cyrilzakka/clinical-trials huggingface dataset:
Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases

The trial will be conducted in the city of Merida extending ongoing longitudinal cohort to follow a population of 4,600 children 2-15 years old randomly allocated to receive either TIRS treatment or not. If efficacious, TIRS will drive a paradigm shift in Aedes control by: considering Ae. aegypti behavior to rationally guide insecticide applications; the change to preventive control (pre- ABD transmission season rather than in response to symptomatic cases); the use of third generation insecticides to which Ae. Aegypti is susceptible.

Contemporaneous urban vector control (truck-mounted ultra-low volume spraying, thermal fogging, larviciding) has failed to contain dengue epidemics and to prevent the global range expansion of Aedes-borne diseases (ABDs: dengue, chikungunya, zika). Part of the challenge in sustaining effective ABD control emerges from the remarkable paucity of evidence about the epidemiological impact of any vector control method. Furthermore, the classic deployment of interventions in response to clinical cases fails to account for the important contribution of out-of-home human mobility and asymptomatic infections.

The trial will be conducted in the city of Merida extending ongoing longitudinal cohort to follow a population of 4,600 children 2-15 years old randomly allocated to receive either TIRS treatment or not. If efficacious, TIRS will drive a paradigm shift in Aedes control by: considering Ae. aegypti behavior to rationally guide insecticide applications; the change to preventive control (pre- ABD transmission season rather than in response to symptomatic cases); the use of third generation insecticides to which Ae. Aegypti is susceptible.

Eligibility Criteria:
Inclusion Criteria:

1. Household Level Inclusion Criteria:

   * Household is located within the bounds of a study cluster (5x5 city-block clusters)
   * City block has at least 60% premises that are residential
2. Individual Level Inclusion Criteria:

   * 2 or more and up to 15 years of age at the time of initial enrollment
   * Living in a house that consented to TIRS

Exclusion Criteria:

1. Household Level Exclusion Criteria:

   * Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)
   * Sites where no residents spend time during the day (i.e. work 7d a week outside the home)
   * Inability for a resident to provide informed consent
   * Non-residential places (e.g., businesses, schools, markets, etc.)
2. Individual Level Exclusion Criteria:

   * Less than 2 years of age or more than 15 years of age at the time of enrollment
   * Not living in a house that consented to TIRS
   * Having a medical condition that prevents implementation of study procedures
   * Temporary visitor to household
   * Plans to leave study area within next 12 months
Combination Chemotherapy Following GM-CSF in Treating Patients With Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. GM-CSF may make cancer cells more sensitive to the effects of chemotherapy. Combining more than one drug with GM-CSF may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of cyclophosphamide plus vincristine, following GM-CSF in treating patients with multiple myeloma that has not responded to previous treatment.

OBJECTIVES: I. Determine the response rate of multiple myeloma patients when treated with cyclophosphamide and vincristine after cycling myeloma cells with sargramostim (GM-CSF). II. Evaluate whether Labelling Index (LI) changes influenced by GM-CSF would predict a group of patients that will respond to this particular course specific design. III. Determine the toxicity of GM-CSF in these patients.

OUTLINE: Patients receive subcutaneous injections of sargramostim (GM-CSF) once a day for 5 days. Two to 3 days later, patients receive cyclophosphamide IV over 30-45 minutes on day 1, vincristine IV bolus on day 8, and oral prednisone 4 times a day on days 1-4. Patients also receive subcutaneous injections of GM-CSF starting on day 2 and continuing for 10 days or until neutrophil count is at least 1000/mm3. Treatment continues every 3 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least stable response receive GM-CSF 3 times a week for up to 2 years. Patients are followed every 3-6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven multiple myeloma Pancytopenia related to multiple myeloma allowed Failed or progressed after at least 2 chemotherapy or biologic therapy regimens

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Platelet count at least 50,000/mm3 Absolute neutrophil count at least 750/mm3 Hepatic: SGOT/SGPT less than 3 times upper limit of normal Bilirubin less than 5.0 mg/dL Renal: Not specified Other: No active infection requiring intravenous antibiotics Not HIV positive Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics May have failed prior bone marrow transplant No other concurrent colony stimulating factors Concurrent immunoglobulin allowed Chemotherapy: See Disease Characteristics Concurrent pamidronate allowed Endocrine therapy: Not specified Radiotherapy: Concurrent standard radiation therapy to treat extra-skeletal and/or skeletal tumor sites allowed Surgery: Not specified Other: Concurrent epoetin alfa for anemia allowed
Is Intralymphatic Allergen Immunotherapy Effective and Safe?

15 patients with moderate to severe allergic rhinitis against grass were recruited and enrolled in the study. They received three open label intralympatic grass allergen injections with the dose 1000 SQ-U each and with one month interval. The next year the patients were randomized double blind to an active or placebo booster injection of 1000 SQ-U before the pollen season. Grass specific IgG4 levels were measured before and at various time ponts after treatment.

The purpose of the study is to evaluate whether intralymphatic administration of AIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT.

The aim of the present substudy is to evaluate if a randomized preseasonal ILIT booster, after three open label ILIT injections, can increase the allergen specific IgG4 antibodies, and if the IgG4 increase can be correlated to clinical effect characterized with seasonal questionnaires.

The first part of the study is completed and published (PMID: 23374268)

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50,
* Seasonal allergic symptoms for birch and/or grass verified by skin prick test,
* Accepted informed consent

Exclusion Criteria:

* Pregnancy or nursing
* Autoimmune or collagen disease (known)
* Cardiovascular disease
* Perennial pulmonary disease
* Hepatic disease
* Renal disease
* Cancer
* Any medication with a possible side-effect of interfering with the immune response
* Previous immuno- or chemotherapy
* Chronic diseases
* Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease)
* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers)
* Major metabolic disease
* Known or suspected allergy to the study product
* Alcohol or drug abuse
* Mental incapability of coping with the study
* Withdrawal of informed consent
Global FKRP Registry

Mutations in the Fukutin Related Protein (FKRP) gene cause the condition Limb Girdle Muscular Dystrophy type R9 (LGMDR9) also known as LGMD2I, and the rarer conditions Congenital Muscular Dystrophy (MDC1C), Muscle Eye Brain Disease (MEB) and Walker-Warburg Syndrome (WWS). LGMDR9 is the most common FKRP-related condition, and is especially prevalent in Northern Europe.

The aim is to facilitate a questionnaire based research study in order to better characterise and understand the disease globally. By maintaining a global registry this will help identify potential participants eligible for clinical trials in the future.

The Global FKRP Registry (https://www.fkrp-registry.org/) is an international registry for patients with an FKRP-related condition; no experimental intervention is involved. Patients will receive information on the most up to date standards of care relating to their disease and may be invited to participate in relevant clinical trials. Their data will be updated annually and stored indefinitely, or until they request their data to be removed.

The data will be collected via an online form and will be stored on a secure server based in the United Kingdom and looked after by the registry staff at Newcastle University. Data collected from patients will include demographic information, diagnosis, current condition, age of onset, medication, contractures, family history and results of genetic testing, if available. Other optional questionnaires will focus on patients' pain and quality of life. Further information collected from patients' doctors will include, heart and lung function, muscle strength, muscle and brain MRI findings and genetics.

The FKRP registry is funded by LGMD2i Research Fund and CureLGMD2i.

The primary objectives of the Global FKRP Registry are to:

* Accelerate and facilitate clinical trials by locating potential research subjects quickly and efficiently
* Facilitate in the planning of clinical trials
* Assist the neuromuscular community with the development of recommendations and standards of care
* Characterise and describe the FKRP population as a whole, enhancing the understanding of the prevalence throughout the world.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a confirmed diagnosis of an FKRP-related condition are eligible for inclusion. Diagnosis will be confirmed via genetic testing results.

Exclusion Criteria:

* There is no exclusion criteria for registration with this patient registry.
Feasability and Clinical Impact Study of Non Pharmacological Interventions in Management of Chronic Pain

This feasability study aims to compare the 6-month success rate of a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong versus usual care in the management of chronic pain.

Chronic pain management is complex. 27.2 to 43.5 % of general population suffers from it. Opoid crisis has shown the limit of the WHO 3 step analgesic ladder. Multidisciplinary pain management programs, shared decision making and non pharmacological interventions targeting subject's empowerment are needed. Among these non pharmacological interventions, patients are increasingly turning to traditional and complementary medicines. Evidence about their safety and efficacy is hard to build. Thus our study aims to assess the feasibility of a systematic proposal for non pharmacological interventions targeting the subject's empowerment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with stable chronic pain defined by the presence of pain for more than 3 months and without substantial change in management in the month prior to inclusion
* Patient with a mean EVA maximum daily pain over 7 days greater than or equal to 4/10
* Patient aged 18 and over
* Informed and written consent signed by the patient (or his / her legal representative).
* Person affiliated with social security or beneficiary of such a scheme

Exclusion Criteria:

* Patient with a cluster headache
* Patient followed for 7 years or more by a pain center
* Patient treated with adjuvant or neo-adjuvant chemotherapy or radiotherapy for the primary tumor
* Patient with a decompensated psychiatric condition
* Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study; this impact is left to the investigator's discretion
* Protected persons
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.

This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

Eligibility Criteria:
Inclusion Criteria:

* Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
* willingness to undergo bone marrow derived autologous cell therapy.
* patient those provide fully Informed consent form for the study.
* Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.

Exclusion Criteria:

* Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
* Alcohol and drug abuse / dependence.
* Severe skin infection.
* Haemodynamically unstable.
* subject with primary and secondary diabetes , Insulin depenence,
Evaluation of the Decision-making During Multidisciplinary Meetings for Digestive Cancers

Nowadays, the recommended approach for decision-making for oncology patients is based on multidisciplinary meetings (MDT). However, the quality of decision-making during MDT depends on other factors such as the quality of presentation of clinical cases, the degree of participation of different specialists.

In this study, the investigators will evaluate the decision-making during digestive oncology MDT using the validated "Metric Of Decision-Making" tool (MDT-MODe), in the national institute of oncology (Rabat, Morocco).

Multidisciplinary cancer meetings are a multidisciplinary discussion and decision-making process for a patient with cancer. It allows a sharing of knowledge and decision-making, taking into account the opinion of all the specialists involved in the treatment of cancer, in order to propose the best possible decision for the patient. Nevertheless, the quality of decision-making during CPR depends on other factors such as the quality of presentation of clinical cases, the degree of participation of different specialists and the dynamics of meetings.

There are several validated tools for the quantitative assessment of the decision-making mode during CPRs. The best known is the Metric Of Decision-Making (MDT-MODe). MDT-MODe is a validated tool for the observational evaluation of teamwork and the quality of decision-making during cancer CPR.

MDT-MODe is designed to encourage teams to make holistic decisions tailored to each patient and allows an observer to assess, on a case-by-case basis, in a quantitative and objective way:

The quality of the clinical information (antecedents, radiological pathologies, pathological, comorbid, psychosocial problems and patients' points of view) Contribution to decision-making in teams of key professional groups (surgeons, physicians, oncologists, nurses, health professionals, radiologists, pathologists) Taken together, these notes provide an indication of the quality of team decision-making.

In this study, the investigators will evaluate the decision-making during digestive oncology MDT using the validated "Metric Of Decision-Making" tool (MDT-MODe), in the national institute of oncology (Rabat, Morocco).

Eligibility Criteria:
Inclusion Criteria:

* All consecutive cases presented during multidisciplinary cancer meeting for digestive cancer.

Exclusion Criteria:

* Cases not registered in the electronic health record system.
Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children

It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.

The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children

Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years old.
* Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
* Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
* Have blood specimens collected for any routine biochemistry test on the date enrollment

Exclusion Criteria:

* Refusal to participate in this study.
Ventricular Volume as Assessed by Cardiac Magnetic Resonance

One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right ventricular (RV) volumes. There are a number of congenital heart defects and acquired conditions in which management decisions are fundamentally based on ventricular volumes. The "gold standard" for assessment of RV volume is CMR. It has better near-field resolution than echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable to the irregular geometry of the RV. The objectives of this study are (1) to assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate. This study hypothesizes that (1) hydration status has an effect on right and left heart volumes, measured by CMR in healthy volunteers; (2) the effect of volume status will be a more significant contributor to variability in RV volumetry than that of inter-observer variability and intra-observer variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume is more accurate than when uncorrected for volume.

1. To assess ventricular volumes in the fasting state and after oral hydration in order to assess the effect of fluid status on ventricular volumes as measured by CMR.
2. To evaluate the effect of hydration on ventricular volumes compared the effect of with inter-observer and intra-observer variability.
3. To evaluate the effects of chamber volume on chamber deformation, including strain and peak strain rate.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy

Exclusion Criteria:

* Individuals who are unable to participate in an overnight fast will be excluded
* Those with known or suspected structural heart disease will be excluded
* A screening form to identify pre-existing cardiac conditions will be completed by the subject prior to participation in this study. If a pre-existing condition cardiac condition is identified, or suspected they will be excluded from the study.
* If any functional abnormality is detected at any stage by echocardiography or by CMR the study will be terminated. Common anatomical variants, which are generally regarded as normal variants (such as a patent foramen ovale, or a persistent left superior vena cava) will not lead to exclusion from the study.
Vaginal Prasterone In Vaginal Atrophy In Breast Cancer Survivors

VAGINAL PRASTERONE in the treatment of VAGINAL ATROPHY IN PATIENTS WITH BREAST CANCER TREATMENT WITH AROMATASE INHIBITORS (VIBRA STUDY)

Verify a clinical improvement of AVV without increasing levels of ultrasensitive blood estradiol in breast cancer survivors treated with aromatase inhibitors by administering vaginal prasterone.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer treated with anti-hormonal therapy based on inhibitors of aromatase (IA) (letrozole, anastrozole or exemestane) ± analogues of the GnRH (aGnRH)
* Menopause (natural or induced) and signs / symptoms of vulvovaginal atrophy
* Cytology and / or determination of Human Papillomavirus (HPV) negative
* Intention or willingness to have sex

Exclusion Criteria:

* To have received topical hormonal treatment in the last 6 months or Have used vaginal moisturizers and / or lubricants during the 30 days prior to the study treatment
* To have received treatment with laser, radiofrequency, hyaluronic acid, etc. in the vagina during the last two years at the beginning of the study
* To Have: an active infection of the genital tract; an intraepithelial neoplasm of the cervix, vagina or vulva; suspected of suffering or having been treated for cancer of the genital tract; suffer a genital prolapse of II degree or greater
Combination of Glinides With Premixed Insulin

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* Who undergoes twice daily injection of premixed insulin
* Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion Criteria:

* Whose change of HbA1c is more than 1.0% during 12 weeks observational period
Influence of Adiponutrin in Chronic Liver Disease

Increasing evidence attests the influence of multiple metabolic genetic risk factors in the progression of alcoholic liver disease. Deleterious pathways involved in metabolism such as lipid peroxidation and cytokines have been implicated in promoting inflammation leading to fibrosis increase and liver injury progression. The aim of this study was to assess the role of rs738409 single nucleotide polymorphism in the PNPLA3 gene in alcoholic liver disease patients.


Eligibility Criteria:
ALD patients:

Inclusion Criteria:

* Excess alcohol intake
* Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or a suspicion of cirrhosis related to ALD
* Caucasian ethnicity

Exclusion Criteria:

* Presence of any other chronic liver disease
* Co-infection with human immunodeficiency virus

Controls:

Inclusion Criteria:

* Caucasian ethnicity

Exclusion Criteria:

* Presence of a disease