cyrilzakka/clinical-trials huggingface dataset:
EMD 640 744 in Montanide ISA 51 VG Administered in Subjects With Advanced Solid Tumors

To compare 3 doses of EMD 640744 administered by subcutaneous injection in combination with Montanide® ISA 51 VG with regard to immunological efficacy.

The primary target variable is the immune response as assessed by ELISPOT before and until week 17 after vaccination with EMD 640744 in Montanide® ISA 51 VG.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Signed written informed consent
* Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
* Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
* Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
* ECOG performance status of ≤1, estimated life expectancy of at least 3 months
* Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x 10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L
* Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN
* Adequate renal function defined by a serum creatinine ≤2 x ULN
* Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels ≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)
* Effective contraception for female and male subjects if the risk of conception exists

Exclusion Criteria:

* Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
* Previous treatment with an investigational anticancer vaccine
* Requirement of concurrent treatment with a nonpermitted drug
* Active significant autoimmune disease (with the exception of vitiligo)
* Receipt of allogeneic stem cell transplantation
* Significant acute or chronic infections (e.g. viral hepatitis, HIV)
* Primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months)
* Rapidly progressive disease (e.g. tumor lysis syndrome)
* Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment
* Pregnancy or lactation
* Active drug or alcohol abuse
* Known hypersensitivity to the study treatment or any of its components
* Any significant disease that, in the Investigator's opinion, should exclude the subject from the study; for questions about this criterion, the Investigator should contact the sponsor.
* Persisting toxicity related to prior therapy ≥grade 2 National Cancer Institute-Common Terminology Criteria For Adverse Events version 3.0
* Legal incapacity or limited legal capacity
Intravenous (IV) Vitamin C With Chemotherapy for Cisplatin Ineligible Bladder Cancer Patients

Bladder cancer is a common disease with high rates of mortality, especially at advanced stages. Neo-adjuvant cisplatin-based chemotherapy (NAC) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as NAC improves surgical outcomes in these patients. However, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. Although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by NAC. Intravenous ascorbate (vitamin C) administration (IVC) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. This trial will add IVC to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.

see protocol

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 -- 2
* Cisplatin-ineligible, muscle invasive bladder cancer
* Adequate organ and marrow functions
* Women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control

Exclusion Criteria:

* Patient simultaneously enrolled in any therapeutic clinical trial
* Current or anticipated use of other investigational agents while participating in this study
* Psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
* Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
* Prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder
* Uncontrolled intercurrent illness
* Current consumption of tobacco products
* History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome

The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air) compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome.

Despite the vast amount of research investigating the cause of central sleep apnea, there remain gaps in knowledge, lending to further research efforts. The decision to compare oxygen to medical air is based on several theorized mechanisms. The first of which is the supposition that provision of medical air may act as an arousal stimulus for the hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen really plays a significant role in treating CSA. Lastly, the delivery of medical air via nasal prongs may provide sufficient arousal to terminate the cycle of events leading to central apnea, as described by Urquhart et al.

A deeper understanding of central sleep apnea is essential to ameliorating its adverse sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and academic difficulties.


Eligibility Criteria:
Inclusion Criteria:

1. infants under age two with genetically confirmed Prader-Willi Syndrome
2. referred to HSC sleep clinic for evaluation with polysomnogram prior to initiation of growth hormone
3. infants found to have clinically significant central sleep apnea, defined as an apnea-hypopnea index (AHI) equal to or greater than 5

Exclusion Criteria:

1. infants delivered prematurely (less than 37 weeks gestational age)
2. term infants with a history of hypoxic-ischemic encephalopathy or stroke
3. any concurrent diagnoses that may cause sleep-disordered breathing (ie. craniofacial abnormalities, arnold-chiari malformation, etc)
4. infants with a need for daytime supplemental oxygen (ie. cardiac anomalies)
5. infants found to have low baseline oxygen saturations on PSG
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy

The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.

This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or older with histologically proven prostate carcinoma
* Imaging stage T3b (as defined on mpMRI) N0M0
* Intraprostatic lesion visible on MRI
* Capable of giving informed consent

Exclusion Criteria:

* History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
* Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
* Absence of pre-treatment PSMA PET CT
* WHO performance score \> 2
* International Prostate Symptom Score ≥ 15
* PSA \> 30
* Prostate volume \>100c
Activity & Safety Study of Lenalidomide & Rituximab as Non-chemotherapy Based Therapy on Chronic Lymphocytic Leukemia

The rationale for combining lenalidomide with rituximab derives from preclinical observations suggesting that lenalidomide may enhance the ADCC (antigen-dependent cellular cytotoxicity) triggered by monoclonal antibodies such as rituximab. Lenalidomide augments NK cytotoxicity by increasing CD56dimCD3 subset, in addition to inducing IL-2 in T cells. These results provide the cellular and molecular basis for the use of lenalidomide as an adjuvant in immunotherapeutic strategies of monoclonal antibodies (mAb)-based therapies. The combination lenalidomide-rituximab was tested in lymphoma cell lines but not specifically on CLL cell lines. However the observed synergism was attributed to NK cells expansion, thus lending support to the notion that this synergism may operate in other B-cell lymphoproliferative malignancies.

The objective was to develop a non-cytotoxic and effective treatment for CLL that would fulfill an unmet medical need, as a significant proportion of CLL patients are elderly and frail. These patients experience an excess in chemotherapy induced toxicity, often preventing the completion of the planned treatment.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent and refractory CLL patients that have received at least one previous treatment with purine analogs.
* Adequate liver function and renal function.
* ECOG performance status ≤ 2.
* Signed informed consent
* Male and female patients who are fertile agree to use an effective barrier method of birth control to avoid pregnancy.

Exclusion Criteria:

* Positive serological markers for hepatitis B with the exception of HBsAc in previously vaccinated patients
* Pregnant patients
* HIV infection
* Concurrent chemotherapy or immunotherapy
* Other malignancy within the last 2 years, except for localized cutaneous carcinoma
* Neurological impairment precluding understanding of protocol and the entailed visits and procedures.
* Patients with Renal insufficiency that requires dialysis.
Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss

The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedure inducing a tolerance to the hormones the women are sensitive to.

This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women.

The Skin Test Panel includes four female hormones and three control solutions.

Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month.

Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups.

Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.


Eligibility Criteria:
Inclusion Criteria:

For both groups:

1. Between ages of 20 to 40
2. Willing to participate as shown by signing the informed consent form.

For healthy group:

Parous subjects without premenstrual syndrome, as per medical history and subject's report ( PMS questionnaire)

For UPRL:

Women with three or more documented early pregnancy losses.

Exclusion Criteria:

For both groups:

1. No hormonal contraceptives (either OC or hormonal IUD (Mirena)), no psychotropic agents (e.g. Antidepressants, anxiolytics, or lithium carbonate) for at least two months prior to screening.
2. No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
3. Significant medical or psychiatric disease.
4. Severe allergies or an inflammatory illness at the time of enrollment

For healthy group:

1. Women who are pregnant or lactating on the day of screening
2. Abnormal routine blood tests

For UPRL:

1. Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A))
2. One or more abnormal test from the list below:

   1. Karyotype of either parent (normal: 46XX or 46XY)
   2. Glucose tolerance test (This can be altered to fasting blood sugar of 100mg/dl or less);
   3. Toxoplasmosis serology (IgM positive);
   4. Hysterosalpingogram, 3-D ultrasound or hysteroscopy, thereby excluding anatomical abnormalities, intrauterine adhesions and cervical incompetence;
   5. Thyroid function (Euthyroid levels;);
   6. Serum prolactin;
   7. Normal luteal phase of at least 12 days and plasma progesterone above 24 ng/lL
   8. Anti nuclear factor (Negative)
   9. Anticardiolipin antibody by Elisa testing (cut off value \<13 GPLu/mL and \<7.6 MPLu/mlL) and Lupus anticoagulant (according to Kaolin clotting time (KCT), Russell's viper venom tome (RVVT) or APTT.
Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer During the Bronchoscopy

The aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (seed extraction in unclear infiltrates, interstitial lung disease, unexplained pulmonary opacities, inspection at hemoptysis)
* patients aged 18 years or above
* written informed consent prior to study participation

Exclusion Criteria:

* known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 \> 55 mmHg) or pCO2 \> 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
* women, who are pregnant or breastfeeding
* alcohol or drug abuse
* expected non-compliance
* patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
* Participation on another clinical trial within the last 3 months
* subjects who are committed to an institution and/or penitentiary by judicial or official order.
* employees of the investigator cooperation companies.
Comparison of Different Feature Engineering Methods for Automated ICD Coding

Using traditional machine learning classifiers, this study targets on comparing bag-of-words, word2cec and roberta on automated ICD coding related to cardiovascular diseases in Chinese corpus.

ICD coding is quite important as it serves as basis for a wide range of economic and academic applications. Currently, manual coding is mainly adopted, which faces several limits like being time-consuming and prone to error, and this makes automated ICD coding via machine learning a hot research topic.

As an inevitable phase during machine learning, feature engineering plays a crucially important role in leading to promising coding performance. Although have reached enlightening conclusions, existing studies lacked comparison of different feature engineering methods. Finding out what methods under what circumstances perform better can be quite helpful in promoting practical applications of automated coding.

The investigators will implement this study based on inpatient' data collected from electronic medical records from Fuwai Hospital, the world's largest medical center for cardiovascular disease. Bag-of-words, word2cec and roberta will be respectively used to extracted features from training data. Then code-wise logistic regression classifiers and support vector machine classifiers will be trained to auto-assign codes. Afterwards, performances of the models on test data will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Admissions in Fuwai Hospital, from January 1, 2019, to February 28, 2019

Exclusion Criteria:

-
Pain Relief After Hiatal Hernia Repair Surgery

Referred shoulder pain (pain felt when the problem is actually in a different location) is very common after laparoscopic (small, narrow cut) hernia surgery. The purpose of this study is to look at the effect of a simple back massager, which can be readily purchased online or in a store, in addition to the use of standard pain medications.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for primary hiatal hernia repair
* Adult 18 years of age or older
* Undergoing minimally invasive surgical technique

Exclusion Criteria:

* Recurrent hiatal hernia
* Children under the age of 18 years
* Undergoing open or hybrid surgical technique
* History of psychiatric disorder or chronic pain
* Has a post-operative complication (Grade \> I on Calvien Dindo classification)
* Allergy to standard pain medication regimen (local anesthetics Marcaine, lidocaine, and epinephrine; morphine; oxycodone; Tylenol)
Internet-delivered Psycho-oncological Support

Cancer patients develop a high psychological burden of the underlying disease. To support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet (called Incobeth®) in cancer patients.

In this study, a randomized trial is conducted in which the online users are allocated into two different care services (MAC-CBT® vs. psycho-educational support program). Participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. All patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. Initial will be done an extensive psychometric survey. The MAC-CBT® group receives an intervention program based on ten modules, in which the aspects of Mindfulness, Acceptance and Commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). The control group will have access to six modules with a psychoeducational support program, which is also constructed according to the MAC principle. Both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. The control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. Input and output results are determined using validated survey instruments. Randomisation is done by a physician not involved in the further course of the evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patient
* psychological distress
* informed consent

Exclusion Criteria:

* no informed consent
* no cancer
Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos

A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.

Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.

The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Female age 18-60.
* Histologically confirmed early stage invasive ductal or lobular carcinoma of a single breast (T1N0M0-T2N0M0) or DCIS/LCIS (TisNxMx or TisN0M0) of a single breast.
* Deemed fit to undergo adjuvant radiotherapy to their breast by their supervising radiation oncologist.
* Able to provide written informed consent.
* Must be willing to be contacted by e-mail and have a valid e-mail account to complete follow up self-reported body image scale questionnaires.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Intact skin at site of standard radiotherapy tattoos. Must have access to a computer and be able and willing to comply with requirements of the protocol.

Exclusion Criteria:

* History of any prior radiotherapy courses to the chest or abdomen.
* Metastatic disease.
* Node positive breast cancer.
* Bilateral breast cancer or bilateral DCIS/LCIS.
* Deep-inspiration breath hold radiotherapy technique.
* Unable or unwilling to comply with the requirements of the protocol as assessed by the study investigator or coordinator.