cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3\*, Visit 4, Visit 5\*, Visit 6. (\* telephone contact)

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult over aged 50 years
* Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent

Exclusion Criteria:

* Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
* Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
* Those who have previously received herpes zoster vaccine
* Those who have a history of herpes zoster
* Those with congenital or acquired immunodeficiency
* Those with active untreated tuberculosis
* Those who have received blood products or immunoglobulin within 3 months prior to screening visit
* Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study
PsilOCD: A Pharmacological-Challenge Feasibility Study

The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD).

This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four weeks apart. To ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session. Additionally, acute post-dosing EEG recordings will be conducted, and blood samples will be taken after each dosing session. OCD symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. Collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and EEG measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 20 to 65 years;
* Any gender;
* A primary diagnosis of OCD (based on the Mini-International Neuropsychiatric Interview (M.I.N.I.));
* Has met diagnostic criteria for OCD for at least 12 months;
* Willing to comply with protocol and associated lifestyle restrictions;
* Adequate understanding of the English language to give informed consent and participate in the study;
* Participant can attend visits as an outpatient;
* Comfortable using a computer, access to internet from home, and willing to participate in some of the study visits via video-link.

Key Exclusion Criteria:

* Current or past history of dependent (according to ICD10 criteria) substance use (not including nicotine and/or caffeine), Tourette's syndrome, autism spectrum disorder, epilepsy, organic mental disorder, or a personality disorder apart from obsessive-compulsive personality disorder;
* Current or past history of psychosis or mania in themselves or a first-degree relative;
* Unstable physical health;
* Significantly abnormal clinical test result;
* Heavy smoker, or unable to attend the dosing days (including the subsequent recovery part) without a smoking break;
* Unwillingness to allow their GP or mental health practitioners to be informed of their participation (or, to allow study team access to Summary Care Record).
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 to 85 with diabetes and hemoglobin A1C \</= 10, or exudative macular degeneration.
* Diabetic macular edema with average retinal thickness central subfield \>/= 290um.

Exclusion Criteria:

* Macular atrophy/fibrosis.
* Ocular anti-VEGF treatment within 3 months.
* Treatment with topical or oral carbonic-anhydrase inhibitor within one month
* Laser photocoagulation within 3 months (diabetic cohort)
Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent.
2. Males or females ≥ 18 years.
3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\*. (\*Lack of efficacy as defined in the NUC-5/PSC trial.)

Exclusion Criteria:

1. History or presence of chronic alcoholic consumption (daily consumption \> 30 g in men, \> 20 g in women).
2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.
4. History of liver transplantation or patient listed for transplantation.
Pharmacokinetics of Sotrovimab as Pre-exposure Prophylaxis for COVID-19 in Hematopoietic Stem Cell Transplant Recipients, COVIDMAB Study

This phase I trial studies the process by which sotrovimab is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics) in hematopoietic stem cell transplant recipients. Sotrovimab is a monoclonal antibody that may target and bind to a specific protein on SARS-CoV-2 and block its viral attachment and entry into human cells. This may slow the progression of the disease and accelerate recovery, and may potentially provide temporary protection against infection with SARS-CoV-2 in hematopoietic stem cell transplant recipients.

OUTLINE:

Patients receive sotrovimab intravenously (IV) over 30 minutes within 1-7 days prior to the start of pre-transplant conditioning. Patients also undergo blood and nasal swab sample collection throughout the trial.

After completion of study treatment, patients are followed up for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients (or legally authorized representative if applicable) must be capable of understanding and providing a written informed consent
* Patients must be at least 18 years of age, of any gender, race, or ethnicity
* Patients must be undergoing HCT (any donor or stem cell source including autologous or cord blood)
* History of prior transplants are permitted
* History of COVID-19, history of vaccination for SARS-CoV-2, positive polymerase chain reaction (PCR) of a respiratory specimen for SARS-CoV-2 as long as it is not within four weeks from conditioning, or seropositivity for SARS-CoV-2 are permitted
* History of SARS-CoV-2 infection or vaccination of the donor are permitted.
* Post-enrollment vaccination is anticipated and permitted
* Administration of intravenous immunoglobulin therapy (IVIG) before or during the study is permitted

Exclusion Criteria:

* Signs or symptoms of uncontrolled, active infection
* Positive PCR result for SARS-CoV-2 within four weeks of scheduled conditioning
* Pregnant or breastfeeding (this population is generally not cleared for transplant)

  * Pregnancy test is obtained as part of pre-transplant evaluation in women of child-bearing potential at arrival to transplant and again within 7 days of conditioning and will be confirmed as negative by review of the chart
* Previous anaphylaxis or severe hypersensitivity reaction, including angioedema, to a mAb
* Previous reaction to a mAb that required medical attention
* Participants of other clinical studies that preclude the use of other investigational compounds
* Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol or unlikely to survive to the end of study
Attention and Visual Perception in Schizophrenia: A Functional Magnetic Resonance Imaging (fMRI) Study

The main objective of the study is to contribute to a better understanding of the physiopathology of schizophrenia, by studying causal relationships between cognitive deficits and the neurobiological basis for these deficits. Processing visual information involves both automatic grouping processes and control processes. Automatic grouping processes allow the building of a global configuration from local contour information. It is necessary in order to recognize objects. Control processes allow tending to and prioritizing information parts. The paradigm the investigators use allows to dissociate these processes, and is used in order to characterize the impairments observed in patients with schizophrenia. It is adapted to fMRI in order to explore the neurobiological basis of the deficits. The investigators will examine whether functional disconnectivity between activated areas subtend the impairments observed in patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia (DSM-IV criteria)
* Healthy controls matched with patients on age, sex and education level
* Ages 18 to 50
* Signed informed consent
* Right-handed

Exclusion Criteria:

* No severe somatic illness
* No invalidating sensory disease
* No drug abuse, as defined by DSM-IV criteria
* No general anaesthesia in the past 3 months
* No intake of drugs affecting the CNS, except for patients
Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment

This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.

The study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. The stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years.
2. Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.
3. Systolic blood pressure \<110/70 mm Hg when measured while sitting.
4. Patient who signed an informed consent form.

Exclusion Criteria:

1. Hypovolemic status (central venous pressure \<2 mm Hg).
2. Any acute illness.
3. Transient ischemic event or stroke within 2 weeks prior to inclusion.
4. Pulmonary embolism \<1 month ago.
5. Epilepsy.
6. An implanted infusion pump.
7. Pacemaker-dependent patients.
8. Patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.
Effect of Fruit and Vegetables on Insulin Resistance

Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. If proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. There are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. There is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. Evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. This study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of CVD using state-of-the-art techniques.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 27-35
* CVD risk \>20% over 10 years (using the Joint British Society risk assessment tables)
* Low consumers of fruit and vegetables (\<2 portions per day)

Exclusion Criteria:

* Diabetes
* Existing CVD
* Food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet
* Subjects taking antioxidant supplements
* Surgery within the last 3 months
* Pregnancy/lactation
* Aspirin
* Subjects following a weight loss diet
Effects of CO-OP Approach on Activity and Participation of Brazilian Children With Developmental Coordination Disorder

The purpose of this study is to investigate the effects of the Cognitive Orientation to daily daily Occupational Performance Approach (CO-OP Approach) on activity and participation in school-aged children with developmental coordination disorder (DCD).

Children with difficulty performing activities that reflect negatively on participation can meet the criteria for Developmental Coordination Disorder (DCD), which might impact their lives, leading to social isolation, depression and anxiety. Several studies have examined the effectiveness of different intervention approaches, including process-oriented approaches that focus on enhancing body functions and structures to improve performance on functional tasks. Although pediatric occupational therapists have traditionally used such approaches, evidence strongly suggests effectiveness for task-oriented interventions that focus on the performance of tasks that the child finds difficult to do. Among these, CO-OP Approach showed strong treatment effects. In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies to improve occupational performance in goals chosen by the children. There is a need to examine systematic intervention alternatives for Brazilian children with DCD, and only one study examined occupational therapy intervention strategies for children with DCD.

The main purpose of the study is to examine the effects of two intervention models based on CO-OP Approach. The investigators will examine if a boosting on parent's engagement in CO-OP can improve skill acquisition, generalization and transfer in children with DCD. A pre-post design will be used and two groups will be included in this study (1) one receiving standard CO-OP Approach, (2) one receiving standard CO-OP Approach and an addition of coaching sessions in groups for parents. Follow-up data will be collected 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* score on MABC-2 below the 15th percentile;
* score on DCDQ-Brazil below age expectation, indicating problems on everyday living and/or academic skills;
* cognitive development within the expected age range according to the Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV);
* no diagnosis or signs of neurological or neuromuscular diseases.

Exclusion Criteria:

* no reading ability;
* child refuses to participate on assessment sessions.
BMAC & Allograft vs BMP-2

The aim of this investigation is to compare the use of bone marrow aspirate concentrate (BMAC) and allograft versus recombinant human bone morphogenetic protein-2 (BMP) versus the gold standard fusion in subjects undergoing elective lumbar spinal fusion with interbody support. The safety and efficacy of the surgical interventions will be evaluated by assessing fusion status and subjects' quality of life outcomes.

This study will be a prospective, randomized clinical study at a single-center, NYU Langone Medical Center. It is intended to compare and evaluate the efficacy of subjects who are either treated with (1) bone marrow aspirate concentrate (BMAC) and allograft or (2) recombinant human bone morphogenetic protein-2 (BMP) or (3) autograft (control) during lumbar spinal fusion with interbody support. The clinical, radiographic, and Health Related Quality of Life (HRQOL) outcomes will be assessed in operatively treated adult spinal degenerative disease patients undergoing lumbar spinal fusion.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years old or older
* Scheduled for elective posterior or anterior and posterior spinal fusion of the thoracolumbar spine with or without anterior interbody support
* Failed at least 6 weeks of conservative care
* No contraindication to BMAC (as per manufacturer)
* Signed consent form

Exclusion criteria:

* Prior lumbar fusion surgery at operative level (prior discectomy and/or laminectomy allowed)
* Incompetent or missing anterior arch at the affected level (e.g. laminectomy, pars defect)
* Currently requires laminectomy at level of surgery
* Facet joints at implant level are absent or fractured
* Post-traumatic vertebral body compromise or acute fracture at implant level
* Body mass Index (BMI) \> 40
* Known allergy to titanium
* Paget's disease, osteomalacia, or any other metabolic bone disease
* Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids)
* Unlikely to comply with the follow-up evaluation schedule
* Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years
* Pregnant or planning to become pregnant during the length of study participation
Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.

The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.

Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. All the participants had undergone a chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative complications.

Eligibility Criteria:
Inclusion Criteria:

- RRD with postoperative follow up \> 3 months, without PVR, or with PVR A-B

Exclusion Criteria:

* RRD with less than 3 months of postoperative follow-up,
* RRD with proliferative vitreoretinopathy grade C (PVR C),
* RRD with uveitis,
* RRD with choroidal detachment,
* Giant retinal tears,
* Retinal dialysis,
* Myopic macular hole RRD,
* Traumatic RD,
* Children \< 16 years old,
* The later vitrectomy (if vitrectomy had been performed for RRD in both eyes)
Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula

Patients with high trans-sphincteric anal fistula will be randomized to one of two equal group: group 1 will have drainage seton with mucosal advancement flap and group 2 will undergo external anal sphincter sparing seton


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from high trans-sphincteric anal fistula

Exclusion Criteria:

* Acute sepsis.
* Specific cause of fistula e.g. Crohn's disease
* Strictured anorectum.
* Any degree of incontinence
* Recurrent anal fistula.
* Low anal fistula.
* Previous anorectal surgery.