cyrilzakka/clinical-trials huggingface dataset:
Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy

The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.

Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.

Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.

Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed of non-small cell lung cancer
* Diagnosed as stage IIIA-NI, N2, except for T4N1M0
* The diagnosis standard of N1 or N2 is as below:
* The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be \> 2.5

Exclusion Criteria:

* Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)
* Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy)
* Resection of primary malignancy
Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Primary objective:

- To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD).

Secondary objective:

- To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of \> 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.
Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke

The most recent treatment for stroke rehabilitation is to combine physical training with other therapies to enhance or accelerate recovery.The hypothesis of this study is that remote ischemic conditioning (RIC) might have a beneficial effect on motor recovery of AIS

Despite the effective reperfusion therapies ,acute ischemic stroke(AIS) is still one of the leading causes of disability, resulting in an economic burden. Multidisciplinary rehabilitation has benefit effects on motor recovery and remains the first-line intervention strategy for attenuating motor function impairments. However, the effect of the physiotherapy application alone is not satisfactory, The potential treatment effect of RIC on motor recovery of AIS has not been investigated. The investigators designed this randomized clinical trial to examine whether RIC has a beneficial effect on poststroke motor function recovery.There are 2 arms in this trial: One arm is RIC treatment, the other one is sham RIC treatment. The motor function will be assessed by Fugl-Meyer Motor Scale before and after the treatment to evaluate its exact effect on motor recovery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18-80 years;
2. First-ever unilateral ischemic stroke,5\~10 days after onset;
3. Had motor dysfunction caused by stroke(Fugl-Meyer≤55)
4. mRS≤1 before stroke
5. NIHSS 6\~20
6. Written consent was obtained from the subject.

Exclusion Criteria:

1. Cannot complete assessments-ie, psychiatric disorders, sensory aphasia, dementia
2. brainstem lesion or cerebellun lesion
3. poorly controlled diabetes mellitus
4. Application of agent which thought to impair or improve recovery based on laboratory and clinical evidence within 1 month (ie,DA,MAOI, SSRI,α1/α2 adrenergic receptor inhibitors,BZD,etc)
5. severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Effect of Breast Milk Olfactory Stimulation

Breast milk olfactory stimulation will improve preterm infants' outcomes.

The researcher will explain the aim of the study and the components of the tools to the studied nurses.

* The researcher will distribute questionnaire to studied nurses for assessing their knowledge and the researcher will observe their practices regarding breast milk olfactory stimulation for premature infants.
* The researcher will be divided preterm infant randomly into two equal groups (control and study). While intervention will be directed to study group only before feeding. Both groups will be subjected to same routine care of the NICU.
* The researcher will be used PIBB scale and neonatal behavioral responses Sheet to assess the premature infants at 1st day of admission as pre intervention after routine care as "change diaper, eye care, cord care, feeding" at morning shift at ten o'clock and one o'clock in the afternoon for study and control group (pre intervention).
* The researcher will apply breast milk olfactory stimulation technique for study group only before feeding but, both groups will be subjected to same routine care of the NICU.
* The researcher will assess the effect of used olfactory stimulation technique to study group at 5th and 6th day of admission post intervention.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant has gestational of 30 \>37.
* Birth weight 1000 \> 2500 gm.
* Preterm infant fed oral or gavage feeding or both of them.

Exclusion Criteria:

* Preterm infants on mechanical ventilation or complicated case
Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

The purpose of this study is to assess safety, tolerance and pharmacokinetics of Multiple-dose Kukoamine B Mesilate in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Gender: male or female, each sex ratio does not exceed 2/3;
2. 18-45 years (including upper and lower limit), the general situation is good;
3. Body mass index (BMI) in 19-28 (including upper and lower limit of the range), bodyweight（BW）≥ 50kg (female) and 60kg (male);
4. Nearly half of the year, no child care program and agreed to take effective measures to contraception during the study period, women of childbearing age blood pregnancy test was negative;
5. Subjects to fully understand the purpose, properties, method and reactions may occur of test drug trials.Voluntarily signed the informed consents, and agreed to abide by the requirements of clinical protocols.

Exclusion Criteria:

1. Primary disease in important organs;
2. Mental or physical disability;
3. Familial hereditary disease;
4. Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood pressure greater than 90-140 millimeters of mercury(mmHg), beyond the scope of 50-90 millimeters of mercury(mmHg), Or pulse (HR) beyond 50bpm-100bpm;
5. Abnormal results of any clinically meaningful physical examination, vital signs, ECG or clinical laboratory;
6. History of immunodeficiency diseases, including HIV antibody positive;
7. Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C / syphilis positive;
8. Alcohol and drug abusers;
9. Who is addicted to alcohol and tobacco (drinking 14 units of alcohol per week: 1 unit = beer 285 ml, or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and drinking in the test period;
10. Any discharge period may affect the study drug, or in the past 3 months participated in any drug clinical trials;
11. Before entering the group 4 weeks using any prescription drugs before entering the group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics, etc.), or into the group within 2 weeks before taking effect of drug metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of acetaminophen, but must record report in case report form（CRF）;
12. The last 3 months had a history of blood donation or significant blood loss (more than 400ml);
13. There are drugs, the clinical significance of the history of food allergy and atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs or similar drug allergy test;
14. Lactating women, pregnant women or unable to take effective contraceptive measures;
15. Researchers believe that participants not suitable to take the test for other factors .
A Novel Method to Improve Acne Outcomes

This is an investigator-blinded, prospective study of 20 subjects aged 13 through 18 with mild to moderate acne. Study subjects will be randomized to an internet survey group, in which an email link for a survey ascertaining the status of the subject's acne is sent weekly, or to a control group. All study subjects will use benzoyl peroxide 5% gel, and adherence and clinical improvement will be monitored over 12 weeks. The investigators hypothesis is that subjects in the internet survey group will have improved adherence to the study medication and clinical outcomes, because the weekly survey will remind subjects to use their medication.


Eligibility Criteria:
Inclusion Criteria:

* male or female 13 to 18 years of age with a diagnosis of mild to moderate acne vulgaris by a dermatologist.
* written consent of participation must be given by parent or guardian and child.

Exclusion Criteria:

* Age less than 13 or greater than 18 years of age.
* Known allergy or sensitivity to topical benzoyl peroxide gel in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for acne vulgaris while participating in the study.
* Subjects may not use topical retinoids or other benzoyl peroxide products, including Proactiv® or topical prescription medications while enrolled in the study.
* Women that are actively trying to become pregnant or wish to become pregnant during the time frame the study is to take place will be excluded.
* Subjects will be carefully selected for this study and only those deemed appropriate for treatment with benzoyl peroxide will be placed on this medication.
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)

Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with dopamine agonists. However it not known whether the exercise anabolic stimulus and the dopamine agonist treatment could act synergistically for the improvement of physical functioning and muscle performance as well as in the amelioration of augmentation symptoms in hemodialysis patients with RLS.

This is a randomized, placebo-controlled study to evaluate the acute and long term (6 months) effect of exercise training in combination with dopamine agonists in quality of life, muscle function, sleep quality and metabolism in patients with restless legs syndrome (RLS) receiving dialysis therapy.

Objectives - Aims:

1. To investigate whether a single bout of intradialytic exercise session could have an effect in motor restlessness often seen during hemodialysis session in patients with RLS
2. To investigate whether a 24 weeks therapy with dopamine agonist or placebo will have an effect in sleep quality, functional capacity and metabolic profile of the hemodialysis patients with RLS
3. To examine whether dopamine agonists or placebo and aerobic intradialytic exercise act synergistically for the improvement of physical functioning and muscle performance as well as it could reduce the signs of augmentation in hemodialysis patients with RLS

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable hemodialysis patients with positive diagnosis in IRLSS questionnaire for the RLS will be eligible to participate. Entry criteria included being on chronic hemodialysis for six months, able to perform an exercise training, with dialysis delivery (KT/V) \> 1.1.

Exclusion Criteria:

* Patients were excluded from the study if they were diagnosed with neuropathies or reasons for being in a catabolic state (including malignancies, HIV and opportunistic infections, active inflammation), within 3 months prior to the start of the study. In addition patients treated with drugs recommended for the treatment of RLS as well as patients with Parkinson's disease or untreated depression will be also excluded.
Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery

Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015 by Hand et al. TLIP block involves injection of local anesthetics between multifidus and longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of thoracolumbar nerves. In new approach differently, the investigators made the injection between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral.

The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar interfascial plane (TLIP) block in patients undergoing spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing spinal surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
Study of the Neural Basis of Analogical Reasoning

Frontal patients are impaired in categorisation and analogical reasoning tasks, and different functional imaging studies from our group have shown the involvement of the prefrontal cortex in categorisation and analogy tasks. The aim of this project is to test our hypotheses about the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects:

* subject affiliated to national health insurance
* informed consent signed
* normal neurological examination
* subject aged at least 20

Patients:

* FTD or PSP diagnostic criteria filled
* patient affiliated to national health insurance
* informed consent signed

Exclusion Criteria:

* Severe psychiatric symptomatology and psychotropic drug use
* unability to understand or perform the cognitive tasks.
Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)

The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are:

1. Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia?
2. How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia?
3. What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored)

Participants will

* Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months
* Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination


Eligibility Criteria:
Inclusion Criteria:

1. Age \&gt; 60 years old
2. Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10
3. Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment
4. Patient is in stable condition without life threatening disease or uncontrolled medical condition
5. Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial
6. Patient with care giver or supporting family who can assist patient with research protocol

Exclusion Criteria:

1. Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse
2. Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection
3. Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder
4. Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial
5. Patient who has allergy or hypersensitivity reaction towards secretome
6. Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications
7. Patient is unable to provide written informed consent and not capable to understand and comply to research protocol
8. Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule
Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure

This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.

Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.

Health Coaching involves a team of health care professionals including a registered nurse (RN). The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with primary or secondary diagnosis of Acute Decompensated Heart Failure (one or more of these symptoms: shortness of breath, orthopnea or edema AND one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
* Adult patients \>18 years old

Exclusion Criteria:

* Overall life expectancy \< 1 year
* Known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
* Active systemic infection
* Pregnant or lactating
* End stage renal disease on dialysis
* Subject or caregiver is not visually and tactile capable of smartphone and home device usage
* Inadequate cell phone coverage (including international patients or international travel during study period)
* Subject or legal guardian is not willing and able to provide appropriate informed consent
Prognosis in Patients With Guillain-Barre Syndrome

The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

Exclusion Criteria:

* nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis

This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
* Severity of disease meeting all of the following three criteria:

  * PASI score of 10 or greater
  * Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
  * Investigator's Global Assessment (IGA) score of 3 or greater

Exclusion Criteria:

* Hematological abnormalities
* Heart rate \< 50 or \> 90 bpm when resting for 5 minutes
* Family history of long QT syndrome
* History of tachyarrhythmia
* History of conduction abnormality i.e., PR \> 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
* Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
* Known history of congestive heart failure
* History of percutaneous coronary intervention (PCI) or cardiac ablation
* History of stroke or transient ischemic attack (TIA)
* Implanted cardiac pacemaker or defibrillator
* History of malignancy of any organ system
* Current guttate, generalized erythrodermic, or pustular psoriasis
* Current drug associated psoriasis

Other protocol-defined inclusion/exclusion criteria may apply
FFA Metabolism in Different Types of Human Obesity

We will give intravenous fat molecules to help us understand how the fat that is released from peoples fat cells is used. This will be done when people are eating, not eating and walking.


Eligibility Criteria:
Inclusion Criteria: BMI 28-36 -upper body obesity and lower body obesity non-obese BMI 19-24. Females premenopausal. Must be a non-smoker.

Exclusion Criteria: BP\> 160/95 on HTN meds, known systemic illness. Medications that affect fat metabolism. We do no cover travel expenses. Known heart and vascular disease.