cyrilzakka/clinical-trials huggingface dataset:
MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients

A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.


Eligibility Criteria:
Inclusion Criteria (Recipient):

* Meets ONE of the following disease criteria:

  1. Primary AML induction failure: no CR after 2 or more induction attempts
  2. Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
  3. AML relapsed \> 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
  4. Relapsed AML for patients \> 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:

     * Relapse within 6 months of last chemotherapy
     * BM blast count \< 30% within 10 days of starting protocol therapy
* Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I serologic typing at the A\&B locus
* Karnofsky Performance Status ≥ 60%
* Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration
* Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications).
* Agrees to use contraception prior to study entry and for the duration of study participation.

Exclusion Criteria (Recipient):

* Bi-phenotypic acute leukemia.
* Transplant \< 60 days prior to study enrollment.
* Active autoimmune disease.
* History of severe asthma
* Uncontrolled intercurrent illness
* New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy
* Pleural effusion large enough to be detectable on chest x-ray.
* Pregnant women
* History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection
* Known hypersensitivity to any of the study agents used
* Received investigational drugs within the 14 days of study registration.
* Known active CNS involvement.

Criteria For Initial Donor Selection:

* Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling).
* 14-75 years of age.
* At least 40 kilogram body weight.
* In general good health as determined by the evaluating medical provider.
* HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus.
* Not pregnant.
* Able and willing to undergo apheresis.
Tracking Triple-negative Breast Cancer Evolution Through Therapy

A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-years or older
2. Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator
3. Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry
4. Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines
5. T1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. Bilateral or multifocal cancer is permitted provided that all sites are HER2-negative and at least one site is ER- and PR-negative.
6. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
7. Patient with social insurance coverage

Exclusion Criteria:

1. Confirmed metastatic disease at initial presentation
2. Any contraindication to the biopsy procedure
3. Previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin
4. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
5. Individuals deprived of liberty or placed under the authority of a tutor
Effects of Food Form and Fitness on Appetite and Digestion.

Energy-yielding fluids induce weaker appetitive and compensatory dietary responses than energy-matched semi-solids or solids. This is problematic because the high and increasing contribution of energy from beverages in the diet may enhance positive energy balance and weight gain. The prevailing view of the overweight/obesity problem is that it stems from a small, sustained positive energy balance. It follows then that only small changes, perhaps manipulations in the rheological characteristics of the diet, will be required to correct the problem. Certain populations that are more prone to weight gain may benefit from such manipulations. Obese individuals have a higher beverage intake and experience greater weight loss with reductions in beverage intake. Further, there is evidence that obese individuals consume more energy after a liquid pre-load than their lean counterparts, yet there is no difference in energy intake after a solid load. In contrast, habitual exercisers have been shown to have an increased accuracy of short-term regulation of food intake at meals following liquid preloads. A better understanding of the mechanisms by which beverages and energy-matched solid food forms elicit differential appetitive and dietary responses in these populations needed. This research will attempt to identify the influence of physical fitness and body fat on the ability to compensate for the energy content of solid and liquid preloads by reduction in energy intake at a subsequent ad libitum meal (i.e., acute compensation) and over the course of the day (i.e., short-term compensation). Furthermore, this study will examine the cognitive contribution to differential responses to energy-matched beverage and solid food forms and the effects of mastication on appetite, GI transit, glycemic response, and selected endocrine responses.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age BMI of 18-23 kg/m2 (lean) or 30-35 kg/m2 (obese) Sedentary physical activity level (\<70th¬ percentile of estimated VO2max for age and sex) or physically Active/Exercisers (\>70th¬ percentile of estimated VO2max for age and sex) Good health and not taking any medications known to influence appetite Non-smokers Not pregnant or lactating Weight stable (≤ 3 kg within last 3 months) Dietary restraint score \<11 on the Three Factor Eating Questionnaire (included in the on-line screening questionnaire) Glucose Tolerant or Non-Diabetic (fasting blood glucose of \<100 mg/dL) Self-reported consumer of breakfast and lunch

Exclusion Criteria:

* History or presence of significant metabolic diseases that may impact study results (i.e., endocrine, hepatic, renal disease) Individuals planning on starting a new diet or exercise regimen during the course of the study Use of obesity pharmacotherapeutic agents or over-the counter anti-obesity agents within the last 3 months Underlying conditions such as any cardiovascular, pulmonary, or neurological dysfunction that may be aggravated with exercise
Inadvertent Hyperventilation During Intraoperative Care in Neonates

In order to evaluate current anesthetic practice in the care of preterm infants and neonates, the investigators will retrospectively review surgical procedures in infants who are less than 60 weeks post-conceptual age in which an arterial cannula was placed intraoperatively or in situ upon arrival in the operating room. They will evaluate the mode of ventilation (pressure or volume-controlled), tidal volume or peak inflating pressure, the level of PEEP, inspired oxygen concentration (FiO2), and respiratory rate used during the procedure to determine the average minute ventilation.


Eligibility Criteria:
Inclusion Criteria:

* neonates (\<60 weeks post-conceptual age) undergoing non-cardiac operative procedures in which arterial access is generally present (exploratory laparotomy or thoracotomy)

Exclusion Criteria:

* none
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Expected visual outcome of 20/25 or better.
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs
  * Diabetic patients with a history of macular edema or diabetic retinopathy
  * AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
  * Only one eye of each patient can be enrolled
Effects of a Home-Based Exercise Intervention in Subjects with Long COVID

The current Coronavirus Disease 2019 (COVID-19) pandemic is the most severe health crisis of the 21st century. This is not only due to the deaths caused by the disease. People that were affected by COVID-19 and supposedly recovered may suffer from long lasting sequelae. The presence of symptoms longer than 3 months after the infection with the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is referred to as Post-COVID-19 Syndrome or Long COVID-19. It is estimated that 10-20 percent of all infected people are affected. The most common symptoms include persistent fatigue, reduced physical capacity, dyspnoea, ageusia, anosmia, musculoskeletal pain and neuropsychological complaints such as depression, anxiety, insomnia and a loss of concentration.

Considering the novelty of the pathology, evidence on the successful treatment of Post-COVID/Long-COVID is scarce. Physical activity has been established as a treatment option for chronic diseases that have similar symptomatic manifestations to those of Post-COVID/Long-COVID. For example, exercise therapy has shown positive effects on the health status of patients with lung disease, depression, anxiety, insomnia and cognitive impairment. However, there has been controversy whether so-called Graded Exercise Therapy (GET) is a safe treatment strategy for patients with Chronic Fatigue Syndrome (CFS). This population may experience Post Exertional Malaise (PEM), a worsening of symptoms after physical, cognitive or emotional exertion. Since COVID-19 might be an infectious trigger for CFS, particular caution has to be taken when recruiting participants and when screening them for adverse events and worsening of symptoms during an exercise intervention.

It can be hypothesized that patients suffering from Post-COVID/Long-COVID can benefit from exercise in various ways, guaranteed that there is sufficient screening for PEM before and during the intervention and training volume and intensity are increased slowly and progressively.

The current study investigates the effects of a home-based concurrent training program on various parameters in people affected by Long COVID.


Eligibility Criteria:
Inclusion Criteria:

* laboratory-confirmed infection with SARS-CoV-2 via PCR a minimum of 12 weeks ago
* presence of at least one or more of persistent symptoms that can be attributed to Long-COVID

Exclusion Criteria:

* previous or current hospitalization due to the COVID-19 disease
* regular engagement in endurance or strength training (more than once per week) in the six months prior to enrollment
* contraindications for physical endurance and resistance exercise according to the guidelines of the American College of Sports Medicine (ACSM)
* a grade of 3 or higher on the Post-COVID-19 Functional Status Scale (PCFS)
* presence of post exertional malaise (PEM)
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling

The aim of this study was to evaluate the effects of digital storytelling on the Self-Management behavior of adolescents with type 1 diabetes (TID).

In this single-blind randomized controlled trial, 60 eligible adolescents with TID were selected based on a convenient sampling method. Next, the participants were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n=30) or control (training with conventional) n=30) groups. Before and three months after the intervention the patients' levels of self-management behaviors according to Self-Management of TID amongst adolescents (SMOD-A); in addition to the Glycated Hemoglobin test (HbA1c) were measured.

Eligibility Criteria:
Inclusion Criteria:

* adolescents with TID
* using medication (insulin)
* willing to participate in the study and complete the informed consent
* having a basic knowledge of working with computers
* ability to communicate on the telephone.

Exclusion Criteria:

* physical or mental disabilities
* take anti-anxiety or antidepressant medication
Mental Health, Addictions and Biomarkers in High Athletes Performance

Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.

Sport is a privileged area to promote socialization and health values, such as companionship; a healthy lifestyle; cooperation to achieve common goals, and justice, rejecting unjustified advantages in competition. The concept of fair play is on which the development of those values pivots. From a holistic perspective, it is possible to define fair play, not only as a way to participate but also as a way of projecting people in life with values, assuming a set of behaviors that enhance a healthy and respectful sporting experience with opponents, the companions, the spectators, the referees and all the agents that take part in the sport practice.

Since 2018, joint actions have been carried out with the Villarreal de Fútbol Club, within the framework of the ENDAVANT agreement. Within these actions, it is proposed to develop different lines of research on sport and health. Within these lines, one of special relevance is that related to the risk of consumption of illicit substances and / or behavioral addictions, in elite athletes, since they are subjected to intense training days and stress situations derived from the demands of performance of professional competitive activity. On the other hand, recently published behavioral studies show that athletes who practice non-contact sports have a greater capacity to identify and assess emotions than athletes who practice contact sports and than those who practice contact sports show higher levels of physical aggression or verbal, and hostility or anger, than athletes who practice individual and non-contact sports.

Eligibility Criteria:
Inclusion Criteria:

* active athletes in the elite soccer competition from the Villarreal CF, who agree to be included in the study by signing an informed consent and who have a health profile made by the club's Medical Service.

Exclusion Criteria:

* athletes who are transferred to other clubs during the study period.
How Nurses Use and Evaluate the Ampoule Peel Device: Comparing Manually Opened Vs. Device-Opened Ampoules

Nurses frequently handle ampoule bottles in their daily work, and due to the fragile nature of these glass bottles, manual opening often leads to hand injuries. According to studies, a high proportion of occupational injuries among nurses are caused by handling ampoule bottles, especially hand lacerations. These injuries not only affect work efficiency but also increase medical risks. Therefore, to improve safety and reduce occupational injuries, this study aims to evaluate a patented ampoule peeling device, which has also won the National Innovation Award, to assess whether it can enhance the safety and satisfaction of nurses during their work.

The primary objective of this study is to evaluate the ampoule peeling device in terms of safety, ease of use, time efficiency, difficulty of operation, and user satisfaction among nurses when opening ampoule bottles of different capacities. A key focus is to determine whether the device can reduce the risk of hand injuries and improve work efficiency.

Study Design and Procedures:

The study will be conducted in three phases:

1. Phase 1 (Experimental Study):

   In a quiet and controlled environment, nurses will manually and using the ampoule peeling device, open different sizes of ampoule bottles (1ml, 2ml, 5ml, 10ml). Each participant will record the time required, safety, difficulty, success rate, and any incidents of hand injuries during the process. After completing both methods, participants will fill out subjective evaluation forms to assess their satisfaction with each method.
2. Phase 2 (Observational Study):

   Nurses participating in Phase 1 will record the number of ampoule bottles they manually open over five consecutive days, noting the success rate and any hand injuries. Then, they will use the ampoule peeling device for the next five days and record similar data for comparison.
3. Phase 3 (Observational Study):

After Phase 2, participants will have the freedom to choose between manual or device-assisted methods for a six-month period. At the end of this period, they will complete a survey summarizing their reasons for choosing a method, usage frequency, and overall safety and satisfaction levels.

Expected Outcomes:

It is anticipated that the ampoule peeling device will significantly improve safety, ease of use, and user satisfaction compared to manual methods. While there may not be a statistically significant difference in time efficiency, the overall success rate and safety should be enhanced.

Eligibility Criteria:
Inclusion Criteria:

* 16 nursing staff members from W72, W75, and the Department of Anesthesiology, who passed the preliminary tests and are willing to continue to the subsequent phases

Exclusion Criteria:

* Nursing staff unwilling to participate, unable to manually break ampoules, experiencing difficulty during the preparatory phase, or deciding to discontinue or withdraw during the process.
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)

This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.

Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* indication for right ventricular lead implantation according to current guidelines

Exclusion Criteria:

* preexisting tricuspid regurgitation ≥ grade 2
* other severe heart valve disease
* history of tricuspid valve treatment
* preexisting right ventricular lead
* chronic dialysis
* contraindication for transesophageal echocardiography
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy

The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma (pRCC) could benefit from adjuvant therapy or not. The investigators invented a multi-classifier system that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups. Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group. Disease-free survival and overall survival are the end points of observation.

kidney cancer represented 4.2% of all new cancer cases, and its incidence has been increasing. Over 90% of kidney cancer cases are renal cell carcinoma (RCC), which includes various subtypes with distinct histologic features, clinical courses, and responses to therapy. Clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC) are the most common histologic subtypes of RCC, accounting for approximately 75% and 20% of all cases, respectively. Adjuvant pembrolizumab showed promising efficacy in ccRCC, however, whether high-risk pRCC patients could benefit from adjuvant pembrolizumab remain unknown.

Participants will be assigned to continue with the study treatment until any of the following occurs: the recurrence of the disease; the emergence of unacceptable adverse events (AEs); the presence of an intercurrent illness that precludes further administration of the treatment; the decision of the Investigator to withdraw the participant; noncompliance with the study treatment or procedural mandates; administrative reasons necessitating the discontinuation of treatment; or the completion of 17 treatment cycles (approximately one year), with each cycle 3 weeks long.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of pRCC
* With confirmed diagnosis of stage III pRCC
* Classified as high-risk by multi-classifier system
* With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
* Receive radical operation for renal cancer with negative margin.
* Receive no anti-cancer treatment before primary surgery.
* The informed consent has been obtained from the patient.

Exclusion Criteria:

* Patients with Transcription factor enhancer 3(TFE3) or transcription factor EB (TFEB) translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH)
* Previously received neoadjuvant therapy
* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive pembrolizumab, such as had a prior solid organ transplant, has a known history of human immunodeficiency virus infection.