cyrilzakka/clinical-trials huggingface dataset:
From Obstacles to Opportunities for Family Planning in Tanzania

The investigators will conduct a cluster randomized trial to determine the effectiveness of an educational intervention for religious leaders in promoting uptake of family planning in Tanzania.

In this community randomized trial, the investigators will randomize 12 rural villages to receive an educational seminar for their religious leaders about family planning. The investigators will compare these uptake of family planning in these 12 villages with 12 matched villages whose religious leaders do not attend an educational seminar about family planning. The investigators will also determine women's reasons for seeking family planning at the village dispensaries..

Prior to the start of the trial, the study team will ensure that dispensaries in all villages in the trial will have a reliable supply of contraceptive options. To mitigate the effect of economic barriers and medication shortages on access to contraception, a dedicated medication supply team will make certain that all dispensaries remain well-stocked with standard contraceptives that are free from the Tanzanian Ministry of Health. These include oral contraceptive pills, implants, injections, copper intrauterine devices, and condoms.

Villages will be paired by proximity (within 50 kilometers of one another). Within the pair, one village will be randomly assigned, using a computer-generated algorithm, to receive the intervention of religiously- and culturally-informed teaching intervention about family planning for religious leaders. The other village will be the control village. Each intervention village will be followed, and its religious leaders mentored in groups, for 12 months after the start of the intervention. Mentorship groups of 25 leaders, led by the study team, will meet for 1 hour per month. The investigators will also conduct focus groups in both intervention and control villages to understand community perceptions of family planning.

Eligibility Criteria:
Inclusion Criteria:

* Rural villages in northwest Tanzania with populations between 8,000 and 20,000
* Village dispensaries present to measure uptake of family planning
* Located in close proximity (50 km or less) to another eligible village with which it can be paired

Exclusion Criteria:

* Private dispensaries at which family planning uptake would be missed
Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections

We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* planned to undergo a major liver resection at McGill University Health Center (MUHC)

Exclusion Criteria:

* patients known with chronic viral liver disease
* uncontrolled or type one diabetes mellitus (DM)
* patients on oral beta-blocker agents
* patients with unresectable disease determined intra-operatively
* patients unable to give consent for the study.
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama

Pre-exposure prophylaxis (PrEP) is an important biomedical human immunodeficiency virus (HIV) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for HIV and Sexually Transmitted Infections (STIs). The purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future HIV acquisition to better understand the factors associated with the risk of STIs and HIV diagnosis and predictors of PrEP use.

To better understand contextual factors among people who identify as women in Alabama that predict STI/HIV infection and PrEP use, we will refine an existing evidence-based mobile health app (HealthMpowerment or HMP) to optimally engage and retain a digital cohort of women at-risk for HIV infection (i.e. prior infection in the past 3 months with gonorrhea or syphilis). Using a sampling strategy based on geospatial analysis of HIV-risk, we will enroll and follow our cohort longitudinally to assess factors associated with incident STI/HIV infection as well as utilization of PrEP through iterative self-collected STI/HIV testing and survey assessments.

Eligibility Criteria:
Inclusion Criteria:

* Self identify as a Cis-gender or Trans-gender woman
* Age 18 - 89
* Reported STI in past 3 months by the Alabama Department of Public Health (ADPH)
* Gonorrhea and Syphilis negative
* HIV negative at screening encounter
* Live in Alabama
* Have access to a private smart phone

Exclusion Criteria:

* Live outside of Alabama
* Positive diagnosis for HIV, Gonorrhea, or Syphilis
Sleep Quality After Stellate-ganglion Block of Patients Undergoing Breast Cancer Operation

Stellate-ganglion block have been done safely for more than 60 years. It has proved to provide survivors of breast cancer with relief from hot flushes and sleep dysfunction with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing breast cancer surgery with Stellate-ganglion block performed in the operation.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to Stellate-ganglion block with 0.25% ropivacaine hydrochloride or saline. The objective of the trial is to evaluate the postoperative sleep quality of patients undergoing breast cancer operation with Stellate-ganglion block 0.25% ropivacaine hydrochloride or saline.

Eligibility Criteria:
Inclusion Criteria:

* At least18 years and pre-menopausal;
* scheduled to undergo elective breast cancer operation;
* American Society of Anaesthesiologists (ASA) risk classification I-II.

Exclusion Criteria:

* (1) patient refusal; (2) known hypersensitivity to the study medication (ropivacaine); (3) long-term use of opioids; (4) a history of psychiatric or neurological disease; (5) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.
Delirium, Electroencephalographic Alterations and Cortical Spreading Depression (CSD) in Critical Illness

Delirium in the intensive care unit is an acutely developed brain dysfunction affecting up to 80 % of patients. It is associated with significantly increased morbidity and mortality during admission and post-discharge. The mechanism behind the condition is poorly understood but assumably multifactorial, and the purpose of this study is to investigate the pathophysiology further.

The pathophysiology behind delirium in critical illness is not clarified but assumed to involve inflammation, changes in cerebral perfusion and neurotransmission, sleep deprivation and the use of i.e. sedatives.

Cortical spreading depression is a phenomenon occuring in critically ill patients with acute cerebral trauma and likely associated with significant secondary neuron damage.

The hypothesis is that

1. Delirium in critically ill patients without acute cerebral damage is a clinical manifestation of cortical spreading depression and can be recorded in a noninvasive direct current-electroencephalography
2. Electroencephalographic alterations or potentially specific signatures occur in delirium and thus, delirium can be predicted by recording continuous alternate current electroencephalography on admission in an ICU

Eligibility Criteria:
Inclusion Criteria:

* expected admission in the ICU \>24 hours

Exclusion Criteria:

* Cerebral trauma \<6 months
* existing delirium
* severe dementia
A Technology-based Exercise Program for Older Adults

This intervention aimed to collect relevant information for the development of a technology-based exercise application. This information-collection is based on the opinions of older adults (65+ years) as well as experts from the field of geriatric rehabilitation/medicine/research.

This intervention aimed to collect relevant information for the development of a technology-based exercise application. This information-collection is based on the opinions of older adults (65+ years) as well as experts from the field of geriatric rehabilitation/medicine/research.

The exercise application will be specifically designed for older adults:

* exercises targeted at endurance, strength, balance, coordination and flexibility
* importance of motivational aspects to motivate older adults to continue the program on the long term

Information that is aimed to be collected is related to a variety of aspects of the exercise application such as 1) information/education regarding the importance (health benefits) of exercise 2) design of the exercise application 3) technological aspect of the exercise application 4) motivational aspect of the exercise application

Eligibility Criteria:
Inclusion Criteria:

* Interested to contribute to the development of a technolgy-based exercise program specifically developed for older adults
* Interested to think about aspects such as "How to motivate older adults to exercise?" "Which information regarding exercise/health is relevant for older adults to motivate them to continue an exercise program?"

Exclusion Criteria:

* No interest in exercise for older adults
European Non-interventional Study on Refractory Epilepsy With Developmental Delay

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review). The identified local site staff (or trained independent data abstractors, if requested by the site) will review the medical records of all participants meeting the eligibility criteria, who have provided a signed inform consent form (ICF) for data collection and analysis. For participants who are less than 18 years of age, in addition to the assent form being signed by the participant, an informed consent would be obtained from parental or legally authorized representative.

In line with the retrospective nature of the study: there is no assignment of a participant to a particular therapeutic strategy; no additional diagnostic or monitoring procedures shall be applied to the participants; epidemiological methods shall be used for the analysis of collected data; the prescription of any medication for the treatment of the epileptic syndrome occur before the collection of the data in this study and is clearly separated from the decision to include the participant in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥2 years
* Disease history of at least 24 months from date of first seizure
* Medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression
* Medical history of onset of seizures in early childhood (≤ 8 years)
* Failure of adequate trials of two tolerated and appropriately chosen and used Anti-Epileptic Drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
* Ongoing refractory epilepsy
* MRI and EEG data are available for the participant
* Participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified.

Exclusion Criteria:

* Normal cognitive development.
* Any acute symptomatic seizures in participants with underlying developmental delay.
* Any progressive intellectual and neurological deterioration conditions.
Left Atrial Function Analysis for Patients With Persistent Atrial Fibrillation Undergoing Pulmonary Vein Isolation

This prospective observational study is designed to describe the factors determining the success of pulmonary vein isolation (PVI) for patients with persistent atrial fibrillation (AF). These factors - described as left atrial (LA) function - are simultaneously studied by multi-modal techniques in patients undergoing radiofrequency ablation. The simultaneous measurements are conducted before the PVI in AF and after the sinus rhythm converted due to PVI. These measurements include invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples. During the one year follow-up period rhythm monitoring is conducted by regular Holter-monitoring. Our aim is to define the predictive values of the above mentioned factors and to create a new score system for predicting PVI success in persistent AF population.


Eligibility Criteria:
Inclusion Criteria:

* documented, symptomatic persistent atrial fibrillation (AF)
* catheter ablation is indicated
* aged 18-75 years
* signed Patient Informed Consent Form
* able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* secondary AF
* paroxysmal, long-standing persistent or permanent AF
* ejection fraction \< 30%
* GFR \<30 ml/min/1.73m2
* unstable angina pectoris or myocardial infarction within the past 2 months
* severe heart failure (NYHA IV)
* severe COPD (GOLD III-IV)
* previous left atrial catheter ablation
* previous transthoracic cardiac surgery
* implanted cardiac device (pacemaker, ICD, CRT, VAD)
* awaiting cardiac transplantation or other cardiac surgery within the next 12 months
* any contraindication for pulmonary vein isolation, MRI or anticoagulation
* coagulopathy
* active malignancy, left atrial myxoma
* autoimmune disorder, chronic inflammatory disease
* acute illness, active systemic infection, sepsis
* women who are pregnant, breast feeding, or planning to become pregnant in the next 12 months
* aged under 18 years or above 75 years
* enrollment in other studies, which exclude participation in other studies
* patient not willing or not able to sign the informed consent form
Tocotrienol in Combination With Neoadjuvant Chemotherapy for Women With Breast Cancer

The purpose of this study is to investigate whether tocotrienol can improve the effect and reduce the side effects of standard chemotherapy before operation for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women with histologically verified breast cancer (adenocarcinoma)
* Age ≥ 18 years.
* Neoadjuvant treatment indicated according to departmental guidelines
* PS 0-2 and suited for surgery.
* Normal heart function, LVEF ≥ 50% by MUGA/ECHO in patients receiving neoadjuvant trastuzumab
* Normal bone marrow function: Hemoglobin ≥ 6 mmol/l; ANC ≥ 1.5x10\^9/l; Thrombocytes ≥ 100x10\^9/l.
* Normal liver function: Bilirubin ≤ 1.5 x upper level of normal, ALAT ≤ 2.5 x upper level of normal, BASP ≤ 2.5 x upper level of normal.
* Normal kidney function: Creatinine ≤ upper level of normal. In case of increased creatinine, measured/calculated GFR must be ≥ 50 ml/min.
* Fertile women must present a negative pregnancy test and use a safe contraceptive during and 3 months after the treatment. Intrauterine device without hormone is considered safe.
* Written and orally informed consent

Exclusion Criteria:

* Bilateral breast cancer or suspected dissemination. Verified by bilateral mammography, bone scintigraphy, chest and abdomen CT, and PET-CT.
* Pregnant and breastfeeding women
* Mental or social conditions that will prevent treatment or follow-up
* Other simultaneous experimental treatment
* Immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy)
* Vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin D)
* Active or latent viral/bacterial infection
* Rheumatoid arthritis or other autoimmune disease
* Other malignant disease within the past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri.
* Previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol
* Hypersensitivity to any of the active or auxiliary substances
Effect of Transcranial Static Magnetic Field Stimulation in Fibromyalgia Syndrome

The main objective is to know if the transcranial static magnetic field stimulation (tSMS) reduces the perception of pain in patients with fibromyalgia and its effect on health-related quality of life. In addition, it will seek to limit the parameters necessary to achieve efficiency with the technique.

Background:

Various non-invasive brain stimulation techniques have been successfully tested in fibromyalgia syndrome (FMS). Transcranial static magnetic field stimulation (tSMS) is a new, portable and inexpensive non invasive brain stimulation (NIBS) technique that has shown security, biological effects, and therapeutical effects in some pathologies. Some studies have studied its effect in pain central processing, our aim is to study its effect on FMS. The safety that tSMS has demonstrated in several clinical trials opens doors to future clinical trials that will extend its clinical utility.

Objectives:

To investigate the effect of tSMS on pain in patients with FMS, using subjective and objective assessment measures. Identify dose response to the treatment to limit the parameters required to achieve effectiveness with the technique.

Eligibility Criteria:
Inclusion Criteria:

* Formal diagnosis of fibromyalgia syndrome (FMS).
* No change in the last 4 weeks on their standard treatment.
* They must have pain for more than 6 months (at least 4 on the VAS scale).
* Score on the fibromyalgia impact questionnaire (FIQ) greater than 39.

Exclusion Criteria:

* Presence of concomitant autoimmune or hematologic diseases.
* Neuropsychiatric disorders.
* Pacemakers or neurostimulators implants.
* Substance abuse or other pathologies that can explain chronic pain.
* Pregnant or lactating women.
* Those who are receiving any other type of physiotherapy treatment.
Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

Anthracycline chemotherapies (e.g. doxorubicin, daunorubicin) are commonly given to treat pediatric cancer, and carry a risk of cardiotoxicity. Over the long term, children who receive these therapies have an increased risk of heart failure and early cardiovascular death. However, current strategies for identifying patients who are at risk prior to the development of significant changes in heart function are limited. This study will focus on imaging markers of cardiac injury and dysfunction with the goal of developing improved diagnostic tests and treatment strategies.

Cardiac remodeling, function, and tissue characteristics will be examined using cardiac MRI in combination with other research assessments to assess the cardiotoxic effects of cancer therapy. Analyses will be performed in a cohort of adolescents and young adults with a history of childhood cancer.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish speaking male and female subjects, ages 13-39 years old
* Diagnosis of cancer at age \<22 years
* Previously treated with anthracyline therapy for cancer, with diagnosis at least two years prior.

Exclusion Criteria:

* Patients who have a contraindication to cardiac MRI, including the presence of non-MRI compatible metallic implants.
* Medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would preclude the subject from undergoing the cardiac MRI without anesthesia.
* Patients with a history of congenital heart disease (more significant than a history of patent foramen ovale or patent ductus arteriosus).
* Pregnancy (at the time of enrollment).
Effect of Passive Ultrasonic Irrigation on the Reduction of Bacteria and Endotoxins in Root Canals

The purpose of this clinical study was to compare the effectiveness of passive ultrasonic irrigation with that of traditional syringe irrigation on the removal of bacteria and endotoxin (lipopolysaccharide \[LPS\]) from root canals.

Forty teeth with apical periodontitis were randomly allocated into two groups according to the irrigation protocol, passive ultrasonic irrigation (PUI, n = 20) and syringe and needle irrigation (NI, n = 20). Microbiological sampling was performed before (S1) and after the root canal preparation (S2), after the tested irrigation protocols (S3). Total bacteria counts were determined by a quantitative PCR (qPCR) assay; and the endotoxin levels by the LAL assay.

Eligibility Criteria:
Inclusion Criteria:

* Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion Criteria:

* patients who had received antibiotics during the previous 3 months or had any general disease,
* teeth that could not be properly isolated with rubber dam,
* non-restored teeth,
* periodontal pockets depths greater than 4 mm,
* previous endodontic treatment,
* open apex,
* crown/root fracture
* root resorption or calcifications.
E-learning to Improve Oral Anticoagulant Use in Hospitalized Older People With AF

Atrial Fibrillation (AF) is the most common cardiac arrhythmia and the main cause of cardioembolic stroke. Oral Anticoagulation (OAC) has been shown to significantly prevent AF-related thromboembolism, however, despite convincing evidences and current guidelines recommendations, OAC tends to be underused in clinical practice especially in the oldest. Education and training to appropriately select people suitable for OAC for stroke prevention could be pivotal in the decision making process. According to the study project, physicians working in Internal Medicine and Geriatric wards, where are mainly admitted elderly people with AF, will undergo to a program of e-learning through computer-based simulation method reproducing clinical scenarios of patients aged 65 years or older, with known or newly diagnosed AF, admitted to hospital for any medical reason and requesting that a decision about long-term antithrombotic therapy is taken.

Primary objective of the study is to investigate whether such educational intervention will improve the appropriate use and prescription rate of OAC in hospitalised elderly patients with AF, multimorbidity and polypharmacy, in comparison to the usual practice.

The study will be a cluster randomised controlled trial involving a network of Internal Medicine and Geriatrics wards. Thirty-two wards will be recruited based on voluntary participation and randomised to receive an educational intervention through computer-based simulation, (N=16) or to continue with the usual practice (N=16). Subjects receiving the intervention will be all the staff physicians of the wards randomised in the intervention arm.

The impact of the intervention compared with the usual practice will be evaluated in patients aged 65 years or older admitted to the participating centres with a known diagnosis of AF or newly diagnosed with AF during the hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* subjects 65 years of age or older, with known or newly diagnosed AF, admitted to the Internal Medicine and Geriatric wards of the REPOSI network,
* consent to participate to the study.

Exclusion Criteria:

* consent denial to participate to the study,
* absolute contraindication to OAC,
* re-hospitalisation for the subject already included in the study,
* life expectancy less than 6 months.