cyrilzakka/clinical-trials huggingface dataset:
Childhood Influenza Immunisation in General Practice Invitation Trial

This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

Previous research has shown that small changes to routine invitations/reminders to attend local health services informed by behavioural science can be used to increase a desired behaviour (e.g. uptake of health checks, reducing missed appointments).

This trial will determine whether an invitation letter, informed by behavioural insights and sent through a central system (Child Health Information System, CHIS), can increase uptake of childhood flu vaccine in primary care.

The trial will take place within the existing national childhood immunisation programme in the participating area in England. Randomisation will be clustered at the primary care practice level. Outcome data will be anonymised, routinely collected, individual-level influenza vaccine uptake data extracted from CHIS. For CHIS data validation purposes, practice-level vaccine uptake data reported through an alternative, routine system will be collected. Data will be collected on additional invitations/communications that primary care practices (in both the intervention and control arms) send to their patients. Cost data for the centralised letter will also be obtained.

The analysis will investigate the main effect of the intervention on uptake of the flu vaccination for all eligible children included in the trial. The model will include primary care practice and Clinical Commissioning Group effects to account for clustering. Secondary analysis will investigate the impact of such individual factors as age, immunisation history and socioeconomic status and practice-level factors (e.g. direct communication from practices) on uptake of the flu vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 2 years or 3 year olds at 31st August 2016
* Registered with a primary care practice in the participating area
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

Aim: eliminating or reducing pain following endodontic treatment is of great importance. The aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis was evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects were 20-60 years of age with no systemic diseases and females were not pregnant;
2. No history of taking any analgesics or other drugs prior to presenting for treatment;
3. Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth.

Exclusion Criteria:
Buteyko Based Remedial Breathing Therapy With Children With Asthma

A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent of the parents
* age 6- 15 years
* information and consent of the consulting doctor
* levels of asthma therapy 1-3

Exclusion Criteria:

* participation in another study
Feasibility Trial in Urban Pakistan for Community Engagement in Preventing Type II Diabetes and Risk Factors

This project aims to adapt, implement, and evaluate PLA based intervention in urban Karachi, Pakistan for TIIDM prevention and control.

The pivotal components of this approach include adapting, implementing, and evaluating the Participatory Learning and Action (PLA) based intervention for the prevention and control of Type II diabetes (TIIDM). TIIDM is considered the fastest-growing health emergency, affecting 537 million adults worldwide. Global projections for the year 2045 suggest that a 12.2% rise in TIIDM is anticipated with an additional 11.4% rise for intermediate hyperglycemia (IHG). Around 80% of people with TIIDM reside in low-and middle-income countries (LMICs), exhausting the already burdened healthcare system.

The intervention, adapted from the "Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycemia in Bangladesh (DMagic)" trial, has been tested and found effective in the rural context of Bangladesh. However, PLA-based intervention has not been previously tested in urban communities. Considering the distinct sociocultural environment of urban settings, a feasibility trial will be conducted in urban Karachi, Pakistan.

The feasibility trial will assess the intervention's adaptability and effectiveness in this new context. It is anticipated that the use of evidence-based approaches, best practices, and meaningful community participation through PLA will enhance the social and behavioral determinants of health and lead to improved health outcomes. This approach aims to control TIIDM and pave the way for managing other non-communicable diseases through similar focused interventions.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 20 years and above.
* Participants residing in the randomized clusters of Karachi, Pakistan
* Individuals willing to participate in the study and provide consent.
* Both individuals with normoglycemia, intermediate hyperglycemia, and diabetes are encouraged to participate.
* Participants who can attend the scheduled meetings and interventions as per the study protocol.

Exclusion Criteria:

* Individuals below the age of 20 years.
* Individuals unwilling to provide consent for participation.
* Participants with severe health conditions that may hinder their active involvement in the study.
* Individuals with non-compliance with research protocols
APRICOT-3: Antithrombotics in the Prevention of Reocclusion In COronary Thrombolysis -3

Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis.

The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.

Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)

Eligibility Criteria:
Inclusion Criteria:

* TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction

Exclusion Criteria:

* Use of oral anticoagulants.
* Known intolerance to aspirin or clopidogrel.
* Bypass graft as infarct-related artery.
* Previously dilated infarct related artery.
* Significant left main stenosis.
* Unidentifiable culprit stenosis.
Mama Empoderada: Adapting a Novel Mental Health Prevention Intervention for Migrant Mothers With Young Children

This pilot randomized controlled trial will test a theory-based, trauma-informed, and culturally-tailored intervention \[Mama Empoderada' (Mom Power)\] to promote mental health and positive parenting among migrant mothers with young children.

The goal of this randomized controlled trial is to adapt and pilot-test a novel mental health prevention intervention for migrant mothers with young children in a humanitarian setting.

This pilot trial will adapt 'Mama Empoderada' \[Mom Power\] - a theory-based, trauma-informed, culturally-tailored group intervention to promote mental health and positive parenting among mothers with young children (0-5 years) for the first time. Aims are to:

1. Conduct a pilot study of the adapted intervention to determine acceptability and estimate effect sizes on symptoms of depression, anxiety, and parenting stress; and
2. Explore which theory-based mechanisms of action predict changes in symptoms of depression, anxiety, and parenting stress, and identify factors associated with differential intervention response.

The intervention group will receive trauma-informed group and individual sessions on parenting, linkage to resources (e.g., food, shelter), social support, and resilience. The control group will receive standard of care programming.

Both groups will complete baseline and exit surveys, as well as follow-up surveys at 2-, 4- and 6- months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as a mother to at least one accompanying child \<6 years of age
* At least 18 years old
* Migrated to Tijuana from a Latin American country other than Mexico, or born in Mexico and internally displaced
* Able to provide informed consent
* Screen below cut-offs for major depression and anxiety disorder
* Able to speak Spanish
* Available to participate in full duration of 'Mama Empoderada'

Exclusion Criteria

* Not a mother or only accompanied by older children (\> age 6)
* Less than 18 years of age
* Migrated to Tijuana from region outside of Latin America or non-migrant
* Unable to provide informed consent
* Screen above cut-offs for major depression and anxiety disorders
* Unable to speak Spanish
* Unable to participate in full intervention (either control or intervention group).
Sustainable Method for Alzheimer's Prediction

This is an observational study with the aim of validating, in a consistent population sample, with appropriate follow-up, whether EEG connectivity analysis combined with the neuropsychological evaluation and ApoE genotype testing in aMCI could be of help in early identification of converted aMCI as a first-line screening method in order to intercept early those subjects with a high risk for rapid progression to AD.

Primary aim of the present project is to investigate the dynamic connectivity among brain centers by using a mathematical (Small World) approach to the analysis of EEG-related neural networks. The aim is to provide reliable discrimination of amnesic-Mild Cognitive Impairment (a MCI) subjects who, on individual basis, will rapidly convert to Alzheimer Disease (AD) after a relatively brief follow-up. Moreover, keeping in mind that the epsilon-4 allele of the ApoE gene is a genetically determined risk factor for pathogenesis of late-onset AD, a secondary endpoint is introduced to investigate whether the EEG connectivity markers together with a genetically determined risk of dementia as represented by ApoE testing can reach higher sensitivity/specificity for early discrimination of MCI converting to AD

Eligibility Criteria:
Exclusion criteria for AD will be:

* frontotemporal dementia;
* behavioural variant of frontotemporal dementia;
* vascular dementia;
* extra-pyramidal syndromes;
* reversible dementias (including pseudodementia of depression);
* Lewy body dementia.

The exclusion criteria for aMCI will be:

* mild AD, as diagnosed by standard protocols including National Institute on Aging-Alzheimer's Association workgroups (McKhann et al. 2011);
* evidence (including magnetic resonance imaging -MRI procedures) of concomitant dementia such as frontotemporal, vascular and reversible dementias (including pseudo-depressive dementia), marked fluctuations in cognitive performance compatible with Lewy body dementia and/or features of mixed dementias;
* evidence of concomitant extrapyramidal symptoms;
* clinical and indirect evidence of depression as revealed by the Geriatric Depression Scale GDS (Yesavage et al. 1982); scores lower than 14 (no depression);
* other psychiatric diseases, epilepsy, drug addiction, alcohol dependence, use of neuro/psychoactive drugs including acetylcholinesterase inhibitors;
* current or previous uncontrolled or complicated systemic diseases (including diabetes mellitus) or traumatic brain injuries.
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.

A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey.

This is a 12-week double-blind randomized controlled trial to evaluate the impact of liposomal curcumin in a high-protein product on inflammation markers for adults undergoing hemodialysis. CRP and oxidative stress will be assessed from monthly blood samples using Elisa kits. Quality of life will be measured using the standard 36-item kidney disease quality of life instrument. There will be a 2-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. Eligible participants will sign the consent form to participate in the study. Once the expected number of participants has been reached, they will be randomized 1:1 using block randomization. Randomization will be done using a computer-generated program.

The intervention will take place over an 8-week period. Participants will have their blood drawn at the beginning of the study by the dialysis practitioner and start receiving the product on their next scheduled dialysis appointment. Participants will be receiving the product three times a week in accordance with their dialysis schedule (M-W-F or T-Th-S), for a total of 24 treatments. Blood will be collected at baseline, at the end of the study and a month after to assess any carryover effects. Additionally, participants will complete 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day), a spice-consumption survey, and a quality-of-life assessment at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* diagnosed with stage 5 CKD.
* receiving hemodialysis at least three months before the trial start date
* All participants can provide signed informed consent, have no dietary restrictions, no food allergies, nor chewing/swallowing difficulties.

Exclusion Criteria:

* Adults with CKD stages 1-4.
* Adults undergoing peritoneal dialysis.
* Pregnant and/or lactating for the duration of the study as confirmed by the dialysis medical staff.
* Use of other IP within 3 months of the initiation of the study.
New Position for Endotracheal Intubation of Obese Patients

The aim of this work is to investigate the feasibility of using the modified a ramped position for mask ventilation and endotracheal intubation of obese patients in comparison to the traditional ramped position

Adequate conditions for endotracheal intubation and mask ventilation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.

In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position.

In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese such as: 1- Impedance to complete mouth opening due to fatty face and neck. 2- Impedance of laryngoscopy by large breasts in females. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope.

The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would enhance mouth opening and bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head could be manually elevated (if required) to achieve sniffing position.

The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.

Eligibility Criteria:
Inclusion Criteria:

* female patients
* obese (with body mass index above 30 kg per squared meter)
* Scheduled for surgery under general anesthesia.

Exclusion Criteria:

* Patients with scars in the face or neck.
* Edentulous patients.
* Patients with airway masses.
Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung

The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene
* Sputum or throat swab culture positive for Pseudomonas aeruginosa at or within 6 months of enrollment
* Age ≥12 years
* Forced expiratory volume in one second (FEV1) 25-90 percent-predicted

Exclusion Criteria:

* Age \<18 years
* Inability to routinely expectorate sputum without induction by hypertonic saline
* Inability to provide or withdrawal of written informed consent
* History of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics
* Serum creatinine ≥ 2.0 mg/dl
* Serum blood urea nitrogen (BUN) ≥40 mg/dl
* Pregnancy or lactating at screening
* History of systemic intravenous anti-Pseudomonal antibiotics within 28 days of enrollment
Cardio-Respiratory Health and Indoor Pollution

The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):

1. the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
2. the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.

The investigators hypothesize that the chronic exposure to indoor pollution

1. can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
2. induce cardiovascular impairment

   The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors
3. to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities.

What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.


Eligibility Criteria:
Inclusion Criteria:

* residents in the villages of the valley

Exclusion Criteria:

* under the age of 14
Increasing Individualism and Collectivism

An online survey is conducted on MTurk populations from India and USA. Participants were assigned either a condition with primes of individualism or one with primes of collectivism, before responding to a scale on culture and indicating details of their demographics.


Eligibility Criteria:
Inclusion Criteria:

* above age 21

Exclusion Criteria:

* below age 21
* not able to make decisions for self
Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery

The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* Must be able to understand, read and sign consent form

Exclusion Criteria:

* Signs of infection upon admission
* Ongoing pregnancy
* Carcinoma of the uterus or cervix
* Recurrent PID
* Women admitted for endometrial ablation
* Women that gave birth 6 weeks ago
* Women participating in another study