cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of NAC in Asthma

This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.

n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.

Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.

This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.

Eligibility Criteria:
Inclusion Criteria:

* Able to perform reproducible spirometry according to ATS criteria
* Clinical history consistent with moderate to severe asthma for 1 year or greater.
* Post-bronchodilator FEV1 \<90% of predicted
* Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.
* CT mucus score \>3 (determined during the initial screening process, provided the prior two conditions are met)
* Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* History of intolerance to study medications.
* Current use of carbamazepine
* Angina which includes a treatment plan with PRN nitroglycerin or nitrites
* Smoking of tobacco or other recreational inhalants in last year and/or \>10 pack-year smoking history
* Current participation in an investigational drug trial Concurrent Medications
Effect of Qigong on Balance, Fall Efficacy, Wellbeing of People With Stroke in Hong Kong

The purpose of this study is to compare the effects of qigong practice with fitness exercise on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of stroke survivors.

Participants: A total of 58 stroke survivors 3 months after the current stroke will be recruited.

Methodology: An assessor-blinded, randomized controlled trial will be conducted. Stroke survivors will be included in the study if they meet the inclusion criteria. Selected patients will be randomly allocated into either the experimental group or the control group. Participants allocated in the experimental group will receive qigong training while this qigong training will be replaced by a home fitness exercise in the control group. The experimental and control groups will be required to practice a total of 50 minutes of qigong and fitness training 3 times per week and for 16 weeks respectively. The main outcome measure is balance capacity with Mini-BESTest. The secondary outcomes are fall efficacy, number of falls, postural stability and control, depression, physical functions and quality of life. Assessments will be done at baseline, 8 weeks and 16 weeks follow-ups by blinded assessors.

Data analysis: The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Science version 21.0. Alpha will be set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke and 3 months after the onset
* First episode of stroke or recurrent of stroke
* Able to stand for more than 15 minutes
* Able to take anterioposterior and lateral step without assistance or aid
* Medically stable
* Sufficient cognition to follow commands Abbreviated Mental Test (AMT) score ≥7

Exclusion Criteria:

* Vital signs unstable
* History or evidence of other neurological deficits other than stroke such as multiple sclerosis
* Severe primary diseases of the cardiovascular system, liver, kidney or hematopoietic system
* Experience in qigong practice
To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.
* Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

* Intake of another investigational drug within the last 30 days prior to enrolment.
* Clinically significant illness or clinically relevant trauma.
Feasibility of EnChroma Use in the Emergency Department Setting

This study addresses whether the use of EnChroma products are feasible for use in the emergency department by color vision deficient providers.

This study addresses whether it is feasible for color vision deficient (CVD) physicians and other healthcare providers to wear EnChroma products in the clinical setting. It is known that color vision is important to the practice of medicine. Identifying red skin or red ear drums, noticing whether lips have turned blue or a patient is pale, and identifying colors under a microscope all are aided by or dependent upon color vision. While color vision deficiency does not preclude a person from becoming and succeeding as a physician, it may be appropriate and desired to utilize devices to improve color vision during patient care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Red-Green color deficiency

Exclusion Criteria:

* Achromatopsia
* Cataracts
* Glaucoma
* Legal blindness
* Macular degeneration
* Retinitis Pigmentosa
Blood Sugars in Children With Idiopathic Seizures.

The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).

Convulsive disorders are among the most frequently occurring neurologic conditions in children. Idiopathic seizures are the most common (67.6%) type of seizure seen in the 0-15 year age group. The highest incidence is in the first year of life. In the United States, 5 percent of individuals experience a seizure of some type by the age of 20.

Seizures have multiple etiologies. These include hypoglycemia, congenital causes, toxic/metabolic causes, infection, neoplasm, perinatal causes, and trauma. The medical evaluation often includes blood work, imaging of the brain, and performing an electroencephalogram. Currently, there is no consensus as to the work-up of children presenting with unprovoked seizures.

Hypoglycemia presents with a wide spectrum of symptoms and severity. In children, hypoglycemia can lead to seizures and coma. In neonates and infants, however, the symptoms are even more varied and nonspecific. They can include cyanotic spells, apnea, respiratory distress, refusal to feed, and myoclonic jerks. The varied symptoms of hypoglycemia make the disorder difficult to diagnose.

The study will have parents checking blood sugars for 14 days and a one time ammonia level. Blood sugar checks will be first thing in the morning and one hour after a meal. If the study identifies a subset of patients with idiopathic seizures who have hypoglycemia, this finding may have implications for future glucose screening recommendations.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be patients with idiopathic seizure disorders.
* The age range will be from birth to 17 years of age.
* Study subjects may be on anti-convulsants; the study does not alter current drug therapy.

Exclusion Criteria:

* The exclusion criteria includes patients with known causes of seizure disorders, including those with an underlying risk factor predisposing them to seizures. The risk factors are:

  1. congenital causes (CNS malformation, cerebral palsy)
  2. CNS infection toxic/known metabolic abnormality
  3. CNS neoplasm perinatal insults (birth trauma, asphyxia/hypoxia),
  4. traumatic
  5. All others who have an anatomic or known biochemical lesion.
Effect of Stablor on Visceral Fat Loss in Patients With a Metabolic Syndrome

The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
* With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :

  * Arterial Blood pressure \> or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
  * Fasting glycemia \> or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic \< 1.26 g/L,
  * Triglycerides \> or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
  * HDL Cholesterol \<0.40 g/L or 1.03 mmol/L (males) and \<0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.

Exclusion Criteria:

* Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
* Woman of childbearing potential without an efficient contraception method,

The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan

This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number: NCT03347422) studies and benefitted from sutimlimab treatment in Japan.

• Study and treatment duration: the period between the participant's completion of the CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

The period between screening/baseline visit (upon the participant's completion\* of the CARDINAL and CADENZA studies) and end of treatment with sutimlimab in this study was determined by sutimlimab or other appropriate CAD therapy becoming commercially available to participants in Japan.

Eligibility Criteria:
Inclusion Criteria:

--Participant must be adults.

* Participants who had been enrolled in and had completed Part B of CARDINAL or CADENZA study.
* Participants who had ongoing diagnosis of CAD.
* Participants who continued to require treatment for CAD upon completion of participation in the previous study evidenced by return of CAD-related symptoms of anemia and/or deterioration on markers of hemolysis after the end of study visit following the 9-week safety follow up period. (9-week follow up period).
* Participants who had acceptable benefit/risk profile.
* Participant who had acceptable infection risk.
* Participants who had no available appropriate alternative therapy for CAD.
* Body weight \>= 39 kg.
* Gave signed informed consent.

Exclusion Criteria:

--Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune disorders.

* Participants who met recent Rituximab and/or immunosuppressive therapy.
* Any of the following medical conditions:

  1. Active, serious intercurrent illness which precluded enrolment until recovery was complete.
  2. Pregnancy or breast-feeding.
* End of Study visit in CARDINAL or CADENZA took place more than 3 months before Baseline visit in this study.
* Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that, in the opinion of the Investigator, contraindicated participation in the study.
SQuISH-COVID: A Pilot Study

This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting the following criteria may be eligible for participation in the study:

1. ≥ 18 years old or older
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
3. A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
4. Signs or suspicion of a respiratory infection, defined as:

   1. Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR
   2. An order placed for a respiratory viral panel. OR
   3. An order placed for a SARS-CoV-2 test. OR
   4. A subject self-reported as having tested positive for the SARS-CoV-2 test within the previous 7 days and returning with a related complaint.

Exclusion Criteria:

Subjects are excluded from study participation if they meet any of the following criteria:

a. Blood sample volume is \< 300 ul; insufficient quantity for SeptiScan testing.
Diabetes Management in Low-Income Hispanic Patients

The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.

Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with T2DM (documented in the medical chart);
2. HbA1c level \> 7.5;
3. Currently treated with diet, oral hypoglycemics or insulin. If currently on insulin, must have a history of prior therapy with diet alone or oral hypoglycemic agents;
4. Hispanic origin;
5. \> 18 years old;
6. Telephone in home or easy access to one;
7. Able to understand and participate in the study protocol;
8. Functionally capable of meeting the activity goals;
9. Understands and can provide informed consent (English or Spanish; for illiterate pts we will require that a representative of the pt also understands and signs the consent form on behalf of the pt);
10. Physician approval to participate in the study.

Exclusion Criteria:

1. History of diabetic ketoacidosis
2. Gestational diabetes
3. Unable or unwilling to provide informed consent;
4. Plans to move out of the area within the 12-month study period;
5. Required intermittent glucocorticoid therapy within the past 3 months;
6. Experienced an acute coronary event (myocardial infarction or unstable angina) within the previous 6 mos
7. Has a medical condition that precludes adherence to study dietary recommendations (e.g., Crohn's disease, ulcerative colitis, end-stage renal disease);
8. Has a medical or psychiatric illness (i.e., dementia, psychiatric hospitalization or suicidality within past 5 years or takes an atypical neuroleptic medication). We will not exclude individuals with a diagnosis of depression or pts taking anti-depressants.
Nutrition Monitoring and Feeding Optimization With the smART+ System - Comparative Study

The smART+ is a comprehensive modular patient care system intended for ICU patients.

The main purpose of the study is the optimization of the delivery of nutrition.

The use of the smART+ Feeding tube includes a feature of facilitating correct tube placement and alerting when the tube is displaced during ongoing use. The system will automatically stop feeding if displacement is detected. If a massive reflux episode is detected by the system, a balloon located on the tube will automatically inflate and automatic GRV feature will open to prevent gastric content from regurgitating to the esophagus.

In addition to tube placement, the system allows to obtain REE (Resting Energy Expenditure) measurements and calculates the optimized nutritional values required by the patient. Furthermore, the system optimizes feeding by compensating for any lost feeding time or discarded nutritional content that was discarded via the GRV (Gastric Residual Volume).

Study participants will be randomly assigned to a study group:

Group A- ICU patients receiving the investigational device ("Treated"). Group B- Control group.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years or older
* Patient that have already been admitted to the ICU (no more than 48 hours before enrollment)
* Expected to be ventilated at least 48 hours after enrollments.
* Patient requires enteral feeding (by naso/oro-gastric feeding tube)

Exclusion Criteria:

* Pregnant women
* Known anatomical anomalies of the nose, oral cavity esophagus or the stomach that may prevent/hinder the ability to insert the feeding tube
Mental Practice in Post-stroke Subjects

Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life. Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill. The objective of the study is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects with unilateral stroke over 6 months, age\> 18 years and who were able to hold objects will be selected. Subjects with painful conditions that affected exercise performance,\> 3 spasticity by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be excluded.

There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes / task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed, remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be applied before and after the sessions, and in 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects

Exclusion Criteria:

* Painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be evaluated by the Mini Mental State Examination (MMSE)
A Study of the Efficacy and Safety of Nebivolol Added to Existing Antihypertensive Treatment in Patients With Hypertension

The purpose of this study was to contrast the efficacy and safety of 3 dose levels of nebivolol vs. placebo, when added to a patient's existing antihypertensive medication(s) for 3 months, in patients with mild to moderate hypertension

Following a washout of any previous beta-blocker medication, if applicable, supine, sitting, and standing cuff blood pressure and pulse rate, 24-hour ambulatory blood pressure monitoring (ABPM), ECG, laboratory assessments and genomics testing were performed before randomization. Patients were randomized to receive placebo or nebivolol once daily in the morning together with their curently prescribed antihypertensive therapy. Patients had four scheduled clinical visits during the study, following the screening visit.

Eligibility Criteria:
Inclusion Criteria:

* Average sitting diastolic blood pressure (DBP) greater then or equal to 90 mmHg and less then or equal to 109 mmHg at screening and baseline, in patients on background antihypertensive therapy taking at least one and no more than two of either ACE inhibitor, ARB, or diuretic.

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta-blocker therapy
Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries

The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral Nerve Injury

Exclusion Criteria:

* Polyneuropathy
* Contralateral peripheral nerve injury
* Severe psychiatric disorders
* Disorders affecting central nervous system
A Novel Neurobehavioral Intervention for Emotion Regulation in Anxiety and Depression Across the Lifespan

The research proposes to use an innovative solution to shape brain circuits that support executive function and emotion reactivity -using targeted neurobehavioral intervention.

Participants will be recruited locally in the San Francisco Bay area with certain symptoms of anxiety and depression. They will complete a clinical assessment and then take part in a cognitive-emotion training delivered online.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of depression on the SCID, a total Ham-D≥16 and Ham-D anxiety/somatization subscale ≥ 7.

Exclusion Criteria:

* Current medication for psychiatric disorders
* Pregnant females
* Head trauma or injury that resulted in loss of consciousness
* MRI contraindication