cyrilzakka/clinical-trials huggingface dataset:
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study

This study compares the outcomes and safety of two standard treatment options called microwave ablation and surgical wedge resection in patients with non-small cell lung cancer, sarcoma and colorectal cancer that has spread to other parts of the body (metastatic). Microwave ablation is designed to kill tumor cells by heating the tumor until the tumor cells die. A wedge resection is a procedure that involves the surgical removal of a small, wedge-shaped piece of lung tissue to remove a small tumor or to diagnose lung cancer. Comparing these two treatment options may help researchers learn which method works better for the treatment of non-small cell lung cancer, metastatic sarcoma, and metastatic colorectal cancer.

PRIMARY OBJECTIVE:

I. Estimate the 2-year local recurrence rate for microwave ablation within a basket.

SECONDARY OBJECTIVES:

I. Evaluate whether microwave ablation offers treatment benefit for safety when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.

II. Evaluate whether microwave ablation offers treatment benefit for efficacy when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.

III. Evaluate whether microwave ablation offers treatment benefit for changes in patient reported outcomes when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.

OUTLINE:

Patients undergo standard care microwave ablation or wedge resection followed by contrast-enhanced computed tomography (CT) imaging at 1, 6, 12, 18 and 24 months. Patients also complete questionnaires over 10-15 minutes at baseline up to 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a lung lesion(s) that is either biopsy-proven cancer or shows sequential growth on CT imaging with clinical suspicion for non-small cell lung cancer (NSCLC)-stage I; NSCLC-stage \> 1; metastatic sarcoma; or metastatic colorectal (CRC) cancer
* 3 cm or less tumor size
* Other sites for cancer are either controlled or there are plans for control
* Expected margin at least 1 cm from critical structures, allowing for protective strategies such as induction of therapeutic pneumothorax. Critical structures include the trachea, main bronchi, esophagus, aorta, aortic arch branches, superior vena cava (SVC), main, right or left pulmonary artery, or heart.

Exclusion Criteria:

* Patient is considered high risk for ablation due to major comorbid medical conditions
* Patient is pregnant or breast feeding
A Study of MEMP1972A in Patients With Allergic Asthma Inadequately Controlled on Inhaled Steroids And A Second Controller (COSTA)

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 75 years of age inclusive
* Body weight \>/= 40 kg
* Physician's diagnosis of asthma for at least 12 months
* Evidence of documented bronchodilator reversibility as defined by protocol
* Prebronchodilator FEV1 \>/= 40% and \</= 80% predicted at Visit 1
* Required daily use of ICS and a second controller for a minimum of 3 consecutive months prior to Visit 1
* History of at least one protocol-defined asthma exacerbation in the 18 months prior to Visit 1
* Inadequately controlled asthma despite compliance with asthma controller therapy

Exclusion Criteria:

* Asthma exacerbation requiring systemic steroids in the 30 days prior to Visit 1
* Pre-existing active lung disease other than asthma
* Any infection
* Clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology
* Known immunodeficiency, including but not limited to HIV infection, regardless of treatment status
* Current substance abuse
* Former smoker with \>10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to Visit 1
* History of anaphylaxis
* Pregnant and lactating women
Blood Pressure First Medication Therapy Management

The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.

Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.

Eligibility Criteria:
Inclusion Criteria:

* All health plan beneficiaries 18 years-of-age and older
* Have filled at least one blood pressure medication in the last three months,
* Have a known hypertension diagnosis or have an uncontrolled blood pressure

Exclusion Criteria:

* Not an adult
* Not a health plan beneficiary of the self-insured employer
* Not ambulatory and able to work or participate in care visits
Effect of Pycnogenol® on ADHD

This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.


Eligibility Criteria:
Inclusion Criteria:

* The patient is between 6-12 years old (both inclusive).
* The patient satisfies the DSM-IV criteria for ADHD or ADD.
* The patient has a responsible caregiver who is able to provide information about the patient's functional status.
* Written informed consent is obtained from the patient and the legally accepted representative.

Exclusion Criteria:

* The patient does satisfy the DSM-IV for autism spectrum disorder.
* The patient does have situational hyperactivity, pervasive developmental disorders, schizophrenia, other psychotic disorders such as mood or anxiety disorder, personality disorder as unsocial behaviour, personality change due to a general medical condition, mental retardation (IQ \< 70), understimulating environments, conduct disorder, chorea and other dyskinesias. The patient does not have tics or Tourette's syndrome, or personal or family history of psychotic disorder, bipolar illness, depression, or suicide attempt.
* The patient does have any chronic medical disorder (diabetes, epilepsy or other seizure disorder, autoimmune disorder, gastrointestinal disorder, renal or cardiovascular disorders, etc.) or acute inflammatory disease. The patient does not have glaucoma, heart disease, heart rhythm disorder, high blood pressure, or peripheral vascular disease such as Raynaud's syndrome.
* The patient did use any of these medications during the 3 months before entering the study: clonidine, guanethidine, blood thinners (e.g. warfarin or Coumadin), antidepressants (e.g. amitriptyline, citalopram, doxepin, fluoxetine, nortriptyline, paroxetine, sertraline), cold or allergy medicine that contains a decongestant, medications to treat high or low blood pressure, seizure medicine (e.g. phenobarbital, phenytoin, primidone), or diet pills.
* The patient did take MAO inhibitor (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline or tranylcypromine) in the past 14 days.
* The patient has any other contraindication for the use of methylphenidate.
* The patient did use vitamin/mineral/herbal/omega-3 supplements or other any medication (psychoactive medication, antibiotics, anti-inflammatory drugs, melatonin, etc.) \> 1 week during the 3 months before inclusion.
Efficacy and Complications of Microvascular Decompression

The study is a non-interventional prospective observational study in patients with trigeminal neuralgia that undergoes micovascular decompression. The aim is to evaluate the efficacy and complications 2 years after microvascular decompression

The aim of this study is to prospectively evaluate effect and complications 2 years after MVD using independent assessors of outcome and complications.

Data of outcome and complications is collected prospectively based on based on standardized follow-up schemes and questionnaires. Patients were assessed by independent assessors before surgery and 3, 6, 12 and 24 months after surgery. Current pain level was evaluated according to VAS and BNI pain scale. Complications were evaluated by the assessors by a questionnaire and physical examination. All patients undergo a pre-surgical protocolized 3.0 Tesla MRI of the brain and brainstem.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Most give Signed informed Consent.
* Must fullfil the ICHD-3 beta diagnostic criteria for classical TN.Patients with purely paroxysmal TN and patients with TN with concomitant persistent facial pain will be included.
* If the ICHD-3 beta diagnostic criteria is fulfilled and if complete clinical history, neurological and physical examination and a 3.0 Tesla MRI do not raise any suspicion of another causative disease such as painful posttraumatic trigeminal neuropathy or symptomatic TN, subjects with sensory abnormalities detected at clinical neurological examination are also included.
* Has had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, prior to the surgical intervention.
* Semi-structured interview and neurological examination by the independent assessors prior to neurosurgical intervention.
* Has tried at least one, preferably two, sodium channel blocker (either carbamazepine or oxcarbazepine) before referral to neurosurgery.

Exclusion Criteria:

Subjects will be excluded if one of the following exclusion criteria is met:

* Psychiatric or mental illness or condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
* Previous microvascular decompression as a treatment for trigeminal neuralgia
Digital Therapeutics for Behavior Problems

In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).

In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 5-8 years
* Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
* Residence with at least one parent/guardian at least 80% of the time
* Parent/legal guardian consent for participation
* Parent/guardian must have a smartphone device with daily internet access

Exclusion Criteria:

* A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
* Currently in treatment for childhood disruptive behavior
Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid

The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with a history of hypersensitivity to study drug(ZSP1273,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption
Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-60 years;
2. American Society of Anesthesiologists（ASA） grade I\~III;
3. TBIL\>ULN and TBA\>ULN; The patients with obstructive jaundice.

Exclusion Criteria:

1. Organs dysfunction(heart,lungs and etc);
2. Mental disorders;
3. in other clinical trial.
Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.

Chronic lung disease (CLD), also known as bronchopulmonary dysplasia (BPD), in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency.

This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge.

The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants.

Neurodevelopment was assessed at 18-22 months postmenstrual age.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 12 hrs of age and less than 10 days chronologic age
* 501-1000 gm
* Intubated and mechanically ventilated before 12 hrs
* Indwelling vascular catheter
* Infants 751-100 gm must be receiving FiO2 greater than 0.30 and have received at least 1 dose of surfactant at randomization
* Parental consent

Exclusion Criteria:

* Major congenital anomaly
* Symptomatic non-bacterial infection
* Permanent neuromuscular conditions that affect respiration
* Terminal illness (defined as pH values less than 6.8 for more than 2 hours or persistent bradycardia associated with hypoxia for more than 2 hours)
* Use of postnatal corticosteroids
TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS
* PDDS \<6, indicating ability to ambulate with or without an assistive device \>/= 50% of the time
* Self-reported walking dysfunction as evidenced by a score of \>/= 30 on MSWS-12 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller.

Exclusion Criteria:

* MS relapse within the past 30 days
* comorbid neurological disorder
* acute orthopedic disorder/injury
* unable to follow study-related commands
Study of ABT-267 in Both Healthy Volunteers and Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

Study of ABT-267 in both healthy volunteers and Hepatitis C virus (HCV) genotype 1 infected subjects.


Eligibility Criteria:
Inclusion Criteria

Main Selection Criteria for Healthy Volunteers:

* Subject has provided written consent.
* Subject is in general good health.
* Females must be post-menopausal for at least 2 years or surgically sterile.
* Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.

Main Selection Criteria for HCV Genotype 1-infected Volunteers:

* Subject has provided written consent.
* Subject has chronic HCV genotype 1 infection at screening.
* Liver biopsy within 3 years with histology.
* Females must be post-menopausal for at least 2 years or surgically sterile.
* Females must not be pregnant or breast-feeding. If male, subject is surgically sterile or practicing specific forms of birth control.
* Subject is in general good health, as perceived by the investigator, other than HCV infection.

Main Selection Criteria for Volunteers in the Resistance Monitoring Portion of the Study:

* Subject has provided written consent, has received at least one dose of ABT-267 or placebo in the study, and is considered suitable by the investigator to participate.

Exclusion Criteria

Main Exclusion Criteria for Healthy Volunteers:

* Positive test for HAV IgM, HBsAg, HCV Ab or HIV Ab.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration.
* Abnormal screening laboratory results.
* Significant sensitivity to any drug.
* Requirement for any over the counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.

Main Exclusion Criteria for HCV Genotype 1-infected Volunteers:

* Significant sensitivity to any drug.
* Positive HBsAg, HAV-IgM, and HIV Ab. Use of CYP enzyme inducers or inhibitors within 1 month of dosing.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid disease (except hypothyroidism on stable thyroid replacement therapy), or any uncontrolled medical illness or psychiatric disorder.
* Use of any medications (prescription and over-the counter) within 2 weeks prior to study drug dosing without prior approval by the Abbott Medical Monitor.
* Use of any vitamins or herbal supplements within 2 weeks prior to study drug dosing.
* Prior treatment with any investigational or commercially available anti-HCV agents.
* Abnormal screening laboratory results.