cyrilzakka/clinical-trials huggingface dataset:
A Phase III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.

A phase III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19


Eligibility Criteria:
Inclusion Criteria:

* Male, female or transgender, ≥ 18 years old at Day 0.
* Provide inform consent form
* Participant who has:
* 3 doses of mRNA vaccines
* 2 doses of mRNA vaccines and previous COVID-19 infection
* 2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
* Participant who has:
* HIV infection with CD4 Tcells counts \<400
* Primary antibody deficiency disorders
* Kidney disease on dialysis
* Kidney transplant at least \>1 year
* Auto Immune Disease (AID) in treatment with rituximab
* For a female of childbearing potential, to have a negative pregnancy test at Day 0
* Use of any of these contraception:
* Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.
* Male: Vasectomized participant, sexual abstinence, condom.

Exclusion Criteria:

* History of anaphylaxis to any prior vaccine
* Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
* Pregnant or breast-feeding at Day 0.
* A confirmed COVID-19 diagnose \<90 days prior to vaccination day 0.
* A clinically significant acute illness or fever at screening or 48h before day 0.
* Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
* Participant has an ongoing severe and non-stable psychiatric condition
* Participant has a problematic or risky use of substances including alcohol
* Participant has a bleeding disorder that contraindicates intramuscular injection
* Participant suffering from post-acute COVID-19 syndrome / long COVID
* Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
* Participant is already participating in another research involving drug, biologics or device
* Participant has donated ≥450 ml of blood products within 12 weeks before screening
* Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.
Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. Previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. Despite advances in medical therapy, the condition still results in a significant symptom burden.

Inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength.

This study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. This will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing).

The study will be based at the Golden Jubilee National Hospital and patients will be recruited from outpatients who are already under the care of the Scottish Pulmonary Vascular Unit.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension
* able to give consent
* stable on medical therapy for at least 3 months

Exclusion Criteria:

* significant contribution to pulmonary hypertension from lung disease
* pregnant
Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

Patients with bone marrow cancer are more susceptible to chest infections than healthy adults; marrow ablation treatment further compromises their immune status and increases the risk of fungal opportunistic infection, which is associated with a high fatality rate. Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).

As patients may have several febrile episodes during their hospital stay, the cumulative dose from LDCTT scans can be significant and increase the lifetime risk of inducing a second cancer. The aim of this project is to determine whether a 75% reduction in radiation dose for LDCTT in other words, an ultralow dose chest CT (uLDCTT) at a dose comparable to chest X-ray, maintains the diagnostic image quality for detection of fungal chest infection in IC patients. If successful, uLDCTT will be adopted as SOC imaging at Princess Margaret Cancer Center (PM) for these patients.

Eligibility Criteria:
Inclusion Criteria:

1. All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
2. 18 years and older

Exclusion Criteria:

1. Patients that cannot follow study procedures
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.

The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.

Eligibility Criteria:
Inclusion Criteria:

* CHILDREN

  * aged 2 to 5 years;
  * who are in good general health;
  * have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.

Exclusion Criteria:

* CHILDREN

  * with systemic or neurological diseases;
  * whose families intend to move from Rio de Janeiro next year;
  * with a history of allergy to silver or any substance present in the different materials to be used for treatment.

TEETH

* with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
* shows possible pulp involvement by radiographic examination
The Effect of Pressure-controlled Ventilation-volume Guaranteed Mode

The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery.

A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume.

This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.

1. Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled.
2. All patients fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg.kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
3. A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
4. All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive either PCV-VG (n=17) or VCV (n=17) mode. The tidal volume in both group were set to deliver 8 mL/kg of ideal body weight. The respiratory rate (RR) was adjust to maintain end tidal CO2 (ETCO2) 33-38 mmHg.
5. Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after turning the patient to the prone position, (3) 60 minutes after turning the patient to the prone position, (4) 15 minutes after turning the patient to supine position at the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled for lumbar spine surgery with the prone position
* American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Age under 20 years old or over 70 years old
* Body mass index \> 30 kg/m2
* Systolic blood pressure \< 100 mmHg
* Heart rate \< 60 bpm
* Uncompensated cardiac disease
* FEV1 \< 60%
* Hypoxemia (PaO2 \< 60 mmHg or oxygen saturation \< 90%)
Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.

The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* one sided ischemic stroke confirmed by radiology
* 20-80 years old

Exclusion Criteria:

* hemorrhagic stroke
* brainstem stroke
* cerebellar stroke
* thalamic stroke
* seizure with the recent stroke
* any history of uncontrolled seizure
* history of epilepsy
* pregnancy or planning on getting pregnant during the next year
* MRI incompatibility (e.g. metal implants in body)
* recent history (past year) of alcohol and drug abuse (due to lack of follow up)

Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy
Does Terlipressin Improve Renal Outcome After Liver Surgery

The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.


Eligibility Criteria:
Inclusion Criteria:

* \>=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial

Exclusion Criteria:

* \< 18 years
* liver cirrhosis
* coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
* pregnancy and breast feed
Sofia Strep A FIA Field Study

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.


Eligibility Criteria:
Inclusion Criteria:

* Presence of sore throat
* Redness of the posterior pharyngeal wall
* Tonsillar exudate
* Tonsillar swelling
* Tender anterior cervical adenopathy
* Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours

Other symptoms that may be present, in addition to above symptoms for GAS:

* Rash, typical of scarlet fever
* Abnormal tympanic membranes
* Palatal petechiae

Exclusion Criteria:

* Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
A Rollover Study of CC-122

The purpose of the study is to provide CC-122 treatment to participants who have been receiving treatment in other CC-122 clinical trials investigating CC-122 for more than 5 years (CC-122-ST-001 \[NCT01421524\], CC-122-ST-002 \[NCT02509039\], CC-122-DBCL-001 \[NCT02031419\], and CC-122-NHL-001 \[NCT02417285\]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant who is currently receiving CC-122 on another CC-122 clinical trial that has met its primary and secondary endpoints.
* Participant who has participated in previous CC-122 protocol (including CC-122-ST-001 \[NCT01421524\], CC-122-ST-002 \[NCT02509039\], CC-122-DBCL-001 \[NCT02031419\], and CC-122-NHL-001 \[NCT02417285\]), and is deemed by the investigator to be deriving benefit from CC-122 as defined by the previous protocol.
* Participant who is able to tolerate study therapy and has not yet experienced progressive disease or any treatment discontinuation criteria of the Parent Study.

Key Exclusion Criteria:

* Participant is not eligible for CC-122 treatment as per the Parent Study.
* Participants not receiving clinical benefit as assessed by the investigator. Any clinical AE, laboratory abnormality, or intercurrent illness which, in the opinion of the investigator, indicates that participation in the study is not in the best interest of the participant.
* Women who are breastfeeding.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Clinical Trial of Several Contact Lenses in Extended Wear

The study is to clinically evaluate currently marketed contact lenses when used in an extended wear modality of up to seven days/six nights.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age, and be between 18 and 39 years of age.
* Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Require a visual correction in both eyes (Monovision not allowed)
* Require a soft contact lens spherical correction between -0.50 and -9.00D.
* Have an astigmatic correction less than 1.50D in both eyes.
* Be able to wear the lens powers available for this study.
* Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
* Be correctable to a visual acuity of 20/30 or better in each eye.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
* No amblyopia.
* No evidence of lid abnormality or infection.
* No clinically significant slit lamp findings
* No other active ocular disease.
* No previous ocular surgery.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* PMMA or RGP lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
* Participation in any concurrent clinical trial.
* Currently wearing B\&L PureVision, Ciba O2 Optix, Ciba Night \& Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
* Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
* Has had an eye injury or surgery within the last eight weeks.
Studies of Families With Hereditary Cataracts

The objective of this study is to discover the genes responsible for the development of hereditary cataracts in families. A cataract is clouding of the lens of the eye that obstructs the passage of light and may impair vision. Information from this study may provide a better understanding of why hereditary cataracts form and perhaps lead to the development of a test that can predict who will likely be affected and to what degree.

Patients or family members of patients with inherited cataracts who participate in this study will be asked questions about their family history, especially concerning eye disease or cataracts, and a family tree will be drawn. They will undergo a complete eye examination, including photographs to document the clarity or opacity of the lens. In addition, a small blood sample will be drawn for use in gene mapping studies of inherited cataract.

Although the etiology of some secondary cataracts is becoming better understood and certain animal models have the promise to elucidate the relationships between lens crystallin and hereditary cataract, little is known about the causes of congenital cataracts in humans. Even the classification of different types of cataracts is cumbersome and imperfect. A better understanding of cataractogenesis will come through an understanding of the molecular components of the lens of the eye and the ways in which lesions of these components are manifested structurally and functionally as opacity of the lens. It is well known that cataracts exhibit marked genetic heterogeneity. In mice and humans, hereditary cataracts have been shown to result from lesions at many distinct loci and those cataracts corresponding to one locus can be morphologically heterogeneous, implying that environmental factors may modify the phenotype of the cataract which a molecular lesion causes. Nonetheless, molecular biological characterization of cataracts in the mouse and guinea pig has suggested that alterations in lens crystallins can cause hereditary cataracts making them reasonable candidate genes for causing hereditary cataracts in humans. In addition, it is apparent that hereditary lesions which mimic or contribute additively to environmental stresses known to cause cataracts might be candidate genes for causing hereditary cataracts. This knowledge increases the feasibility of genetic linkage studies and provides a rationale basis on which to begin the molecular analysis of naturally occurring hereditary cataracts. Therefore, it is the purpose of this protocol to concentrate upon hereditary cataracts.

Eligibility Criteria:
The proband must have documentation of congenital or hereditary cataract.

Patients with cataract due to radiation, steroid, or associated with other ocular diseases such as uveitis, retinitis pigmentosa etc. and age-related cataracts will be excluded.
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants

The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last about 46 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants with mild, moderate or severe hepatic impairment and healthy participants with normal hepatic function
* Males and females of non-childbearing potential.
* Within body mass index (BMI) range 18.5 to 40.0 kilograms per square meter (kg/m²).
* Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory tests, as determined by the Investigator (or designee).
* Able to comply with all study procedures, including the 8-night stay at the Clinical Research Unit and follow-up phone call.

Exclusion Criteria:

* History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:

  1. pancreatitis
  2. peptic ulcer disease
  3. intestinal malabsorption
  4. gastric reduction surgery
  5. history or presence of clinically significant cardiovascular disease.
* Participants with out-of-range, at-rest vital signs.
* Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
* Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
* Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
* Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
* History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
* Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
* Receipt of blood products within 2 months prior to Check-in (Day -1).
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator).