cyrilzakka/clinical-trials huggingface dataset:
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.


Eligibility Criteria:
Inclusion criteria:

* Documented history of mild or intermittent asthma
* Have PEF and FEV1\>80% predicted
* Not a smoker
* BMI of 19 - 29

Exclusion criteria:

* Have had a life threatening episode of asthma
* Have had a respiratory tract infection in the last four weeks
* Have other respiratory disease
* Have taken certain medications within restricted time periods
Bariatric Surgeries in Elderly

an examination of the different aspects of bariatric surgery in elderly in comparison with non-elderly patients.

the study examines the success rate, complications, revisions, days of hospitalization and co-morbidities in elderly and in non-elderly patients that underwent bariatric surgery in our medical center

Eligibility Criteria:
Inclusion Criteria:

bariatric surgery

Exclusion Criteria:

below 18 years old
Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer

Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.

Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days.

The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years old
2. Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
3. Patients with distant metastases or postoperative recurrence
4. EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
5. At least one line of platinum-based doublet chemotherapy was administrated
6. Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1
7. At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors)
8. Asymptomatic brain metastases or symptomatic brain metastases under control
9. If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications

11) Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis

Exclusion Criteria:

1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
2. Suffering from other malignant tumors within five years
3. EGFR, ALK sensitive mutations are positive or unknown
4. ECOG PS≥2
5. Uncontrolled pleural effusion or pericardial effusion
6. Uncontrolled symptomatic brain metastases
7. Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy
8. severe interstitial pneumonia with severe diffuse dysfunction
9. Autoimmune diseases require long-term hormone therapy patients
10. Patients required consistent application of prednisone
11. Uncontrolled pulmonary infection or antibiotics stopped within 1 month
12. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month
13. Patients during pregnancy or lactation
14. Life expectance of 3 months or less
Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair

A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method


Eligibility Criteria:
Inclusion Criteria:

* With mild to severe cleft lip deformity requiring repair.
* Neonates up to 1 year of age.
* Patients with or without cleft palate.
* Systemically healthy patients.
* Patients follow postoperative instructions provided by their legal guardians.

Exclusion Criteria:

* Patients with a syndromic type of cleft lip.
* Patients suffering from relevant systemic and metabolic diseases.
* Patients suffering from immunosuppressive diseases.
* Patients suffering from neuromuscular disorders like Myasthenia Gravis.
* Patients with special needs.
Zero-time Exercise for Depression

This study will examine the feasibility and effectiveness of a new lifestyle-integrated exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep disturbances, and sedentary lifestyles is associated with depression. The conventional psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT), emphasises the relationship between activity and mood. One of the treatment components in CBT for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to initiate simple behaviour change as an entry-level step for facilitating BA for participants with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the effectiveness of ZTEx for the management of depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18-65 years
* Cantonese language fluency
* Patient Health Questionnaire (PHQ-9) score ≥ 10 and ≤ 14; and
* Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

* Pregnancy;
* Have high levels of suicidal ideation (referral information to professional services will be provided);
* Unstable psychotropic drugs within 2 weeks before study entry and throughout the treatment phase;
* Current involvement in psychotherapy for depression;
* Having unsafe conditions and are not recommended for exercising by physicians; and
* Major psychiatric, medical or neurocognitive disorders that would make participation infeasible or interfere with the adherence to physical exercising.
Improving Health Behavior and Outcomes After Angioplasty

The objective of this randomized trials is to evaluate, among coronary artery disease patients who have just had either angioplasty or stents, whether a novel intervention based on feedback of individualized risk profiles framed as the opportunity to reduce one's biological age is more effective after two years in reducing mortality and major cardiovascular morbidity (specifically, myocardial infarction, stroke, class II-IV angina, and severe ischemia) than the standard risk reduction approach, which is framed as one's opportunity to reduce future risk. The novel strategy is based on the theory of net-present value and is tested in coronary artery disease patients who have a high risk of adverse outcomes by two years.

1. To determine whether patients who receive the net-present value intervention have more improvements in their risk factor profile than those in the control group at two years.
2. To determine whether the net-present value intervention will enable patients to sustain behavioral change over the long-term.
3. To determine whether the net-present value intervention will improve overall functional status and prevent further disability.

The long-term objective of this study is to determine whether a net-present value approach for motivation behavior change is effective in reducing risk factors, improving treatment outcomes, and enhancing quality of life among a high-risk group of patients.

Eligibility Criteria:
Inclusion criteria:

* All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment. Patients must be able to provide informed consent within the one week after the procedures.

Exclusion criteria:

* Patients must be verbally fluent in English. To ascertain this, we ask the patient to rate their fluency on a scale of 1-10 (with 10 as best), and if the score is 7 or more, they are approached for consent. The patient must be able to provide their own consent without translation.
* Enrollment in other trials designed to modify post-procedure behaviors.
* Patients who refuse to participate will be excluded.
* If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.
AMD3100 Plus Mitoxantrone, Etoposide and Cytarabine in Acute Myeloid Leukemia

This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML.

We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.

The interaction of leukemic blasts with the bone marrow microenvironment is postulated to be an important mediator of chemoresistance in AML. Although a number of receptor / ligand pairs have been implicated, the CXCR4 / SDF-1 axis functions as the principal regulator of homing and retention of both normal and malignant hematopoietic cells in the marrow. AMD3100 is a bicyclam molecule which reversibly blocks CXCR4 binding to SDF-1 and is being developed clinically as a mobilization agent for hematopoietic stem cell transplantation. Preclinical data from our group has demonstrated that in murine models, plerixafor can disrupt the interaction of leukemic cells with the marrow microenvironment and sensitize blasts to the effect of chemotherapy. Based on these data, we have initiated a phase I/II study in patients with relapsed or refractory AML in which plerixafor is administered prior to salvage chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Acute myeloid leukemia diagnosed by WHO criteria with one of the following:

   1. Primary refractory disease following \>= 1 rounds of induction chemotherapy
   2. First relapse or higher
2. Age between 18 and 70 years of age
3. Adequate organ function defined as Creatinine \<= 1.5 x institutional ULN; AST, ALT, total bilirubin \<= 2 x ULN; Left ventricular ejection fraction of \>= 40% by MUGA scan
4. Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
5. Able to provide signed informed consent prior to registration on study

Exclusion Criteria:

1. Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
2. Peripheral blood blast count \> 20 x 103 /mm3
3. Active CNS involvement with leukemia
4. Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
5. Pregnant or nursing
6. Receiving any other investigational agent
7. Colony stimulating factors filgrastim, pegfilgrastim or sargramostim within 2 weeks of study
8. Less than 2 weeks from the completion of any previous cytotoxic chemotherapy
9. Severe concurrent illness that would limit compliance with study requirements
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients

A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients

1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis B aged 18 years or older
* Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit
* Subjects who have HBsAg positive test at screening visit
* Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test
* Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening

Exclusion Criteria:

* Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus
* Subjects with creatinine clearance of less than 50 ml/min at the screening visit
* At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma
* Subjects with decompensated liver disease who meet the following criteria:

  1. Total bilirubin levels greater than 2.5 mg/dl
  2. Prothrombin time is at least 3 seconds longer than normal upper limit
  3. Serum albumin value less than 30 g/l
  4. Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer

The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.

Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.

Every week that chemotherapy is given, blood tests and vital signs will be taken.

After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.

CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.
* ECOG performance status of \< 1
* \> 4 weeks since completion of previous chemotherapy
* \> 4 weeks since participation in any investigational drug study
* Peripheral neuropathy of grade \< 1
* Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Hemoglobin \> 9.0gm/dl
* Platelets \> 100,000/mm3
* Total bilirubin \< 2.0mg/dl
* AST and alkaline phosphatase \< 5 x upper limit of normal (ULN)
* Albumin \> 2.5gm/dl
* CA 19-9 \> 1.5 x ULN

Exclusion Criteria:

* Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
* More than one prior chemotherapy treatment
* Clinically significant cardiac disease
* Major surgery within 4 weeks of the start of study treatment
* Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
* Uncontrolled serious medical or psychiatric illness
* Pregnant or breast-feeding women
* Other active malignancy
* Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
* Known severe hypersensitivity to Iressa
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
* History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
* Any evidence of clinically active interstitial lung disease
* Ascites requiring paracentesis
Injectable Platelets Rich Fibrin Versus Hyaluronic Acid for Alveolar Ridge Preservation

Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.

The aim of this study was to compare injectable platelets rich fibrin (I-PRF) versus hyaluronic acid (HA) in combination with xenografts for ARP. Methods: Thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had ARP either with I-PRF with xenograft, HA with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. The assessment was done by cone beam CT preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. Clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. Histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%

Eligibility Criteria:
Inclusion Criteria:

* non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar)
* socket type I according to Elian et al., 2007 classification
* tooth to be extracted was free from acute periapical infection or sinus tracts
* thick gingival biotype
* Systemically free according to modified Cornell medical index

Exclusion Criteria:

* smokers patients
* bruxism habits
* patients with poor oral hygiene or not willing to perform oral hygiene measures
Neurofeedback and Computerized Cognitive Training in Different Settings for Children and Adolescents With ADHD

Attention deficit/hyperactivity disorder (ADHD) is among the most common childhood-onset psychiatric disorders, with a negative and long-lasting impact on academic achievement, social integration and quality of life. In recent years, the efficacy of non-pharmacological treatments for ADHD, such as neurofeedback training (NF) and computerized cognitive training (CCT), has been at the centre of research. Although an increasing number of well-designed studies have shown that both methods may improve ADHD core symptoms according to parents' ratings, the underlying mechanisms are still a matter of debate. Teachers often report smaller improvements, if any. This has been explained by their lesser involvement in the training. It remains questionable, however, whether other factors may also account for this effect and whether methods other than placebo control may be applied in order to demonstrate the specificity and efficacy of NF and CCT.

The main purpose of this project is to demonstrate and compare the efficacy of two different computer-based treatment methods for children and adolescents with ADHD, namely NF and CCT, and to examine the impact of different treatment settings, with half of the participants being trained in a clinical setting and the other half at school. The investigators want to show that is feasible to implement NF and CCT in a school setting and that both methods, conducted either at school or in a clinical setting, may lead to significant improvements of ADHD symptoms as well as to specific and differential effects. Besides the differential impact of the settings on informant ratings, the investigators will evaluate the effects of the training methods on neuropsychological and electrophysiological outcome. Classroom behavior of the children before and after the training will be evaluated by trained observers not informed on treatment assignments and settings.


Eligibility Criteria:
Inclusion Criteria:

* ADHD (DSM IV)

Exclusion Criteria:

* Estimated IQ \< 80
* Known neurological impairment / brain injury
* Severe comorbid conditions (e.g. CD, ODD, autism)
Videoscope Guided Flexible LMA Insertion

Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its unique design. The flexometallic tube allows it could be used in head and neck related surgery but also make insertion more difficult. The ideal position of LMA Flexible is important because in most case, the surgery requiring LMA Flexible allows movements of the stem or patient's head during operation without dislodgement of LMA Flexible. Several studies have examined different techniques like assisting LMA Flexible with rigid introducers or lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital manipulation technique in regard to the ideal anatomical position and sealing pressure in anesthetized adult patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American society of anesthesiologist) physical status classification system I and II,
* scheduled to elective general anesthesia with the use of LMA

Exclusion Criteria:

* suspected difficult airway
* a history of a recent upper airway tract infection
* gastroesophageal reflux
* body mass index \> 30 kg/m2
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.

Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance \< 50 ml/min and who are not dialysis dependent.

Exclusion criteria:

* Cardiogenic shock or hypotension with systolic BP \< 90 mmHg.
* Patients with acute or chronic aortic dissection.
* Patients who are enrolled in other studies that have an effect the renal function.