cyrilzakka/clinical-trials huggingface dataset:
Multicenter Trial Treatment of Philadelphia Chromosome Negative B-cell Acute Lymphoblastic Leukemia of Young Adults

The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).


Eligibility Criteria:
Inclusion Criteria:

1. Whose blood and bone marrow explorations have been completed before the steroids prephase
2. Aged 18 to 59 years old with not previously treated (including intrathecal injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with ≥ 20% bone marrow blasts
3. Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)
4. With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
5. With or without central nervous system (CNS) or testis involvement
6. Without other evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be finished at least since 6 months
7. Having signed a written informed consent
8. With efficient contraception for women of childbearing age (excluding estrogens and IUD)
9. With health insurance coverage
10. Who have received or being receiving the steroid prephase

Exclusion Criteria:

1. With lymphoblastic lymphoma and bone marrow blasts \< 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
2. With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:

   * Aspartate transaminase (AST) and/or alanine transaminase (ALT) \> 5 x upper limit of normal range (ULN)
   * Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
   * Creatinine \>1.5x upper limit of normal range (ULN) or creatinine clearance \<50 mL/mn
3. Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ventricle ejection fraction (LVEF) \< 50% and or Shortening fraction \< 30%,
4. Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
5. Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
6. Not able to bear with the procedures or the frequency of visits planned in the trial
7. Unable to consent, under tutelage or curators, or judiciary safeguard.
VR and Chronic Pain Pilot Usability Study

This is a pilot feasibility and usability study of a virtual reality device for patients with chronic pain.

The investigators will conduct a study of patients with chronic pain to identify interest in participating in a large VR trial and, for those willing to join the team to test the device in person, to pilot 2 sessions of VR to assess usability and collect preliminary data on pain and mood and to obtain data on patient satisfaction with device use. Researchers expect the entire session to last 45 minutes to 1 hour.

All patients recruited will be in the active arm; this is not a randomized pilot study.

The intervention being piloted is the EaseVRx - AppliedVR, Los Angeles, CA - VR hardware and software. EaseVRx incorporates evidence-based principles of cognitive behavioral therapy, mindfulness, and pain neuroscience education into an immersive and enhanced biofeedback experience. EaseVRx includes breathing training and relaxation response exercises that activate the parasympathetic nervous system. EaseVRx was designed for at-home use and comes with a sequence of daily immersive experiences, with each VR experience being 2-16 minutes in length (average of 6 minutes). For this pilot, researchers will be doing one in-person session, using two interoceptive VR experiences (out of 56 total).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Chronic pain (using self-report) with pain intensity \>=4 and confirmed by ICD-10 codes in medical record
3. Fluency in English

Exclusion Criteria:

1. Inability to give informed consent
2. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines
3. Medical condition predisposing to nausea or dizziness
4. Hypersensitivity to flashing light or motion
5. No stereoscopic vision or severe hearing impairment
6. Injury to eyes, face, or neck that prevents use of VR headset
7. Currently pregnant, by self-report
Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE)

The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

The primary objectives of the study were to evaluate the efficacy of OCR-002 for treatment of an acute hepatic encephalopathy (HE) episode in cirrhotic patients requiring hospitalization and the safety and tolerability of OCR-002 in hospitalized cirrhotic patients with an acute episode of HE.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with an acute episode of hepatic encephalopathy as complication of cirrhosis
* Elevated venous ammonia

Exclusion Criteria:

* Renal failure with serum creatinine \> 3 mg/dL or need for dialysis
* Molecular Adsorbent Recirculation System utilized
* Pregnancy or breastfeeding
Effects of Ballistic vs Plyometric Training on Performance of Badminton Players

Ballistic and plyometric training are both frequently utilized to enhance physical performance in a variety of sporting activities that require the ability to jump, sprint, and change direction. both are designed to improve explosive power, but they differ in their approaches and focus. Although many studies highlight the significance of both plyometric and ballistic exercises in enhancing athletic performance in badminton players no direct comparison has been made between the two.

In this study we compared the effectiveness of Ballistic exercises versus Plyometric exercises on performance in Badminton players, which is going to help us to select the best possible training program for badminton athletes

Ballistic and plyometric training are both frequently utilized to enhance physical performance in a variety of sporting activities that require the ability to jump, sprint, and change direction. both are designed to improve explosive power, but they differ in their approaches and focus. Although many studies highlight the significance of both plyometric and ballistic exercises in enhancing athletic performance in badminton players no direct comparison has been made between the two.

In this study we compared the effectiveness of Ballistic exercises versus Plyometric exercises on performance in Badminton players, which is going to help us to select the best possible training program for badminton athletes

Eligibility Criteria:
Inclusion Criteria

* Active Badminton player.
* Age between 20-28 years.
* Male Badminton players

Exclusion Criteria

* Athletes with injuries, trauma, pathology, any neurological or psychological complications.
* Athletes with Metabolic diseases.
* Age above 28 years or less than 20.
* Other than male Players.
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer

This pilot clinical trial studies how well social media listening works in improving clinical trial recruitment in patients with cancer. Social media listening and recruitment on Twitter may enhance enrollment for cancer-related clinical trials.

PRIMARY OBJECTIVES:

I. Examine the feasibility (acceptance among University of Southern California \[USC\] Norris study team members and Twitter users in Los Angeles \[LA\] county) of targeted social media listening (SML) via Twitter as a tool for enhancing recruitment to cancer trials.

II. Gain preliminary data on the impact (i.e., numbers recruited versus projected accrual compared to historic recruitment) of targeted social media listening (SML) as a tool for enhancing recruitment to cancer trials among Twitter users in LA county.

III. Estimate the effect size of the number of people enrolled associated with the use of targeted social media listening (SML) via Twitter as a tool for enhancing recruitment to cancer trials.

OUTLINE:

Patients who mention specific cancer disease keywords and/or hashtags are identified and receive a message via Twitter. Patients are then contacted for recruitment into a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* TRIAL INCLUSION:
* Focus on one of the following disease categories: non-small cell lung cancer, colon cancer, breast cancer, prostate cancer, kidney cancer, lymphoma
* Be a phase 1 trial in expansion, phase 2, or 3
* Be interventional trials
* Recruit in English
* Be Institutional Review Board (IRB)-approved and open to accrual at USC Norris
* Recruit for at least 9 months at the point of enrollment
* Set monthly accrual target \>= 1/ and annual accrual target \>= 12
* PATIENT INCLUSION:
* Will include all prospective trial participants in this study that come from Twitter in response of our SM recruitment interventions, provided they meet the specific trial's eligibility criteria

Exclusion Criteria:

* TRIAL EXCLUSION:
* Phase 1 trials in dose escalation
* PATIENT EXCLUSION:
* Persons who do not meet the eligibility criteria of any of the trials open to accrual will be excluded from participation, and persons who may be eligible (e.g., disease/histology, stage, prior treatment) but do not meet additional trial-specific requirements such as insurance or allergy to drug)
Comparison of Two-treadmill Test Protocols to Evaluate Endurance in People With Cancer

During this study the investigators will compare the use of two treadmill tests in people diagnosed with cancer. The STEEP treadmill protocol is often used to evaluate the endurance of people diagnosed with cancer, however, since it is based on step increases in speed or ramp, it may not related to normal function. The new test, which is based on the body response to increased activity has not been used with people with cancer but may provide a better approximation of endurance demands during daily function. Our question is whether the new treadmill test can be used to evaluate aerobic function with people with cancer better than the STEEP treadmill test.


Eligibility Criteria:
Inclusion Criteria:

* Participants are required to be adults (age 16 or over),
* Diagnosed with cancer, at any stage of treatment (during or after treatment),
* Able to follow instructions in English, and provide informed consent.
* Participants need to be considered "well" to participate. A "well participant" has been defined as a cancer survivor who is living at home, able to ambulate independently without a gait aid (single point cane is acceptable), has no acute medical conditions, and passes pre-exercise safety screening.

Exclusion Criteria:

* Cancer survivors with metastatic disease.
* Cancer survivors who are defined as unwell.
CyberKnife Radiosurgery for Locally Recurrent Prostate CA

The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.

This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
* Karnofsky performance status \>80.
* Greater than 5 year life expectancy
* Greater than 2 years since the original course of radiotherapy.
* Absence of distant metastases by radiologic or pathologic assessment.
* Absence of lymph node involvement by radiologic or pathologic assessment.
* Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

* Stage T4 disease (AJCC 6th Edition, see Appendix II).
* Less than 2 years since the original course of radiotherapy.
* Lymph node involvement (N1).
* Evidence of distant metastases (M1).
* Radical surgery for carcinoma of the prostate
* Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* History of inflammatory bowel disease
* Late GI or GU Morbidity \> Grade 1 from the prior course of radiotherapy
Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis

Rectosigmoid involvement by endometriosis causes intestinal symptoms such as constipation, diarrhea, and dyschezia. A non-invasive diagnosis of bowel endometriosis is relevant to provide the patients information on the potential hormonal or surgical treatments. The objective of the current study was to compare the performance of three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS) and computed colonography (CTC) in predicting the presence and characteristics of rectosigmoid endometriosis.


Eligibility Criteria:
Inclusion Criteria:

- pain and intestinal symptoms suggestive of rectosigmoid endometriosis

Exclusion Criteria:

* previous surgical diagnosis of intestinal endometriosis
* previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema
* history of colorectal surgery (except appendectomy)
* contraindications to bowel preparation or computed colonography (such as non-- compliant patients and rectal malformations)
* previous bilateral ovariectomy
* psychiatric disorders
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors

The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

The trial is an open-label, multi-center first-in-human trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.

Eligibility Criteria:
Inclusion Criteria (main):

* Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial.
* Patient must be ≥ 18 years of age
* Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
* Have an acceptable hematological status
* Have an acceptable renal function
* Have an acceptable liver function
* Have an Eastern Cooperative Oncology Group performance status of 0 or 1
* Body weight ≥ 40kg
* Patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of GEN1029

Exclusion Criteria (main):

* Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first GEN1029 administration
* Have clinically significant cardiac disease
* Have uncontrolled hypertension as defined in the protocol
* Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
* History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of Investigational Medicinal Product (IMP)
* Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first GEN1029 administration
* History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial
* Radiotherapy within 14 days prior to first GEN1029 administration
* Any prior therapy with a compound targeting DR4 or DR5
* History of chronic liver disease or evidence of hepatic cirrhosis
A Study in Healthy Adult Participants to Assess the Effects of Ciclosporin Administration on Rilematovir

The purpose of this study is to evaluate the pharmacokinetic (PK) of a single-dose of rilematovir co-administered with a single-dose of ciclosporin compared to a single-dose administration of rilematovir alone.


Eligibility Criteria:
Inclusion Criteria:

* Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight kg/height\^2 \[meter {m\^2}\]) within the range 18.0 to 30.0 kilograms per meter square (kg/m\^2) (inclusive)
* Female participants, except those that are of non-childbearing potential, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -1 of Treatment Period 1
* A female participant using hormonal contraceptives as a means of birth control (a stable treatment for at least 30 days prior to screening) must agree to continue use of the same hormonal contraceptives throughout the study and for 90 days after the end of last study treatment
* Blood pressure (after the participant is supine for at least 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: normal sinus rhythm (heart rate between 45 and 90 beats per minute, extremes included); QTc interval less than or equal to (\<=) 450 milliseconds (ms) for men, \<= 470 for women; QRS interval of less than (\<) 110 ms; PR interval \<= 200 ms; electrocardiogram morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

* Participants with abnormal values for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) Grade 1 or greater (greater than \[\>\] 1.25\* upper limit of normal \[ULN\])
* Participants with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Known allergies, hypersensitivity, or intolerance to rilematovir or its excipients. Known allergies, hypersensitivity, or intolerance to ciclosporin or its excipients
* Participant has received an experimental drug, vaccine or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study intervention is scheduled
* Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers

This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.


Eligibility Criteria:
Inclusion Criteria:

- Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).

Exclusion Criteria:

* Children and subjects with other diagnoses than those mentioned in the inclusion criteria.
* Patients without the means to visit the clinic on the assigned dates.
* Patients who are pregnant or are expecting to become pregnant.
Effect of Vitamin D Therapy in Autism Spectrum Disorder

The aim of this work is to study the adjuvant effect of vitamin D supplementation on inflammatory marker (IL4) and habilitation outcome in children with Autism Spectrum Disorder in order to evaluate its efficiency as a treatment option based on correction of immune dysfunction.

Vitamin D is one of environmental factors potentially modulating brain development and functioning. Vitamin D3 deﬁciency during pregnancy and early childhood is suggested to be one of several risk factors for development of ASD in genetically predisposed individuals (Cies´lin´ska et al., 2017). Many studies e.g (Eyles et al., 2013; Grant and Sole, 2009; Noriega and Savelkoul, 2014) suggested that vitamin D has an important role as a neuroactive steroid, which can affect neuronal differentiation, axonal connectivity and brain structure and function. Vitamin D has been increasingly recognized for its immunomodulatory role and has been implicated in the pathogenesis of autoimmune disorders. Also it has numerous and dynamic effects on the immune system, ranging from altering T cell responses and regulating cytokine pathways (Kocˇovská et al., 2017). So from this point of view, this study will be conducted to show adjuvant effect of vitamin D supplementation on ASD children at clinical level and inflammatory marker (IL4).

Eligibility Criteria:
Inclusion Criteria:

1. Delayed language development due to ASD.
2. Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency).
3. Normal hearing and vision.

Exclusion Criteria:

1. History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil.
2. Known chronic disease.
3. Known neurological disorders or psychiatric disorders.
4. Known autoimmune or gastrointestinal disorders.