cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.

Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment
* EGFR Gene mutated
* ECOG 0-1
* liver, kidney and bone marrow are functional healthy，WBC\>4.0×109/L，PLT\>100×109/L Hb\>10g/dL;Cr\<1.8mg/dL，bilirubin\<1.5mg/dL，GPT\<1.5 upper limit of normal
* No vital systems dysfunction or malnutrition
* No other malignant diseases in 5 years（except non melanoma or Cervical carcinoma in situ）
* Have never accepted radiation therapy、overall chemotherapy or biotherapy
* Know the whole protocol，Voluntary participate and sign a consent form

Exclusion Criteria:

* Tumor has violated the surrounding tissue organs（T4）
* Preoperative have evidence of distant metastasis including the contralateral mediastinal lymph nodes
* Arrhythmia need anti-arrhythmic treatment（except for β-blockers or digoxin），Symptomatic coronary artery disease and myocardial ischemia (myocardial infarction) in the past 6 months or more than NYHA class II congestive heart failure
* Adverse drug control severe hypertension
* Moderate to severe proteinuria
* History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other active clinical severe infection
* Cachexy,organ function decompensation
* History of chest radiotherapy
* Not fully control the eye inflammation
* Epilepsy patients needed treatment（such as Steroids or antiepileptic cure）
* Interstitial pneumonia
* Drug abuse and medical, psychological or social conditions may interfere with the patients involved in the research or have an impact on the results of evaluation
* Known or suspected to study drug allergy or to give any drug allergies associated with this test
* Any unstable situation or may endanger the patient safety and compliance
* Fertility and pregnancy or lactation women, and have not been sufficient precautions
Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female, aged (18-70) years
* Belongs to American Society of Anaesthesiologists physical status class II.
* Scheduled for breast cancer surgeries.

Exclusion Criteria:

* Patient refusal.
* Local infection at the site of the block.
* Cardiac dysfunction (ejection fraction \<45%).
* Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device.
* Allergy to one of the study drugs.
* Pregnancy.
* Coagulopathy (PC \<60% and platelet count\<100.000).
Partial Caries Removal in Permanent Molars Restored Using Giomer

Dental manufacturers\&#39; constant tweaks and improvements to composite compositions have resulted in a wider spectrum of restorative materials with positive long-term clinical performance. For example, the creation of bioactive giomer material with proven continuous multi-ion release has been beneficial in avoiding demineralization and imparting acid resistance to enamel and dentin.

Giomer resin not only reduces the risk of secondary caries around restorations by releasing fluoride ions, but it also has good esthetic, physical, and handling features. Furthermore, advancements have been made to reduce giomer resin polymerization shrinkage by incorporating filler technology into the matrix system. As a result of these efforts, giomer resin is currently distinguished by its low shrinkage feature. According to the manufacturer, low shrinkage giomer resin has volumetric shrinkage of 0.8% and a polymerization shrinkage stress of 2.72 MPa. Several investigations were carried out to examine the overall clinical performance of low shrinkage giomer resin with equivalent success rates when compared to other restorative materials. The aim of the current study is to evaluate the effect of giomer in maintaining pulp health and dentin bridge formation after partial caries removal in permanent teeth with deep occlusal carious lesion when compared to resin composite restoration.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria of participants:

   * 18 -35 years.
   * Not received antibiotic therapy since 1 month before sampling.
   * Males or Females (Both genders).
   * Co-operative patients approving the trial.
   * Good to fair oral hygiene
2. Inclusion criteria of teeth:

   * Class I cavitated lesions in permanent molars (reaching \&gt;1/2 of the dentin on radiographic examination)
   * Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).

Exclusion Criteria:

1. Exclusion criteria of participants:

   * known allergic reaction to resinous materials.
   * Systemic disease or severe medical complications.
   * Periodontal problem.
   * Bruxism
   * Poor oral hygiene
2. Exclusion criteria of teeth:

   * Class II caries lesion
   * Shallow or enamel caries
   * Teeth with periapical lesions.
   * Mobile teeth, arrest caries and non-vital teeth
Conservative Treatment For Ventral Hernia

The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.


Eligibility Criteria:
Inclusion Criteria:

All patients (older than 18 years) referred to the Surgical Department of Køge University Hospital from 2009 - 2014 with the diagnosis ventral hernia
Local Infiltration Analgesia During Total Knee Arthroplasty

The primary objective is to evaluate whether local infiltration analgesia (LIA) will reduce oxycodone consumption during the first 48 postoperative hours in patients undergoing total knee arthroplasty (TKA).

The goal of LIA is to gain an effective and safe pain control during the first postoperative days. The study is a single-center, randomized controlled trial, which will be performed in Coxa Hospital for Joint Replacement in Tampere, Finland. The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline with occasional variations if the patient is unusually small, very elderly, infirm or has a history of significant intolerance to analgesics or anesthetic agents. The RKA mixture is diluted with normal saline. Total volume of the solution is 100 ml depending on the size of the wound. The normal saline injection are used in the control group in the same manner than in the RKA group.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring primary TKA for primary OA
* Patients aged 75 years or less
* Patients suitable for all applicable devices

Exclusion Criteria:

* Rheumatoid arthritis or other inflammatory diseases
* Patients requiring bone grafting during surgery
* Unwilling to provide informed consent
* BMI \> 35
* ASA \> 3
* Renal dysfunction
* Allergic to ASA
* Previous high tibial osteotomy or previous osteosynthesis
* \> 15 degrees varus / valgus malalignment
* Physical, emotional or neurological conditions which would comprise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
* Known sensitivity to materials in the devices
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.

One of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. This is an important safety aspect for the patient.

Main study question: In patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?


Eligibility Criteria:
Inclusion Criteria:

* neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
* operability given based on general medical condition
* informed consent

Exclusion Criteria:

* antiplatelet drugs stopped \<7days (except acetylsalicylate \<= 100mg p.o. qd)
* prothrombine time \<70%
* age \<18 years
* patronized Patients
* pregnancy
* severe poor medical condition
Assessing Patient Confidence in Biologic Medications

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).

Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with psoriasis (ICD-9: 696.1)
* Age 18-80

Exclusion Criteria:

* Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
* Currently or previously managed with a biologic medication
Post-exercise Dietary Protein Strategies

Protein ingestion increases the rate at which the body builds new proteins in skeletal muscle (muscle protein synthesis. This study is designed to examine how the pattern of feeding affects muscle protein synthesis following resistance exercise. There is reason to believe that the large rapid increase in blood amino acid concentrations that accompanies the ingestion of a bolus of protein is important to increasing muscle protein synthesis. Thus, we hypothesize that the consumption a bolus of protein will elevate muscle protein synthesis to a greater extent than the consumption of an equivalent amount of protein that is consumed in small divided doses.

The rapid appearance into the blood of essential amino acids, and leucine in particular, may act as an important signal to stimulate muscle protein synthesis after resistance exercise. This may explain why consuming rapidly-absorbed whey protein may have an anabolic edge over slowly-absorbed proteins such as casein. Previous investigations into importance of the rate of absorption to muscle protein synthesis that have used 'fast' and 'slow' proteins have been confounded by differences in amino acid composition. The present study addresses this issue by administering the same protein source, whey, as either a bolus or in small divided 'pulse' doses to achieve divergent amino acid profiles after a bout of resistance exercise.

This study is being conducted in young (18-35) men.

Our outcome measures include: blood amino acid concentrations, rates of myofibrillar protein synthesis, anabolic intracellular signalling markers

Eligibility Criteria:
Inclusion Criteria:

* Non-obese men (BMI \<27) between the age of 18 and 35 yrs.

Exclusion Criteria:

* Type II diabetes or other known diseases
* Use of medication
* Female
* Other ages or BMI than indicated above
* Resistance training \> 3X/wk
Fermented Iron-rich Supplement in Reducing Anemia

The consequences of iron deficiency anemia in women are enormous, and especially in developing countries, as the condition adversely affects both their productive and reproductive capabilities. The study seeks to: 1) compare changes in iron status indicators among women receiving an iron-rich organic food supplement versus ferrous sulfate supplement, and 2) determine the suitable level of food supplement needed to prevent/reduce iron deficiency anemia among women in developing country settings.

A double-blind, randomized, controlled, intervention trial will be implemented in women of childbearing age, 60 women with iron deficiency anemia and 60 women with iron deficiency. After screening potential subjects (up to 500 expected), approximately 30 will be recruited into each of four study groups; assuming 30% dropout rate, to detect an increase of 30% in ferritin as significant between the two time points at 80% power and alpha value of 0.05. Subjects who meet the inclusion criteria will be randomized into the four groups consisting of: 2 control groups (daily 60mg ferrous sulfate (FS-60) or daily 10mg ferrous sulfate (FS-10)), and 2 test groups (daily 60mg iron-rich supplement (IRS-60) or 10mg iron-rich supplement (IRS-10)). Subjects will take daily FS-60 and IRS-60 under supervision for 8 weeks while subjects taking FS-10 and IRS-10 will take the supplement under supervision for 12 consecutive weeks.

The design will involve screening of about 500 female adult students and staff of the University of Ghana who meet initial the inclusion criteria. Screening will involve pregnancy testing, assessment of hemoglobin, and ferritin and also administration of a health history questionnaire.

Thereafter, 120 eligible subjects will enrolled and randomized to recieve the treatment. All subjects will complete 3-day dietary record (including 2 weekdays and 1 weekend) at baseline and at endline (i.e. one week prior to treatment completion). The dietary data will be analyzed using nationally-generated food composition tables together with the ESHA food processor software. In addition, body weight and height will be measured using standard methods at baseline and end of the study. Weekly monitoring of side effects will be recorded. Fasting blood samples will be collected at baseline and endline to enable determination of anemia status and other indicators including serum ferritin, transferrin receptor and full blood count, together with C-reactive protein.

Eligibility Criteria:
Inclusion Criteria:

* 18-49 years
* Regular menstruation in the last three months
* Hemoglobin \<12 mg/dl;
* Serum Ferittin\<20mcg/L
* BMI 18.5Kg/m\^2 to 29.9 kg/m\^2

Exclusion Criteria:

* history of gastrointestinal or hematological disorders,
* taking medications that could interfere with hematopoiesis or dietary iron absorption
* pregnant (based on pregnancy test).
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have non-sustained or sustained VA (VA ≥ 30s or receiving appropriate ICD therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes.
* The causes of VA are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia).
* Subjects are 18 years of age and older.

Exclusion Criteria:

* Female patients who is pregnant or of childbearing potential and not on a reliable form of birth control.
* Allergic to skin patch electrodes.
* Vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With Endovascular Therapy (INSIST-ET)

To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who received recanalization operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Acute ischemic stroke patients who is eligible for endovascular treatment;
3. Signed informed consent.

Exclusion Criteria:

1. Modified Rankin Score \>2 caused by a history of prior stroke;
2. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<80000/mm3);
3. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
4. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
5. Unsuitable for this clinical studies assessed by researcher.
Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System

The purpose of this study is to:

* determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
* analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.


Eligibility Criteria:
Inclusion Criteria:

* ASA status 1 and 2.
* Consent approval written and oral.
* Patients scheduled for elective abdominal surgery under general anesthesia.

Exclusion Criteria:

* Patients with neuromuscular disorders.
* Patients with history of stroke, flaccid paralysis or other neurological disorders.
* Significant renal, hepatic or cardiac dysfunction.
* Consent refusal.
Pilot Study Freeze and Transport Immune Cells

To evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants

To evaluate: 1) The procedures for obtaining umbilical cord blood; 2) the methods for ensuring immune cell viability, freezing, and shipping; 3) the conditions for optimization of immune cell isolation procedures.

Eligibility Criteria:
Inclusion Criteria:

For the portion of the pilot study conducted at the UCLA CVR, an umbilical cord blood sample will be obtained from approximately 8 to 12 healthy pregnant women who are delivering neonates at the Obstetrical delivery ward of Harbor- UCLA Medical Center. Informed consent will not be obtained because the blood will be obtained after delivery from a clamped umbilical cord attached to the placenta (afterbirth) that otherwise would be discarded.

Exclusion Criteria:

A cord blood sample will not be collected from women who have requested special arrangements for a cord blood registry service.
Omega 3 in LES and APS

It has been demonstrated that EPA and DHA supplementation may have anti-inflammatory properties in several chronic diseases, namely, diabetes, obesity, and in rheumatoid arthritis, although not with controversy. Systemic lupus erythematosus (SLE) and Antiphospholipid Antibody Syndrome (AAS) are autoimmune diseases characterized by a chronic inflammatory state which is associated with the disease´s clinical symptoms. Thus, we hypothesized that EPA and DHA supplementation may beneficially affect the inflammatory cytokine profile and clinical features of LES and AAS patients.


Eligibility Criteria:
Inclusion Criteria:

• Age between 7 and 40 years

Exclusion Criteria:

* Cardiovascular dysfunction
* Rhythm and conduction disorders
* Musculoskeletal disturbances
* Kidney and pulmonary involvements
* Peripheral neuropathy
* Use of tobacco
* Treatment with lipid-lowering or hypoglycemic drugs
* Fibromyalgia
* Use of chronotropic or antihypertensive drugs
* Physically active subjects