cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of S-488410 to Treat Non-small Cell Lung Cancer

The investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this clinical study, the investigators examine using a combination of three peptides from these three antigens (S-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers who failed to standard therapy.

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. In this phase II trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC that cannot undergo curative surgery.
* Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
* Histologically diagnosed NSCLC.
* Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
* ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
* Life expectancy \> 3 months.
* Age between 20 to 79
* Male or Female.
* In patients or out patients.
* Able and willing to give valid written informed consent.

Exclusion Criteria:

* Other malignancy requiring treatment
* radiation, immunotherapy, hyperthermia, or surgery.
* Active and uncontrolled infectious disease
* Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
* Autoimmune disease.
* HIV-Ab or antigen positive
* Prior anti-cancer therapy within 4 weeks
* Laboratory values as follows: 2000\<mm3 \< WBC \< 15000/mm3, Platelet count \< 50000/mm3, Asparate transaminase \> 5 X cutoff value, Alanine transaminase \> 5 X cutoff value, Total bilirubin \> 3 X cutoff value, and Serum creatinine \> 3X cutoff value.
* Patients knows HLA-A type.
* Breastfeeding and Pregnancy (woman of child bearing potential)
* Refusal of pregnancy conception.
* Treated with S-488401, S-488402, or S-488403.
* Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
* Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Effect of High Intensity Training on Motor and Cognitive Functions

Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders.

However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions.

Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age
* Clinical diagnosis of Multiple Sclerosis (MS)
* Stable disease course without worsening more than 1 EDSS point over the last 3 months, -EDSS between 1.5 and 6 points
* Must be able to maintain upright posture without any assistance for 30 seconds
* Must be able to release a written informed consent.

Exclusion Criteria:

* MS relapse within the previous three months;
* Unable to comprehend the aims of the study and to follow test instructions;
* Diagnosis of major depression (DSM-5);
* Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment);
* Cardiovascular diseases;
* Unconfirmed or uncertain diagnosis of MS (McDonald criteria)
* Other concomitant neurological disease;
* Patients already performing aerobic or walking exercise.
Endeavor™ in Pediatric MS

This study will examine the feasibility of using an Endeavor™ application as a treatment modality for cognitive impairments in the pediatric MS population. Participants will be asked to undergo a hour-long baseline evaluation, followed by at-home Endeavor™ application sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at the end of the study. They will undergo another hour-long follow-up evaluation at the end of the study.

Duration of subject participation in this study is anticipated to take 3-4 months. After consent/assent, participants will complete an one hour-long baseline study visit in-person at the MSCCC, or through a video visit. During this visit, participants will complete a neuropsychological evaluation and baseline study surveys and get trained on the use of the Endeavor™ video game. Participants will then be instructed to target a completion of at-home game play 5 days a week, for a total period of 8 weeks, using their own iOS mobile device, or a study-provided device if needed, approximately 25-30 minutes each day. Subjects will be instructed to complete the User Experience Feedback Form weekly via REDCap to assess feasibility and acceptability of Endeavor™. At the conclusion of participation, participants will complete an hour long neuropsychological evaluation and end of study User Experience Feedback Form via REDCap (in-person at the MSCCC, or through a telehealth video visit).

Eligibility Criteria:
Inclusion Criteria:

* Age at enrollment: 12 years 0 months to 22 years 11 months
* Confirmed Diagnosis of Multiple Sclerosis with onset \< 17 years and 11 months (defined by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu, Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum, Wassmer, \& Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)
* Followed at NYU Langone Health MSCCC
* Expanded Disability Status Scale (EDSS) score of ≤3.5

Exclusion Criteria:

* Previous report of an IQ \< 70
* Non-English speaking, learned English in the past three years, or learned English after the age of 12 years
* Neurological disorder (other than MS) with potential to significantly influence cognition (e.g. head injury)
* Other serious chronic or unstable medical condition (e.g., epilepsy, sickle cell disease, Type 1 diabetes)
* Not willing to comply with all study procedures
* Insufficient visual and motor ability to carry out academic and cognitive tests
* Relapse ≤ 2months prior to academic and cognitive data collection
* Steroid treatment ≤ 1 month prior to academic and cognitive data collection
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in participants with relapsing forms of multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing multiple sclerosis
* Active disease
* Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

Exclusion Criteria:

* Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within the last 12 months
* Treatment with alemtuzumab within the last 12 months
* Pregnant or nursing mothers
Continuous Oral Contraceptives (COCs): Are Bleeding Patterns Dependent on the Hormones Given?

While there may be a decrease in the total number of bleeding days women experience with continuous-dosed COCs (no menstrual withdrawal week), these regimens frequently result in an increased number of "breakthrough" or non-scheduled bleeding days. Breakthrough bleeding is among the main reasons cited for discontinuation of combined COCs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed COCs. The exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. This study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (COC) dosed continuously.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 to 49 years old
* Good general health
* No medical contraindications to combined COC therapy.
* In addition, all participants were required to have taken cyclic COCs for at least three months at the time of enrollment, in order to avoid common transition bleeding with the initiation of COCs.
Virtual Reality-Supported Hypnofertility

This research was conducted to determine the effect of virtual reality-supported hypnofertility on fertility preparedness, stress and coping with stress in women having in vitro fertilization. At the end of research It has been determined that initiatives based on the hypnofertility philosophy increase the level of preparedness to fertility, decrease the stress level and provide effective coping with stress in women who had IVF treatment.

It is estimated that the infertility affects 8-12% of all couples in reproductive age across the world. Various alternative methods were implemented for years for alleviating the stress which was felt by infertile women. The women in the process of infertility treatment make more efforts to be impregnated, their fertility preparedness is negatively affected and they need more psychosocial support. Upon the review of the relevant literature, it is discerned that there was a limited number of studies in which mind-body programs, namely, hypnofertility methods, were applied to the cases of infertility. In this research, in the first meeting with infertile women who would be assigned to the experimental group, the research objective was explained, and their consent to partake in the research was received in written and verbal format and pretest data were obtained. Later during in vitro fertilization, VR-supported hypnofertility treatment initiative which applied to the experimental group was implemented in four stages, namely, 'Stage 1 (the first folliculometry day)', 'Stage 2 (the second folliculometry day)', 'Stage 3 (oocyte retrieval stage)' and 'Stage 4 (embryo transfer stage)'. And posttest data were obtained at the end of last stage. Each process took 20 minutes on average. Meetings with infertile women who were assigned to the control group were held twice. In the first meeting, pretest data were collected. VR-supported hypnofertility treatment initiative was not applied to the control group, and posttest data were collected from the control group via the second meeting held on the same date as the fourth stage of treatment, namely, the day of embryo transfer. It is considered that the stress levels of women who are in the process of having IVF treatment will fall down and hence the fertility preparedness and the ability to cope with infertility stress will be positively affected by virtue of the effective use of hypnofertility method, which is still a new method in Turkey, by midwives and other health professionals.

Eligibility Criteria:
Inclusion Criteria:

* Having IVF treatment

Exclusion Criteria:

* Having IVF treatment
Effect of Preoperative Individualized Education on Anxiety and Recovery.

Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education.

Patients who met the research criteria were consulted prior to surgery, during which the research objectives were explained, and written consent was obtained. Following baseline assessment, patients were randomly allocated to either the individualized education group or the routine education group. Sociodemographic information was collected through face-to-face interviews conducted in the ward. Additionally, levels of anxiety and adverse events (sleep, pain, nausea, vomiting) were measured using the Visual Analog Scale (VAS) and Hospital Anxiety and Depression Scale (HADS). Patient anxieties regarding different aspects were assessed using specific concerns and fears scales.

The intervention group received individualized educational interventions utilizing audiovisual materials. Based on identified personalized educational needs, researchers administered individualized preoperative education to the intervention group in the ward. Patients in the control group received only routine preoperative education from clinical nurses.

The second assessment was conducted before patients were transferred to the operating room. Anxiety levels and adverse events (preoperative sleep, pain, nausea, and vomiting) were assessed using HADS and VAS. Postoperatively, pain, nausea, vomiting, and coughing were evaluated three times daily for the first three days (every 8 hours) using the Visual Analog Scale (VAS), and sleep was assessed daily using the Athens Insomnia Scale (AIS). Chronic symptoms and quality of life were assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough was evaluated using the Leicester Cough Questionnaire, and chronic pain was evaluated using the Brief Pain Inventory. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and HADS were used for continuous assessment of quality of life, anxiety, and depression status.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or above;
2. Received single-port thoracoscopic surgery;
3. Volunteered to participate in the study and signed an informed consent form.

Exclusion Criteria:

1. Presence of a mental disorder
2. Preoperative pain
3. Pregnancy
4. Presence of other tumours requiring treatment.
Impact of COVID-19 Infection on the Incidence of Ventilator-acquired Infections

Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

COVAPID is a multicenter cohort study with two retrospective control groups. No intervention will be performed in included patients, only patient characteristics and data on VA-LRTI will be collected.

Patients with confirmed SARS-CoV-2 community-acquired pneumonia, admitted to the participating ICUs from the start of COVID epidemic will be eligible for this study. Those admitted before the beginning of this study will be included retrospectively, and those admitted after the beginning of the study will be included prospectively. 10-20 patients per center will be included in this group. SARSCoV2 infection will be confirmed by a nasopharyngeal PCR or respiratory secretions (tracheal aspirate or bronchoalveolar lavage) PCR. Two retrospective groups will be constituted in order to give some insight of potential impact of SARS-CoV2 infection on the incidence of VALRTI :1) Influenza group : patients with influenza (A or B) community-acquired pneumonia. All patients with influenza community acquired pneumonia and admitted in the same ICU will be eligible in this group.

The number of patients included in this group per center will be similar as that of patients included in the SARS-CoV-2 pneumonia group (10-20 patients). These consecutive patients will by identified using the files of Virology Lab. The first included patient will be the last of the current influenza season (2019-2020), and others will be taken consecutively back to 2019 of 2018 if necessary. PCR (nasopharyngeal or respiratory secretions) confirmation of influenza (A ou B) is required for patients in this group. 2) No viral infection group: patients with no viral community acquired pneumonia. All patients receiving invasive mechanical ventilation for more than 48h before COVID epidemic, for any reason other than viral pneumonia are eligible for this group. The number of included patients in this group will be similar as that of patients included in the SARS-CoV-2 group in the same center (10-20 patients) These consecutive patients will be included starting at the end of January 2020 and going back to 2019 if necessary. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.

Eligibility Criteria:
Inclusion Criteria:

For all three groups:

* Major patient
* In patients in ICU
* Patients intubated and mechanically ventilated for more than 48 hours.

For the SARS-CoV2 group: community-acquired SARS-CoV2 pneumonia For the influenza group: community-acquired influenza pneumonia For the "No Viral Infection" group: no viral pneumonia on admission.

Exclusion Criteria:

* Refusal to participate
* Lack of social security coverage
SOLARIS Endoprosthesis in Iliac Occlusive Disease

Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Rutherford Class 2 to 5;
* Tasc II Class A, B, C or D;
* Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
* Target lesion of 3 to 10 cm length;
* ≥ 50% stenosis or common iliac or external iliac artery;
* Reference vessel diameter ≥ 5 and ≤ 9 mm;
* Deep femoral artery patent and at least one infrapopliteal artery patent;
* Informed Consent provided.

Exclusion Criteria:

* Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
* Target lesion near to aneurysm, highly calcified or excessively tortuous;
* Previous stent on target vessel;
* Presence of other lesions that need treatment within 30 days;
* Rutherford Class 6;
* Acute thrombotic occlusion;
* History on amputation on the target limb.
Temperature Control During Dialysis Treatment

The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control

To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years,
2. both men and women,
3. chronic renal failure and dialysis treatment for at least three months

Exclusion Criteria:

1. Heart failure,
2. Lung insufficiency,
3. Chronic liver disease,
4. Diabetes mellitus,
5. Malignant disease,
6. Nephrotic syndrome,
7. Lack of compliance,
8. Unwillingness til participate
HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis

* Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
* HSPA12B is primarily located in endothelial cells and detectable during sepsis.
* The investigators speculated that HSPA12B from endothelial cells might be correlated with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients meet the diagnostic criteria according to the grouping

Exclusion Criteria:

* patients without informed consent
* patients who were undergoing continuous renal replacement therapy before sampling
* patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resectable pancreatic adenocarcinoma
* Age over 18 years old and younger than 70 year old
* Performance status (ECOG scale): 0-1
* Adequate organ functions

  * Hb ≥9.0 g/dl
  * ANC ≥1,500/mm3
  * PLT ≥100,000/mm3
  * Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
  * Creatinine ≤1.5 ULN
* Patients should sign a written informed consent before study entry.

Exclusion Criteria:

* Tumor type other than adenocarcinoma
* Unresectable for resection on preoperative evaluation
* Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
* Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
* Prior radiotherapy
* Major surgery within 4 weeks prior to study treatment
* Serious illness or medical conditions, as follows;

  * congestive heart failure (NYHA class III or IV)
  * unstable angina or myocardial infarction within the past 6 months,
  * significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
  * uncontrolled hypertension
  * hepatic cirrhosis( ≥ Child class B)
  * interstitial pneumonia, pulmonary adenomatosis
  * psychiatric disorder that may interfere with and/or protocol compliance
  * unstable diabetes mellitus
  * uncontrolled ascites or pleural effusion
  * active infection
* Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug
* Pregnant or lactating woman
* Women of child bearing potential not using a contraceptive method
* Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
* Any patients judged by the investigator to be unfit to participate in the study