cyrilzakka/clinical-trials huggingface dataset:
Ma-Spore ALL 2020 Study

The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.

This is a multicenter open-label phase II study involving children and young adult (\< 41 years old) who are newly diagnosed with B-ALL and treatment naïve. There will be 3 parallel cohorts whose risk to be stratified based upon leukemia genetics profiles and patient's treatment response:

1. Standard Risk (SR)
2. Intermediate Risk (IR)
3. High Risk (HR)

All drugs being used are commercially available chemotherapy drugs. There will be no novel chemotherapeutic agent without marketing authorization being tested in this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Has been diagnosed with B-lineage ALL as evidenced by:

   1. BMA blasts \> 20% AND
   2. Leukemic process in the bone marrow, peripheral blood or any extra medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically
2. Age \< 41 years of age at enrolment
3. Written informed consent obtained from patient or legally acceptable representative (LAR)

Exclusion Criteria:

1. T-lineage ALL
2. Down syndrome with ALL
3. History of previous malignancies or this ALL is a second malignancy
4. Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
5. Mature B-cell leukemia/lymphoma
6. Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient pre-treated with short term steroid (\< 7 days of duration within last 1 month prior to ALL treatment start) may be enrolled after discussion and written approval from PI. These patients should be treated on at least intermediate arm.
7. Persistent renal dysfunction with creatinine more than upper limit of normal for age before start of induction therapy. Patients requiring temporary dialysis without persistent renal dysfunction can qualify.
8. Liver dysfunction with direct bilirubin \> 10x upper normal limit for age.
9. Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy
10. Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator
Training in the Workplace

We are testing whether various cognitive training procedures can enhance cognition and brain function


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 18-50 years old
* Right handed
* Must have reliable internet access from a desktop computer with webcam
* English speaking

Exclusion Criteria:

* Neurological conditions
* pregnancy
* metalic implants
Safety of Total Knee Replacement Surgery Before and After the Implementation of Enhanced Recovery Program

The objectives are to describe the transition from traditional care to an enhanced recovery program for the management of total knee arthroplasty, and to evaluate the effect on patient outcomes.

Enhanced recovery programs are an organizational evolution in surgical patient management, in which the patient becomes an actor of his or her own recovery. This multimodal approach aims at optimizing patient physiological and psychological states across preoperative, intraoperative and postoperative domains of care.

At la Rochelle hospital, the decision to take the step happened at the end of 2016. It was proposed by a young surgeon that have been trained on this new approach during his studies and who convinced the head of the surgery department of the benefits for the patients, the healthcare workers, and the institution. The transition took place in two stages, first operative and postoperative techniques were modified, and then preoperative education and counselling were added.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated on for posterior-stabilized total knee arthroplasty between January 2015 and December 2018
* unilateral arthroplasty
* a known address for mailing the study information letter

Exclusion Criteria:

* revision arthroplasty
* patients who refused to the use of their data
dCBTi With and Without Coaching Support

The current research aims to evaluate the adherence and efficacy of dCBTi with different types of coaching support.

Participants will be randomly assigned to one of the five conditions. C1: Sleep Hygiene and Self-Monitoring Control Condition; C2: dCBTi without coaching; C3; dCBTi with virtual coaching; C4: dCBTi with non-therapist coaching; C5: dCBTi with therapist coaching.

Question 1:

Does dCBTi work better than the active control?

Hypothesis 1:

Participants in C2, C3, C4, and C5 will have greater improvement in insomnia than those in C1.

Question 2:

Does coaching support, virtual or human, improve treatment adherence and outcome?

Hypothesis 2:

Participants in C3, C4, and C5 will have greater improvement in insomnia and greater adherence to treatment recommendations than those in C2.

Question 3:

Does human coaching enhance treatment adherence and outcome?

Hypothesis 3:

Participants in C4 and C5 will have greater improvement in primary outcome than those in C3.

Question 4:

Does therapist-coaching-support enhance treatment adherence and outcome to a greater extent than virtual and non-therapist coaching support?

Hypothesis 4:

Participants in C5 will have greater improvement in primary outcome than those in C3 and C4.

Eligibility Criteria:
Inclusion Criteria:

* (a) Hong Kong resident,
* (b) Aged 18 or above,
* (c) Able to read and write Chinese,
* (d) Has regular access to a smart phone and internet,
* (e) insomnia severity index ⩾10;
* (f) Willing and can be contacted by experimenter via phone between 9 am - 9 pm

Exclusion Criteria:

* (a) significant untreated/unstable mental or medical illness,
* (b) known factor to interfere with participation in this research,
* (c) serious medical, neurological, or psychiatric illness that may affect participation in this research,
* (d) sleep apnea,
* (e) concurrent treatment for insomnia,
* (f) unstablized medication that can affect sleep
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma

Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC. In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse effects rate and quality of life. This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70 ears ;
* Eastern Cooperative Oncology Group performance status of 0-1;
* diagnosed with first-treated NPC (Ⅲ/Ⅳa stage) confirmed by pathology;
* ecurrent and metastatic NPC with indication of chemoradiotherapy;
* one measurable lesion at least (according to the RECIST guidelines, the lesion iameter≥20 mm with MRI);
* life expectancy of ≥ 12 weeks;
* adequate hematologic, renal, cardiac and liver function;
* hemameba≥4.0×109/L;
* neutrophil≥2.0×109/L;
* platelet≥100×109/L;
* hemoglobin≥95g/L;
* Serum bilirubin, ALT and AST ≤1.5 times of maximum criteria;
* sufficiently understand this study situation and signed the informed consent.

Exclusion Criteria:

* allergy or intolerance to study drugs;
* receiving other anti-cancer therapy;
* uncontrolled central nervous system lesions;
* dysfunction of important organs；
* history of cardiovascular disease(including congestive heart-failure, uncontrolled arrhythmia, angina pectoris which require long-term drug treatment, lular heart disease, myocardial infarction and resistant hypertension);
* pregnancy or lactation in women;
* protracted Infective wound;
* history of mental illness which is not easy controlled.
Study of the Effects of Plx on Bioparametric Measurements.

The main objective is to study the effects of the intake of a nutraceutical on health indicators, focused on sleep and stress, as well as cardiovascular (blood pressure...), circulating (cortisol) and body composition parameters in a Spanish adult population.

Anxiety is a normal part of life, and generally is a temporary condition. However, anxiety can occasionally prolong in time, having an impact on everyday activities, and give rise to other conditions, such as depression, drug abuse, cardiovascular disease, and insomnia. There are a number of synthetic drugs that are commonly used to treat anxiety. These are mainly antidepressants and benzodiazepines. However, their high cost, important side effects and a rising interest in natural solutions have driven researchers to search for botanical-based formulas. To this end, there are a number of plants that have been described to possess potential sedative and anxiolytic effects. Of note is lemon verbena (Lippia citriodora), which is native of Western South America but is also cultivated in the Mediterranean region and Middle East.

Eligibility Criteria:
Inclusion Criteria:

1. Over 21 years of age;
2. Without any chronic pathology;
3. Score on the Spielberg Trait-State Anxiety Inventory (STAI-S) comprising 20 items, greater than 40 (probable clinical levels of anxiety);
4. Pittsburgh Sleep Quality Index (PSQI) score greater than 5 (poor sleep quality).

Exclusion Criteria:

* Failure to meet the inclusion criteria.
Comparison Bioavailability Study of Quinine Sulfate in Chocolate Pudding

This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648 mg(2 x 324 mg) when mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules.

Prior studies have shown that intact quinine sulfate capsules can be taken without regard for food. This is an open label randomized single dose two-way crossover study to compare the bioavailability of a single oral dose of quinine sulfate 648mg(2 x 324 mg capsules) when opened and mixed with 120 ml of chocolate pudding relative to the same dose given as two intact capsules. Eighteen healthy adult subjects will be enrolled. Following a fast of at least 10 hours subjects will be randomized to receive either 648 mg of quinine sulfate as the intact capsules or opened mixed in 120ml of chocolate pudding. Following a washout period of at least 7 days all subjects will be given the alternate dose under similar conditions. Following each dose, blood samples will be collected at times sufficient to determine the difference in bioavailability (if any) between the two methods of drug administration. In addition patients will be monitored for any adverse events including Electrocardiogram (EKG) changes (at baseline and 4 hours after each dose).

Eligibility Criteria:
Inclusion Criteria:

* Healthy nonsmoking adults with hemoglobin at least 12 g/dl. Males at least 52 kg, females at least 45kg with body mass index in the normal range, females must be chemically or surgically sterile or postmenopausal (amenorrhea at least 2years)

Exclusion Criteria:

* Pregnant or lactating
* Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) Recent (1-year) history or evidence of alcoholism or drug abuse History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease, myasthenia gravis, optic neuritis or Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Prolonged corrected QT interval(QTc) on Electrocardiogram(EKG) at screening -males \>430 msec, females \>450 msec.

PR interval on EKG \>200 msec at screening or prior to dose in either dosing period

* Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 30 days prior to the first dose and throughout the study
RESECTED LYMPH NODES AND SURVIVAL OF PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA: AN OBSERVATIONAL STUDY

To clarify the effect of the number of lymph node dissection and the number of stations on survival


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18-85;
2. Histologically confirmed primary thoracic esophageal squamous cell carcinoma,
3. Staging PT1-4A, N0-3, M0 AJCC eighth edition;
4. Excluding lymph node dissection \< 15,(meeting the guideline criteria)

Exclusion Criteria:

1. Patients with a history of previous thoracic and abdominal surgery that may affect lymphatic reflux
2. Patients with distant metastasis confirmed by imaging;
3. Patients with obvious surgical contraindications.
Effect of Continuing Versus Holding Metformin During Hospitalizations.

A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.

The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes.

The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Admitted to an internal medicine service.
* On Metformin prior to admission.

Exclusion Criteria:

* Inability to take oral medications
* eGFR \< 30 ml/min/1.73 m2
* Dialysis
* Current Acidosis (pH \< 7.35) including diabetic ketoacidosis
* Child-Turcotte-Pugh class C hepatic cirrhosis
* Acute Decompensated Heart Failure
* Cognitively impaired and/or unable to consent
* Lack of or unwillingness to share contact information
* Pregnant women
Myocardial Work and Metabolism in CRT

Several attempts have been made to refine selection criteria for cardiac resynchronisation therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously proposed parameters probably do not sufficiently reflect the underlying mechanical dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that better candidate selection can rely on the direct observation or measurement of this LV mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate regional myocardial workload and metabolism, and determine their predictive value in CRT response.


Eligibility Criteria:
Inclusion Criteria

Subject is eligible for CRT implantation according to current European Society of Cardiology guidelines of 2013.

* The patient should receive guideline-directed optimal medical therapy for heart failure and left ventricular (LV) function must be severely depressed (LV ejection fraction ≤35%).
* The patients should be in NYHA functional class II, III or ambulatory IV.
* The patient should present a left bundle branch block (LBBB) with QRS duration of \>120ms or a non-LBBB with QRS \>150ms.
* Also patients with conventional pacemaker in NYHA functional class III and ambulatory IV if high percentage of ventricular pacing, are eligible for CRT implantation.
* Subject is in stable sinus rhythm at the time of CRT implant and during the last 2 weeks prior to inclusion.
* Subject is 18 years or older and able and willing to consent.

Exclusion Criteria:

* Impossible to obtain LV volumes by echocardiography.
* Right bundle branch block.
* Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm).
* Recent myocardial infarction, within 40 days prior to enrolment.
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
* Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year.
* Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year.
* Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period).
* Complex and uncorrected congenital heart disease.
* Breastfeeding women, women of child bearing potential.
* Enrolled in one or more concurrent studies that would confound the results of this study.
Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to determine the effectiveness of an intervention conducted by a pulmonary nurse in patients with COPD.

The hypothesis is that in a sample of COPD patients with clinically relevant problems in health status (physiological functioning, symptoms, functional impairment and quality of life), a motivational intervention conducted by a pulmonary nurse will lead to patient-tailored treatment and an improved health status.

Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow that is not fully reversible. Besides problems in physiological functioning, the patient also can experience symptoms, functional impairment and a diminished quality of life (see Vercoulen et al., 2008). Problems in the three latter domains of health status are hardly recognized in usual care, and remain untreated until escalated. This is mainly caused by two phenomena: doctor delay and patient delay. Doctor delay: the physician does not directly identify symptoms, functional impairment, and problems in quality of life. Patient delay: the patient does not report problems in these health status domains.

What is necessary is a screening instrument that can be used in routine care and identifies patients with problems in the four domains of health status. If clinically relevant problems exists, and additional treatment is recommended, an intervention by the pulmonary nurse is indicated. This intervention is directed at increasing awareness of existing problems and motivating the patient for additional treatment. By means of the screening and intervention, problems in health status are detected and treated early, before escalation. Treatment is patient-tailored, based on the existing problems in the four domains of health status, eventually leading to an improved health status.

A randomized controlled trial is conducted to test the hypothesis described above. Based on the independent clinical interpretation of the PatientProfileChart (see Peters et al., 2009) by three professionals, patients are assigned to one of the following groups: 1. Patients with no clinically relevant problems in health status (group I), and 2. Patients with clinically relevant problems in health status (group II/III). Patients with clinically relevant problems in health status are randomized to a control group (group II: usual care as delivered by the outpatient clinic) and the experimental group (group III: intervention conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, increasing motivation to engage in additional treatment, and improving health status).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* Written informed consent

Exclusion Criteria:

* Not able to adhere to study protocol
* Not competent enough in understanding Dutch language
* Participation in pulmonary rehabilitation program within previous 6 months
* Current participation in other research study in COPD
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.


Eligibility Criteria:
Inclusion Criteria:

* Presence of permanent dentition
* Eligible and scheduled for full mouth fixed orthodontic treatment.
* Class I or Class II malocclusion (no more than ½ cusp in Class II)
* Non-extraction in all quadrants
* Non-smoker, non-use of chewing tobacco
* Good oral hygiene
* No adjunct treatment such as extra or intraoral appliances
* Age 12-40

Exclusion Criteria:

* Pregnant females
* Patient is currently enrolled in another clinical study
* Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
* Periodontally involved teeth
* Use of bisphosphonates
* Unerupted erupted teeth
* Teeth blocked out of alignment and unable to engage initial arch wire
Realization of the Recommendation for Influenza Vaccination in Pregnant Women

Introduction:

In 2010, the vaccination recommendations for pregnant women against seasonal influenza were published by the German Standing Committee on Vaccination (STIKO). This work deals with the immunization coverage and the influencing factors.

Method:

A cross-sectional study was realized at two Level 1 perinatal centers in two German federal states during the influenza saisons 2012/2013 and 2013/2014. Pregnant women were interviewed by using a standardized and pre-tested questionnaire covering their knowledge about the influenza vaccination and other factors influencing the vaccination decision. Furthermore, data from the vaccination card and the pregnancy record booklet have been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women older than 18
* vaccination records
* signatetd letter of agreement

Exclusion Criteria:

* younger than 18