cyrilzakka/clinical-trials huggingface dataset:
Evaluation of IGM-6268 in Healthy Volunteers

This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple ascending (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of IGM-6268 administered intranasally and intraorally in healthy volunteers. IGM-6268 or placebo will be administered by intranasal + intraoral spray using a Teleflex Mucosal Atomization Device Nasal™ Intranasal Mucosal Atomization Device once (SAD), or once or twice each day for 5 days (MAD).

IGM-6268 is an engineered Immunoglobulin M (IgM) antibody that specifically targets the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. This humanized pentameric IgM antibody has 10 binding sites to the spike protein and a J-chain to enable the formation of IgM pentamers.

IGM-6268 is being developed as a treatment for or prophylaxis of symptoms associated with mild to moderate COVID-19. The primary mechanism of action of IGM-6268 is to block the binding of the SARS-CoV-2 RBD on the spike protein to human angiotensin converting enzyme 2 (hACE2), the cellular receptor for SARS-CoV-2. By blocking this binding, IGM 6268 neutralizes the infectivity of the virus.

Eligibility Criteria:
Inclusion Criteria:

* Is male or non-pregnant female adult ≥ 18 and ≤ 55 years of age
* Has a body mass index (BMI) \< 35 kg/m2.
* Is healthy as determined by medical history, physical examination, 12-lead electrocardiogram, laboratory assessments, and vital signs at screening.
* For women of childbearing potential or men, agreement to use at least one highly effective form of non-hormonal contraception or one highly effective form and one effective form of non-hormonal contraception through the course of study treatment and for 3 months after the last dose of IGM-6268.
* Agrees to the collection of blood, urine, saliva, and nasopharyngeal samples, per protocol.

Exclusion Criteria:

* Receipt of any COVID-19 vaccine or contemplating receipt of any COVID-19 vaccine (or participating in a COVID-19 vaccine trial) during this study and follow-up periods (approximately 65 days from enrollment). Subjects are permitted to withdraw at any time if they decide to receive the vaccine
* History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT), or positive SARS-CoV-2 serology test, at any time before enrollment.
* Confirmed or suspected pulmonary or systemic bacterial infection.
* Current or planned participation in any interventional clinical trial during the study and follow-up periods.
* History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Uncontrolled human immunodeficiency virus (HIV) infection.
* Nasal polyps (history or physical exam) or any structural abnormality of nose that, in the opinion of the investigator, could compromise administration or receipt of study drug (e.g., nasal septal deviation).
* History of reactive airway disease or hypersensitivity to any component of study drug or placebo.
* Use of any nasally-administered drug between 5 days prior to study enrollment and 2 days after receipt of last dose administered.
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis

This trial uses multi-parametric magnetic resonance imaging (MRI) to develop and validate imaging risk score to predict radiation necrosis in participants with brain metastasis treated with radiation therapy. Diagnostic procedures, such as multi-parametric magnetic resonance imaging (MRI), may improve the ability to diagnose radiation necrosis early and help establish treatment strategies.

PRIMARY OBJECTIVE:

I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.

II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.

SECONDARY OBJECTIVE:

I. To predict radiation necrosis using imaging risk score.

OUTLINE:

Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent stereotactic radiosurgery (SRS, gamma-knife radiosurgery or cyberknife radiosurgery) for brain metastases
2. Patients with lesions eligible for SRS :

   * One to ten newly diagnosed brain metastases
   * Patients without acute neurological symptom
3. Patients with a Karnofsky performance status score of 70 or higher
4. Patients who underwent brain MRI within 1 month of enrollment
5. Patients with measurable enhancing lesions on MRI.
6. Patients who have available reference standard (second-look surgery for recurrence) or available follow up imaging for clinic-radiologic reference standard.
7. A longest diameter \> 1.5 cm for tumor habitat analysis.

Exclusion criteria:

1. Patients who have undergone prior brain surgery, SRS, or whole-brain radiation therapy.
2. Patients who are diagnosed with leukemia, lymphoma, germ-cell tumor, small-cell lung cancer, leptomeningeal disease, or unknown primary tumor.
3. Patients with age \< 18 years.
4. Patients without baseline MRI.
5. Patients with nonmeasurable enhancing lesions on MRI : all other lesions, including lesions with longest dimension \< 10 mm, lesions with borders that cannot be reproducibly measured, dural metastases, bony skull metastases, and leptomeningeal disease.
Zoonotic Influenza Surveillance in Belgium

The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people.

Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans.

Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic.

As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.


Eligibility Criteria:
Inclusion Criteria:

* worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study
* to have regular contacts with animals within job/activity framework
* being committed to take the regular samples

Exclusion Criteria:

- people who had a broken nose might have difficulties to perform self-swabbing
Cognitive Impairment in Ageing People

Mild cognitive impairment (MCI) and neurocognitive disorder such as Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. The study will construct a prospective cohort to establish database that provide not only comprehensive epidemiological data on the MCI and neurocognitive disorder in ageing people, but also complete the construction of biological samples bank and clinical diagnosis and treatment information database. Using the database, the study will identify the conversion rates from MCI to dementia and risk factors for the progression from MCI to dementia or AD. The study will also apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study have goals to identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of cognitive disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 50 years old.
2. Sign informed consent.
3. According to DSM-IV, the diagnostic standard of dementia was not met.
4. The clinical dementia rating (CDR) was 0.5.

Exclusion criteria:

1. Subjects with mental retardation.
2. Refuse to have blood sampling, imaging and other examinations.
3. Uncooperative subjects that have serious organic diseases, or have a history of mental illness, or have physical disability (including severe aphasia).
4. Contraindications of MR scanning.
5. Suffering from serious physical or mental illness.
Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.

This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy.

With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased.

In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who understand and sign the consent form for this study.
* Age :19-60, males
* Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
* Duration of injury : \> 2 months

Exclusion Criteria:

* Subjects who must put on a respirator
* Subjects who had malignant tumor within 5 years
* Subjects with a infectious disease include HIV and hepatitis
* Subjects who injured brain or spinal cord before spinal cord injury
* Subjects who has high body temperature more than 38℃ or acute disorder
* Subjects with anemia or thrombocytopenia
* Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
* Subjects with congenital or acquired immunodeficiency disorders
* Subjects with muscular dystrophy or articular rigidity
* Patients with clouded consciousness or speech disorder
* treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
* participating another clinical trials within 3 months
* other serious disease or disorder that could seriously affect ability to participate in the study
A Randomized Trial to Improve Quality of Life Outcomes in Asthma Patients

Among 180 patients with moderate asthma, the specific aim of this randomized trial is to assess the effectiveness of an intervention involving education, enhancement of self-efficacy, and asthma social support in preventing deterioration in functional status over two years.

The goals of this study are to develop and implement a multi-component intervention to improve quality of life and decrease urgent resource utilization in adult asthma patients followed in a primary care practice. Specifically, the intervention involves a two-component self-directed self-management workbook. The first component focuses on increasing knowledge by providing patients with factual information about asthma and self-management. The second component focuses on asthma self-efficacy using case vignettes and making a contract to adopt a behavior to improve asthma. Asthma-related social support is achieved through interval telephone contact.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for this study if they are 18 years of age or older and have moderate asthma based on the NHLBI Asthma Expert Panel's classification which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.

Exclusion Criteria:

* Patients will be excluded from this study for the following reasons: if they are have other pulmonary diseases; if they are unable to provide informed consent because of cognitive deficits; if they are not fluent in English; if they refuse to participate.
Reliability and Validity of DIDA-Q in Parkinson's Disease

The aim of our study is to investigate the validity and reliability of the Dual Task Impact on Daily-living Activities (DIDA-Q) to assess the degree of difficulty felt when performing dual tasks during activities of daily living in patients with Parkinson's disease. In our study, the validity and reliability of a questionnaire to assess the degree of difficulty felt while performing dual tasks during activities of daily living in Parkinson's Disease will be examined for the first time. The study will include 95 participants with Hoehn-Yahr Stage 1-3, diagnosed with Idiopathic Parkinson's Disease and able to walk 10 metres without an assistive device.

Dual task ability is defined as the ability to perform two activities simultaneously . It is known that the ability to perform a motor or cognitive secondary activity at the same time during walking (talking to a person next to you while walking or carrying objects while walking) leads to gait and balance problems of different severity depending on the type of secondary task in Parkinson's Disease (PD). When patients with Parkinson's Disease (pwPD) are exposed to dual-task walking, their walking speed and length of stride decrease, and the frequency of freezing phenomena during walking increases. Consequently the risk of falling increase during activities of daily living. Individuals often perform dual tasks while performing activities of daily living because of the nature of the tasks' requirements. Therefore, it has become important to evaluate dual task performance in order to create the right treatment plan in the field of neurological physiotherapy and rehabilitation. Although dual task performance is evaluated with different formulae in the literature, the number of scales evaluating the level of difficulty perceived by the patient during the performance of activities of daily living under dual task is limited. The validity of the existing scales for PD has not been studied. The Dual-task Impact on Daily-living Activities Questionnaire (DIDA-Q) is a patient-reported questionnaire developed to assess the degree of difficulty perceived when performing dual tasks during activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's Disease according to UK Brain Bank criteria
* Walking at least 10 metres without an assistive device
* To have the cognitive capability to understand and answer the questions asked in the scale

Exclusion Criteria:

* Having any neurological disease other than idiopathic Parkinson's Disease
* The person has an orthopaedic or cardiopulmonary disease that affects walking
* Severe hearing-visual impairment
Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery

This study has been planned to compare the effect of opioid free anaesthesia using dexmedetomidine and ketamine with opioid based anaesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing Transsphenoidal surgery of pituitary tumors.

Opioid Free Anesthesia (OFA) is a technique where no intraoperative opioid is administered during the anesthetic management. Opioid free anesthesia is usually achieved through sympatholysis, analgesia, and anesthesia with dexmedetomidine and analgesia with low dose ketamine. In addition paracetamol and other non-steroidal anti inflammatory drugs (NSAIDS) may be used as adjuncts to the multi-modal pain regimen.

Dexmedetomidine, a highly selective agonist of the alpha2 adrenergic receptor, has many clinical benefits, such as sedation, analgesia, preventing unwanted stress responses and low risk of respiratory depression. Because of concern that opioids might cause perioperative respiratory depression, substitution with dexmedetomidine will be helpful with its analgesic and sympatholytic properties. Dexmedetomidine has shown to reduce minimum alveolar concentration (MAC) of inhalational anesthetics and the requirement of perioperative opioid by 30-50%. In neurosurgical patients, dexmedetomidine is helpful in maintaining intracranial pressure (ICP) and intraoperative hemodynamic stability, especially during intubation and extubation. It can allow for faster awakening and thus an earlier neurological examination by decreasing necessary volatile agent and opioid doses.

Ketamine, an N-methyl-d-aspartate(NMDA) antagonist, blunts central pain sensitization at sub-anesthetic doses (0.5 mg/kg or less) and has been studied extensively as an adjunct for perioperative analgesia. Sub-anesthetic ketamine improves pain scores and reduces perioperative opioid consumption in a broad range of surgical procedures.Recent literature has suggested that adjuvant ketamine administration in mechanically ventilated patients has no cerebrovascular effects.

The present study has been planned to compare the effect of opioid free anesthesia using dexmedetomidine and ketamine with opioid based anesthesia using fentanyl in maintaining the intraoperative hemodynamic stability and recovery characteristics in patients undergoing TSS of pituitary tumors.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering significant pituitary adenocarcinomas posted for transsphenoidal resection of tumor
* age group between 18 to 65 yr
* Both males and females
* ASA physical status 1 to 2

Exclusion Criteria:

* pts taking opioid for chronic pain
* Pregnant or nursing woman
* Preoperative GCS \<15
* HR\<50/min
* Patients with allergies to study medication
* Patients with psychiatric disorder
* Patients with unstable cardiorespiratory disorder
* Patients with hepatic and renal insufficiency
Effects of Vitamin D3 Supplementation on Antioxidant Enzymes Status in Vitamin D3 Deficient Asthma COPD Overlap (ACO) Patients

Asthma-COPD overlap (ACO) is a new entity in the world of respiratory ailments. The respiratory tract of these patients are continuously exposed to oxidants (due to cigarette smoking) causing oxidative stress. Antioxidant enzymes such as, superoxide dismutase (SOD) and catalase (CAT) neutralize these oxidants or free radicals and transform them into safer. Vitamin D is a natural antioxidant which has few evidence of increasing antioxidant enzyme level in COPD and asthma, but not in ACO patients. To evaluate the effects of vitamin D3 supplementation on antioxidant enzymes level in vitamin D3 deficient patients with stable ACO. The randomized controlled trial was conducted in Department of Physiology Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from March 2018 to February 2019. For this study, a total number of 40 vitamin D3 deficient (serum 25 hydroxycholecalceferol \<30 ng/ml) male, stable (diagnosed patient, who was not experienced any acute exacerbation, hospitalization, urgent care visits or changes in routine medication within 4 weeks prior to study) patients with ACO of age ≥40 years was selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and randomly grouped as A (control) and B (study). Then serum Superoxide dismutase and Catalase level of all the patients was assessed. Along with the standard pharmacological treatment of ACO (according to GOLD criteria), oral vitamin D3 (80,000 IU per week) will be supplied to the patients of the 'Study group' and placebo for 'Control group' for consecutive 26 weeks. At 26th week of follow up, all the study variables were examined. With this, all patients of both the groups were advised to continue ad lib (according to their own choice) diet. The results was expressed as mean±SD and the data was statistically analyzed by SPSS Version 16, using Independent sample 't' test (between two groups) and paired student's 't' test (between paired groups before and after intervention). In the interpretation of results, \<0.05 level of probability (p) was accepted as significant.


Eligibility Criteria:
Inclusion Criteria:

* Smoker
* Stable ACO patients
* Vitamin D3 deficieny
* Duration of ACO: 1-4 years

Exclusion Criteria:

* With acute exacerbation of any pulmonary diseases, as- respiratory tract infection, bronchiectasis,pleural effusion,tuberculosis, interstitial lung disease, pneumonectomy or pulmonary lobectomy.
* Any cardiac disease.
* Chronic liver disease
* Malignancy
* Use of drugs within 1 month prior to study, as- calcium supplement, Phenytoin, Carbamazepine, Clotrimazole, Rifampicin, Nifedipine, Spironolactone, Ritononavir, Saquinavir, Cyproterone acetate, glucocorticoids, bisphosphonate
* With biochemical evidence of - uncontrolled diabetes mellitus, renal insufficiency