cyrilzakka/clinical-trials huggingface dataset:
Effect of Washing With Clove Extract on Inflammation and Infection Place Logging Shaldon Needle

This randomized clinical trial will conducted involving 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block). In the both intervention and control group, first will be washed the Catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

This study is a randomized clinical trial that will conducted on 60 patients under hemodialysis and hospitalized to Imam Reza and Montasareyeh hospitals of Mashhad in 2016. Patients were assigned to experimental and control groups of 30 people, randomly (double block).

In the both intervention and control group, first will be washed the shaldon catheter with Betadine, but in intervention group, after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence and severity of inflammation as well as infection of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-80

Exclusion Criteria:

* lack of cooperation patient to participate in the post test
Acute Bronchiolitis in Infants and Allergic Asthma

Predicting the risk of allergenic sensitizations and asthma development in the first year of life is difficult.

Investigator decided to follow prospectively two cohorts of infants with acute bronchiolitis, hospitalized or treated at home, from the epidemic seasons of 2011-2012 and 2015-2017 to know their respiratory evolution, especially if they developed allergen sensitization and / or asthma.

Follow-up consultation 6 years after an episode of acute bronchiolitis at Clermont-Ferrand hospital with:

* Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking;
* Physical examination ;
* Evaluation of precariousness during the same interview with the EPICES questionnaire;
* Prick tests with positive control (histamine) and negative (physiological saline) and prick for the main pneumallergens (mites, alternaria, grasses, cat and dog) and trophallergens (egg, milk, fish, soy, wheat, peanut);
* Blood test with blood count, determination of specific IgE (5 pneumallergens and 5 trophallergens), dosage of sRAGE;
* Fonctionnal respiratory test with reversibility test

Eligibility Criteria:
Inclusion Criteria:

- Acute bronchiolitis in an infant less than one year old, included in studies KL6 (winter period 2011-2012) or CC16 (winter period 2015-2016) at clermont-ferrand hospital.

Exclusion Criteria:

* Bronchopulmonary dysplasia;
* History of prematurity \<34 AS;
* Mucoviscidosis;
* known immune deficiencies;
* Primary ciliary dyskinesia suspected;
* Congenital heart disease;
* Acute renal failure.
* Refusal of parents to participate
Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study

This study is part of the East Jakarta Cohort Study to assess the current micronutrient status of the mothers and their children. The study also includes the assessment of genotyping of MTHFR 677C--\>T of the mother and DNA methylation of IGF2 gene of the children.

The initial study recruited 315 mothers in the public health centre and one district hospital in East Jakarta. The follow-up study is able to re-visit the 127 of them. This also includes 127 peers of the subject that lives in the same neighbourhood. The design of the study is case-cohort design, part study of the existing cohort. The assessment of the follow-up study includes the mother and the children born in the initial study. Anthropometric measurement, socioeconomic data from a structured questionnaire, biomarker assessment, blood pressure were obtained from the subjects.

Eligibility Criteria:
Inclusion Criteria:

* participant in the previous study
* apparently healthy
* data complete
* voluntarily to participate

Exclusion Criteria:

* not complete data
* migrate
* refuse to participate in the study
Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?

We hypothesize that the FilmArray Blood Culture ID Panel will reduce the duration of empiric broad-spectrum antimicrobial therapy typically administered in patients who have positive blood cultures, improving clinical outcome and reducing cost. To test this hypothesis we propose a prospective, randomized controlled study comparing outcomes among patients with positive blood cultures who receive either: Standard culture and antimicrobial susceptibility testing (AST) of positive blood culture bottles as is done today (control), standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel (intervention group 1), or standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel testing along with expert infectious diseases phone consultation (intervention group 2). In both intervention groups, results of the FilmArray test will be communicated by phone to the primary service, along with templated comments about optimal antimicrobial therapy, based on the result. (Templated comments will also be used in the control group). In intervention group 2, an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy, if appropriate, based on microbiology results and clinical information obtained through medical record review and discussion with the primary service.

Eligibility Criteria:
Inclusion criteria:

* Positive blood culture during the study period.
* No positive blood cultures in prior 7 days
* Minnesota state research authorization provided

Exclusion criteria:

* No Minnesota state research authorization
* Deceased or transitioned to comfort care within 24 hours of enrollment
* Positive blood culture in prior 7 days
* Previously enrolled in this study
* Negative Gram stain
New Genetic Mutations in Thromboembolic Venous Disease Idiopathic. Study "FIT GENETIQUE".

Identify new genetic mutations predisposing to an increased risk of VTE by locating and / or identifying genes involved in subjects at high risk for thrombotic and in whom screening for detectable hereditary thrombophilia was negative.

Venous thromboembolism desease is a public health problem justifying major primary and secondary prevention policy. When VTE occurs in the absence of risk factor clinically identifiable ( "idiopathic"), an inherited biological risk factor ( "inherited thrombophilia") is found in 30% of cases. However, in patients with idiopathic VTE, the risk of recurrent venous thromboembolism is very high, whether detectable inherited thrombophilia was found or not.

This first observation suggests that patients with idiopathic VTE and no detectable thrombophilia are likely to have an underlying unknown thrombophilia that are yet to be discovered.

This hypothesis is further supported by the results of the study "FIT" (Regional PHRC 2001, promoter CHU Brest, Investigator Main: Francis Couturaud, EA3878 Brest, France, and investigator Associate: Clive Kearon, McMaster University, Hamilton, Ontario, Canada), a cross international study evaluating the risk of VTE among the family members first degree of patients a first idiopathic VTE episode. In this large study cross-1950 family members first degree (topics study) of 372 patients with a first episode of VTE Idiopathic (propositi) were included (50% included in Brest and 50% inclusive in Canada). The main result is that the risk of VTE among family members first degree is high and similar, the proband either bearer or without a detectable hereditary thrombophilia. In other words, even in the absence of detectable hereditary thrombophilia, the risk of VTE among family members first degree is high. This study has identified the subjects in that it is likely they have an inherited thrombophilia which has not yet been discovered.

Eligibility Criteria:
Inclusion Criteria:

* Family members in the 1st, 2nd, 3rd and 4th degree (and their spouses if they have a descent) of patients (propositi) who:

  1. / have a single episode of unprovoked venous thromboembolic disease without detectable inherited and acquired thrombophilia ;
  2. / were included in the "FIT" study;
  3. / consenting that their family members 2nd, 3rd and 4th degree are approached to participate in the this study.
* Written Consent of propositi and their members in the 2nd, 3rd and 4th respective degree to participate in this study.

Exclusion Criteria:

* Presence of detectable thrombophilia in the propositi.
* Presence of hereditary thrombophilia or detectable gained at family members.
* No information may be obtained on previous venous thromboembolism among family members on 1 degree
* Everything about the study (depending on the population and members of proband Family 1st, 2nd, 3rd and 4th degree) less than 15 years.
* The family member is an adopted child
CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning

The aim of this project is to study the effects of exogenous glucocorticoid exposure on substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy adults. The hypotheses are:

Short-term high dose glucocorticoid exposure in healthy subjects disrupts:

* The inherent circadian pattern of the respiratory exchange ratio and REE
* Sleep quality, appetite and food intake
* Clock gene expression and function in adipose tissue, skeletal muscle and blood leukocytes


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* BMI 20-30 kg/m2
* Written informed consent

Exclusion Criteria:

* Any chronic disease requiring daily medication excluding atopic skin or hay fever
* Alcohol consumption \>21 units per week
* Strong CYP3A4 inhibitors or inducers
* Use of glucocorticoid (GC) formulations: Inhaled corticosteroids, intra-articular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area
* Permitted glucocorticoid formulations: eye-drops, nasal spray, GC creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only
* Shift work
* Severe claustrophobia
* Use of melatonin
* Previous diagnosis of a sleep disorder
* Known severe sleep apnea (\>30 respiration breaks/hour over 10 seconds)
* Deemed unable to complete the study safely by investigator
Heart Rate Recovery and Mortality

To investigate whether impaired heart-rate recovery after exercise is a powerful and independent predictor of mortality.

BACKGROUND:

Although there has been considerable attention paid to the prognostic significance of the heart rate rise during exercise, only recently has it been noted that the heart rate fall after exercise, or "heart-rate recovery," may be an even more powerful predictor of outcome. Heart-rate recovery after exercise is a consequence of central reactivation of vagal tone. As impaired parasympathetic function has been associated with increased risk of death, the study tests the hypothesis that an impaired heart-rate recovery is a powerful and independent predictor of mortality.

DESIGN NARRATIVE:

The overall aim of this project was to use heart-rate recovery to substantially improve the prognostic value of the exercise test. The specific aims of this project were: 1) Derive biologically meaningful mathematical models of heart-rate recovery. Data from over 20,000 patients who had undergone exercise testing at Cleveland Clinic Foundation between 1990 and 1998 were used; all of these patients had had their tests performed on exercise workstations which recorded heart rates every 10 seconds during and after exercise. Heart-rate recovery measures were the difference between heart rate at peak exercise and heart rate at different points during recovery. Modeling was based on exponential families, using stepwise selection, bootstrapping, and information theory approaches. Correlates of different patterns of heart rate recovery were determined. 2) Using the results of modeling of heart-recovery derived from the work in Specific Aim 1, determined a prognostically defined optimal definition of abnormal heart rate recovery and demonstrated that an abnormal heart rate recovery was a powerful and independent predictor of mortality in diverse patient groups. Data from exercise tolerance tests of over 40,000 patients studied at the Cleveland Clinic Foundation between 1990 and 1999 were analyzed. Statistical methods used included the nonparametric Kaplan-Meier product limit method and the Cox proportional hazards model with bootstrap validation, which included use of the random forest technique. 3) Using completely parametric techniques, developed predictive survival models in which heart-rate recovery was included along with clinical data and other exercise findings, including exercise capacity and heart rate changes during exercise. The advantages of the parametric technique included: a) it allowed for modeling of nonproportional hazards that might permit differential strength of effect at different follow-up times for different sets of risk factors; b) it generated absolute risk, not just relative risk; and c) it permitted patient-specific prediction.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments

It is well known that patients with spinal muscular atrophy (SMA) have progressive decline of respiratory muscle function. Therapy traditionally involved supportive means to ensure optimal nutrition and airway clearance. Nusinersen (spinraza) is a disease-modifying medication approved for treatment of SMA in pediatric and adult patients. The goal of this study is to observe pulmonary function test (PFT) changes and respiratory muscle strength trends throughout the first year of treatment. A prospective, longitudinal study measuring pulmonary function testing (PFTs) changes in spinal muscular atrophy (SMA) patients. Patients will be patients with SMA who are approved and maintained on nusinersen. Patient will have a baseline PFT. Investigators will repeat PFT at 3, 6, and 12 months while on nusinersen treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SMA of any type who are eligible to start nusinersen treatments at NYU Winthrop Hospital.

Exclusion Criteria:

* Patients unable to comply with nusinersen treatments according to recommended schedule (first 3 doses every 2 weeks, then the 4th dose is administered 1 month after the 3rd dose, and then maintenance dose administered every 4 months).
Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children

Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age with congenital heart disease.

Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used

Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation
* congenital heart disease (biventricular anatomy)

Exclusion Criteria:

* univentricular hearts
* ECMO/VAD
Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.

The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65, both gender;
* Active Ankylosing Spondylitis;
* Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
* Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
* Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
* Understand and voluntarily signed informed consent.

Exclusion Criteria:

* A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
* A history of any other autoimmune rheumatic disease;
* Any history of joint prosthesis infection, and the prosthesis is still in place;
* Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
* Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
* Participants who have drug abuse or alcohol dependence;
* Participants who have had herpes virus infection in the past month;
* Participants who have a history of venous thrombosis (regardless of current treatment);
* Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator；
* Participants who cannot be treated and followed up according to the trial protocol;
* Any Participant considered by the investigator to be unsuitable to participate in this clinical study
A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.

The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) \<90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
9. Pregnant or nursing women
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design


Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 and older who was healthy
2. Was of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema

Exclusion Criteria:

-
The Efficacy of Zinc-biofortified Rice in Bangladeshi Children

To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh.

Rationale: Around the world and estimated 30% of the population is at risk of Zinc deficiency, mainly due to monotonous plant base diets and the poor bioavailability of this sources. One staple food crop which is low in zinc content is rice. Therefore, zinc deficiency is highly common in Asia. Zinc plays a major role in child growth and neurobehavioral development. Furthermore, it is linked to infection control and normal immune response. One way to add extra zinc to someone's diet is zinc bio fortification of staple crops, which can be a cost saving sustainable approach to improve zinc nutrition. However, data on long-term intake of biofortified crops with zinc is scarce and efficacy of newly developed rice crops high in zinc are not well known.

Objective: The objective is to assess the efficacy of a newly developed zinc biofortified rice variety on plasma zinc concentrations in children in a rural area of Bangladesh when compared to their controls in a 9 month randomized controlled trial (RCT).

Study design: A double randomized control trial. Study population: Stunted children whom are zinc deficient at start of the study intervention determined by plasma zinc levels \<9.9 µmol/L.

Main study parameters/endpoints: The difference in zinc status between the intervention and control group expressed in blood plasma zinc levels. Plasma zinc will be measured 4 times during the intervention period. Besides plasma zinc other zinc biomarkers will be tested for their usefulness.

Eligibility Criteria:
Inclusion Criteria:

* 12-36 months of age (at baseline assessment)
* Low plasma Zn concentration (\<10.71 µmol/L)
* Marginally stunted (height for age Z-score \<-1.75)
* The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)

Exclusion Criteria:

* Severe Anemia (Hb\< 70 g/L)
* Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would affect Zn metabolism or would render the participant unable to comply with the protocol (based on self-reporting or diagnosed during screening)
* Participants taking part in other studies requiring the drawing of blood
* Not planning long-term residence in study site
* Regular intake (\>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months
* Chronic use of drugs that affect the metabolism of Zn, including reducing absorption or increasing excretion; e.g., tuberculosis medications (ethambutal and isoniazides), drugs used as treatment for entamoeba hystolica (diiodohydroxyquin), drugs that reduce stomach acidity (H2 blockers and proton pump inhibitory), antidepressants (nialamide and socarboxazid), anti-inflammatory drugs (corticosteroids), diuretics (thiazides).