ciprofloxacin for patients on high-flux hemodialysis. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic levels will be measured in each blood sample. This data will be used to develop population-pharmacokinetic models for each antibiotic. Finally, Monte Carlo simulations will be used to develop evidence-based dosing recommendations.

The goal of this study is to optimize the dosing of three commonly used antibiotics, thereby improving the treatment of serious, often life-threatening infections in patients on intermittent high-flux hemodialysis (iHFHD).

The hypothesis is that current antibiotic dosing is suboptimal, thereby increasing the risk of poor outcomes including treatment failure, adverse drug reactions and antibiotic resistance.

A prospective, non-interventional pharmacokinetic (PK) study of cefazolin, ceftazidime, and ciprofloxacin will be conducted in the St. Boniface Hospital outpatient hemodialysis unit.

The 1st objective of this study is to measure the free and total plasma concentrations of cefazolin, ceftazidime, and ciprofloxacin in adult patients on iHFHD and receiving antibiotic therapy for suspected or proven infection. For each antibiotic 20 participants will be enrolled and three blood samples will be collected from each participant. Antibiotic concentrations will be measured using an ultra high performance liquid chromatograph mass spectrometer. Total antibiotic concentrations in plasma will be measured in all patient samples. To describe protein binding, free levels will also be measured in the first two samples collected from the first 10 patients for each antibiotic.

The 2nd objective of this study is to characterize the PK of cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD using population-PK modelling. Covariates with potential influence on PK such as gender, age, body weight, dialyzer type, blood and dialysate flow rates, duration of dialysis and Kt/Vurea will be investigated, and incorporated as appropriate. For each antibiotic, the best PK model will be selected using established goodness-of-fit tests, and then independently validated.

The 3rd objective of this study is to translate findings to patient care using Monte Carlo simulations to evaluate conventional antibiotic dosing and develop optimized evidence-based dosing recommendations for cefazolin, ceftazidime, and ciprofloxacin in patients on iHFHD.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Proven or suspected infection
* Receiving cefazolin, ceftazidime, or ciprofloxacin for treatment
* Treatment course allows for collection of three 6 mL blood samples as per protocol

Exclusion Criteria:

* Chronic liver disease, Child Pugh Class C or higher
* Received study drug as part of a different treatment course in 1-week preceding start of new treatment course
* Acute kidney injury or recovering kidney function
Study Regarding the Incidence of Anti-platelet Factor 4-antibodies in Patients Aged 18 to 60 Years With Spontaneous or Infection- or Vaccine-associated or Recurrent Venous and/or Arterial Thrombosis

Prospective investigation of the incidence of anti-platelet factor 4 antibodies in suspected immune-associated arterial and/or venous thrombosis

Patients with venous and/or arterial thrombosis aged 18 to 60 years are included.Thromboses should have occurred spontaneously or within 30 days after an infection or vaccination. In addition, patients with recurrent thrombosis, despite anticoagulation, are also included in the study. The primary aim of the study is to determine the incidence of anti-platelet factor 4 antibodies in relation to venous and/or arterial thrombosis. For this purpose, we will take a blood sample from the patients within 120 days of the occurrence of the thrombosis.

As a secondary objective, platelet count, D-dimer and results of a thrombophilia screening as well as thrombosis localization are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-60 years
* Written informed consent of the patient
* Spontaneous arterial and/or venous thrombosis
* infection-associated arterial and/or venous thrombosis within 30 days of infection
* Vaccine-associated arterial and/or venous thrombosis within 30 days of vaccination
* Recurrent arterial or venous thrombosis despite anticoagulant therapy

Exclusion Criteria:

* Lack of consent of the patient
* Risk-associated venous thromboses (e.g. following surgery, immobilization, plaster cast, fractures or sprains)
* Risk-associated arterial thromboses (in the presence of vascular risk factors such e.g. diabetes mellitus, hypercholesterolemia, hypertension, nicotine abuse)
* Thromboses more than 120 days old at the time of blood sampling
Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease

Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.

Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs.
* Mini Mental State Examination (MMSE) \>24.
* Activities of Daily Living \>3.

Exclusion Criteria:

* Mini nutritional assessment \<17; BMI \<18, hypoalbuminemia or lymphopenia.
* acute or chronic liver diseases;
* renal function impairment (Clearance creatinine \<30ml/min);
* cancer;
* acute inflammatory diseases;
* thyroid diseases;
* diabetes mellitus;
* dysphagia;
* dementia;
* dyslipidemia;
* history of recent cardiovascular or cerebrovascular events;
* psychiatric diseases;
* iatrogen parkinsonism.
Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical management, treatment outcomes and healthcare resource use of adult patients aged 18 years and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care setting in Europe and Latin America on or before 31-May-2019.

Eligibility Criteria:
Inclusion criteria:

1. Age 18 years or older at admission date to the hospital;
2. Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and
3. Admitting diagnosis to the hospital was either CAP or cSSTI.

Exclusion criteria:

1. Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered;
2. Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP;
3. Patients whose hospital medical records are missing details of dosing with Zinforo®;
4. Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and
5. Patients whose hospital medical records are missing discharge date and status information.
Effect of Phosphorus Supplementation on Body Weight

Phosphorus is a mineral that is naturally present in our foods and is required by our bodies for normal function. It has been found that phosphorus supplementation taken before meals has the potential to reduce meal size. However its long term effect has not been measured yet. It is well accepted that changes in body weight require about 3 months. Using body weight as the outcome, which is the ultimate outcome of weight loss approaches, would provide robust information on the role of phosphorus.

A double-blind, randomised, placebo-controlled trial of 63 adults aged 18 to 45 years with a body mass index (BMI) of 25 kg/m2 or higher and normal kidney function at the American University of Beirut. Participants were randomly assigned to the placebo or phosphorus group where daily placebo or phosphorus supplements were ingested with three main meals (breakfast, lunch, and dinner) for a period of 12 weeks. Primary outcomes were changes in anthropometric measures, blood metabolites (including lipid profile, glucose, and insulin), and subjective appetite scores.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>25
* CR\>1mg/dl for women; Cr \>1.2 mg/dl for men
* GFR \>60ml/min/1.73m2

Exclusion Criteria:

* BMI\<25
* presence of any significant medical disease,
* pregnancy or lactation,
* regular administration of drugs that affect body weight, and
* weight loss of 3% or more within 3 months of study entry.
Transgender Education for Affirmative and Competent HIV and Healthcare

Educational workshops are an efficacious strategy to increase healthcare providers' ability to provide gender-affirming care for transgender (trans) people. This strategy may also reduce healthcare providers' stigma towards trans people and people living with HIV. There is less evidence, however, of educational workshops that address HIV prevention and care among trans women. This protocol details the development and pilot testing of the TEACHH: Transgender Education for Affirmative and Competent HIV and Healthcare intervention that aims to increase gender-affirming HIV care competency among healthcare providers.This community-based research (CBR) project involves intervention development and implementation of a non-randomized multi-site pilot study with pre- post-test design. First, the investigators will conduct a qualitative formative phase involving focus groups with 30 trans women and individual interviews with 12 providers to understand HIV care access barriers for trans women and elicit feedback on a proposed workshop. Second, the investigators will pilot test the intervention with 90-150 providers (n=30-50x3 in-person settings). Primary outcomes include feasibility (e.g., completion rate), workshop satisfaction, and willingness to attend another workshop. Secondary pre- and post-intervention outcomes, assessed directly preceding and following the workshop, include perceived competency, intention to provide gender-affirming HIV care, and attitudes/biases towards trans women with HIV. Primary outcomes will be summarized as frequencies and proportions (categorical variables) and means and standard deviations (continuous variables). The investigators will conduct paired-sample t tests to assess pre- and post-intervention differences for secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Workshop participants must be 18 years or older and identify as working at a location that provides health or social services to trans women or being in-training to work in health or social services (e.g., medical student, social work student). Workshop participants may include a mix of HIV- and non-HIV service providers.

Exclusion Criteria:

* Not fitting the above criteria.
Simulation in Teaching Vaginal Examination

Teaching technical skills during medical training can lead to some issues, which can concern ethical or medico-legal risks. In this context, the vaginal examination (VE) is specific because it concerns the genital area and it interferes with obstetrical management.


Eligibility Criteria:
Inclusion Criteria:

* Interns who finished their study in faculty of medicine
* Interns who never performed VE before
* Interns who accept to participate in the study

Exclusion Criteria:

* Interns who refuse to participate in the study
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848

The primary purpose of this study is to investigate effect, tolerability and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of season in an allergen challenge model.

A double-blind, placebo controlled, randomised, parallel group phase IIa study to investigate the efficacy, tolerability, and safety of different dosing regimens of AZD8848 administered intranasally to seasonal allergic rhinitis patients out of pollen season in a nasal allergen challenge model

Eligibility Criteria:
Inclusion Criteria:

* Seasonal allergic rhinitis patients out of pollen season
* Have a history and presence of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test)
* Patients with need of treatment for their nasal symptoms during the pollen season

Exclusion Criteria:

* Symptomatic perennial allergic or non-allergic rhinitis
* Family history of autoimmune disease A history of asthma
A Study in Healthy Men to Test How BI 765080 is Taken up in the Body When Given as an Injection Under the Skin Compared With an Infusion Into the Vein

A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once administered as subcutaneous (SC) injection and once administered as intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian male subjects according to the assessment of the investigator, as based on a complete medical history, a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good clinical practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections Further exclusion criteria apply.
Oral Dydrogesterone in the Management of Preterm Labor

This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy with gestational age 24-33 weeks 6 days
* preterm labor
* received treatment with tocolysis and corticosteroids

Exclusion Criteria:

* conditions that need immediate delivery such as fetal distress, chorioamnionitis
* have medical complications such as heart disease, seizure
* fetal anomalies
* cervical dilatation more than 5 cm
* allergy to dydrogesterone
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pediátrico David Bernardino, Luanda, Angola.

The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.

The principal objective of the study is to examine if mortality of childhood bacterial meningitis can be reduced by slow continuous infusion of cefotaxime combined with high-dose paracetamol orally for the first 4 days (instead of the traditional qid administration of cefotaxime without concomitant paracetamol). Children qualifying for entry (see criteria below), whose guardian has given informed consent,will be randomized into 2 treatment arms (see details below)and receive the treatments in a double blind fashion (see details below). Primary and secondary outcomes (detailed below) will be evaluated according to predefined criteria and time points (see below).

Results will be analyzed for all patients in ITT datasets and in prespecified subgroups (etiology, nutritional status, etc.) in both crude and adjusted analysis. The efficacy results will be expressed as OR with 95% confidence intervals.

Eligibility Criteria:
Eligibility criteria:

The study entry is assessed for all children at age 2 months - 15 years who present at these centers with the symptoms and signs suggestive of bacterial meningitis (BM), and to whom lumbar puncture is performed.

Inclusion criteria:

All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study.

Participants: Exclusion criteria

Exclusion criteria:

1. Trauma, or relevant underlying illness such as intracranial shunt, previous neurological abnormality (cerebral palsy, Down's syndrome, meningitis)
2. Previous hearing impairment (if known)
3. Immunosuppression, except HIV infection
4. More than one parenteral dose of a pretreatment antimicrobial. Children with oral antimicrobials are included, this information being marked in the FOLLOW-UP sheet.
5. Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be included in intention-to-treat (ITT) analysis)
6. Known hepatic disease.