cyrilzakka/clinical-trials huggingface dataset:
Direct and Indirect Protection by Influenza Vaccine Given to Children in India

The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.

Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age.
* All individuals in enrolled households will be eligible for enrollment into surveillance arm.

Exclusion Criteria:

* Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin B)
Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic

The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.

Renal colic, an intensely painful condition, is a common presenting complaint to the emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and acetaminophen are commonly used to provide relief from renal colic. The aim of the present trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the emergency department.

Study Design and Setting: A prospective, randomized, double-blind, placebo controlled, single-center, clinical trial will be conducted in emergency department of a tertiary care university hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with renal colic admitted to emergency department.
2. Adult patients who were definitively diagnosed with acute renal colic due to urinary system stones using unenhanced computed abdominopelvic tomography

Exclusion Criteria:

1. Patients below 18 years of age
2. Patients with haemodynamic instability, with fever (temperature=38°C \[100.4°F\]), with evidence of peritoneal inflammation,
3. Patients using any analgesic within the previous 48 hours of emergency department presentation
4. Patients who declined to participate
Enhanced Diagnostics for Early Detection of Atrial Fibrillation

Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present.

The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.

In the first part of this trial different diagnostic techniques to detect arrythmogenic substrates of atrial fibrillation will be tested. If suitable parameters can be identified, a follow up trial to identify patients at risk for AF will be conducted before a stroke happens.

Parameters tested are

1. Electrophysiological differences between patients with paroxysmal AF and no history of AF
2. "Vascular Stiffness" detected by an iPhone app

All patients will undergo a cardiogoniometrie and a pulse wave analysis with an iPhone. Each exam takes 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria:

* acute cerebral trauma
* antiarrhythmic medication
Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the effect of bevacizumab and VEGF on platelet clustering.

PURPOSE: This research study is looking at the effect of bevacizumab and VEGF on platelet clustering in patients with cancer who are receiving bevacizumab.

OBJECTIVES:

* To determine the influence of bevacizumab on platelet aggregation in patients receiving bevacizumab for cancer.
* To determine the influence of VEGF on platelet aggregation.
* To determine the influence of VEGF or bevacizumab on cyclooxygenesis.
* To determine if the sequence of medication plays a role in platelet aggregation.

OUTLINE: Blood samples are collected before and after bevacizumab infusion. Samples are analyzed for measurements of platelet aggregation, coagulation parameters, and endothelial activation (e.g., fibrin fragment F1 and 2, thrombin and antithrombin complex, soluble P-selectin, Von Willebrand factor and factor VIII, tissue factor, and endothelin 1).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Receiving bevacizumab for cancer

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)

The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption

Exclusion Criteria:

* Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
* Patient has uncontrolled high blood pressure
* Patient has a history of drug and/or alcohol abuse within the last 5 years
* Patient has taken part in another investigational study within 4 weeks of the start of study
* Patient is breast-feeding
* Patient has an active ulcer or inflammatory bowel disease
Effect of Personalised Citizen Assistance for Social Participation(APIC) on Older Adults Health and Social Participation

Global aging and the growing burden of chronic diseases represent a challenge. Innovative interventions acting upon health determinants, like social participation, are required. Social participation, defined as the involvement of a person in activities that provide interactions with others in the community is critical to promote health and prevent disabilities. Many older adults do not have equitable opportunities to achieve full social participation, and interventions under-empower their personal and environmental resources and only reach a minority. To optimize current practices, the Personalised citizen assistance for social participation (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation.

The first aim of this study is evaluate the impacts of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation. The second aim is to evaluate the cost-effectiveness of the intervention. In parallel, the implementation of the APIC, including factors facilitating and impeding it, will be documented.

Concerning the first two objectives, two hypotheses are formulated: 1) the APIC will prevent a decline in older women's and men's health, social participation and life satisfaction, and reduce their use of healthcare services, and 2) the APIC will be associated with lower costs, from older adults', healthcare system and societal perspectives, including healthcare expenditures.


Eligibility Criteria:
Inclusion Criteria:

1. be aged 65 or older,
2. live at home or in seniors' residences,
3. be restricted in at least one instrumental activity of daily living (e.g. house cleaning, shopping), and
4. have a good understanding of French or English.

Exclusion Criteria:

* Moderate to severe cognitive impairments
Simplified Treatment of Anti-retrovirus in China (C-STAR)

To observe the efficacy and safety of simplified therapy regimen for treating with HIV-1 infected patients in Chinese real word.

This is an phase IV open-label, multicenter, single-arm clinical trial in. A total of 600 cases were planned to be recruited. These cases were given simplified therapy regimen of lopinavir (200mg) and ritonavir (50mg) (500mg, oral, bid ) combined with lamivudine (300mg, oral, qd. The observation duration is thirty-sixth months. Patients will be followed up before and 12, 24 and 36 months after receiving the simplified regimen, observing the viral inhibition rate and the change of CD4 cell count, the safety and patients'compliance.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infection confirmed
2. Agree to use simplified therapy regimen.
3. Agree to detect CD4 count at least once per half a year

Exclusion Criteria:

1. Have participated in HIV vaccine clinical trial or other drug trials in the past three months.
2. Patients who could not complete the scheduled follow-up (such as weakness and poor compliance).
3. Patients who have the history of resistance or allergy to LPV/r or 3TC.
A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate

The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.

This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.

The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.

Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.

The total duration of the study will be approximately 148 days.

Eligibility Criteria:
Inclusion Criteria:- Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Version IV

* Dissatisfied with current medication (Medication Satisfaction Questionnaire score of less than or equal to 4) or by clinician's judgment and who may benefit from switching medication
* Have received an oral antipsychotic for at least 4 weeks before randomization
* Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

History of neuroleptic malignant syndrome

* Presence of congenital prolongation of the QT interval - History of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days
* Any relevant medical history or current presence of systemic disease
* Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
Effects of Elastic Resistance Training on Performance and Biochemical Parameters

The aim of this study was to investigate the acute and chronic effect of elastic resistance exercise in elderly women living in a nursing home. The primary outcome was the functional performance and hand grip strength. The secondary outcomes were myokines and inflammatory markers analysis.

Evidence regarding the relationship between RT and systemic myokine responses, as well as inflammation and physical performance in elderly is limited. Thus, this study aimed to evaluate the effect of short-term progressive elastic resistance training on muscular strength and physical performance, as well as the acute and chronic response of myokines and inflammatory markers after resistance exercise in elderly women living in a nursing home. From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home in the south of Slovenia to participate in our study.

The experimental design consisted of 1) baseline testing; 2) acute elastic resistance exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of supervised, progressive elastic resistance training program of moderate intensity; and 4) post-training testing.

The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a human premixed 4-plex kit (R\&D System Inc., Minneapolis, MN, USA), strictly following the manufacturer's instructions.

Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test was applied for statistically significant interaction. To test for significant differences between groups relating anthropometric and biochemical variables, we used a Student's t-test. All values are expressed as mean and standard deviation (SD). P values of \<0.05 is considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).

Eligibility Criteria:
Inclusion Criteria:

* nursing home residents
* participants did not perform any regular resistance training

Exclusion Criteria:

* immobility
* implantable cardiac peacemaker
* severe dementia
* terminal illness
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome

CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.

To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 18 years of age at signing of informed consent.
* Subjects are scheduled to receive CAR T-cell treatment.

Exclusion Criteria:

* Refusal to sign the informed consent
* Subjects having previously been treated with CAR-T therapy.
* Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
* Subjects presenting primary CNS lymphoma
* Pacemaker or other implanted electrical device incompatible with the MR environment
* Subjects with a neurodegenerative disease (PD, AD)
* Subjects with a previous or evolving neurological pathology
* Pregnant or breastfeeding women
Clinical Study of a Single Ciliopathy: Alström Syndrome

The aim of the study is to characterize the clinical manifestations of ALMS within the ciliopathies to prevent complications and determine preventive and therapeutic targets.

The investigators believe that the clinical consequences of mutations in the gene result ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about the understanding and decision support other ciliopathies, but also about some common diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated a model of the channel concerned. Secondarily, the clinical data generated by this project will also be used as part of basic research (eg comparison with results in animal models, use of human cells for in vitro studies or transcriptomic ....) (which will be a secondary upgrading to this work).


Eligibility Criteria:
Inclusion Criteria for Patients with Alström syndrome:

* Age\> 2 years
* Affiliated with a social security scheme
* Informed consent signed
* Retinal dystrophy and proved at least three diagnostic criteria Alström syndrome (Criteria Marshall et al, 2005):
* Early obesity
* Deafness
* Dilated cardiomyopathy
* Type 2 diabetes
* Hypogonadism
* Absence of polydactyly
* Lack of mental retardation
* A family history of the ALMS
* Mutation in the ALMS gene identified

Inclusion Criteria for Related of Alström patients :

* Father / Mother of a patient diagnosed with Alström
* Age greater than 18 years
* Affiliated with a social security scheme
* Informed consent signed

Exclusion Criteria for Patients with Alström syndrome:

* Current pregnancy (a pregnancy test is routinely performed at baseline)
* Pregnant or breastfeeding women
* Intercurrent diseases do not allow the practice exams in protocol
* Subject to exclusion period (determined by a previous study or a study in progress)

Exclusion Criteria for Related of Alström patients :

* Age less than 18 years
* Subject to exclusion period (determined by a previous study or a study in progress)
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

This is a 3-arms randomized-controlled, parallel group, single center, double-blind study investigating the bioavailability of olive oil extract (OLE) in two different OLE formulations (enzymatically treated and co-administered with a probiotic) compared to original OLE formulation in healthy adult subjects.

Male or female healthy adults between 25 and 65 years of age will be randomized into one of the 3 following groups to receive:

1. Capsule of OLE + 1 stick of maltodextrin
2. Capsule of OLE enzymatically treated + 1 stick of maltodextrin
3. Capsule OLE + 1 stick of probiotic

52 subjects will be randomized to achieve 15 subjects per group to complete the trial.

The study will involve 3 phases:

1. PK1 (all subjects will receive one capsule of OLE in the morning and blood samples will be collected at different timepoints for 24h) followed by a washout period of 1 day
2. 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days
3. PK2 period (subjects will receive one capsule the product thy have benn assigned to

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign written informed consent prior to trial entry
2. Male or female healthy adults between 25 and 65 years of age
3. Body Mass Index (BMI) within the range 18.5 - 29.9 (both inclusive)
4. In good health as determined by medical judgment and medical history

Exclusion Criteria:

1. Any food allergy/intolerance
2. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
3. Taking or anticipated initiation of any lipid-modifying or blood-clotting medication e.g. statins, cholesterol lowering
4. Smokers
5. Alcohol intake higher than 2 servings per day (one serving is 0.4 dL of strong alcohol, 1 dL of wine, or 3 dL of beer) or drug abuse
6. Receiving or having received antibiotics in the past 4 weeks prior to the day of inclusion
7. Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
8. Hormonal treatment for women linked to menopause (contraceptive treatment accepted)
9. Pregnancy or breastfeeding
10. Supplements or foods containing probiotics (yogurts allowed)
11. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands

This is a pilot study evaluating if treatment for scabies also treats headlice in the same community

Background:

Scabies and head lice are both ubiquitous ectoparasitic infections that have been identified as common public health problems in the Pacific Island Country Territories. Mass drug administration using ivermectin is increasingly recognised as an effective strategy for scabies treatment and control, however, its possible impact on prevalence of head lice has not been evaluated. Given that oral ivermectin is an effective treatment option for pediculosis capitis, we hypothesise that community treatment with ivermectin for scabies would also provide benefit by reducing prevalence of head lice infestation in the community. We aim to test this hypothesis with a small-scale pilot study in the Solomon Islands.

Methodology:

The study would be carried out at the Atoifi Adventist Hospital campus, on the North-Eastern coast of the island of Malaita. The campus houses an estimated 180 individuals and all residents would be invited to participate in the study and be offered treatment.

At baseline all individuals would undergo a standardized examination to collect data on the presence of scabies, impetigo and head lice. Following examination individuals would be weighed and given directly observed standard treatment for scabies.

Treatment for scabies consists of one oral dose of ivermectin (200 micrograms per kilogram) at day 1 and at day 8.

Individuals with contra-indications (pregnancy, breast feeding, weight under 15kg) would be offered the alternative of 5% permethrin cream and malathion shampoo.

Individuals would be re-examined at 48hours (to assess immediate killing of head lice) and again at 2 weeks. Final follow-up will be at 3 months to establish: 1) whether changes in head lice prevalence have been sustained 2) what the impact of treatment on scabies and impetigo with ivermectin is in this specific community.

Eligibility Criteria:
Inclusion Criteria:

* All participants living in the community will be offered treatment

Exclusion Criteria:

* Patients with a contradindication to study medication
* Patients unable to provide consent