cyrilzakka/clinical-trials huggingface dataset:
The Effect of Seaweed Derived Polyphenols on Inflammation and Oxidative Stress in Vivo - The SWAFAX Study

Cardiovascular disease (CVD) is currently the leading cause of death worldwide. Epidemiologic studies have shown a diet rich in plant food protects against chronic degenerative diseases especially cardiovascular disease. Many of these studies have highlighted a potential role for phenolic compounds, which are abundant secondary plant metabolites, and which provide antioxidant and anti-inflammatory properties and are increasingly being shown to have an important role in influencing critical cell signalling pathways. A less well known, but nevertheless rich source of polyphenolic compounds is seaweed. In Ascophyllum nodosum, a common brown alga in the British Isles, polyphenols have been reported to comprise up to 14% of the dry weight of the plant. Some studies suggest that the potential antioxidant and anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive components with commercial potential for food and pharma applications. Preliminary work in our laboratory has revealed potent antioxidant activity of Ascophyllum nodosum extracts.

Therefore, the aim of this randomised, double-blind, placebo controlled, crossover design study is to investigate the biological activity of a food grade seaweed polyphenol extract in terms of reducing oxidative damage to DNA, modulation of inflammatory responses and reduction on chronic, low level inflammation in vivo. Apparently healthy volunteers (aged 30-65 years) will be randomised to receive either a capsule containing 100mg seaweed extract or a matched placebo daily for an 8 week period, with an 8 week washout period between each treatment. Fasting blood and urine samples will be taken from each volunteer at 4 time-points during the study, at baseline and completion of the 2 treatment phases.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoker
* Omnivores and vegetarians
* Aged 30-65 years
* BMI \>25kg/m2

Exclusion Criteria:

* Smokers
* Pregnant/lactating women
* Vegans
* Diabetes mellitus, CVD
* Autoimmune/inflammatory disorders
* History of neoplasm
* Recent acute illness
* Anti-inflammatory medication
* Habitual use of vitamin supplements
DWP450 for Treating Moderate to Severe Glabellar Lines

A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of moderate to severe glabellar lines


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females aged 20-65 years old.
* Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.

Exclusion Criteria:

* Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening.
* Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period.
* Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines.
* Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.
Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778

Open-label, single-dose, Phase 1 study to assess the absorption, metabolism, excretion and pharmacokinetics of \[14C\]-AKB-9778 in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* BMI 18 - 33 kg/m2

Exclusion Criteria:

* Significant cardiovascular, pulmonary, or renal disease
Semaglutide and Preoperative Residual Gastric Volumes

Given the pharmacodynamic and pharmacokinetic properties of glucagon-like peptide-1 (GLP-1) agonists, the Canadian Anesthesiologists' Society has recognized that patients on GLP-1 agonists may have an increased aspiration risk due to a 'full stomach,' even after following preoperative fasting guidelines. In other words, safe fasting timelines are not known in individuals taking GLP-1 agonists, as demonstrated by recent case reports of patients who either retained or regurgitated stomach contents despite being adequately fasted.

To address this gap, we plan to measure preoperative residual gastric volumes with point-of-care ultrasound (POCUS) in patients taking this medication. The priority is to first gather data to identify which patient populations need risk stratification and to then use this data to support the development of specific guidelines that reduce anesthetic complications, such as aspiration pneumonia.

Our primary objective is to use POCUS preoperatively to assess gastric volumes of fasted patients to demonstrate if there is a clinically significant increase in residual gastric volumes in patients on semaglutide.


Eligibility Criteria:
Inclusion Criteria:

* all elective surgical patients (\> 18 years of age)
* followed institutional fasting protocol for surgery
* patients taking GLP-1 receptor agonist (subcutaneous for weight management and/or blood glucose control in type II diabetes mellitus, N = 45)
* patients not taking GLP-1 receptor agonist (N =45)

Exclusion Criteria:

* confounding delayed gastric emptying due to pregnancy
* previous esophageal or gastric operation
* etiologies at increased risk for delayed gastric emptying (hiatal hernia, Parkinson's disease, scleroderma, multiple sclerosis, and amyloidosis)
* on medication that could potentially cause gastroparesis or delayed gastric or intestinal emptying (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, loperamide, diphenoxylate, oxybutynin, hyoscine butylbromide, scopolamine, promethazine, glycopyrrolate, atropine, chlordiazepoxide, and lithium)
Enhancing Motivation in Recent Onset Schizophrenia

This project will result in the development of a personalized intervention strategy to improve motivation for treatment engagement and functional outcomes in individuals with a recent onset of schizophrenia. Motivational impairment is arguably the single most important factor that determines a patient's ability to engage in and adhere to effective treatment. In our study, sixty participants will be enrolled in a randomized controlled trial comparing the feasibility and tolerability of two types of motivational interventions (Daily Goals or PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also receive an 8-week course of cognitive training delivered via iPads. Participants will undergo pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of the interventions. By enhancing motivation, schizophrenia patients would be able to engage more fully with treatment and develop full and productive lives. This study may also pave the way forward for other health conditions in which motivational impairments impede health outcomes.

All assessments will be conducted at the University of California, San Francisco; however, we offer some assessments to be done remotely.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder.
* Onset of diagnosis within 5 years.
* 14-30 years old.
* Clinically stable (outpatient status for 1 month and stable dose of medication for 1 month).
* Good general health

Exclusion Criteria:

* Substance dependence within the past 12 months,
* Current substance abuse,
* No history of neurological disorder
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP\~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.

WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.

To assess the safety of Pentaxim.

Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:

Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.

Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.

All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
* Healthy male or female newborn
* Age ranging from birth to 48 hours of life (included)
* Birth weight \>2.5 kg and gestational age \>37 weeks
* Born to HBs antigen-negative mother

Exclusion Criteria:

* Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
* Infant presently enrolled or scheduled to be enrolled in another clinical trial
* Infant with moderate or severe illness, mainly infectious diseases
* Infant with fever (rectal temperature \> 38°C or axillary temperature \> 37.5°C)
* Infant with severe congenital defects or abnormalities
* Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Known immunological deficiency (including a known HIV seropositive mother)
* Administration of vaccine since birth (other than BCG)
* Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

SAV006-03 is an open-label extension study for participants who had completed the IMPALA study.

At the baseline visit, eligible participants may continue or re-start treatment with 300 µg inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor; GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once daily, and seven days off treatment.

Participants will be treated with inhaled molgramostim for up to 36 months.

During the trial, whole lung lavage will be applied as rescue therapy.


Eligibility Criteria:
Inclusion Criteria:

* Completer of the IMPALA trial.
* Females who have been post menopausal for \>1 year, or females of child-bearing potential who are not pregnant or lactating and are using acceptable contraceptive methods.
* Males agreeing to use using acceptable contraceptive methods.
* Willing and able to provide signed informed consent.

Exclusion Criteria:

* Treatment with GM-CSF products other than molgramostim nebuliser solution within three months of Baseline.
* Treatment with any investigational medicinal product other than inhaled molgramostim within four weeks of Baseline.
* History of allergic reactions to GM-CSF.
* Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone.
* Previous experience of severe and unexplained side effects during aerosol delivery of any kind of medicinal product.
* History of, or present, myeloproliferative disease or leukaemia.
* Apparent pre-existing concurrent pulmonary fibrosis.
* Any other serious medical condition which in the opinion of the investigator would make the subject unsuitable for the trial.
Project AFECT (Autism Family Empowerment Coaching and Training Program)

The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are:

* Age greater than 1 and up to 5 years old;
* Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
* Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).

The main questions it aims to answer are:

* Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence;
* Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments;
* Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention.

Participants will be asked to:

* Complete surveys at enrollment and 3 and 6 months later.
* Work with Project AFECT Coach.

Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.

This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion criteria will be invited to participate in this study at the time of their child's autism diagnosis at Stanford Medicine Children's Health.

Participants in the control group will receive treatment as usual. In addition to treatment as usual, participants in the intervention group will be connected with Project AFECT Coaches who will provide: Coaching to (1) assure parents understand diagnosis, (2) assist parents in finding accurate, current information about autism, (3) guide parents to free online autism training resources, (4) empower parents to evaluate child's intervention plan holistically, and (5) provide emotional support to reduce stress; Navigation to (1) help family access autism treatments, and (2) connect to early intervention and educational services.

Eligibility Criteria:
Inclusion Criteria:

1. Parents of children just diagnosed with autism (with or without other diagnoses) who are:

1. Age greater than 1 and up to 5 years old;
2. Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
3. Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).

Exclusion Criteria:

* Non-legal guardians or foster parents who provide care to children newly diagnosed with autism.
* Parents of children without diagnosis of autism.
Peri Implant Marginal Bone Height and Bone Density

This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.

In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups.

Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture.

All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT).

Measurements will be obtained at denture insertion, after 1 month and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker Patients
* Highly cooperative and motivated patients.
* Patients Systemically free from any immunosuppressive diseases.

Exclusion Criteria:

* Diabetic, hypertensive, cancer patients.
* Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies.
* Patients with temporo-mandibular joint disorders and bad oral habits.
AI-based Multi-center Research on Identification/Classification/Aided Diagnosis of Mood Disorder

At present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. The corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. Therefore, it is of great significance to explore objective diagnostic indicators to remedy the deficiencies.

Therefore，the investigators collect psychological and physiological information data of patients with bipolar disorder and depression.Then the investigators aim to construct and verify the multidimensional emotion recognition model to analyze the personality characteristics, negative emotions and cognitive reactions of different individuals, and form a systematic accurate recognition and evaluation tool.


Eligibility Criteria:
Inclusion Criteria:

1. Age 15-55, regardless of gender;
2. The brief International Neuropsychiatric Interview Chinese version (MINI) was used to meet the diagnostic criteria for DSM-IV-TR depressive disorder or bipolar disorder (type I);
3. Total score of Hamilton Depression Scale (HAMD-17) ≥17, and Young's Manic Scale (YMRS) ≤6;
4. Junior high school or above.

Exclusion Criteria:

1. The patient conforms to DSM-IV schizophrenia and related spectrum disorders.
2. The patient has a history of severe head trauma (loss of consciousness for more than 5 minutes), current or previous history of epilepsy, intracranial hypertension, or other serious neurological diseases;
3. Had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test;
4. Those considered unsuitable for inclusion by the researcher.
Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement

In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal

In this study we will prospectively collect relevant clinical data on 60 neurological patients, who are being referred for an elective lumbar puncture (eg. suspected multiple sclerosis, raised intracranial hypertension, etc). Each enrolled patient will be monitored in parallel to the lumbar puncture with the HeadSense ICP monitor. Subjects who meet the study inclusion and exclusion criteria will be enrolled in the study.

Step 1: 10 minute measurement of HeadSense monitor. Once the patient is inclined with his upper body 30 degrees to the bed the pressure values, the clinical procedure can begin. The device must be preset in a continuous monitoring mode. The continuous monitoring allows a loop of measurements for an unlimited time in a rate of four measurements per minute.

Step 2: 10 minute measurement of HeadSense monitor in supine position.

Step 3: Patient will be placed in a left lateral position. The lumbar puncture will be done and CSF pressure will be measured following standard procedures.

Step 4: 10 minute measurement of HeadSense monitor in supine position.

Lumbar puncture and HeadSense measurement will be done by two different doctors and they will not share measurement values during the procedure.

After the study the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred and the family or advocate of the patient will be informed. In case of clinical relevant adverse events appropriate clinical action will be taken.

As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female in the age range of 18 years and older
* All patients who are referred for elective or subacute lumbar puncture including CSF pressure measurement

Exclusion Criteria:

* Local infection in the ear
* Pregnant or lactating women
* Cervical spine stenose
* Arnold-Chiari malformations
* Aqueductal stenosis or other changes causing an uneven CSF pressure between different compartments
* Mass lesions
* Current or previous craniotomy or craniectomies
* Suspicion of meningitis or encephalitis
Safety and Efficacy of Using the New Tissue Containment System During Laparoscopic Myomectomy Morcellation

The study is designed to evaluate the safety of performing the new tissue containment system during laparoscopic myomectomy morcellation. Pre- and perimenopausal women, aged 18-45 undergoing laparoscopic myomectomy morcellation


Eligibility Criteria:
Inclusion Criteria:

* Pre- and Peri-menopausal woman patient age 18-45 years

  * Women with fibroids and indication for laparoscopic myomectomy.
  * Normal Pap smear result within one year
  * MRI ( Magnatic Resonance Imaging ) or other imaging findings indicate the diameter of the largest uterine fibroids is between 4 to 10cm.
  * The body mass index of the patients is 18.5-27.9kg/m2
  * Signed informed consent form

Exclusion Criteria:

* • Women with Known or suspected malignancy

  * patients with severe pelvic adhesion found during the operation
  * The body mass index of the patient ≥ 28kg/m2
  * Diameter of a single uterine fibroid\>10cm
  * patients during pregnancy and lactation
  * Known blood diseases, bleeding coagulation disease, any part of the active bleeding or bleeding tendency of the constitution of the patient
  * Patients with known severe liver and kidney dysfunction;Liver function (ALT, AST) ≥ 2 times of normal upper limit, or renal function (Cr) ≥ normal upper limit
  * Patients who are known to have participated in any other clinical trial within 3 months
  * Patients who cannot sign informed consent
  * Patients with acute stage infection of the reproductive system or other sites