cyrilzakka/clinical-trials huggingface dataset:
Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer confirmed by histology.
* Tumor size is measured according to RECIST standard.
* Unresectable stage IIIA (N2) and IIIB/IIIC, confirmed by PET-CT/or chest and abdomen CT, brain MRI, and whole body bone scan.
* 18-75 years old, regardless of gender.
* The ECOG score is 0-1.
* Newly treated or underwent neoadjuvant chemotherapy and/or immunotherapy.
* Have not received chest radiotherapy in the past.
* Serum hemoglobin ≥10 mg/dL, platelets ≥100000/μL, absolute neutrophil count ≥1500/μL.
* Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 ml/min.
* Serum bilirubin ≤1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤2.5 times UNL, alkaline phosphatase≤ 5 times UNL.
* FEV1\>1 L.
* CB6 normal range.
* The patient and his family members agree and sign an informed consent form.

Exclusion Criteria:

* Other malignant tumors in the past or during treatment, except for non-melanoma of the skin or carcinoma in situ of the cervix.
* Any other diseases or conditions are contraindications to chemotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
* Pregnant or breastfeeding women, women who have not undergone a pregnancy test (within 14 days before the first dose), and pregnant women.
* Those who are pregnant, breastfeeding or have fertility but have not taken contraceptive measures.
* People with bleeding tendency.
* Those who participated in other clinical trials within 30 days before participating in this experiment.
* Drug addiction, long-term alcoholism, and AIDS patients.
* People with uncontrollable seizures or loss of self-control due to mental illness.
* People with a history of severe allergies or specific physique.
* The researcher believes that the patient is inappropriate to participate in this trial.

Exit criteria

* The treatment cannot be carried out in accordance with the requirements of the research protocol;
* The patient has an allergic reaction ≥ grade 4 or a serious adverse reaction to the study drug;
* The patient is pregnant or has not used adequate contraceptive measures;
* The researcher judges that the patient should not continue to participate the clinical trial;
* The subject asked to withdraw.
Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis

The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in the postoperative period will be evaluated.

Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all patients before and three months after the operation.

Eligibility Criteria:
Inclusion Criteria:

1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy

Exclusion Criteria:

1. Malignant disease
2. Ovarian failure
3. Acute pelvic inflammatory disease
4. Smokers
5. Pregnancy
6. Chronic autoimmune disease
Evaluation of the Safety of Reoperation for Ipsilateral Recurrent Tumors After Nephron-sparing Partial Nephrectomy

To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. ipsilateral local rRCC (any recurrence in the ipsilateral kidney and retroperitoneum)

Exclusion Criteria:

1. With distant metastasis;
2. Lacking essential sugery information.
How Much Opioids Do You Need After Your Emergency Department Visit

Pain is one of the most common complaints in emergency department (ED) and is still often poorly managed. A major prospective multicenter study reported that 74% of patients that had a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly, physicians frequently prescribed analgesic after discharged for these patients, and opioid is given in 29% of ED visits involving pain complaints. However, few studies evaluate pain management after ED discharge: the frequency and length of opioids prescriptions, the opioids quantity taken by the patients, are the patients relieved and satisfied by these pain treatments, what are the adverse effects associated with the use of these medications, and what are the chances of developing addiction?

The primary aim of this study is to determine the required minimal opioids prescription for patients treated for acute pain after being discharge from the ED. Secondary objectives include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the patients' level of pain relief associated with their respective opioids treatment; 3) determine the patients' level of addiction following post-ED opioids treatments.

The design of the project is a prospective observational cohort study. A cohort of consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and discharged from the ED in less than 48 hours with a prescription of opioid will be asked to participate in the study. Patients will be excluded if there is ongoing treatment for a pre-existing chronic pain condition or if they used opioid drugs in the past year. Research nurses will contact the patients by phone at three follow-up time points (1 week, 1 month, and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses will also question the patients about their daily opioids usage and if they were relieved from pain.

This study will provide the base for future guidelines regarding the prescription of opioids treatment for specific pathology encountered in ED. It will also give indications on how to adjust the treatments according to adverse events and the level of addiction experienced by patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Pain level at 4 or greater at triage
* Acute pain (2 weeks or less)
* Opioids prescription at discharge

Exclusion Criteria:

* Language barrier
* Pregnancy
* Treated for chronic pain
* Hospital stay greater than 48 hours
The Influence of Collective Schemas on Individual Memory

Schemas describe mental structures storing recurrent and organized pattern of information. Schemas may have a strong influence on the process of storing and retrieving new information into memory. Previous approaches in the cognitive neuroscience of memory have entirely focused on the individual dimension of preexisting schemas. In the real world though, much of the researchers' experiences and knowledge are collective or shared. Such social-cultural frameworks stored in collective memory may also reshape and reconfigure the construction of individual memories. Attempting to ascertain the influence of collective schema on the neural substrates of individual memories using cutting-edge brain imaging methods represents the challenge that MULTIBRAIN2 seeks to tackle. To achieve this goal, the researchers will record brain activity during MRI scanning sessions in a group of 24 participants while they are performing an encoding followed by episodic memory retrieval tasks on pictures of the World War II Memorial of Caen. This study will seek to identify brain areas of the prefrontal cortex encoding the organization of knowledge in collective memory using multivariate analyses of brain activity patterns, and then to understand how such regions might modulate the recruitment of the hippocampus during episodic memory retrieval using analyses of effective connectivity. The organization of knowledge in collective memory is measured in parallel through 1) the analysis of French social memory of World War II using a corpus of thousand of television and radio shows from the National Institute of Audiovisual, and 2) an internet task measuring the organization of shared individual knowledge about World War II. Once collected, these data will help us to understand how collective schemas may shape the organization of individual memories.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants between 20 and 38 years old
* Affiliated to the French national health care system
* French native speaker
* Having not visited the Memorial of Caen for the past four years
* Right-handed
* At least 2 years of education after graduating from high school
* Body mass \< 30kg/m2
* Signed written consent form

Exclusion Criteria:

* Pregnancy or intent to get pregnant
* Person deprived of their liberty
* Person hospitalized without consent
* Minor
* Protected adults or people unable to give informed consent
* Person subjected to an exclusion period related to another protocol
* History of neurological or psychiatric disorders or existence of traumatic brain injury with loss of consciousness for more than one hour
* History of cancer with the last 5 years, excluding squamous cell carcinomas
* Alcoholism, antecedents of chronic alcoholism or drugs abuse
* Severe psychiatric disorders (according to DSM V diagnostic criteria) or psychological troubles which could affect participant's judgment
* Use of medication that may interfere with cognitive or cerebral functioning
* Presence of visual or hearing troubles that may compromise participant's ability to participate in the study
* MRI Contraindications
Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.

The follow up of endpoints will be performed using SWEDEHEART and national registries. Follow up of primary endpoints and stroke will also be performed by telephone contacts with the patients or first degree relatives by a nurse phone call after 7 days and 180 days. The nurses will also accumulate hospital record information on these endpoints.

A central adjudication will be performed for all reported primary endpoints for the first 180 days follow up. Every site will prepare source documents for the event and send it to UCR for central adjudication by an independent committee.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or, patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
* PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI).
* Treated with bolus dose of ticagrelor or prasugrel before start of PCI. See 2.6
* Ability to provide informed consent
* Age 18 years or older

Exclusion Criteria:

* Previous randomization in the VALIDATE-SWEDEHEART trial.
* Known terminal disease with life expectancy less than one year.
* Patients with known ongoing bleeding
* Patients with uncontrolled hypertension in the opinion of the investigator
* Patients with known subacute bacterial endocarditis
* Patients with known severe renal (GFR \< 30 ml/min) and/or liver dysfunction
* Patients with known thrombocytopenia or thrombocyte function defects
* Any other contraindication for the study medications.
* Heparin \> 5000U Before arriving to PCI lab or \> 3000 U given during angiography before randomization.
* GpIIb/IIIa inhibitors have been given or are pre-planned to be given during the procedure.
A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HBe-antigen positive or negative chronic hepatitis B, and no other chronic viral infections who completed therapy for Hepatitis B with Pegasys ± lamivudine
* Inclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432
* Samples from patients treated with either Pegasys or Pegays + lamivudine are included in this analytical study
* Samples will only be analyzed for patients where Investigational Review Board approval has been granted

Exclusion Criteria:

* Exclusion criteria relevant to the clinical studies WV16240, WV16241, and Neptune/WV19432
A Trial of Plerixafor/G-CSF as Additional Agents for Conditioning Before TCR Alpha/Beta Depleted HSCT in WAS Patients

Treatment Study to assess of safety and efficiency of conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation with TCR alpha/beta grafts depletion in patient with Wiskott-Aldrich syndrome.

Severe graft dysfunction, such as the degree of donor chimerism predominantly in the myeloid compartment is one of major problem in patients with Wiskott-Aldrich syndrome (WAS), especially after hematopoietic stem cell transplantation (HSCT) from alternative donor. It often leads to the development of severe thrombocytopenia or even transplants rejection. In this study the hypothesis is that the use of plerixafor and G-CSF as additional agents in conditioning regimen would offers advantages due to lowing risk of mixed chimerism after HSCT. This effect is based on the fact that simultaneous use of plerixafor with G-CSF is efficient in inducing stem cell release and opening of bone marrow (BM) niches. Moreover, stem cell release probably leads to liberation of host stem cells from the anti-apoptotic effects of the BM stroma for the more powerful effect of chemotherapy.

In this study, the investigators use TCR alpha/beta grafts depletion of the grafts as basic technology for HSCT from haploidentical and unrelated donors approved in Institution.

Thus, the purpose of this study is to evaluate the safety and efficiency of myeloablative conditioning with Plerixafor and G-CSF as additional agents for prevention of graft failure after transplantation with TCR alpha/beta grafts depletion in patients with Wiskott-Aldrich syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 1 months and \< 19 years
* Patients diagnosed with Wiskott-Aldrich syndrome eligible for an allogeneic transplantation and lacking a related HLA-matched donor
* Lansky/Karnofsky score \> 40, WHO \> 4
* Signed written informed consent

Exclusion Criteria:

* Dysfunction of liver (ALT/AST \> 5 times normal value, or bilirubin \> 3 times normal value), or of renal function (creatinine clearance \< 30 ml / min)
* Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction \<40%)
* Serious concurrent uncontrolled medical disorder
* Lack of parents' informed consent.
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera

The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia.

The secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with DMF discontinuation ; description of the evolution of ALC during DMF treatment; description of the time to reach a discontinuation of DMF treatment; exploration of the time to reach clinical outcomes (Expanded Disability Status Scale \[EDSS\] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from DMF initiation and according to DMF discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from DMF initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an ALC reconstitution after DMF discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) count in overall population on DMF if available.

The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RRMS at DMF initiation
* Minimum of 3 months of continuous treatment with DMF\*
* Initiation of DMF between January 1st, 2016 and December 15th, 2020
* Minimum of 2 ALC assessments:

  1. 1 ALC at DMF initiation (or within 6 months before DMF initiation); or under DMF treatment
  2. 1 ALC before the database extraction (15/06/2021).

     * to avoid the early DMF discontinuations for reasons other than lymphopenia.

Exclusion Criteria:

* Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke

Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.

Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.

Study design: A prospective, open-label within-subject intervention study

Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.

Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency.


Eligibility Criteria:
Inclusion Criteria for patients:

* Age ≥ 18 years;
* First-ever ischemic stroke or intracerebral hemorrhage in a cerebral hemisphere or the brainstem;
* Unilateral paresis of an upper extremity with a Motricity Index (MI) between 9 and 99
* Inclusion possible between 3 weeks and 6 weeks after stroke onset;
* Signed informed consent.

Inclusion Criteria for healthy controls:

* Age ≥ 18 years;
* Signed informed consent.
* Normal motor function with a minimum Motricity Index (MI) of 99.

Exclusion Criteria:

* Disabling medical conditions (severe heart disease, severe head trauma, severe mental illness);
* Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician;
* Contraindications to TMS and/or MRI (ferrous implants, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy);
* Life expectancy shorter than one year;
* Upper limb paresis prior to stroke onset.
A Study to Evaluate the Bioavailability of BMS-986205

Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of \[13C\]BMS-986205 solution for intravenous administration in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive
* Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
* Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical illness
* Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply
PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS

Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.


Eligibility Criteria:
Inclusion Criteria:

the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[IOPA\]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing \[SRP\]) in asymptomatic teeth.

Exclusion Criteria:

1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (\<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.