cyrilzakka/clinical-trials huggingface dataset:
New Strategy of Improving Treatment Outcome and Larynx-preservation Rate in Locally Advanced Hypopharyngeal Carcinoma

To develope stratification treatment for the patients who have locally advanced hypopharyngeal carcinoma. Experimental group patients were treated individually according to the response status after induction chemotherapy, receiving chemoradiotherapy or surgery. Thus to achieve a better survival rate and a higher larynx-preservation rate as well as a lower treatment related toxicity rate compared with standard treatment.

Eligiblity patient were assign to induction chemotherapy plus concurrent chemotherapy group (IC +CCRT group, Arm A)and concurrent chemoradiotherapy group(CCRT group, Arm B). For patients in Arm A, treatment response were evaluated after 2cycles, if the response reached partial response/complete response, patients received concurrent chemoradiotherapy, otherwise, patients will received surgery and radiotherpay/concurrent chemoradiotherapy after surgery. For patients received concurrent chemoradiotherapy (both in Arm A and Arm B) , treatment response were evaluated at 50 Gy. if response reached complete response or major partial response(\>80% tumor regression), patients will received radical chemoradiotherapy, otherwise, patients will received surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of hypopharynx
* Stage III/IV M0, with T3/4 N0-3 or T1-4 N2-3
* Karnofsky Performance Status\>=70
* Have measurable lesions on CT/MRI
* Treatment for the first time
* Expected lifetime \> 6 months
* Normal blood test, hepatic and renal functions
* Normal hearing
* Can understand and sign the consent
* Have follow up condition

Exclusion Criteria:

* Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ)
* Previously treatment for cancer
* Pregnant or breeding woman, female without contraception
* Enrolling in other drug trials
* Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes
* Without follow up
* Receive target therapy
Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients

In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

Docetaxel Docetaxel + Gemcitabine

For ever 2 patients treated, 1 will receive treatment A (docetaxel) and 1 will receive treatment B (Docetaxel + Gemcitabine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Biopsy-proven non-small cell lung cancer
* No previous chemotherapy.
* Age \> 65 years
* Age \< 65 years requires significant assistance to perform activities of daily
* Stage IV disease or stage IIIB disease
* Ability to perform activities of daily living with minimal assistance
* Measurable or evaluable disease
* Adequate bone marrow, liver and kidney
* All patients must sign written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Brain metastases
* Meningeal metastases
* Other uncontrolled malignancies
* History of invasive cancer during the last 5 years
* Moderate to severe peripheral neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records

The project includes a systematic review to inform refinement of intervention components and a pilot RCT to determine the uptake, feasibility, and potential value of a hypertension self-management strategy using personal health records. The review follows generally acceptable systematic review and/or meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care. Findings of the review will be used to expand/modify an existing intervention 'template' to yield an evidence-based strategy with potential to enhance self-management of hypertension in primary care. The pilot RCT will assess the utility of the multifaceted intervention, delivered in part via a secure patient-controlled personal electronic health record, compared with the usual family practice management, for patients with undiagnosed or uncontrolled elevated blood pressure. Patients who are hypertensive or identified as high risk are expected to benefit from the increased flexibility and autonomy of out-of-physician-office self-monitoring with self-management support. This initial evaluation will focus on the change in hypertension knowledge, patient self-efficacy, and patient engagement in self management activities after 3 months, in the intervention group compared to the control group; the feasibility and acceptability of the intervention to patients and providers; and the processes involved in linking the patient self-management experience back to the patient's health care providers to promote coordination of care. Secondary outcomes include change in blood pressure, number and content of interactions with providers, and changes in management, including antihypertensive medication.


Eligibility Criteria:
Inclusion Criteria:

* Over 40 years of age
* Diagnosed with HTN, or being monitored for diagnosis, with a systolic BP \>140 (SBP \>130 mmHg if diabetes is diagnosed) at an office visit in the previous 6 months
* Own, borrow or be interested in purchasing a BP measurement device for home monitoring; or visit the clinic for self-assessment using the BpTRUTM (www.bptru.org)or monitor BP with a consistent device at a community pharmacy
* Regular access to email, to receive notices of new messages or prompts/reminders in MyOSCAR
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.

The purpose of this study is to examine whether a behavioural intervention changes attitudes, knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an educational component and use of a mobile smartphone 'app' will increase knowledge and/or intake of vitamin D.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18-25 years
* Must be fluent in English
* Must be currently living in Canada
* Must own iPhone, iPad or iPod Touch running iOS 7.0 or higher (handheld 'app' used in intervention is only available in Apple Store; not available for Android or Blackberry platforms at this time)

Exclusion Criteria:

* Outside age group
* Not fluent in English
* Not living in Canada
* Does not own the specified Apple device
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
* Positive skin testing or IgE determination to the relevant allergen

Exclusion Criteria:

Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline
Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis

Compare the effect of Radiofrequency to long pulsed Nd:YAG 1064 nm laser in treatment of fingernail psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Nail Psoriasis

Exclusion Criteria:

* Manual workers
A Relative Bioavailability Study of Two Formulations of BCX7353

This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect

In this study, 24 healthy subjects will be randomized to receive a single dose of two formulations of BCX7353 and one of the formulations administered with a high-fat meal. A 14-day washout period will separate each dose.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* acceptable birth control measures for male subjects and women of childbearing potential
* complies with all required study procedures and restrictions

Exclusion Criteria:

* clinically significant medical history, current medical or psychiatric condition
* clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
* current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1
* participation in any other investigational drug study within 90 days of screening
* recent or current history of alcohol or drug abuse
* regular recent use of tobacco or nicotine products
* positive serology for HBV, HCV, or HIV
* pregnant or nursing
* donation or loss of greater than 400 mL of blood within the previous 3 months
Comparison of Oxygen Controllers in Preterm InfanTs

Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.

Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. The currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear.

This randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. The primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. This is excluding a 1-hour wash-out period after a change in ventilator.

Eligible infants are randomized to start with either the Oxygenie algorithm or CLiO2 algorithm and will switch to the other study arm after 24 hours of measurement.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
* Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
* Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
* Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
* Written informed parental consent must be present.

Exclusion Criteria:

* Major congenital anomalies
* Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
* If the attending physician considers the infant not stable enough for a switch to another ventilator.
Transanal Decompression Tube Versus Stent for Acute Malignant Left-sided Colonic and Rectal Obstruction

The purpose of this study is to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

Approximately 8-47 % of patients with colorectal cancer will present with colonic obstruction. Left-sided colonic and rectal cancer is responsible for nearly 70% of acute colonic obstruction. Emergency colonic surgery for acute obstruction is associated with a higher mortality and morbidity rate than elective surgery. Preoperative decompression results in a less dilated bowel that is more amenable to an elective surgery. Both transanal decompression tube and stent can serve a good preoperative decompression effect and serve a good bridge to surgery. Investigators aim to compare the clinical outcomes of transanal decompression tube as a bridge to surgery with stent as a bridge to surgery for acute malignant left-sided colonic and rectal obstruction.

Eligibility Criteria:
Inclusion Criteria:

1. definite diagnosis of left-side colonic or rectal obstruction;
2. symptomatic colonic obstruction for less than 1 week;
3. colonic obstruction caused by a histologically proven malignant colonic tumor

Exclusion Criteria:

1. suspected benign colonic or rectal obstruction;
2. right-side colonic obstruction;
3. patients with signs of peritonitis;
4. dysfunction of blood coagulation, active bleeding, active infection, and significant cardiac or pulmonary disease;
5. patients who do not want to undergo surgery.
A Study:the Different Outcomes Between Natural Cycle and Hormone Replacement Cycle in FET

There are three main cycle regimens used for endometrial preparation for frozen embryo transfer（FET）: natural cycles (NC) with/without ovulation triggering, hormone replacement therapy cycles (HRT) in which the endometrium is artificially prepared by estrogen and progesterone hormones with/without a gonadotrophin releasing hormone agonist (GnRH-a) down regulation, and ovulation induced cycles (OI) in which follicular development is supported with increasing doses of gonadotrophin hormones and ovulation is induced. At present, there is still no sufficient evidence that which kind of FET cycle regimen to plan more advantage. The purpose of this study was to compare the pregnancy outcome of NC-FET to that of HRT-FET in women with regular cycles.

This study is a prospective randomized controlled trial. Patients with regular cycles undergoing FET in reproductive medicine renter of Sun Yat-sen Memorial Hospital will be recruited，who should not be elder than 40 and had more than 3 frozen embryos. They will be randomized to receive either the NC-FET cycle (group NC-A) or the HRT-FET cycle (group HRT-B). In group NC-A, the ovulation is monitored spontaneously or induced by human chorionic gonadotropin(HCG) when the dominant follicle is larger than 18mm without luteinizing hormone surge(LH). Transfer of thawed embryos will be performed 4 days after LH /HCG administration or 3 days after ovulation is observed. In group HRT-B, oral estradiol, 2 mg, once daily, is introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness is greater than 7mm, progesterone 40-60 mg in oil will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later. This study was approved by the reproductive medicine ethics committee of Sun Yet-sen Memorial Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age forty years old or less
* Has regulation Menstruation (cycle 24-35 days) or previous data suggest that normal ovulation
* Frozen embryos number more than three

Exclusion Criteria:

* Has Chocolate cyst or adenomyosis of uterus
* Clear hydrosalpinx
* Uterine scar or intrauterine adhesion and endometrial thickness \<7mm before ovulation
* recur thick endometrium（\<7mm）
* repeated implantation failure（≥3 times）
* Cancel the cycle because of having no dominant follicle in the NC+FET before or the growth of endometrium not good in the HRT+FET before
Folate Metabolism in Normal Weight and Obese Women of Child-bearing Age

The purpose of this study is to determine if there is a difference in the short term response in serum folate after a single dose of folic acid in normal weight and obese women of childbearing age.

Current recommendations established in 1998, specify that all women capable of becoming pregnant consume 400 micrograms of folate daily from supplements, fortified foods, or both, in addition to consuming food folate from a varied diet. Despite this recommendation, obese women have a lower folate status than women of normal weight which suggests that obesity may have a negative impact on folate metabolism. Therefore, the objective of this study is to determine if there are differences in the metabolic response to a single dose of folate between normal weight and obese women of child bearing age. The two groups of women will be given the currently recommended amount of folic acid, 400 micrograms, and blood samples will be taken before the vitamin is given and at various points afterwards to determine serum folate response to the folate dose. Results of this research should help determine if folate requirements are higher for obese than for non-obese women. The long-term goal of this and follow-up studies is to generate data that will contribute to the evidence base used by scientific advisory panels to determine whether dietary folate intake recommendations should be based on body weight.

Eligibility Criteria:
Inclusion Criteria:

* Female 18-35 yr
* Caucasian
* Body mass index 18.5 - 24.9 or \> 30 kg/m2

Exclusion Criteria:

* Currently pregnant, pregnancy within the past 12 months
* Greater than 2 previous pregnancies
* Use of prescription drugs other than oral contraceptives
* Chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease)
* Acute illness (e.g. pneumonia, urinary tract infection, mononucleosis)
* Use of antibiotics in past 30 days
* Current smoker
* Use of dietary supplements including multivitamins in the past 30 days
* Significant weight change in past 12 months
* Typical alcohol consumption of 2 or more drinks per day
* Consumption of any alcohol in the week preceding testing
Effect of Bariatric Surgery on Blood Pressure

Bariatric surgery is generally recommended for obese people with a body mass index (BMI) of at least 40kg/m2, and for people with BMI 35 kg/m2 and serious coexisting medical conditions such as diabetes. A variety of studies showed that it cause significant weight loss, recovery from diabetes and improvement in cardiovascular risk factors, such as blood pressure. The recent guidelines suggest that patients with a BMI of more than 30 kg/m2 with co morbidities is a candidate for bariatric surgery. However, the patients with diabetes in Chinese has lower BMI than that in west country. Therefore, this research is designed to observe whether bariatric surgery reduce blood pressure in patients with diabetes and relatively lower BMI.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 60 years old.
* Type 2 Diabetes diagnosis defined according to WHO 2006 guideline.
* Body mass index between 25.0 and 39.9 kg/m2.

Exclusion Criteria:

* Hypertension ≥ 180/120 mmHg;
* Type 1 diabetes, other types of diabetes or gestational diabetes;
* Acute complications of diabetes;
* Cerebrovascular diseases in the last 6 months.
* Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 6 months.
* Baseline psychiatric disorders: schizophrenia, bipolar disorder, severe depression, psychosis.
* Renal diseases: diabetic nephropathy, creatinine clearance \< 30 ml/min.
* Advanced peripheral arterial disease
* Atrophic gastritis
* Alcoholism or use of illicit drugs
* Previous laparotomy
* Severe hepatic disorders
* Pregnancy or women not using effective contraceptive methods.
* Recent neoplasm (\< 5 years)
* Immunosuppressant drugs
* Unable to understanding and follow the study protocol orientations.
Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

The purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in approximately 30 subjects with AL amyloidosis.

The purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2 recommended dose in approximately 25 additional evaluable subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged ≥18 years;
2. ECOG performance status (PS) 0-2;
3. Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible);
4. Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis;
5. Have adequate organ function;
6. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures.

Exclusion Criteria:

1. Secondary or familial amyloidosis;
2. Life expectancy of \< 3 months;
3. Symptomatic multiple myeloma;
4. Hypersensitivities to other monoclonal antibodies;
5. Known HIV infection;
6. Women who are lactating;
7. Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.