cyrilzakka/clinical-trials huggingface dataset:
Neural Mechanisms of Attention Lapses in Adult ADHD

ADHD is a common disorder, leading to a significant disability that often persists in adulthood. ADHD is characterized by attentional disturbances that are difficult to asses with standard neuropsychological tests.

Attention tends to stall after a certain time of fatigue (i.e. an attention lapse). The aim of this study is to study the electroencephalographic (EEG) characteristics of these attention lapses in a sustained attention task, comparing ADHD patients with healthy subjects.

The main goal is to assess with EEG the timing of the attentional demobilization that precedes a sustained attention lapse in patients with ADHD.

The secondary objectives are: 1 / To analyze impaired cognitive control mechanisms during lapses in patients with ADHD; 2 / Study the relationships between the deficits identified through EEG recording, clinical evaluations, and the subjective perception of daily difficulties; 3 / To measure the impact of the subjective attention state on the neuronal precursors of the attentional lapses; 4 / Evaluate the relation between propensity to wandering mind and attentional lapses.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD according to DSM-5 criteria by a psychiatrist with clinical experience with ADHD
* aged 18 to 60
* having signed an informed consent
* able to understand the objectives and the risks related to the research

For Healthy controls

* Absence of psychiatric disorder or neurological disease
* Matched in sex, age (± 2 years) and level of study (± 2 years) to each ADHD patient

Exclusion criteria:

* treatment by Methylphenidate or amphetamine in the 3 months preceding the study
* treatment by a psychotropic drug other than antidepressant SSRI: anti-depressant non-SSRI, antipsychotic, mood stabilizer, benzodiazepine or hypnotic daily intake
* neurological pathology or neurological sequelae
* history of head trauma with loss of consciousness of more than 15 minutes
* Subject under the protection of justice
* Subject under guardianship, curatorship
* Subject in exclusion period (determined by previous or current study),
* Impossibility to give the subject enlightened information (subject in emergency situation, difficulties of comprehension of the subject (for example mental retardation, illiteracy, subject not including French ...)
Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation

Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Underwent liver transplantation at MDMC between February 4th 2019 - February 4th 2020 and February 5th 2020 - February 5th 2021

Exclusion Criteria:

* Below 18 years of age
* Did not undergo liver transplantation
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma

The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of relapsed or refractory cHL
2. Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria:

   Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell transplant (HSCT)
   1. Has failed to achieve a response or progressed after autologous HSCT
   2. Is not a candidate for additional autologous or allogeneic HSCT

   Cohort 2: Relapsed or refractory to salvage chemotherapy, and has not received prior autologous or allogeneic HSCT
   1. Is not a candidate for autologous or allogeneic HSCT
   2. Has received at least 1 prior systemic regimen for cHL
3. Measurable disease defined as ≥ 1 2-\[18F\] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is \> 1.5 cm in the longest diameter, or ≥ 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is \> 1 cm in the longest diameter
4. Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

1. Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
2. Prior allogeneic hematopoietic stem cell transplantation
3. Prior therapy targeting PD-1 , PD-L1,PD-L2, or CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) pathways
4. Active autoimmune disease or history of autoimmune disease that may relapse

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Metabolites Markers in Adjuvant Breast Cancer

The breast cancer is composed of multiple biological entities. Recent progress in molecular biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those technics, leads to an increased in the molecular biology knowledge and a better oncogenesis understanding. Breast cancer taxonomy was established following the tumor genetic profile. Moreover this classification is incomplete and didn't include the metabolic pathways other than hormonal or HER2 pathways.

The metabolomics is an expanding field of research exploring the metabolites in cells, tissues or biologics fluids. It allows assessing the variation activation of the different cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances, the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis using the tumor cells metabolites profiles.

Compared to genomic, the metabolomics integrated the impact of the cells environments on the cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic in order to assess a better knowledge of the impact of the extracellular environment on the tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive compatible with routine practice.

The main objective of this study is to highlight a metabolic alteration specific to certain tumors phenotypes in order to have better understanding of the biology of the numerous breast cancer entities and find some biomarkers which could be some possible therapeutic target. Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank. The tissue analysis could be associated with a serum sample analysis from the frozen serum bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the surgery, The investigators will analyzed the correlation between the tumoral activation of the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17 frozen serums available, the investigators will perform a screening to identify some metabolites or metabolites profile which could be detected in the serum in order to develop a new liquid biopsy approach. This study is a retrospective study based on data and sample already available in the center and collected during the routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient with breast cancer who undergoes a initial surgery with frozen preservation of the surgical specimen in the Centre Antoine Lacassagne tumor bank
* Patient who sign the Biological research center consent allowing the the preservation of tumor and blood sample in biobank and use of the sample for research purpose

Exclusion Criteria:

* other treatment the initial surgery (neodjuvant chemotherapy...)
* Absence of tumor tissue available in the tumor bank
* Absence of Biological research center consent signed
Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)

This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion Criteria:

1. Be able to provide a signed and dated, written informed consent.
2. Adults aged ≥18 to 75 years.
3. ECOG performance status 0-1.
4. Predicted life expectancy ≥ 12 weeks
5. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
6. Without EGFR or ALK mutations.
7. Adequate bone marrow reserve and organ system functions.
8. Patients with stable and symptomatic brain metastasis (BM) can be enrolled.

Part A Dose escalation:

Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC

Part B dose expansion:

1. At least one measurable lesion according to RECIST 1.1.
2. Previously systemic untreated for advanced disease.
3. PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)

Exclusion Criteria:

1. Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Prior malignancy within 5 years
4. History of organ transplantation or hematopoietic stem cell transplantation
5. Sever lung function decline or interstitial lung disease that has required oral or IV steroids
6. Active autoimmune disease requiring systemic therapy within 2 years
7. Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
8. Active infections
9. Significant cardiac disorder
10. Other serious or uncontrolled systemic diseases assessed by the investigator.

Part A Dose escalation:

1. Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks

Part B Dose Expansion:

1. Any prior systemic anti-tumor therapy
2. Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)
Effects of Low- or High-glycemic Index Diets on Metabolic and Inflammatory Responses in Diabetics

Background/Aims: Verify the effects of glycemic index (GI) on body composition, and on inflammatory and metabolic markers concentrations. Methods: Eighteen type 2 diabetics, (aged 42.4 + 5.1 years, BMI 29.2 + 4.8 kg.m-2) were randomly allocated to low GI (LGI) or high GI (HGI) groups. High or low GI meals were provided in the laboratory twice a day during 30 consecutive days. The other meals were consumed under free living condition and subjects were instructed to select foods presenting GI values corresponding to the allocated group. Body composition (body mass index, body fat percentage, waist circumference and waist-hip ratio), and inflammatory markers concentrations (interleukin-6, tumor necrosis factor-alpha, high molecular weight adiponectin, ultra-sensitive C-reactive protein and fibrinogen) and metabolic markers (glucose, insulin, total cholesterol, HDL cholesterol, free fatty acids, triglycerides and fructosamine) were assessed at baseline and after intervention. Food intake was monitored during the study. The criterion for statistical significance was P\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Level of physical activity light to moderate
* Use of sulfonylureas or biguanides oral hypoglycemic drugs
* Stable medications for the previous 3 months

Exclusion Criteria:

* Cardiovascular, renal, or liver disease
* Treatment for cancer
* Smokers
* Daily consumption of \> 50g/day of alcohol
* Pregnant, lactating, postmenopausal women,
* Hormone replacement therapy
* Recent change (last three months) in the level of physical activity or diet
* Weight instability (\> 3 kg in the previous three months),
* Therapeutic diet
* Allergies, test foods intolerance
* Use of drugs affecting body metabolism and/or food intake.
A 4-Day Study to Evaluate the Photoxicity of Diacerein 1% Topical Ointment in Healthy Volunteers

This study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

This was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. Product was applied according to the randomization scheme in an amount of 0.2 mL, once during the study.

Patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. The irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.

Eligibility Criteria:
Key Inclusion Criteria:

* Is a healthy male or female (to be confirmed by medical history);
* Is 18 years of age or older;
* In the case of a female of childbearing potential, is using two acceptable forms of birth control;
* In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) at Day 1 and are willing to submit to a UPT at the end of study (EOS);
* Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs);
* Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key Exclusion Criteria:

* Has a history of photosensitivity or photoallergy;
* Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
* Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
* Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (occasional use of acetaminophen will be permitted);
* Is taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs \[NSAIDs\]);
* Has psoriasis and/or active atopic dermatitis/eczema;
* Has known sensitivity or allergy to constituents of materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
* Has damaged skin in or around the test sites, including sunburn, excessively deep tans,uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
* Has received treatment for any type of internal cancer within 5 years prior to study entry;
* Has any known sensitivity to adhesives; and/or
* Has received any investigational drug(s) within 4 weeks prior to study entry
Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure

Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.

Research plan Open-label randomized trial Twelve months duration trial Setting: Medical and Surgical Intensive Care Unit of the University Hospitals of Geneva Start of trial: Mid-May 2008

Patients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients):

* Group 1: control group (40 patients)
* Group 2 : 20000 IU rhu Epo (20 patients) administered by the i.v. route
* Group 3 : 40000 IU rhu Epo (20 patients) administered by the i.v. route

3.2. Trial design Day 0 Consent form signed Patients randomly allocated to control or treatment groups (20000 and 40000 IU) Serum Cystatin C determination Serum Creatinine determination Urinary NGAL determination Administration of intravenous rhu Epo on Day 0 or no Epo (control group) Day 2 At 48 hr after rhu EPO injection, samples will be taken for

* Serum Cystatin C determination
* Serum Creatinine determination
* Urinary NGAL determination Day 4 At 96 hr after rhu EPO injection, samples will be taken for
* Serum Cystatin C determination
* Serum Creatinine determination
* Urinary NGAL determination

Stopping rules

The trial for an individual subject, parts of the trial or the entire trial will be stopped when:

* at Day 4 for an individual subject
* after enrollment of 80 patients

Treatment The treatment will consist of intravenous (i.v.) injections of recombinant human erythropoietin (r-hu-EPO). The trial medication will be provided by JANSSEN-CILAG AG. The brand name is EPREX® which is epoietinum-alpha in sterile buffered solution for i.v. or s.c. injection.

Patient group 1 will not receive EPO treatment. Patient group 2 will receive 20'000 U of rhu EPO and patient group 3 will receive 40'000 U of rhu EPO (i.v. route).

Eligibility Criteria:
Inclusion Criteria:

* Patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure.
* Consent form signed

Exclusion Criteria:

* Patients with malignant hypertension
* Patients with systolic BP \> 150 mmHg at enrollment
* Patients with Hb level \> 120g/L
* Patients with acute coronaropathy
* Pregnancy
* Patients with urine output \< 600 ml/12 h
A Study of Laquinimod Eye-drops in Healthy Participants

This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.

Laquinimod administered as an oral capsule formulation has previously been studied in neurodegenerative and autoimmune diseases. The clinical side effect profile of orally administered laquinimod is well-characterized based on this previous experience.

This trial will establish a safe and tolerated dose of laquinimod when administered as an eye-drop formulation following single ascending dose (SAD) and multiple ascending dose (MAD) administrations. There are four planned groups in the SAD-part of the study which will enroll 28 participants, if all dose levels are explored. The subsequent MAD-part of the study will enroll another 28 participants.

Eligibility Criteria:
Main inclusion criteria:

* In good health according to medical history, physical examination, vital signs, ECG and clinical chemistry, urinary and hematological laboratory tests

Main exclusion criteria:

* Unable or unwilling to use eye-drops
* Current usage of contact lenses
* History of eye surgery
* Sign or symptom of active eye disease
* History of an eye disease or other condition that could interfere with eye examinations in the study, or with ocular absorption of the investigational product
* History of inflammatory ocular disease
* History of cardiovascular or pulmonary disorder
* Family history of known or suspected hereditary cardiovascular disease
* Autoimmune disease or known family history of autoimmune disease
* Any other condition that would contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures
Investigation of Low Back Pain Level on Symptoms in Chronic Consipation

Consipation is the most common digestive complaint in the general population

Chronic constipation and low back pain are two common and often co-existing health conditions that affect millions of people worldwide. On the surface, these conditions appear to be unrelated and are associated with different anatomical sites (gastrointestinal tract and musculoskeletal system). However, a growing body of research is beginning to shed light on the complex interplay between chronic constipation and low back pain, highlighting potential links between these seemingly disparate health conditions. Common etiologic factors such as neuromuscular function, chronic inflammation and lifestyle-related variables are known to exist

Eligibility Criteria:
Inclusion Criteria:

* 18-65 ages
* Rome III diagnostic criteria

Exclusion Criteria:

* Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as
* Multiple sclerosis, stroke, Parkinson's disease or spinal injury,
* Impaired awareness (mini-mental score \< 15),
* Legal blindness, pregnancy,
* Rectal prolapse
* Anal fissure and altered constipation and diarrhea pattern.