cyrilzakka/clinical-trials huggingface dataset:
A Study of Sublingual Immunotherapy in Peanut-allergic Children

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.

Eligibility Criteria:
Inclusion Criteria:

* Peanut IgE \> 7kU/L (\> 2kU/L for children aged 2 years and under) AND
* History of significant clinical symptoms within 60 minutes after the ingestion of peanuts.

Exclusion Criteria:

* History of severe life-threatening anaphylaxis to peanut, OR
* Medical history that would prevent a DBPCFC to peanut, OR
* Subjects with wheat or oat allergy (which are used in the placebo), OR
* Unable to cooperate with challenge procedures, OR
* Unable to be reached by telephone for follow-up
Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase

This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.

The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion
* Completed permanent dentition
* Crowding ≥ 6 mm

Exclusion Criteria:

* Tooth loss or extraction except third molars
* Having cross bite
* Having genetic or hormonal disorder
* Using a chronic drug
* Previous orthodontic treatment and prosthetic restoration
* Inappropriate oral hygiene and periodontal diseases
Next Generation Pathogen Sequencing for Prediction of Infection in Rheumatic Disease

The majority of patients diagnosed with rheumatic disease, such as systemic lupus erythematosus, inflammatory myositis, and vasculitis, will experience fever or infection during their course of therapy. The most common microbiologically documented infection is bacterial, virus, and fungal, which can be associated with the severity and mortality of disease. Current methods of diagnosis require a significant load of pathogen making early detection difficult. Delayed diagnosis and delayed optimal therapy of infection are associated with increased morbidity and mortality.

This study seeks to identify whether next generation sequencing (NGS) of pathogens can identify patients with infection treated with corticosteroid and immunosuppressive agents. This would enable preemptive targeted therapy to replace prophylaxis treatment which often leads to some adverse events and antibiotic resistance.

Plasma/Serum samples collected but not required for clinical care (discarded samples) will be collected and stored. Results of NGS will be compared between patients who develop definite infection immediately (within 72 hours) after sample collection, and those who remain well. Clinical data describing baseline information about the patient and rheumatic diseases, antibiotic and steroid or immunosuppressor therapy exposure, pathogen testing, immunology results, and infection-related events will be collected prospectively from the electronic medical record.

An initial exploratory phase will examine approximately 50 participants to determine whether the effectiveness of predicting infections. The study may then enroll up to 200 participants to collection additional data for analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years to 70 years;
* Undergoing care for rheumatic disease at Peking University People's Hospital;
* In a category of patients who are considered by the investigator to be at high risk of infection

Exclusion Criteria:

* Any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects


Eligibility Criteria:
Inclusion Criteria:

* Agreement with written informed consent
* Adult healthy male or female subject age 20 to 45

Exclusion Criteria:

* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
* Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days
* Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
* Subject with known for hypersensitivity reactions to isoniazid
* Subject who can not perform contraception during study periods
* Female woman who are pregnant or are breast feeding
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients

A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of acute myeloid leukemia with the confirmed first or second complete remission
* ≥ 55 years of age
* Not candidates for allogeneic stem cell transplantation as decided by the panel of hematologists at the transplant center
* Patients with a HLA-haploidentical donor who should be able to provide informed consent for peripheral blood apheresis
* No severe concurrent illness that limits life expectancy to less than 2 years

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Karnofsky index \<70%
* Acute promyelocytic leukemia
* Other tumor requiring treatment at the time of enrollment
* Active or prior documented autoimmune disease requiring systemic treatment
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01

RATIONALE: Treatment for pediatric extracranial germ cell tumors may cause side effects and secondary cancers later in life. A study that evaluates patients after receiving combination chemotherapy or surgery may help doctors understand the side effects and secondary cancers that occur later in life.

PURPOSE: This study is looking at treatment outcome and quality of life in patients with pediatric extracranial germ cell tumors previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.

OBJECTIVES:

* Determine the late effects of treatment and the quality-of-life of patients with germ cell tumors (GCT) previously treated on clinical trial CCLG-GC-1979-01 or CCLG-GC-1989-01.
* Evaluate the late effects of carboplatin, etoposide, and bleomycin in patients treated on clinical trial CCLG-GC-1989-01.
* Determine the toxicity of bleomycin and a combination of either cisplatin and vinblastine, etoposide and cisplatin, or carboplatin and etoposide in patients treated on clinical trial CCLG-GC-1979-01.
* Evaluate tumor-associated/surgical morbidity (bladder, bowel, and lower limb function) in patients with malignant sacrococcygeal tumors treated in these clinical trials.
* Evaluate tumor-associated/surgical morbidity (sexual function/fertility) in patients with malignant gonadal or pelvic GCTs.
* Evaluate tumor-associated/surgical morbidity (respiratory function) in patients with thoracic GCTs.
* Develop a methodology and recommendations for the prospective late evaluation of patients treated on future extracranial GCT clinical trials and those included in this study.
* Inform clinicians about the late effects of treatment of malignant GCTs and advise them on what long-term care these patients require.

OUTLINE: This is a cohort, multicenter study.

Patients complete questionnaires about ototoxicity, bladder and bowel dysfunction, and sexual function and fertility as appropriate. They also complete a health-related quality-of-life questionnaire over 20 minutes.

Treating physicians complete a lower-limb and neurologic dysfunction questionnaire. Data from myelodysplasia, second malignancy, ototoxicity, nephrotoxicity, and pulmonary toxicity assessments are collected from the patient's treating physician.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously enrolled in 1 of the following United Kingdom Children's Cancer Study Group (UKCCSG) clinical trials for treatment of extracranial germ cell tumors:

  * CCLG-GC-1989-01
  * CCLG-GC-1979-01

    * Received bleomycin or cisplatin therapy
* At least 5 years since completion of therapy in these clinical trials
* Attending or in contact with a UKCCSG center

  * Patients treated for sacrococcygeal teratomas and discharged from follow-up are eligible
* No recurrent or progressive disease

PATIENT CHARACTERISTICS:

* No patient deemed unsuitable for this study by the treating clinician

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps.

Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.

Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed.

This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx.

In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one colorectal polyp found and resected during colonoscopy in regular care;
* Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp;
* Overall high quality of the colorectal polyp image;
* Availability of the histological results of the colorectal polyp;
* Minimal age of 18 years old.

Exclusion Criteria:

* Objection to participate in medical scientific research, reported in the medical file;
* Endoscopic instruments visible at the colorectal polyp image;
* More than one polyp visible at the colorectal polyp image.
Group-based Positive Psychotherapy in Psychological Resilience of Only-Child-Lost People

A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. A total of 80 only-child-lost people who met the inclusion and exclusion criteria were expected to recruit. There were six weeks in the intervention, including positive introduction, positive reaction, gratitude, meaningful, three good things, and using personal strength. The measurements were conducted at the baseline, immediately after the intervention, 3-month after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. having only one child or legally adopting;
2. No surviving children;
3. basic language expression and comprehension skills;
4. the score of Connor-Davidson Resilience Scale is lower than 82

Exclusion Criteria:

1. in the acute bereavement period (\<6 months);
2. unable to participate in activities due to severe physical illness;
3. having diagnosis of sever mental illness;
4. receiving other psychological therapy.
WB-EMS Increase Energy Expenditure at Rest and During Uphill Walking Exercise

Whole-body electrical stimulation (WB-EMS) has become increasingly popular as a tool to provide additional benefits compared to conventional exercise. However, the effects of the different electrical parameters on energy expenditure (EE) and respiratory exchange ratio (RER) remain poorly understood. This study aims to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise

Obesity is a critical public health problem worldwide since it is a risk factor for cardiovascular diseases and mortality. Increased body weight and obesity are the results of an imbalance between energy intake and energy expenditure (EE). Body weight regulation and obesity are highly influenced by different factors such as genetic, physiology, and socioeconomics. It is well known that physical exercise is an effective strategy to increase EE, improve body composition, physical fitness, and cardiometabolic risk factors. Unfortunately, the principal barriers to abstaining from exercise are time constraints, the risk of injuries, and the lack of enthusiasm observed during the exercise sessions. In this context, whole-body electromyostimulation (WB-EMS) training is becoming increasingly popular worldwide as a potential and attractive alternative to traditional training methods to increase EE. The present study aimed to determine and compare the effects of different electrical frequencies applied with WB-EMS in EE and RER at supine resting and during uphill walking exercise.

Eligibility Criteria:
Inclusion Criteria:

* (i) no previous experience with WB-EMS training
* (ii) having a stable body weight (variation of \<5 kg in body weight over the previous 3 months)
* (iii) normal weight (body mass index (BMI) between 18.5-25.0 kg/m2)

Exclusion Criteria:

* (i) Suffering from any health problem that might be aggravated by exercise or any contraindications for WB-EMS, such as total endoprosthesis, epilepsy and abdomen/groin hernia
* (ii) Taking medications
* (iii) Chronic metabolic disease or cancer
Management of Symptomatic Advanced Pancreatic Adenocarcinoma

This study assessed the feasibility and effects of an early integrative supportive care program in patient with advanced pancreatic adenocarcinoma (aPDAC).

This is a national, multicenter, prospective study, including:

* A 14-day (+/-2 days) integrative supportive care program (14-EISCP) initiated as early as the clinical suspicion of aPDAC,
* Follow-up period after the 14-EISCP.

ECOG PS ≥2 patients with pathologically confirmed or suspected aPDAC on imaging were included at first oncology visit in the 14-EISCP including pain, nutritional, diagnostic and stenting procedures.

Post-EISCP ECOG PS ≤1 patients received mFOLFIRINOX or gemcitabine/nab-paclitaxel, ECOG PS ≥2 patients received mFOLFOX7 or investigator choice chemotherapy or best supportive care.

Eligibility Criteria:
Inclusion criteria

1. Pathologically confirmed or highly suspected aPDAC defined as a pancreatic mass on imaging, suspected distant metastases, no features suggestive of a neuroendocrine tumor, and/or clinico-biological abnormalities compatible with the diagnosis of aPDAC,
2. Age ≥ 18 years,
3. Patients with ECOG PS ≥ 2 and clinico-biological features precluding initial therapeutic clinical trial and/or treatment with FOLFIRINOX or gemcitabine + nab-paclitaxel,
4. No prior history of cancer, except: in situ breast, cervix cancer, or basal cell carcinoma and/or complete remission for more than 3 years from another cancer.
5. Registration in France with the French National Health Care System (CMU included)
6. Patient able to comply with study protocol requirements in the view of the investigator,
7. Before patient registration, written informed consent must be obtained according to ICH/GCP and national/local regulations,
8. Patients requiring at least two components of the integrative care program (pain management, nutritional management, pathological assessment or imaging, and endoscopy/stent).

Exclusion criteria:

1. Any medical, psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial,
2. Patient protected by law,
3. Pregnant or breast feeding women
Mechanisms of Cognitive Change

This study will determine whether targeted cognitive training, a low-cost and low-risk commercial cognitive remediation therapy, directly impacts therapeutic targets as well as secondary outcomes in college undergraduates. The active intervention will be compared to an active control condition (computer games). Participants will also attend CSU TILT (The Institute for Teaching and Learning) Academic Workshops.

The primary goal of this project is to investigate whether commercial cognitive remediation therapy improves cognitive functioning in college undergraduates. The secondary goal is to investigate neurophysiological, cognitive, and psychosocial mechanisms of change. The investigators will compare cognitive remediation therapy to computer games. The active control condition will allow the investigators to determine whether targeted cognitive training, as an adjunct to academic skills training provided by CSU TILT, provides significant improvement over computer games alone (which is also thought to provide some value as "brain training"). Participants who agree to enroll in the study will be randomized to one of two intervention arms: cognitive remediation (CR) or active control (AC). In the CR arm, participants will complete 20 hours of targeted cognitive training, in 30-min session, 5 days per week, over 8 weeks. The AC Arm will follow the same schedule, except that participants will complete video games (e.g., pong). All participants will repeat assessments at randomly determined midpoint, as well as after the 8 weeks of training have been completed.

Eligibility Criteria:
Inclusion Criteria:

* College undergraduate;
* English fluency, and the ability to complete study requirements.

Exclusion Criteria:

* College seniors (i.e., students with more than 89 credits at CSU);
* Students who are concurrently enrolled in another study investigating the efficacy or effectiveness of novel learning or cognitive development techniques (not including tutoring or other existing programs available to CSU undergraduates);
* Participants less than age 15.
Calmer Life: A Worry Reduction Program for Older Adults

Calmer Life is a research study for older adults with anxiety. In the program participants will have the opportunity to learn skills that may help cope with anxiety. Participants have the option of including religion and spirituality into the skill. Skills participants can learn include: how to relax, how to change the way you think about things, and how to solve problems more effectively.

Preliminary work in a related study (H-22763) suggests that a significant percentage of older patients think that incorporating religion and/or spirituality into counseling is important. Based on data from this study, available scholarly literature, and input from consultants, we have developed an initial version of Calmer Life that is sufficiently flexible to incorporate a range of religious and spiritual beliefs and coping skills based on each patient's unique values and beliefs. The manual for this treatment includes intervention components from evidence-based treatment for late-life anxiety (H-23798; H-15958), suggested strategies for incorporating religion or spirituality into the coping skills for anxiety and depression, and spiritually-based interventions (e.g., forgiveness, gratitude). Patients have a choice to include or not include religious or spiritually based components. The proposed project will begin to test this broad spiritually based CBT for older adults (Calmer Life) with Generalized Anxiety Disorder (GAD) with or without depression. Further modifications to the Calmer Life manual and in the treatment approach will be made based on patient, clinician, and consultant input.

Eligibility Criteria:
Inclusion Criteria:

* Age 50+;
* A principal or co-principal diagnosis of General Anxiety Disorder;
* Interest in receiving CBT for anxiety/depression with the option of including religion and spirituality;
* Must be English speaking

Exclusion Criteria:

* Active suicidal intent;
* Current psychosis or bipolar disorder;
* Substance abuse within the last month