cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Effect of Different Doses of SAR156597 Given to Patients With Idiopathic Pulmonary Fibrosis (IPF)

Primary Objective:

To assess in adult patients with Idiopathic Pulmonary Fibrosis (IPF) the safety and tolerability of ascending doses of SAR156597 administered subcutaneously (SC) once weekly over a 6-week period.

Secondary Objectives:

To assess in adult patients with IPF:

* The pharmacodynamic effects of SAR156597, as measured on pulmonary function tests (PFTs), pulse oximetry and patient reported outcome and peripheral blood biomarkers.
* The trough plasma concentrations of SAR156597
* The potential immunogenicity of SAR156597.

The study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. Total study duration is up to 22 weeks.

Eligibility Criteria:
Inclusion criteria:

* Adult (aged \>18 years) male or female patients,
* Documented diagnosis of IPF according to the current American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/American Latin Thoracic Association (ATS/ERS/JRS/ALTA) guidelines

Exclusion criteria:

* Forced vital capacity (FVC) \<50% of predicted value Carbon monoxide diffusing lung capacity (DLCO) (corrected for hemoglobin) \<35% predicted value
* Oxygen saturation \<90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min)
* Known diagnosis of significant respiratory disorders other than IPF
* Active vasculopathy or use of vasoactive drugs
* Known HIV or chronic viral hepatitis
* Patients with active tuberculosis or latent tuberculosis infection
* Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than IPF) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator
* Clinically significant abnormal ECG at screening
* Clinically significant laboratory tests at screening
* Current history of substance and/or alcohol abuse
* Females who are lactating or who are pregnant.
* Use of any registered therapy targeted to treat IPF within 4 weeks prior to screening
* Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.

The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance


Eligibility Criteria:
Inclusion Criteria:

1. The subjects are between 35 and 65 years old (inclusive), regardless of gender;
2. The subject's body mass index (BMI) is between 20kg/m2 and 30 kg/m2;
3. The subjects were assessed by the clinical expert group as having abnormal glucose tolerance (PPG 7.8-11.0mmol/L 2h postprandial);
4. Subjects voluntarily participate in this clinical study and sign a written informed consent.

Exclusion Criteria:

1. The subject has a severe allergy or is allergic to any component used in cell culture;
2. The subject has used or is using drugs that affect glucose metabolism (such as glucocorticoids, tricyclic antidepressants, etc.) within 1 month;
3. The subjects have chronic diseases such as diabetes and hypertension (very high-risk group) which have not been effectively controlled after treatment;
4. Subjects with severe cardiovascular and cerebrovascular diseases: patients with a history of decompensated cardiac insufficiency (NYHA grade Ⅲ or Ⅳ), myocardial infarction or cerebral infarction, or cerebral hemorrhage within 6 months before screening;
5. The subjects had abnormal liver function (ALT and/or AST≥ 2.5 times the upper limit of normal), significant abnormal renal function, male serum creatinine ≥1.5mg/dl, female serum creatinine ≥1.4mg/dl; 6, the subject's HIV antibody, hepatitis B surface antigen, hepatitis C antibody, syphilis test positive, hepatitis B virus DNA quantitative \> the upper limit of normal test unit;

7. Subjects with other serious systemic diseases affecting the study, including malignant tumors, nervous central system, blood system, digestive system, endocrine system, respiratory system, infectious diseases, etc.; (8) Drug or alcohol abuse (subjects who consumed \>2 alcoholic beverages per day or \>14 alcoholic beverages per week (one alcoholic beverage is defined as 150ml of wine, 350ml of beer, or 50ml of 80% (40 proof) spirits); Or drug abusers; 9. Pregnant and lactating women; Have a pregnancy plan in the next 2 years (including the spouse's pregnancy plan); Refusal to use effective contraception; 10. Exclude intracranial lesions and early lung tumors; 11. Used stem cell (exosome) therapy or participated in stem cell (exosome) clinical researchers 3 months before screening; Clinical investigators who have participated in drugs within 3 months before screening; 12. High risk groups with Padua score ≥4 or Caprini score ≥5; 13. The subject has a history of major surgery within the past six months or is expected to have surgery within six months; 14. There are other conditions that the researcher considers inappropriate to participate in this clinical study.
Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.

To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine + cisplatin）in advanced gastric cancer

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18 to 70 years old.
* The preoperative evaluation: gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
* Karnofsky score ≥ 70, life expectancy \> 6 months.
* Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
* the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; GOT, GPT within twice the institutional limit,serum total bilirubin \< 1.5 times the upper limit of normal, serum creatinine\< 1.25 times the upper limit of normal and creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%.
* have not received prior chemotherapy, radiotherapy and biological therapy.
* signed informed consent.
* must accept the standard D2 or D2 + radical gastrectomy.
* with good compliance.

Exclusion Criteria:

* pregnancy, breast-feeding women.
* allergy with chemotherapy drugs or metabolic disorder.
* the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
* had long received systemic steroid treatment (Note: short-term users of withdrawal \> 2 weeks can be selected.)
* The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
* patients with severe infection requires treatment.
* patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
* severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
* with other malignancies which were not cured.
* EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.
Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases

This study is being conducted to test study drug AZD1480 to see how it may work to treat myeloproliferative diseases. The main purpose of this study is to determine the safety and tolerability of AZD1480. This is the first time the drug has been given to humans and is classed as a first time in man study. Its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. The study will also assess the blood levels and action of AZD1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with myelofibrosis requiring therapy
* Evidence of post-menopausal status or sterile
* ECOG Performance Status \</=2

Exclusion Criteria:

* Prior therapy with any JAK2 medications
* Significant lung disorder or lung disease
* Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 28 days before study screening
* Eye disease of the cornea
* Patients requiring oxygen supplementation
* Ejection fraction \<45% (ECHO/MUGA) or significant pulmonary hypertension \>40 mm Hg (by Echo/Doppler)
* Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) \<70% predicted or \>130% predicted
* Diffusing capacity of the Lung for Carbon Monoxide (DLCO) corrected for hemoglobin \<60% predicted, oxygen saturation \<88% at rest or after a 6-minute flat walk, without supplemental oxygen
* Chest infection requiring antibiotics within 7 days of the first dose of Investigational product.
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma

To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* mild-to-moderate persistent asthmatics
* FEV1 = OR \> 50% of predicted

Exclusion Criteria:

* Previous history of renal disease or serum creatinine is more than 2 mg/dl.
* Previous history of liver disease.
* Pregnancy or lactation.
* Are already receiving or are known to be allergic to statins or to have developed myositis.
* Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
* Being treated with immunosuppressive agents.
* Unwilling to cooperate the study.
Study of Oral AEE788 in Adults With Advanced Cancer

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor
* Adequate hematologic, renal and hepatic function
* Age ≥ 18 years
* Karnofsky performance status score ≥ 70%
* Life expectancy ≥ 12 weeks

Exclusion Criteria:

* Active brain metastases
* Peripheral neuropathy \> grade 2
* Diarrhea \> grade 1
* Gastrointestinal (GI) dysfunction
* Compromised cardiac function
* Concurrent severe and/or uncontrolled medical conditions
The Impact of Problem-Based Learning (PBL) and Lecturing

The present study aimed to compare the effect of education through problem-based learning (PBL) or lectures on behavior, attitude and learning of nursing students.

A total of 40 second-year nursing students participated: 20 students in the PBL group and 20 students in the traditional lecture (control) group. The students underwent a one-semester course using the two methods of education

Eligibility Criteria:
Inclusion Criteria:

* Students must not have been exposed to PBL

Exclusion Criteria:

* Biased and specific students
France PCI Registry : National Observatory of Interventional Cardiology

Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.


Eligibility Criteria:
Inclusion Criteria:

* Age =\>18 years at enrollment
* Patient who have had a coronary angiogram or angioplasty

Exclusion Criteria:

* Patient who didn't want to participated
Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment

The purpose of this project is to investigate if the magnitude of a loading based 12 weeks rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon structure and function.

The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a more positive clinical outcome, tendon structure and function in patients with patellar tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise volume is equal in both groups.

Randomized controlled intervention study with one year follow-up

Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral patellar tendinopathy
* Symptoms \> 3 months
* Ultrasonographical tendon swelling
* Ultrasonographical hypo-echoic area with doppler
* BMI 18.5-30

Exclusion Criteria:

* Patellar tendinopathy \> 12 month
* Previous knee surgery
* Confounding diagnosis to the knee joint
* Diabetes or arthritis
* Previous corticosteroid injection for patellar tendinopathy
* Smoking
* Being elite volleyball players
Psychiatric Assessment Of Parents Of Children With ADHD

The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . These problems may be a precipitating factor to cause ADHD in their child or have a genetic predisposition to be passed to their children. On the other hand these psychological problems may be caused by the difficulties they encounter in raising their ADHD child. The exact relation needs more researches and to be more investigated.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children diagnosed with ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V).
* Children are between 4 and 16 years of age for both sexes.
* Children with normal IQ \> 70%.
* Parents are able to give informed consent and able to complete the research assessments.

Exclusion Criteria:

* Parents having chronic debilitating diseases e.g. chronic liver cirrhosis.
* Parents were participating in other clinical research.
* Refusal to participate.
Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes

This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump
* Diabetes duration \> 2 years
* Body-mass-index between 19 and 35 kg/m², including
* written consent

Exclusion Criteria:

* No pregnancy in woman
Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy

Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic, gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires expertise in dosage calculations and application technique to avoid potential side effects. Most adverse events (AEs) related to BoNT are local and related to its mechanism of action, i.e., paralysis of unwanted muscles. However, systemic AEs may also be observed. Flu-like symptoms (FLS) are well recognized AEs in patients treated with BoNT; however there is a paucity of information regarding the frequency, clinical impact, and associated risk factors of this particular complication.

Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of non-serious side effects.

In this study, the investigators aim to assess prospectively the frequency, clinical characteristics, and risk factors for development of FLS in a group of patients affected with diverse movement disorders and treated with BoNT type A at the Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The investigators will also assess biomarker of inflammatory response in those patients who develop FLS after treatment with BoNT.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with any movement disorder: dystonia, tremor, tics, myoclonus or tardive dyskinesias and treated with botulinum toxin type A (Botox or Dysport) to type B (Myobloc)
2. Patients who will be injected in at least two consecutive visits in our clinic, three months apart.
3. We will invite patients who are regularly treated in our clinic "established patients" and those who will be treated for the first time "new patients".
4. Patients who are willing to complete with the study requirements.
5. Patients who deny the blood sample will be included for the symptoms and risk factors analysis.
6. Patients who give written informed consent.

Exclusion Criteria:

1. Patients who will only be injected with BoNT once in our clinic at BCM.
2. Patients who deny participating in the clinical survey.
The Children's Amalgam Trial

The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only such trial in the United States, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.

The safety of silver amalgam as a dental restorative material has been controversial since its introduction 150 years ago, but until recently it has been assumed that the exposure to mercury from dental amalgam is limited to the acute placement phase. However, some recent studies have raised safety concerns by demonstrating chronic release of mercury vapor from amalgam fillings during chewing and brushing. The Children's Amalgam Trial (CAT) is a two-arm randomized trial of safety, comparing amalgam with a mercury-free restorative material. A single masking procedure is used to ensure that all investigators and staff measuring outcomes are unaware of assigned trial arm. The study follows 534 New England children, aged 6-10 years at enrollment, for 5 years. The children were recruited from two northeastern U.S. communities, one in rural Maine, and one in urban Massachusetts. No trial subjects received prior amalgam restorations, and all were in need of at least two posterior occlusal fillings. Participants were randomized to receive either amalgam or composite material for all posterior restorations at baseline and at subsequent visits. The primary endpoint will be 5-year change in IQ scores. Secondary endpoints will include measures of other neuropsychological assessments and renal functioning.

Eligibility Criteria:
* 6 - 10 years of age at last birthday
* Fluent in English
* No prior or existing amalgam restorations
* Two or more posterior teeth with dental caries such that restoration would include the occlusal surfaces
* No clinical evidence of existing psychological, behavioral, neurologic, immunosuppressive, or renal disorders.
Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients With Sickle Cell Disease

Pediatric patients with sickle cell disease are at greater risk for exhibiting nocturnal enuresis (bedwetting) compared to the general population. This increased risk has been attributed to a decreased ability to concentrate urine caused by sickling-induced nephropathy. The sociodemographic, psychosocial, and medical factors associated with nocturnal enuresis are not well defined. In addition, the impact of these behaviors on emotional and behavioral functioning, along with health-related quality of life are not clear. Despite the availability of evidence-based interventions for nocturnal enuresis, very few families with a child with sickle cell disease have utilized these methods. The reasons for this underutilization of interventions are not clear.

PRIMARY OBJECTIVE: To examine differences between those who do and those who do not exhibit nocturnal enuresis in regard to health-related quality of life, emotional and behavioral functioning, family functioning, stressful life events, sociodemographic factors and medical factors.

SECONDARY OBJECTIVE: To identify barriers to intervention implementation for nocturnal enuresis.

In this study, children and adolescents with sickle cell disease ages 6-18 years and their parents/guardians will each complete an interview with questionnaires assessing nocturnal enuresis, health-related quality of life, emotional and behavioral functioning, family functioning, and stressful life events. Participants who report nocturnal enuresis will identify interventions they have used in the past, along with barriers to intervention implementation.

The future goal will be to use this information to develop an effective intervention strategy for nocturnal enuresis specific to the needs of children and adolescents with sickle cell disease.

Eligibility Criteria:
INCLUSION CHARACTERISTICS:

* Child Characteristics:

  * St. Jude Children's Research Hospital (SJCRH) patient with a primary diagnosis of sickle cell disease (HbSS, HbSC, HbSβ0thalassemia, HbSβ+thalassemia)
  * Age 6.0-17.99 years at the time of enrollment
  * Primary language is English
  * Has the cognitive capacity to complete questionnaires
* Caregiver Characteristics:

  * Parent or guardian of SJCRH patient who meets above criteria
  * Primary language is English
  * Has the cognitive capacity to complete questionnaires

EXCLUSION CRITERIA:

* Child Characteristics:

  * Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever).
* Caregiver Characteristics:

  * Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.