cyrilzakka/clinical-trials huggingface dataset:
Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults

This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology).

Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:

* T ALL or B ALL non Ph (N=810 patients planned).
* GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).
* GRAAPH 2005: ALL Ph+ (N=270 patients planned)

GRAALL 2005: T ALL or B ALL non Ph

Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.

(N=810 patients planned)

GRAALL 2005 R: B ALL non Ph CD20+

Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.

Randomization between Mabthera (rituximab) or no Mabthera during all induction and consolidation courses.(N=220 patients planned)

Allogenic transplantation will be performed depending on unfavourable risk factors.

GRAAPH 2005: ALL Ph

Randomization between an imatinib-based induction and a chemotherapy + imatinib induction. (N=270 patients planned)

Allogenic transplantation will be systematically performed in the presence of related or unrelated donors.

Autologous transplantation could be performed in the absence of a donor in case of Molecular Residual Disease (MRD) ≤ 10-4.

Consolidation therapy will be performed in the absence of a donor in case of MRD \> 10-4.

Eligibility Criteria:
Inclusion Criteria:

* 18-59 years
* ALL newly diagnosed (blast \< 20%)
* Central Nervous System (CNS) positive or negative
* Signed written informed consent
* For GRAAPH trial only: t(9;22) or BCR- ABL positive

Exclusion Criteria:

* Lymphoblastic lymphoma
* ALL 3
* Chronic myeloid leukemia
* Severe organ condition
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* Children aged birth to \< 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to \< 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days.
* For children younger than 6 months:

  * Gestational age at birth of at least 37 weeks.
  * Oral feeding/nasogastric/gastric feeding for at least 10 days.
  * Body weight ≥2600 g

Exclusion Criteria:

* Active bleeding or bleeding risk contraindicating anticoagulant therapy
* An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation)
* Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT\> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
* Platelet count \< 50 x 109/L
* Sustained uncontrolled hypertension defined as \> 95th age percentile
* Life expectancy \< 3 months
* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
* Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
Shifting Brain Excitation-Inhibition Balance in Autism Spectrum Disorder

This study investigates brain response to single acute dose of cannabidiol, cannabidivarin, and placebo in healthy men with and without autism spectrum disorder

Previous research suggests that cannabidiol (CBD) and cannabidivarin (CBDV) could have the potential to shift brain excitation and inhibition (E-I) in the healthy brain and in neurodevelopmental psychiatric conditions, where this balance is disrupted, such as autism spectrum disorder (ASD). However, no study to date has investigated this. Therefore, in this study, we invited 20 healthy men with and without ASD. Each participant received each drug once (600mg CBD/CBDV, or matched placebo) and magnetic resonance imaging was used to obtain measures of brain biochemistry, activity, and connectivity. We further obtained questionnaires, task data, saliva, urine and blood samples, and conducted visual tasks using eye tracking, electroencephalography, and retinal imaging.

Eligibility Criteria:
Inclusion Criteria:

* men
* pass diagnostic threshold for ASD on the ADI-R (if informant is available)
* currently symptomatic on ADOS
* age 18-50 years
* can give informed consent
* IQ\>70 (on a standard instrument such as WASI)
* medication-free in the month preceding participation (but regular medication with drug, which does not affect glutamate or GABA directly may be permitted)
* willing to provide urine samples to screen for use of illicit substances prior to each scan

Exclusion Criteria:

* IQ\<70
* history of psychosis, co-morbid major mental illness, significant physical illness (heart disease, high blood pressure, seizures)
* habitual substance misuse (including alcohol)
* known allergy to cannabis
* ASD caused by a known genetic syndrome e.g. Fragile X or 22q11 deletion syndrome,
* past/present treatment for epilepsy
* Women will be excluded from this pilot study to reduce heterogeneity in a small sample; avoid the issues around exposing women of reproductive age to a drug; and because pregnancy is a routine exclusion criteria for research MRI. Lastly, ASD is more common in men.
Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

Upon determination of eligibility, all patients will be receive:

* Topotecan

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Biopsy-proven small cell lung cancer, extensive stage disease
* Age \> 65 years
* No previous chemotherapy or radiation therapy.
* Measurable or evaluable disease.
* Adequate bone marrow, liver and kidney function.
* Must be \> 4 weeks from previous major surgery
* Must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Meningeal involvement
* Serious active infections
* Serious underlying medical conditions
* Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer

This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old, female and male;
* Pathological confirmed MSS or pMMR rectal adenocarcinoma;
* Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;
* No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
* Adequate organ function defined at baseline as:

ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr

* 60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);

  * Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;

Exclusion Criteria:

* Pathological confirmed rectal squamous cell carcinoma;
* History of other uncured malignancies within 5 years;
* Allergic to any component of chemotherapy or immunotherapy;
* History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.
* With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema

The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema with central foveal measurement over 300 micrometers

Exclusion Criteria:

* Glaucoma
* Vitreoretinal surgery
* Cataract Surgery less than 3 months prior inclusion
* Unilateral cataract surgery
* Uncontrolled Glycosylated Hemoglobin
* Previous Intraocular Injection
* Systemic Corticosteroids less than 1 month prior inclusion
* Macular ischemia at Fluorescein Angiography
* Cataract precluding fundus examination
* Active Proliferative Diabetic Retinopathy
Prediction of Pain in Total Knee Arthroplasty

In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Eligibility Criteria:
Inclusion Criteria:

* Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.

Exclusion Criteria:

* Bilateral / revision arthroplasty
* Disease affection central or peripheral nerve function
* Alcohol and medical abuse
* Daily use of opioids or glucocorticoids
* Malignancy
* BMI \> 40
* Depression
* Dementia or other cognitive dysfunction
COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)

A prospective single blinded (subject blinded) 1:1:1 randomised control trial with three parallel arms testing superiority of analgosedation regimen based on remimazolam and total intravenous anesthesia over propofol based analgosedation. The primary composite endpoint consists of hypoxaemia, hypotension, or hypertension requiring intervention.


Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation (AF) (paroxysmal, persistent or long standing persistent) with indication for catheter ablation
* Age above 18 years
* Capacity to give informed consent

Exclusion Criteria:

* Heart failure (NYHA III-IV), irrespective of left ventricular ejection fraction
* Left ventricular ejection fraction \< 20%
* Significant valvulopathy (moderate or severe aortic stenosis, severe mitral regurgitation, severe aortic regurgitation, moderate and severe mitral stenosis, severe tricuspid regurgitation)
* Obstructive sleep apnoea syndrome (AHI \>30)
* Low oxygen saturation (\<93%) at baseline
* High aspiration risk (hiatal hernia, gastroesophageal reflux disease on chronic pharmacotherapy)
* Hypersensitivity to the study drugs
* Chronic kidney disease (stage 4 and 5 of CKD), liver cirrhosis
* Anticipated difficult airways
* ASA (American Society of Anaesthesiologists) score \> 4
* Schizophrenia
* Epilepsy
* Other individual contraindications (will be reported in detail)
A Clinical Study on Efficacy & Safety Profile of Propionyl-L-carnitine Tablets for Peripheral Arterial Diseases

The main objective of this study is to evaluate the effectiveness and safety of the propionyl-L-carnitine hydrochloride tablets among Chinese population in comparison with the placebo, for treatment of the peripheral arterial diseases (intermittent claudication) with oral supplementation of 2g daily for a 4 months continuous administration.

This is a randomized, multi-centre, double-blind and placebo controlled clinical study. Propionyl-L-Carnitine (PLC) is a kind of natural derivative of L-Carnitine (LC) and is produced in the body and concentrated by 90% in the skeletal muscle and myocardium via an enzyme-mediated reaction involving propionyl-CoA and LC. For oral adminsitration, PLC shows that the decrease of the leg muscle carnitine of the PAD patient appears to correlate with poor exercise performance. It has recently been shown that the severity of the impairment in walking distance is correlated with the impairment in carntine metabolism at the muscle level. 2g daily of PLC supplementation can significantly improve the walking ability in patients with IC with a maximum walking capacity between 50 and 250 meters on the treadmill.

Eligibility Criteria:
Inclusion Criteria:

* The variability between the two standardized claudication tests during the wash-out period must be \<20%, as assessed by the formular: (Highest MWD-Lowest MWD)/(Lowest MWDxx100%)
* At the last visit during the wash-out period, the ABI at rest must be ,0.9

Exclusion Criteria:

* with rest pain, ulceration, and/or gangrene
* PAD of a non-atherosclerotic nature
* Aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 6 months; any above ankle level amputation. Any type of major surgery during the last three months.
* Except PAD, any concomitant disease that can limit patients' performance in the treadmill exercise.
* with angina (at rest or activity) or any symptom which is sufficiently severe to discontinue the treadmill exercises.
* Myocardial infarction within 6 months
* Severe cerebral dysfunction
* Type I diabetes (Stable type II diabetes can also be included)
* alcohol or drug abused history within 3 months
* Medium or severe anaemia (Hb,90g/L)
* Platelets \<100 x 10 9/L
* Bleeding diathesis
* Renal insufficiency or hepatic function laboratory test result\>1.5 normal value
* Treatment with LC or carnitien derivatives in the past 3 months
* Pregnancy, lactation, fertility without adequate protest against pregnancy
* Reject to sign the informed consent form
A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)

Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students.

The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* presence of clinically significant anxiety symptoms (DASS-21 \> 4)
* presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \> 75);
* obtaining informed consent to participate in the study;
* Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);
* absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).

Exclusion Criteria:

* absence of clinically significant anxiety symptoms (DASS-21\< 4);
* absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \< 75);
* lack of obtaining Informed Consent to participate in the study;
* presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).
* presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).
A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies

This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies.

Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s).

Estimated enrollment is 15 subjects per Sub-Protocol.

Patients will have a short-course (4-weeks) administration of a given compound in the timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor biopsy will be obtained, and blood samples will be collected before, during, and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Must have biopsy-proven solid tumor that is eligible for elective surgical resection, disease does not require immediate therapy, and there is NO approved/ standard therapy available that is shown to prolong overall survival.
2. ECOG performance status of 0 or 1.
3. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
4. Willing to provide tissue and blood samples for research.

Exclusion Criteria:

1. The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma, Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III rectal cancer.
2. Any active malignancy within 3 years prior, except: Adequately treated basal cell or squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1) treated with curative intent.
3. Any uncontrolled intercurrent illness, including but not limited to: Symptomatic congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social situations that would limit compliance with study requirements, or Ongoing or active infection.
4. Any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s).
5. Unwilling or unable to follow the study schedule.

Other protocol defined inclusion/exclusion criteria may apply.
Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke

This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>/= 18 years of age
2. Subject has been diagnosed with acute ischemic stroke with onset ≤ 24 hours from enrollment.
3. Subject has NIH stroke score (NIHSS) ≥ 6 and ≤ 25.
4. Subject or legally authorized representative is willing and able to sign written informed consent.

Exclusion Criteria:

1. Subject is currently prescribed angiotensin-converting-enzyme inhibitors (ACEi) and is unable or unwilling to convert to another antihypertensive pharmacological treatment during the active treatment period (+5 days) of the study.
2. Subject has a history of significant allergic diathesis such as urticaria, angioedema or anaphylaxis.
3. Subjects with current malignancy or active malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and at least six months have elapsed since the procedure.
4. Subject has a history of clinically significant acute bacterial, viral, or fungal systemic infections in the last four weeks prior to enrollment.
5. Subject has clinical or laboratory evidence of an active infection at the time of enrollment.
6. Subject has known alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screening.
8. Subject is pregnant or nursing.
9. Subject is male or female of childbearing potential, is participating in heterosexual sexual activity that could lead to pregnancy, and is unable or unwilling to practice medically effective contraception during the study.
10. Subject is participating in any other investigational device or other drug study ≤ 4 weeks or 5 half-lives of the investigational product, whichever is longer.
11. Subject does not have sufficient venous access for infusion of study treatment or blood sampling.
12. In the opinion of the Investigator, subject is unlikely to be followed for the duration of t the study.
13. Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
14. Subject has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
15. Pre-stroke Modified Rankin Scale ≥4