cyrilzakka/clinical-trials huggingface dataset:
Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases

Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are characterized by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. A precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies.

The objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed.

The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a monocentric study conducted at the University Hospital of Reims, France. Adult patients (\>18 year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD, bronchiectasis, or CF will be considered for inclusion. Patients will sign an informed consent for inclusion. Exclusion criteria include "subjects protected by the law" as required by the French authorities. Control patients with no respiratory diseases after clinical and pulmonary function tests assessment will be also included. The expected number of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019 (9/30/2019).

For all COPD, ILD, bronchiectasis, and CF patients included, data will be registered at inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care with no specific therapeutic intervention. For control patients, data will be registered at inclusion with no follow-up.

Data will be registered in a centralized anonymized database. The characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. Comparisons and associations between groups and variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as applicable. A p\<0.05 will be considered as significant.

This study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 year-old) with COPD, CF, bronchiectasis or ILD

Exclusion Criteria:

* \<18 year-old
Text Messages and Physical Activity Among Teens

The purpose of this study is to assess whether text messages can be used as a way to increase the amount of physical activity teens get each day.

This research will develop an innovative intervention that promotes physical activity to 14-17 year olds (roughly high school aged youth). It is guided by Self Determination Theory and seeks to enhance adolescents' feelings of physical activity autonomy, competence, and relatedness, key psychological needs related to motivation to be physically active. The physical activity to be promoted is walking, which has broad appeal and can be performed as part of usual-day activities. Since youth are heavy users of cell phones and texting, the intervention will send theoretically-grounded text messages designed to enhance physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 14-17 years old
* access to a computer with high speed internet access
* home email address
* cell phone that can send/receive text messages
* text message plan
* fluent in English

Exclusion Criteria:

* mental or physical limitations that impair ability to fully participate in the program and/or complete baseline and post assessment data collection.
Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven CHC genotype 4
* 18 years old or more,
* prior HCV treatment failure to sofosbuvir /daclatasvir
* compensated liver disease.

Exclusion Criteria:

* Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.
Healthy Bellies - Intervention Program During Pregnancy on Women and Newborn

"Healthy Bellies" is an intervention program with pregnant women, based on the promotion of healthy lifestyles. It aims to evaluate the impact of the program in the health of both pregnant and newborn. This trial is being conducted with pregnant women, divided into control and intervention group. Are performed 3 assessment periods: 1 - beginning of the program; 2 - postpartum; 3 - 1 month after delivery. The intervention group has a program of 3 weekly physical exercise classes and the control group has the basic information that is usually provided by health professionals. With this program, it is expected to contribute with evidence to the best practice in the field of interventions in pregnancy and improve health outcomes of both pregnant and newborn.


Eligibility Criteria:
Inclusion Criteria:

* Do not have any medical or obstetric contraindication for physical exercise

Exclusion Criteria:

* Haemodynamically significant heart disease;
* restrictive lung disease;
* incompetent cervix/cerclage;
* multiple gestation at risk for premature labor;
* persistent second or third trimester bleeding;
* placenta praevia after 26 weeks gestation;
* premature labor during the current pregnancy;
* ruptured membranes;
* pregnancy induced hypertension;
* severe anaemia;
* unevaluated maternal cardiac arrhythmia;
* chronic bronchitis;
* poorly controlled type I diabetes;
* extreme morbid obesity;
* extreme underweight (body mass index \<12);
* history of extremely sedentary lifestyle;
* intrauterine growth restriction in current pregnancy;
* poorly controlled hypertension/pre-eclampsia;
* orthopaedic limitations;
* poorly controlled seizure disorder;
* poorly controlled thyroid disease; heavy smoker).
Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage

The purpose of the present study is to explore the efficacy of small doses of oral glibenclamide on brain edema after acute primary intracerebral hemorrhage (ICH), and improving the prognosis of patients.

In order to explore the efficacy and safety of oral glibenclamide on brain edema after acute primary ICH, a web-based 1:1 randomization process will be employed to assign 220 subjects to Glibenclamide group (giving standard management for ICH plus glibenclamide) or Control group (giving standard management for ICH). The investigators will make a neurofunctional assessment at baseline, and 3 days, 7 days, 90 days after enrollment. The investigators also assess the midline shift, and the change in the volume of ICH and perihematomal edema (PHE) from the initial to follow-up (3 days and 7days after enrollment). The serious adverse events of all-cause mortality, cardiac-related and blood glucose-related adverse events will be collected to assess the safety of glibenclamide.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years with a primary ICH
2. A baseline CT with basal ganglia hemorrhage of 5 to 30 mL
3. Glasgow Coma Scale (GCS) score ≥ 6
4. Symptom onset less than 72 hours prior to admission
5. Informed consent

Exclusion Criteria:

1. Supratentorial ICH planned to evacuation of a large hematoma
2. Hemorrhage breaking into ventricles of brain
3. Prior significant disability (mRS ≥ 3)
4. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \<30ml/min/1.73m2
5. Severe liver disorder, or ALT \>3 times or bilirubin \>2 times upper limit of normal
6. Blood glucose \< 55 mg/dL (3.1 mmol/L）at enrollment, or with the history of hypoglycemia
7. With acute ST elevation infarction, or decompensated heart failure, or cardiac arrest, or acute coronary syndrome, or known history of admission for acute coronary syndrome, or acute myocardial infarction, or coronary intervention in the past 3 months
8. Treatment with sulfonylurea in the past 7 days, including glyburide, glyburide plus metformin, glimepiride, repaglinide, glipizide, gliclazide, tolbutamide and glibornuride
9. Treatment with bosentan in the past 7 days
10. Be allergic to sulfa or other sulfonylurea drugs
11. Known G6PD deficiency
12. Pregnant women
13. Breast-feeding women disagreeing to participate the study or stop breastfeeding during and after the study
14. Be enrolled in other non-observation-only study with receiving an investigational drug
15. Life expectancy \<3 months due to other diseases rather than current ICH
16. Refusing to be enrolled, or having poor compliance, or tending to withdraw
The Impact of Fish Oil Supplementation on the Outcome of Children with Pneumonia I

The aim of study is to investigate the effect of enteral feeding of Omega-3 on the outcome of children with Pneumonia in PICU

Group A(cases) will be supplemented by omega-3 fatty acids for immediate post admission consecutive 7 days besides conventional treatment of pneumonia, in a dose of 350 mg twice daily for children less than 3 years and 450 mg twice daily for older children according to the standard treatment per the American Institute of Medicine of the National Academies guidelines for maximum dose for this age group. (Institute of Medicine of the National Academies,2016)

Side effects of omega-3 supplements are usually mild. They include unpleasant taste, bad breath, bad-smelling sweat, headache, and gastrointestinal symptoms such as heartburn, nausea, and diarrhea. (Office of Dietary Supplements ,2016)

Group B(controls) will be received enteral feeding without omega-3 fatty acid support.

Eligibility Criteria:
Inclusion Criteria

* All children patients with severe pneumonia admitted to PICU
* Both sexes
* Age: under 5 years
* Whose parents or caregivers approve for participation in the study

Exclusion Criteria

* Patients with chronic illnesses to exclude bias that could be emerged due to the chronic disease effect
* Whose parents or caregivers will not apply for participation in the study
* Patients who will be contraindicated for enteral feeding
Dexmedetomidine in Children for Magnetic Resonance Imaging (MRI) Sedation

Sixty patients aged between 1-10 years, American Society of Anesthesia (ASA) physical status I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes heart rate (HR), saturation (SpO2) and Ramsey Sedation Score (RSS) were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

OBJECTIVES OF STUDY Anesthetic agents used for MRI in paediatrics should have few adverse effects, allow fast induction and recovery. The administration route is also important and should be minimally invasive. In this study the investigators aimed to compare two different doses of intranasal dexmedetomidine applied to children for MRI sedation.

MATERIALS AND METHODS Sixty patients aged between 1-10 years, ASA I-II scheduled for MRI were allocated in this randomized double-blinded study. Group 1 received 3 mcg/kg, Group 2 received 4 mcg/kg intranasal dexmedetomidine before imaging. From the beginning on every 10 minutes HR, SpO2 and RSS were recorded. Induction time was time interval to receive RSS 5. MRI began and separation-score was noted. If intranasal sedation failed, an intravenous canula was placed and propofol was applied. Imaging quality was evaluated. Recovery time was time interval to receive Aldrete-score 9. Parents' satisfaction was questioned before patient was discharged.

Eligibility Criteria:
Inclusion Criteria:

* MRI
* ASA I-II

Exclusion Criteria:

* hepatic and renal failure
* difficult airway
* nasal deformity
* anaphylaxis to dexmedetomidine
* neurologic disease
* metabolic disorders
* electrolyte imbalance
* dehydration
* malnutrition
Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)

This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care

This is a small, one-armed pilot study testing a physical activity intervention for pregnant patients with diabetes. The intervention will use both counseling and technology (a FitBit physical activity tracker and smartphone app) to create an individualized, interactive program for each patient. The primary aims of the study are to assess the feasibility of recruiting patients and implementing the program in the clinical setting, and the acceptability of the program for patients and clinicians. Participants will receive a counseling session based on the principles of motivational interviewing to help them set physical activity and step goals, then the interventionist will help them personalize the Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and email their goals and activity weekly to their physicians. In addition to assessing feasibility and acceptability, we will also evaluate change in activity to explore potential efficacy.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 2 diabetes or gestational diabetes
* currently pregnant
* in week 5-25 of gestation
* under active (\<100 minutes/week of physical activity)
* access to a smartphone

Exclusion Criteria:

* any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
* moving from the area within 3 months
The Influence of CYP2C19 Polymorphism and Clinical Outcomes in Stroke Patients

Background:

Clopidogrel, an antiplatelet prodrug, is widely used for prevention of the recurrent cardiovascular events. CYP2C19 is one of the crucial enzymes for the activation of clopidogrel. Recent studies, mostly done in cardiovascular patients, showed association of the CYP2C19 genotypes with recurrent cardiovascular events. However, prospective data on the impact of the genetic variants in stroke patients are limited.

Methods:

Five hundred and eighteen Japanese non-acute stroke patients treated with clopidogrel were registered at 14 institutions. Three CYP2C19 variants (CYP2C19\*2, \*3, \*17) were genotyped and the patients were classified into three clopidogrel metabolizer groups inferred from the CYP2C19 genotypes: extensive (EM: \*1/\*1), intermediate (IM: \*1/\*2 or \*1/\*3), and poor (PM: \*2/\*2, \*2/\*3, or \*3/\*3). The CYP2C19\*17 carriers were excluded from the analysis. The antiplatelet effects of clopidogrel were assessed by Adenosine diphosphate (ADP) -induced platelet aggregation and vasodilator-stimulated phosphoprotein (VASP) phosphorylation, expressed as VASP index. The endpoint was the composite incidence of stroke, transient ischemic attack, myocardial infarction, revascularization, other thromboembolic disease, or cardiovascular death during 2 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had received long-term clopidogrel therapy (once a day for at least one month) with a minimum one-month interval between enrollment and the last cerebral ischemic or TIA event.
* Males and females aged 20 years or older who were prescribed clopidogrel for the secondary prevention of cerebral infarction or transient ischemic attack and who were willing and able to give written informed consent.

Exclusion Criteria:

* Malignancies
* Congenital bleeding tendency
* Atrial fibrillation
* Concomitant use of an oral anticoagulant agent
* a platelet count of \< 100 x 109/L or \> 450 x 109/L within 3 months of enrollment
* Modified rankin scale \> 4
Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

This is a double blind, randomized, crossover pilot study of Voxx Human Performance Technology Socks versus placebo socks for the treatment of chemotherapy-induced peripheral neuropathy in patients with cancer. Patients will be randomized 1:1 to one of the following regimens:

* Arm A: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)
* Arm B: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)

Patients will be evaluated at three time points using an objective neuropathy assessment as well as self-report questionnaires assessing chemotherapy-induced peripheral neuropathy, quality of life, and cancer-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer, stage 1-4.
* Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib at least three months (90 days) ago. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay.
* Clinical diagnosis of chemotherapy-induced peripheral neuropathy by clinician. This will be based on symptom history (paresthesias, dysesthesias, allodynia), loss of deep tendon reflexes, decreased vibratory sensation, or the presence of symmetrical stocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy.
* Self-reported average neuropathic pain score of at least 4 on a 10-point scale over the past 1 month.
* Age ≥ 18 years
* Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to randomization).
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
* Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels as assessed by treating physician.
* Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
* Currently participating in another chemotherapy-induced peripheral neuropathy-targeted program or trial.
* Participated in a non-pharmacologic therapy specifically for the treatment of chemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulness meditation, or other mind-body activities within 14 days (2 weeks) prior to randomization.
An fMRI Study on Temporal Discounting in Bipolar Disorder

The investigators propose to explore the link between bipolar disorder, anxiety, and suicide by investigating intertemporal discounting in depressed, suicidal patients with bipolar I and II disorder who have various levels of anxiety. The investigators will determine the effect of anxiety on their intertemporal discounting (small rewards now compared to larger rewards later) in a decision-making paradigm and investigate the associated functional neuroanatomy using functional magnetic resonance imaging (fMRI).

Among the various psychological properties of the decision making process is temporal discounting, which is a decrease in the subjective value of a good as a function of the amount of and delay to reward. The ability to decide between immediate versus future rewards depends on self-control and consideration of the future. We can reconceptualize suicide as intertemporal discounting with an interaction between cognition and mood. Someone contemplating suicide weighs the time value of costs and benefits with shifting negative and positive valence systems. To the best of our knowledge, no one has assessed the interaction between mood symptoms, anxiety, and their impact on the temporal discounting paradigm in bipolar patients. If we better understood the difference between anxious, suicidal and non-anxious, suicidal bipolar patients, we could design more effective interventions to prevent this tragic outcome. We propose a novel paradigm to explore the link between bipolar disorder, anxiety, and suicide. If we conceptualize suicidal behavior and death by suicide as decisions, then it makes sense to examine key aspects of decision making in these patients. In particular, we can examine how mood, anxiety, and suicidal ideation and behaviors arise from patterns of decision making, along with neural correlates of decision-making, as assessed with fMRI.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-IV criteria for BD I and II current depressive episode
2. Able to give written informed consent
3. Age \> to 18 years and \< 65 years
4. Currently suicidal as defined by a MADRS suicide item score of \> 3 or previous history of serious suicidal ideation that required hospitalization.
5. All subjects need to have normal hearing and normal/corrected-to-normal vision.

Exclusion Criteria:

1. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
2. Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results)
3. Substance abuse within the past 3 months or current substance dependence (confirmed by MINI)
4. Left-handedness
5. Contraindications to MRI (metallic implants, claustrophobia, etc.)
6. Subjects who need urgent psychiatric care requiring hospitalization (evaluated by clinicians).