cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Examination of Asthma From Childhood Through Adolescence

Asthma is a common disease that is often diagnosed in childhood. In some teenagers, asthma symptoms disappear and treatment can be stopped; however, for some of these people, asthma symptoms return in adulthood. This study will examine data collected over the lifetime of 18-year olds to identify factors that may increase a person's chance of having recurrent asthma as an adult.

Asthma is a serious, long-term illness that affects around 15% of children in the United States. During adolescence, up to 50% of teenagers stop experiencing symptoms and are able to discontinue treatment. However, asthma symptoms often reoccur in adulthood for many of these people. It is not known exactly what causes this recurrence, but potential risk factors may include obesity, elevated serum leptin levels, early onset of puberty, exposure to pollutants, parental smoking habits, and lack of breastfeeding. Additionally, it is not known why childhood asthma is initially more prevalent in boys, but during adolescence it becomes more prevalent in girls. Beginning in 1989, a group of children born on the Isle of Wight in the United Kingdom has been followed by study researchers to provide long-term information on asthma. These children have been periodically evaluated over the years and are now 18 years old. The purpose of this study is to analyze participants' data collected over a span of 18 years to identify factors that may increase a person's risk of experiencing persistent or recurrent asthma in adulthood.

At previous study visits that occurred when participants were 1, 2, 4, and 10 years old, information on the following was collected: asthma and other allergic diseases, family history of asthma, and early life risk factors, including breastfeeding and tobacco smoke exposure. A blood sample was collected at participants' 10-year study visit. For this current study, all 18-year-old participants will return for a study visit. Participants will complete questionnaires on asthma and allergy symptoms and environmental exposures, including tobacco smoke and pollution. Blood collection, an allergy skin prick test, lung function testing, and a bronchial challenge test to assess airway function will occur. Select participants will also have a sputum sample collected.

Eligibility Criteria:
Inclusion Criteria:

* Born on the Isle of Wight in the United Kingdom between January 1, 1989 and February 28, 1990

Exclusion criteria:

* Refused consent
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* active rheumatoid arthritis;
* receiving outpatient treatment;
* an inadequate response, or intolerance, to \>=1 anti-TNF agent.

Exclusion Criteria:

* other rheumatic autoimmune disease or inflammatory joint disease;
* concurrent treatment with any anti-TNF-alpha therapy;
* joint or osseous surgery during 8 weeks prior to recruitment.
Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy

The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

The proper period of anti-seizure medication (ASM) treamtment is important for decreasing side effect of ASM and recurrence of seizure. We evaluate reliable risk factor analysis for safe withdrawal of ASM in children with epilepsy. Futhermore, we develop the scoring system for prediction of seizure recurrence to set the standard for safe withdrawal of ASM.

The enroll criteria as follow:

1. patients with epilepsy or acute provoked seizure accroding to the ILAE definition
2. patients who have been 2 years of seizure free with or without ASM

The patients with seizure recurrence during follow-up or end of follow-up period of 24 months will end this stutdy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Epilepsy or acute provoked seizure according to the ILAE guideline
* Patients with 2 years of seizure free periods

Exclusion Criteria:

* Uncertain diagnosis of epilepsy or acute provoked seizure
* Patients who do not want to participate in the study
Comorbidities and Outcomes in Early Rheumatoid Arthritis

Identify the burden of comorbidity at the time of diagnosis of rheumatoid arthritis. Identify the impact of comorbidity present at diagnosis on cardiovascular disease, death, rheumatoid arthritis disease progression and infections.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis prior to 1st January 2017
* Aged ≥18 years old

Exclusion Criteria:

* Patients with another other rheumatic disease
Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle

Muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.


Eligibility Criteria:
Inclusion Criteria:

* A first stroke older than nine months (acute phase and subacute stroke).
* Hemiplegia cerebral vascular following this stroke.
* Hemiplegia with an overall motor deficit plegic lower limb muscle testing level less than or equal to 3 and associating a localized spasticity lower plegic member, on the plantar flexors, assessed by the upper Ashworth Scale or equal to 1 with an injection of botulinum toxin indication of the sural triceps.
* written consent.

Exclusion Criteria:

* Old stroke with motor impairment of the lower limb in the chronic stage.
* Concomitant muscle disease (eg myopathy, myositis ...).
* Patients who already received a botulinum toxin injection into the gastrocnemius muscles.
* Subjects with defibrillator
Combined Application of EEN in the Induction of Remission in PUC

The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week12 will be compared between the two groups (combine with EEN group VS non-combine group).

The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed UC
2. Years 6 to 18
3. Moderate to severe disease activity at diagnosis

Exclusion Criteria:

1. With mild disease activity at diagnosis
2. Had been treated with corticosteroids or biologics
Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort

Development of a Danish Sarcoidosis Registry. Characterization of a cohort of sarcoidosis patients with respect to the baseline epidemiological characteristics, comorbidities, radiology, histopathology, diagnostic investigations and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent
Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program

This study aimed to reveal the role of inspiratory muscles exercise using Inspiratory Muscle Trainer (IMT), which is a form of weight training. The pre- and post study of this experiment were conducted in chronic obstructive pulmonary disease (COPD) outpatient clinic during the period of September 2017 until April 2018. Patients were recruited by consecutive sampling. Inclusion criteria were stable COPD patient with The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria A-D, who has never received prior exercise for pulmonary rehabilitation, and willing to participate in the study. The exclusion criteria included any problem with extremities and cardiovascular disease. Patients underwent an interview about their medical history, tested spirometry using CareFusion®, and the inspiratory muscle strength was assessed using Micro RPM CareFusion®. The St George Respiratory Questionnaire (SGRQ) was used to assess the health status and the 6-Minute Walking Test (6MWT) was conducted to assess functional capacity. Subject exercised using inspiratory muscle trainer (Philips Respironic®) for eight weeks.

Intervention is given using Inspiratory Muscle Trainer Philips Respironic®. Impact on inspiratory muscles strength, health status, and functional capacity are observed. Muscle strength is evaluated using Micro RPM (Respiratory Pressure Meter) Carefusion®. Health status is evaluated using St. George's Respiratory Questionnaire (SGRQ), while functional capacity is evaluated by the 6-Minute Walk Test (6MWT).

Patients were recruited by consecutive sampling. This study was granted ethical approval from the Institutional Review Board (IRB) of the Faculty of Medicine Universitas Indonesia Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Inspiratory muscles strength (Maximal Inspiratory Pressure, MIP) and 6MWT were done at the beginning for basic data and were re-evaluated during the second, fourth, sixth and eighth week (last week). Questionnaire (SGRQ) was done at the initial and end of research.

Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.

Eligibility Criteria:
Inclusion Criteria:

* stable COPD patient with GOLD criteria A-D,
* never got exercise for pulmonary rehabilitation before,
* willing to participate in the study by signing the written informed consent.

Exclusion Criteria:

* any problem with extremities,
* cardiovascular disease
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Eligibility Criteria:
Inclusion Criteria:

* multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.

Exclusion Criteria:

* currently pregnant or were pregnant within 6 weeks of study entry
* had a prior attempted or successful IUD insertion
* had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
* any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
* active vaginitis or cervicitis
* undiagnosed abnormal uterine bleeding
* pelvic inﬂammatory disease within the last 3 months
* ﬁbroids or other uterine abnormalities distorting the uterine cavity
* contraindication or allergy to dinoprostone.
Soluble Forms and Ligands of RAGE in ALI/ARDS (SoLiRAGE).

RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury. Soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS, but one should acknowledge that the RAGE/NF-B axis is also involved in the pathophysiology of various other conditions. Few data are available about the levels of soluble forms and ligands of RAGE in the setting of ALI/ARDS. The purpose of this observational prospective study is to describe soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in ICU patients with ALI/ARDS.

BACKGROUND:

The receptor for advanced glycation end products (RAGE) is now identified as a marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE, and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal studies, and RAGE levels could reflect impaired alveolar fluid clearance. Frequently, the biology of RAGE coincides with settings in which ligands of the receptor accumulate, especially in a proinflammatory environment. More work is needed for us to understand the mechanisms by which RAGE is regulated during ALI/ARDS, especially with regard to the expression of its soluble forms and the involvement of its potential ligands.

DESIGN NARRATIVE:

This observational prospective clinical study will describe and compare soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) levels in the alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours after onset of ALI/ARDS, and from patients under mechanical ventilation (control group).

Edema fluid and plasma samples will be collected simultaneously on day 1, day 3 and day 6, in order to describe kinetics of evolution of soluble forms and ligands of RAGE levels. Undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be simultaneously gathered from indwelling arterial and central venous catheters. The concentrations of soluble forms (sRAGE, esRAGE) and ligands of RAGE (HMGB-1, S100A12, AGEs) will be measured in duplicate by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients under mechanical ventilation
* Patients within the first 24 hours after onset of ALI/ARDS according to the 1994 American-European Consensus Conference (AECC)

Exclusion Criteria:

* Pregnancy
* Acute exacerbation of diabetes
* Dialysis for end-stage kidney disease
* Alzheimer's disease
* Amyloidosis
* Evolutive neoplastic lesion
Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients

A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common complication of diabetes treatment and is a major barrier to the maintenance of healthy glucose levels in individuals with diabetes. The primary purpose of the study is to test the proof-of-concept that there is an association between the rate of GAM and susceptibility to insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be measured in a patient population known to frequently experience hypoglycemia, i.e., individuals with type 1 diabetes mellitus (T1DM).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Ages 18-40 years
* Diagnosed with type 1 diabetes with positive antibodies or dependent on insulin therapy
* HbA1c of ≤8.5%
* Modified Clarke's Hypoglycemia Questionnaire score of 12-24
* Willing to participate in continuous glucose monitoring (CGM)

Exclusion Criteria:

* Contraindication to MRI
* Consume \>10 alcoholic drinks/week
* Current use of CGM
* Current use of insulin pump
* Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.
* Current use of steroids, e.g. cortisone, and prednisone.
* History of chronic smoking or have quit less than 10 years ago
* History of cancer in the past 5 years (individuals with basal cell or squamous cell skin cancer would be allowed)
* History of seizures
* Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease
* Significant liver disease as defined as more than twice the upper limit of normal for liver enzymes
* Significant renal disease as defined as a estimated glomerular filtration rate less than 30
* Pregnant, planning to become pregnant, or breastfeeding
* Have been hospitalized or treated in the past 3 months for severe hypoglycemia
* Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)

The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.

The duration of treatment is 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* A 2-year documented history of seasonal allergic rhinitis
* A 1-year documented history of chronic asthma
* Positive allergy testing

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Multi-variable Prediction Model of Total Knee Replacement Outcome

Total knee arthroplasty (TKA) is a surgical procedure applied as a common solution to overcome limitations produced by advanced stages of severe gonarthrosis. The procedure has high prevalence, high associated costs, and is considered to be cost-effective. Rehabilitation is essential to optimize outcomes. However, in clinical practice, the length of rehabilitation for each patient may be highly variable, and the programmed times may lack the necessary objectivity. Current limitation of resources and increasing prevalence make essential to generate strategies to optimize surgical results, so that the use of resources of the health system is efficient without detriment to the patient's benefit. For this purpose, objective and pragmatic information must be available, and should be based on scientific evidence in order to assist in making clinical decisions. Indeed, a number of demographic, biomedical and psychosocial factors have been identified as predictors of TKA results (i.e weight, age, expectations...). Some of them have been associated with the need for hospital resources after surgery. However, most researches base their predictions in retrospective studies, which are limited in the type of variables that can be used (clinic history), quality of registries, and limitations of retrospective designs. On the other hand, most of prospective researches base their predictions in a limited number of outcomes. To overcome this limitations, this project has been designed as a prospective observational study with two observations of each patient.

* The primary goal is to implement a multi-variable prediction model of TKA outcome, so that the procedure become optimal in two aspects : patient recovery (social and economic benefit) and use of health system resources (economic benefit). The implementation requires a processing of the information sampled through various algorithms and innovative data processing in this field, based on data mining and machine learning techniques. This will be used in search of the model with the greatest predictive capacity.
* As a secondary objective, information extracted from patients both in the final stages of the condition, and in the medium term after the intervention will allow to study the functional and psychosocial reality of the subjects with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Over 60 years old
* Severe knee osteoarthritis
* In the surgery waiting list for undergoing total knee replacement surgery

Exclusion Criteria:

* Lobo Mini-mental State examination \< 20 (not able to properly understand the tests and study)
* Vestibular affection that prevents to perform the tests