cyrilzakka/clinical-trials huggingface dataset:
Phase III Randomized Trial of Adjuvant XP Chemotherapy and XP/RT for Resected Gastric Adenocarcinoma

The objective of the trial is to compare disease-free survival between adjuvant capecitabine/cisplatin alone vs capecitabine/cisplatin with radiotherapy (chemoradiation) in curatively resected gastric cancer patients.

Although gastrectomy is the only potentially curative treatment in gastric cancer patients, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is the relapse after surgical resection. During the past few decades, the principle of combined modality treatment has been developed and applied in practice for various solid tumors and gastric cancer has not been an exception. In an attempt to prevent recurrence and increase the cure rate of gastric cancer patients after surgery, multiple studies using variable modalities have been undertaken. One of the landmark study in adjuvant trials was the Intergroup study INT-0116, which reported a significant improvement in survival with the use of chemoradiation therapy after gastric resection of stage Ib to IV gastric cancers. Thereafter, the chemoradiation therapy has gained popularity and has been increasingly recognized as a standard of care in U.S. Nevertheless, the result from INT-0116 study has been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection.

It is still disputable if chemoradiotherapy after D2 can improve the results of D2 alone. Thus, the assessment of the effect of adjuvant chemoradiotherapy in D2 resected gastric cancer is essential.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven gastric adenocarcinoma
2. ≥ D2 resection
3. Stage IB(T1N1,T2bN0), II, IIIA, IIIB, IV(T4,N3 포함, M1 lymph node 제외)
4. 18 ≤ age ≤ 75
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent

Exclusion Criteria:

1. Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer
2. Active infection requiring antibiotics
3. Pregnant, lactating women
4. Psychiatric illness, epileptic disorders
5. Concurrent systemic illness not appropriate for chemotherapy
6. Resection margin (+)
7. Pathologic stage IA
8. History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
9. M1 lymph node (+)
10. D0, D1 resection
An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have intact skin on the area used in the investigation

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
* Participate in other clinical investigations or have previously participated in this investigation
Cytokeratin 8 Level in Age-related Macular Degeneration

The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.

In this non-randomized, and open-label study, the investigators will prospectively evaluate 58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual (the best corrected visual acuity change) and anatomical (optical coherence tomography parameters) after Ranibizumab injection will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
2. A recent onset of disease confirmed by history and clinical findings.
3. Patient is required to be least 50 years of age

Exclusion Criteria:

1. Myopia with a refractive error \>-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
2. Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
3. History of cataract surgery within 3 months prior to presentation
4. Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
5. Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
6. Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location
How to be Safe With Alcoholic Drinks in Diabetes

The purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin Bolus.

Participants will get two times a height, weight an gender based amount of beer.

One time (Standard) there will be no Insulin given for the beer. Second time (Intervention) half of the carbohydrates containing in the beer will be covered with Insulin, additionally the basal rate will be set to 50% for 12 hours.

All the time, Glucose will be monitored by continuous subcutaneous Glucose Monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by participants
* Signed informed consent by parent or legal guardian of adolescent participants \<18 years of age
* Age between16-21 years (both including)
* \>1 year Type 1 Diabetes
* continuous subcutaneous insulin infusion for at least 3 months
* HbA1c 7-10 % (both including)
* BMI between10-95th percentile for gender and age (both including) for adolescents, \<95th percentile for adults
* Ability to wear glucose sensor
* Normal liver enzymes (alanine aminotransferase , aspartate transaminase , Gamma-Glutamyl-Transferase, bilirubin) in age appropriate range by local lab

Exclusion Criteria:

* Severe hypoglycaemia or diabetic ketoacidosis in the past 6 month
* Alcohol or drug abuse
* Psychiatric disorder
* Unstable other metabolic disease as judged by investigator
* Intake of glucocorticoids or growth hormone
* Allergy to adhesive
* Coeliac disease
* Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
Systemic Prevention and Management for Perioperative Hypothermia and Its Effect on Patients Outcome

This is a randomized, single-blinded, multi-center study clinical trial to determine both clinical and health outcomes of stratified warm strategy to prevent intraoperative hypothermia. Participants enrolled into this trial will be from elective major surgery population in PUMC Hospital, Beijing Hospital and Xuanwu Hospital. investigators plan to enroll approximately 800 participants. Hypothermia risk will be evaluated through PREDICTOR model in all participants. According to hypothermia risk level, these participants will be stratefied into high, moderate and low risk group. Participants in each group will be randomly categorize into warm group and control group. Active warm and fluid warm strategy, prewarm and fluid warm strategy and only prewarm strategy are used for high risk, moderate risk and low risk patients seperately. For controll group traditional passive warm was used.


Eligibility Criteria:
Inclusion Criteria:

Age≥18 Core temperature preoperation ≥36.0 ℃ and ≤37.5℃ ASA I-III Informed consent

Exclusion Criteria:

* emergency operation
* uncontrolled diebete mellitus with insulin treatment （preoperative blood glucose\>250mg/dL）
* hyperthyroidism and hypothyroidism
* Raynaud's disease
* patients with hematopathy and immune disease
* anticoagulant and non-steroid anti-inflammatory drug intake with 14 days before operation
* infectious fever within 4 weeks before operation
* laboratory abnomality as follow
* Hemoglobin≤10.0g/L
* Platelet≤100,000/ml
* White blood cell\<3000/dl or\>14,000/dl
* Fibrinogen\<200mg/dL
* Thrombin time\>40 second
* International normalized ratio\<70%
Comparison of On-hours Versus Off-hours Anesthesia of Hip Surgery

To explore the impact of the begin time of anesthesia on in-hospital mortality and early prognosis of patients undergoing hip surgery.

The patients undergoing hip surgery between were divided into the on-hours group or the off-hours group depending on the begin time of anesthesia in this retrospective cohort study. In-hospital mortality and early prognosis were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All patients who had hip surgery between January 1, 2015, and December 31, 2020 in Tongji Hospital.

Exclusion Criteria:

* under 18 years old
* had incomplete perioperative data
Sequential Belimumab and T-cell Based Therapy in SLE

Systemic lupus erythematosus (SLE) is a disease in which the immune system (the bodily system that fights infection) attacks the body's own cells and tissues, causing inflammation and organ damage if not promptly and appropriately managed. Autoantibodies (specific proteins produced by the immune system which participate in attacking self tissues and organs) are the hallmarks of SLE which are produced by a specific type of white blood cells called B cells. Belimumab (Benlysta®) is a monoclonal antibody against the B cells by blocking the action of BLyS, a protein that prolongs the longevity and enhances the functions of B cells and is found to be elevated in patients with SLE, was approved by the FDA to treat patients with SLE. This study aims to study the effects of Belimumab on T cells, another specific type of white blood cells which also play a crucial role in SLE, in patients with SLE. In this trial, 80 adult patients with SLE will be recruited, 40 of them will be assigned to receive intravenous (IV) Belimumab with standard of care therapy (SOC), and 40 to receive SOC only. After 48 weeks of exposure to Belimumab + SOC and SOC alone, the phenotype and functions of T cells will be studied and compared.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21
2. Able to understand the details of the trial and willing to give written informed consent and comply with the requirements of the study protocol.
3. Patients who fulfill the classification criteria (SLICC 2012 or ACR 1997) for SLE and have active disease (SELENA-SLEDAI ≥ 6).
4. Patients whose sera are positive for ANA (titre ≥ 1:80) or anti-dsDNA (\>100U/L based on NUH standard laboratory cut-off).
5. Patients who are on stable dose of prednisolone (0-40mg/day) and/or non-steroidal anti-inflammatory, antimalarial or immunosuppressive drugs for at least 30 days before first study dose.
6. Females of child-bearing potential and non-sterilized males with female partners of child-bearing potential may participate this trial only if they use a reliable means of contraception.
7. Females of child-bearing potential must have a negative serum pregnancy test within three weeks prior to baseline.

Exclusion Criteria:

1. They have severe active nephritis and/or active CNS lupus and/or other autoimmune diseases e.g. RA, mixed connective tissue disease, scleroderma, dermatomyositis and polymyositis.
2. They are pregnant.
3. They have had previous treatment with any B-cell and T-cell targeted biologic therapy, intravenous (IV) cyclophosphamide within 6 months of enrolment, intravenous immunoglobulins or prednisolone (\>100mg/day) within 3 months.
A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

The purpose of this clinical research study is to see if Glucovance, a medication currently approved for use in adults with type 2 diabetes, can control type 2 diabetes safely and effectively in children 9 to 16 years of age.


Eligibility Criteria:
Children ages 9-16 years with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, with or without oral hypoglycemic therapy, and have an HbA1c greater than 6.4%
Acoustic Cardiographic Assessment of Heart Function in Comparison to Doppler-echocardiography

In this study, the investigators sought to determine whether an acoustic cardiographic assessment of heart function is equivalent to Doppler-echocardiography in patients who are treated with cardio-toxic cytostatic agents.

Patients receiving cardio-toxic cytostatic agents are examined by Doppler-echocardiography and acoustic cardiography before, during, and after the cytostatic treatment. Doppler-echocardiography measures ejection fraction, TDI, speckle tracking, and further parameters. Acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Heart function as assessed by Doppler-echocardiography is then compared to the heart function as assessed by Audicor ECG.

Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant disease with scheduled anthracycline and trastuzumab therapy
Study of Tongue Strengthening for Swallowing Problems

This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.


Eligibility Criteria:
Inclusion Criteria:

* referral by a physician for swallowing evaluation because of suspected dysphagia
* complaint of difficulty swallowing
* aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
* between the ages of 21 and 95
* ability to perform the exercise protocol independently or with the assistance of a caregiver
* physician approval of medical stability to participate
* decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician)

Exclusion Criteria:

* degenerative neuromuscular disease
* poorly controlled psychosis
* patient unable to complete the exercise program
* allergy to barium (used in videofluoroscopic swallowing assessment)
Translation, Cross-cultural Adaptation and Validation of PRO-CTCAE for Italian-speaking Cancer Patients

The purpose of this study is to see if the Italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to Italian speaking patients. The questionnaire is called the PRO-CTCAE, and was originally developed at the U.S. National Cancer Institute to help get information about patients' symptoms directly from the patients themselves. The Italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.

This study will be conducted in two steps. The first is the Italian translation and cross cultural adaptation of the original US NCI's version of the PRO-CTCAE questionnaire. The questionnaire will be translated and administered to a sample of 96 Italian patients. After protocol amendment in November 2016, the second step was modified and consists of test-retest reliability assessment of the Italian language version of the PRO-CTCAE questionnaire that was developed in the first step, with a minimum of 59 Italian speaking patients to be enrolled. A validation study is planned and will be the subject of a separate protocol.

Eligibility Criteria:
Eligibility Criteria for cross-cultural adaption phase:

Inclusion criteria:

* patients receiving (or who have received within 6 months) chemotherapy or radiotherapy with curative or palliative intent for an advanced cancer at one of the study sites
* ≥18 years of age
* able to speak and understand Italian
* providing written informed consent

Exclusion criteria:

• Patients judged unable to report on their symptoms from the last seven days due to cognitive impairment.

Eligibility Criteria for Validation phase:

Inclusion Criteria:

* ≥18 years of age.
* Patient is able to complete PRO-CTCAE on two consecutive days.
* Patient is actively receivingmedical treatment for cancer or has completed treatment not more than 4 weeks before Visit 1
* Any type of cancer
* Able to complete questionnaire by themselves or with assistance.
* Providing informed written consent.
* Able to speak and understand Italian

Exclusion Criteria:

* Clinically significant cognitive or memory impairment in the opinion of clinical or research staff.
* Other important acute medical conditions that, in the opinion of the Investigator, may prevent compliance..
Follow-up of Patient Implanted With the Staple ASTUS®

There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of them.

The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by Baciu and Filibiu (1979). In the technique, they did take the dowel out before turning it. The healing process takes place between surfaces of spongious bone. They showed excellent results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994) combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5 weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason may be the circular bone gap of at least 1 mm left by the saw blade.

A new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow the dowel to be turned in situ without leaving in position. The staple is introduced into the joint line and will compress the dowel surfaces against the surrounding bone. Instruments are available to ensure the correct position and length of the dowel, and to rotate it in situ before the special wedge staple is introduced.

Dr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series with 83 arthrodesis. The purpose of this study is now to collect and publish data from several centers, several users.

The objective of this study is to obtain the percentage of healing 3 months after an implantation of the staple ASTUS.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Have willingness to give his/her data transfer authorisation;
* Patient candidate for an arthrodesis in the following joints (Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, calcaneum - Cuboid) and whose surgeon has recommended the implantation of an ASTUS Staple from Newdeal-INTEGRA.

Exclusion Criteria:

* Patient candidate for an arthrodesis not listed in the inclusion criteria (as Subtalar arthrodesis and Metatarso-cuboid arthrodesis) will not be included in this study;
* Patient re-operated due to a previous failed of fusion of the same joint will not be also included;
* Patients will be excluded from the study if they have an history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol.
Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance

The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.


Eligibility Criteria:
Inclusion Criteria:

One of them

* Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) \< 80% predicted and FEV1/forced vital capacity (FVC) ratio \< 0.7)
* Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography
* Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure \> 25 mm Hg at right heart catheterization
* Cystic fibrosis, as diagnosed by a positive sweat test (\>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.

AND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test \< 88%

Exclusion Criteria:

* Exacerbation of the primary lung disease in the past 8 weeks
* Exercise limiting diseases other than the primary lung disease.
* Not reaching the target dyspnea score during the walking tests.
* Stage 1 pulmonary sarcoidosis
* History of syncope on exertion
* SpO2 with effort less than 90% despite the use of 6 L of O2 per minute
* Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)
* Disabling or severe rheumatological or neurological condition
* Participation in a pulmonary rehabilitation program within the last year
* Patients with multi-resistant bacteria
Avanz Phleum Pratense Maintenance Dose

The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+ (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen induced allergic rhinoconjunctivitis with or without asthma.


Eligibility Criteria:
Inclusion Criteria:

* A history of grass pollen allergy
* Positive skin prick test to grass
* Positive Immunoglobulin E test to grass

Exclusion Criteria:

* Other allergies overlapping the grass pollen season
* Severe Asthma (defined as a Forced expiratory volume in 1 second (FEV1) below 70 % after adequate treatment)