cyrilzakka/clinical-trials huggingface dataset:
Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury

This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders \[i.e., major depression (MD\], cognitive disorders \[i.e., executive function deficits (EFD)\], and functional impairment following repetitive/mild traumatic brain injury (MTBI).

This will be a prospective study of subjects with MTBI, body injury and healthy controls. Subjects who meet the study criteria will be enrolled in the study after they provide informed consent.

All subjects will be followed longitudinally at 3 and 6 months post-injury.

All subjects will have 3-4 visits:

Screening visit to determine eligibility; first study visit within 1 month of injury for those with brain or body injury (at the time of screening or within 1 month of screening for healthy controls); second study visit at 3 months post-injury (3 months after the first visit for healthy controls) and third study visit at 6 months post-injury (6 months after the first visit for healthy controls).

Eligibility Criteria:
Inclusion Criteria:

Individuals with MTBI: Inclusion Criteria:

1. Have sustained a closed head injury, defined as externally inflicted trauma without skull fracture;
2. Have a Glasgow Coma Scale (GCS) score 13 or above
3. Meet the American Congress of Rehabilitation Medicine criteria for mild traumatic brain injury
4. Have experienced the last injury within 1 month
5. Be in excellent/good medical health as assessed by the General Medical Health Rating (GMHR) scale
6. Have sufficient cognitive capacity to provide informed consent
7. Be between 18-65 years of age and
8. Be willing to have brain MRI and a blood draw,

Individuals with Body Injury will meet inclusion criteria 4-8. Instead of criteria for head injury (1-3) they would have had body injury (defined as injury below the neck (e.g., limb fractures, stab wound abdomen).

Age, and sex, matched normal controls: Inclusion Criteria:

1. No history of head injury or any other types of brain injury
2. Inclusion criteria 5-8

Exclusion Criteria:

1. History of stroke, seizures or other pre-injury neurological diseases
2. Mental Retardation
3. History of skull fracture
4. Presence of severe unstable medical disease
5. Contraindications to the MRI brain scan
6. Possibility of pregnancy
7. Presence of communication difficulties, such as moderate to severe hearing or language impairment.
Implementation of Caring Contacts

This quality improvement (QI) project will adapt and improve an evidence-based suicide-prevention initiative for Sunnybrook patients at high risk of suicide following psychiatric inpatient discharge, targeting one of Sunnybrook's QI Plan goals of reducing suicide at Sunnybrook. Caring Contacts, brief communications of hope, support and information sent to patients post-discharge, are a simple and low-cost intervention with proven effectiveness in reducing suicide attempts, suicidal ideation, and loneliness, while increasing hopefulness and feelings of connection to the health care system. Pilot data provides some initial, promising evidence however additional patient input is required to improve the acceptability and effectiveness of the intervention to reduce suicide-related outcomes. Feedback from patients and peer advisors will guide iterative improvements with the ultimate goal of implementing an improved version of Caring Contacts as a standard clinical practice for all patients discharged from the Sunnybrook Adult Inpatient Psychiatry Unit.

For phase one of this QI project, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality and community members with lived experience of psychiatric hospitalization and suicidality. Investigators will conduct focus groups on the inpatient unit of 8-12 inpatient participants to gather feedback about the current Caring Contact intervention. For community members virtual focus groups will be conducted. For phase two, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality. The updated intervention will be sent to 8-12 participants. Then investigators will host virtual focus groups to gather feedback from these participants about the intervention. For phase three, participants will be patients from the Sunnybrook Inpatient Psychiatry Unit with suicidality. Investigators will send the revised intervention to 30-40 participants. Participants will complete symptom and feedback questionnaires when they receive the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent
2. Age 18 or above
3. Ability to read and understand English
4. Have an email address
5. The ability to understand and comply with the requirements of the project and capable of providing informed consent

For inclusion in the outpatient focus groups participants must additionally have previous lived experience of psychiatric hospitalization with suicidal ideation or behaviour.

For inclusion in the inpatient focus groups during phase one and for inclusion in the second and third phases of the project, participants must additionally 1) be an inpatient on the Sunnybrook Adult Inpatient Psychiatry Unit at the time of recruitment and 2) they must have been admitted to the unit with suicidal ideation or behaviour as determined by their C-SSRS score at admission.

Exclusion Criteria:

* A primary diagnosis of a Major Neurocognitive Disorder
Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

This study will investigate the potential drug interactions between vemircopan and metformin, rosuvastatin, levonorgestrel/ ethinyl estradiol (LNG/EE)-containing oral contraceptive(s) (OCs), and carbamazepine in healthy participants.

This a 3-part drug-drug interaction (DDI) study. Part 1 - Potential Drug-drug Interaction Between Vemircopan, Metformin, and Rosuvastatin, Part 2 - Potential Drug-drug Interaction Between Vemircopan and LNG/EE-Containing OCs (Female Participants Only) Part 3 - Potential Drug-drug Interaction Between Vemircopan and Carbamazepine

All the 3 parts of the study includes:

* Screening Period: 27 days (Day -28 through Day -2)
* Two Treatment Periods:

  * Part 1: Treatment Period 1 (Day -1 through Day 8) and Treatment Period 2 (Day 1 through Day 12)
  * Part 2: Treatment Period 1 (Day -1 through Day 7) and Treatment Period 2 (Day 1 through Day 10)
  * Part 3: Treatment Period 1 (Day -1 through Day 4) and Treatment Period 2 (Day 1 through Day 22)
* Follow-up/Early Discontinuation Visit: 7 (± 2) days following the last dose of study intervention

Up to 20 participants will be enrolled per study part. Participants will be enrolled in only one study part and will not be allowed to participate in more than 1 study part.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead ECG, screening clinical laboratory profiles (hematology, biochemistry, coagulation, and urinalysis), as deemed by the Investigator or designee.
* Body weight of at minimum 50 kg and body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive) at the Screening.
* Male and female participants should adhere to the protocol defined contraceptive methods.

Exclusion Criteria:

* History or presence of medical (eg, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders) or psychiatric conditions or diseases.
* History of clinically significant hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
* History of drug or alcohol abuse within 2 years prior to first dosing
* Current tobacco users or smokers (defined as any tobacco or nicotine-containing product use within 3 months prior to first dosing).
* Donation of whole blood from 3 months prior to first dose administration, or of plasma from 30 days before first dose administration.
* Female participants who have a positive pregnancy test at Screening or Day -1, or who are lactating.
* Positive drugs of abuse, cotinine, or alcohol screen at Screening or Day -1.
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
* Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \<18 years of age

  * Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
  * Neonates: defined as newly born (within 4 weeks)
* Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system

Exclusion Criteria:

* Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug
* Active bleeding or high risk of bleeding
* Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \[NG tube\] or gastronomy tube \[G-tube\])
Comparison of the Fekry Oral Intubating Airway and Ovassapian Fibreoptic Intubating Airway for Fibreoptic Orotracheal Intubation

The fibreoptic bronchoscope remains one of the most important methods of intubating patients particularly when there is difficulty with intubation Facilitating fiberoptic oropharyngeal intubation procedure, specific airways have been devised to push the tongue anteriorly to clear a passage for the fibrescope into the trachea.

Of these airways Ovassapian Fibreoptic Intubating Airway (Kendall, Argyle, New York, New York, USA) and Fekry Oral Intubating Airway (Ameco Tech, Cairo, Egypt).

Ovassapian Fibreoptic Intubating Airway :

The Ovassapian Fibreoptic Intubating Airway has a flat lingual surface that widens distally. This provides better retraction of the tongue to prevent it and the soft tissues of the anterior pharyngeal wall from herniating around the side of the airway. The airway has a pair of vertical sidewalls and two pairs of curved guide walls at its proximal section. These walls are separated by a gap which allows removal of the airway after intubation has been completed.

Fekry airway:

● It has two parts are: Airway body\& Special connector

1. Airway body consists of:

   1. Flange → it is the buccal end it is 7 cm wide to prevent it from moving deeper into mouth \& may also serve to fix airway in place.
   2. Bite Portion → it is straight \& fits between teeth \&oral cavity.
   3. Oral straight part → open anterior lingual part; it varies in length according to size
   4. Pharyngeal curved part → extends backwards to correspond the shape oropharynx and ends below laryngeal inlet.
2. The connector: it is a special type (two sizes: adult and pediatric) can attach to all ventilating machines\& it has a teeth rest act as a bite block.

Eligibility Criteria:
Inclusion Criteria:

1. ASA 1 to3,
2. Aged 18 to 60 years
3. Who presented for elective surgery requiring tracheal intubation

Exclusion Criteria:

1. All patients with a past history of difficult tracheal intubation
2. Patients with signs of possible difficult tracheal intubation (including modified Mallampati score 3 or 4
3. Limited mouth opening, thyromental distance \< 4 cm, limited neck movement or upper airway disease
Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* diffuse infiltrative type HCC
* HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations

This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.

This study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage IA-IB) non-small cell lung cancer (NSCLC) who have undergone complete surgical resection but are at high risk of recurrence. Based on each patient's specific driver gene mutation status (e.g., EGFR or ALK/ROS1) or wild-type status, participants will receive either targeted therapy or immunotherapy compared to routine follow-up (observation). The goal is to see if these approaches can improve disease-free survival and potentially reduce the risk of lung cancer recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years and able to provide written informed consent.
* Primary non-squamous NSCLC confirmed by pathology, with no brain metastases.
* Complete R0 surgical resection (lobectomy, segmentectomy, or pneumonectomy) of stage IA or IB NSCLC (AJCC 8th edition).
* High-risk disease (one or more): low differentiation, solid/micropapillary/complex glandular patterns, vascular invasion, visceral pleural invasion, alveolar space spread, or intermediate/high risk on 14-gene test.
* Documented driver gene status (EGFR mutation, ALK/ROS1 fusion, or wild-type) via postoperative tumor sample.
* ECOG performance status 0 or 1, with stable condition over the last two weeks.
* Surgery within 4-10 weeks before starting treatment, with full recovery.
* Adequate organ function as per protocol-defined labs.
* Negative pregnancy test (if applicable) and use of effective contraception during and 3 months after treatment.

Exclusion Criteria:

* Evidence of unresectable/metastatic NSCLC, incomplete resection (R1/R2), or wedge resection only.
* Prior systemic therapy (e.g., chemotherapy, targeted therapy, immunotherapy) for the current NSCLC.
* Major surgery (excluding lung cancer surgery) within 3 weeks before first study dose.
* Planned concurrent anti-cancer therapy (chemo, radiotherapy, or targeted therapy) during the study.
* Clinically significant cardiac disorders (e.g., poorly controlled hypertension, recent MI or stroke, prolonged QTc).
* History or suspicion of interstitial lung disease requiring treatment.
* Active or uncontrolled infection (e.g., hepatitis B with detectable HBV DNA, hepatitis C, HIV, active TB).
* Severe GI conditions impairing drug absorption (e.g., Crohn's, ulcerative colitis).
* Use of strong CYP3A inducers/inhibitors within 1 week or ongoing need for warfarin.
* Participation in another interventional trial within 4 weeks or receipt of a live vaccine within 180 days.
* Any condition that may compromise adherence or safety, per investigator judgment.
The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau

OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity. These beneficial OPV effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of OPV against polio infection. They have been coined "non-specific effects" (NSEs). Such NSEs have also been observed for other live attenuated vaccines such as BCG vaccine and measles vaccine. The underlying immunological mechanisms are unknown. Other live vaccines with beneficial NSEs have been shown to induce epigenetic changes leading to "trained immunity". They have also been associated with decreased inflammation. In the present study it will be investigates whether OPV can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in Guinea-Bissau.

The aim is to study the non-specific immunological effects of providing a single dose of OPV to seniors aged 50 and above in Guinea-Bissau:

Hypotheses

1. OPV induces innate immune training (substudy A)
2. OPV is associated with reduced systemic inflammation (substudy A)
3. OPV induces epigenetic modifications of the innate immune cells (substudy B)

Setting: Bandim Health Project (BHP)'s Health and Demographic Surveillance System (HDSS) in Bissau.

Design: Individually randomized trial in BHP's study area. Participants will be randomized 1:1 to OPV or placebo. To limit the amount of blood drawn from one single participant, two substudies with similar design will be conducted, with two different outcomes.

The outcomes of the two substudies will be as follows:

Substudy A: Immunological impact of OPV. Study the stimulation of cytokine production by heterologous stimuli as a biomarker of trained immunity induction and circulating biomarkers as a mirror of systemic inflammation induced by OPV.

Substudy B: Transcriptional and epigenetic reprogramming of immune cells by OPV. Study the transcriptional and epigenetic rewiring of immune cells induced by OPV by single-cell ATAC-Sequencing and RNA-Sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Male.
* Living in a household which had a Bandim Health Project census visit conducted after 1 January 2017.
* Age above 50.
* Has a visible BCG scar.

Exclusion Criteria:

* Previous adverse events to OPV
* Suspicion of active viral/bacterial/HIV infection.
Molecular Stethoscope

The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.

In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer sent for surgical colonic resection (all stages) OR
* High risk adenoma sent for surgical colonic resection

Exclusion Criteria:

* Chemotherapy before surgical treatment
* Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
* Radiation therapy before surgical treatment
* Bone marrow transplant
Impact of a Pharmacist-anesthesiologist Collaboration During Anesthesia Consultation on Prevention of Perioperative Medication Errors of Patients in Programmed Surgery

The investigators will evaluate the efficiency of a pharmacist-anesthesiologist collaboration in the anesthetic consultation in the prevention of medical errors perioperatively in patients undergoing scheduled surgery


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent
* The patient must be a member or beneficiary of a health insurance plan
* The patient has at least one chronic medication prescription (associated with a chronic illness)
* The patient is hospitalized for a programmed surgery in the service of urology or digestive surgery at the CHU Nimes or orthopedic surgery in the CHU Montpellier or Toulouse

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is having ambulatory programmed surgery
* The patient has an anesthetic consultation in a different health establishment
Prospective Validation of the OHI Index

Hemophagocytic lymphohistiocytosis (HLH) associated with hematologic malignancies (HM-HLH) is a syndrome with an abysmal prognosis (10-30% 5 years overall survival). We have recently established an improved diagnostic and prognostic index for HM-HLH, termed the Optimized HLH Inflammatory (OHI) index. The OHI index is comprised of the combined elevation of soluble CD25 (sCD25) \> 3,900 U/mL and ferritin \>1,000 ng/mL . However, the true incidence and outcomes of HLH/OHI+ in an unselected cohort are unknown and so is the mechanism of HM-HLH.

The investigators will enroll patients with new/transformed hematologic malignancies. We will follow the patients until the end of the study, report their survival at one year and examine their prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies
* At least 18 years old

Exclusion Criteria:

* Prior recent treatment (chemotherapy/ other cytoreductive therapies in the last month)
Gait Evaluation in Haemophiliac Patients

Joint damage secondary to recurrent haemarthroses and chronic synovitis represents the commonest clinical manifestation of haemophilia. Incapacitating pain, loss of joint stability and mobility, axial deviation, deterioration and decreased function are the most frequent complains in patients with severe haemophilic arthropathy In this context, the purpose of our study is to examine and analyse specific changes in gait in patients suffering from haemophilic arthropathy and determine the impact on health-related quality of life in terms of conceptual components of pain and stiffness, psychosocial stress, disability, and activity limitations as recommended by the International Classification of Function (ICF) recently published by the World Health Organization.


Eligibility Criteria:
Inclusion Criteria:

* haemophilia A or B
* aged more than 4 years

Exclusion Criteria:

* impossibility to walk on a treadmill
* recent joint haemarthrosis or muscle haematoma