cyrilzakka/clinical-trials huggingface dataset:
Cognitive and Cerebral Blood Flow Effects of Vitamin C

This investigation is interested in the effects of high dose vitamin C on endothelial function in healthy humans. A high fat meal will be utilized to induce endothelial dysfunction. It is hypothesized that, via antioxidant actions, vitamin C will reverse these effects and in turn improve blood flow- the involvement of nitric oxide suggests that this could extend to cerebral blood flow. This will be monitored by trans cranial doppler flow meter and near infrared spectroscopy.

The acute effect of administering vitamins has received little research attention. The exceptions are a number of studies that have observed that single doses of a variety of vitamins, including Vitamin C, E and several B vitamins, ameliorate endothelial dysfunction in the periphery in participants who smoke, or suffer disorders such as diabetes mellitus and cardio-vascular disease. Endothelial function also varies in healthy people as a consequence of diet, and it is possible that antioxidant vitamins can attenuate the vaso-constriction associated with commonly consumed foodstuffs. Indeed, a study by Title et al (2000) showed that vitamin C improved endothelial function in the forearm following a glucose drink. Given the putative underlying mechanisms involved (e.g. nitric oxide synthesis) any improvement may well also extend to cerebral blood flow (CBF), and therefore improvements in aspects of cognitive function.

The study will therefore assess the effects of a single dose of 1000 mg of vitamin C on cognitive performance and cerebral arterial blood flow velocity (cBFV) using Trans-cranial Doppler, following a high fat meal that has been used in previous endothelial function research.

The high fat meal will be administered 2 hours before testing begins. Research shows that a meal of this type produces effects on the endothelium which are similar to those induced by dysfunctions such as diabetes i.e. blood flow restriction. No adverse effects have been reported with regards this methodology however.

In order to monitor the effects of vitamin C (or not in the case of placebo) on endothelial function and cerebral blood flow near infrared spectroscopy (NIRS) and trans cranial Doppler (TCD) recordings will be taken throughout (in the case of the former technique) and at intermittent stages (in the case of the latter). Both neuroimaging modalities, when used correctly) are entirely safe. Blood pressure readings will also be taken intermittently throughout testing sessions.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female,
* 18-35

Exclusion Criteria:

* Smokers,
* not proficient in English,
* are (or are seeking to become) pregnant, are currently taking illicit,
* over the counter/prescription medication (including the contraceptive pill),
* and/or dietary/herbal supplements.
* Food allergies or sensitivities that are relevant to the study,
* a history of/current head trauma,
* learning difficulties,
* ADHD and
* migraines.
Thromboelastography in in Patients With Sepsis

Methods:

The study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the American College of Chest Physicians/ Society of Critical Care Medicine consensus conference.

Patients whose primary reason for hospital admission is sepsis or patients developing sepsis after elective invasive procedure will be included.

Only patients with known former primary coagulation/hypercoagulability disorder wil be excluded.

Procedure:

Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the following:

Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be performed.

These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V, VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.

Demographic data will be collected according to patient chart, and the acute physiologic and chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will be collected from monitors.

Informed consent will be waved due to lack of any intervention and the general condition of patients unable to sign an informed consent.

Control group will include 10 healthy individuals.

End point:

The primary end point is to determine the common hypercoagulable/coagulation disorders according to TEG.

The secondary end point is to determine whether TEG results have prognostic implications on this group of severe septic patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 years or older admitted to ICU whose primary reason for admission was sepsis or suffering sepsis or septic shock after elective surgical procedure

Exclusion Criteria:

* Patients suffering primary disease affecting the coagulation system
A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification (according to endoscopy imaging manual) performed at Visit 1 (Day -28 to -7, Screening)
* Biologic-naïve subjects or biologic-experienced for the treatment of Crohn's disease. Biologic-experienced subjects are eligible if they have not failed more than one marketed biologic therapy for the treatment of Crohn's disease due to lack of efficacy (primary or secondary efficacy failures)

Exclusion Criteria:

* Body mass index (BMI) equal to or above 38.0 kg/m\^2
* Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation, total colectomy or subtotal colectomy with less than 20 cm colon remaining, any abscesses not adequately treated
* History of dysplasia in the colon
* Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy
* Any history of serious recurrent infections requiring hospitalisation
DNA Variations in the Gene in Young Patients With Wilms' Tumor

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms' tumor.

OBJECTIVES:

Primary

* Determine the presence of the A133S polymorphism in the RASSF1A tumor suppressor gene by screening germline DNAs of children with Wilms' tumor.
* Determine the inheritance pattern of the A133S polymorphism by evaluating the parents of children who carry this polymorphism.

Secondary

* Determine the differences in age at diagnosis, stage, histology, site of primary tumor, and outcome, between patients with vs without the A133S polymorphism.
* Determine whether the S131F RASSF1A variant is a true polymorphism in these patients.
* Determine the polymorphic differences in this gene between these patients based on ethnicity and sex.

OUTLINE: This is a multicenter study. Patients are stratified according to age at diagnosis, stage, histology, site of primary tumor, and outcome.

Genomic DNA samples are purified from peripheral blood of patients and controls and analyzed by polymerase chain reaction for the RASSF1A gene. DNA is also analyzed from parents of patients with the A133S polymorphism.

PROJECTED ACCRUAL: A total of 471 participants (229 Wilms' tumor patients and 200 control participants plus 42 parents) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Wilms' tumor OR
* Control participants matched for race, sex, and age

  * No prior or concurrent history of cancer OR
* Parents of children involved in the study

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
A Study of LY3372993 in Healthy Participants and Participants With Alzheimer's Disease (AD)

The main purpose of this study is to evaluate the safety and tolerability of LY3372993 in healthy participants and participants with AD. The study will also investigate how much LY3372993 gets into the bloodstream and test the effects of LY3372993 in participants with AD.

The study has two parts:

* Part A - Healthy participants will receive LY3372993 or placebo. Part A will last up to 17 weeks;
* Part B - Participants with AD will receive LY3372993 or placebo. Part B will last about 317 days.

In April, 2019, Eli Lilly and Company made a business decision to terminate Part B. No participants were enrolled.

Eligibility Criteria:
Inclusion Criteria :

Part A:

* Overtly healthy males or females as determined by medical history and physical examination
* Are between 18 to 45 years old, inclusive
* Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
* Female participants not of child-bearing potential
* Have a body mass index of 18.0 to 32 kilograms per square meter (kg/m²) inclusive

Part B:

* Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD
* Positive florbetapir scan
* Men or nonfertile women, at least 55 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year
* Have up to 2 study partners who can provide health information related to the study about the participant. Study partner(s) will provide a separate written informed consent to participate

Exclusion Criteria:

* Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
* Have significant allergic reactions to LY3372993, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results

Part A:

* Have family history of early onset Alzheimer's Disease (AD)
* Have impaired cognitive function

Part B:

* History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy
* Previously dosed in any other study investigating active immunization against amyloid beta (Aβ)
* Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months
* Have current serious or unstable illnesses
Observing the Effect of Fascial Manipulation in Athletes With Shin Splits.Tibial Stress Syndrome.

Aims \& objectives:

1. The aim of the study is to find out the influence of fascial manipulation on running kinematics among athletes with medial tibial stress syndrome (MTSS).
2. The objectives of our study are

i. To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running kinematics before and after treatment intervention. iii. To compare pain perception before and after treatment intervention.

The justification for study:

1. MTSS is associated with altered lower extremity kinematics.
2. There is an association between tibial fascia tightness and forces acting along the tibial crest due to alterations in the transfer of energy from foot proximally in the closed kinematic chain.
3. Fascial manipulation is found to be effective in improving the pliability of connective tissues in the management of musculoskeletal conditions.
4. Therefore there is a need to determine the influence of fascial manipulation on MTSS.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-40 years, both sexes Athletes with shin pain or diagnosed with MTSS Symptoms lasting for 2-3 weeks in the last 1 month

Exclusion Criteria:

* Trauma to lower extremity in the past 3 months Neurological, Cognitive, Psychological factors affecting the test Acute injuries- laceration, sprains, strains, recent fractures Lumbopelvic-hip complex and knee pathologies(intra-articular lesions, osteoarthritis, rheumatic arthritis, osteomyelitis)
Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer

To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.

NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood.

Eligibility Criteria:
Inclusion Criteria:

* Age (\>18 years old).
* Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
* The status of dMMR/pMMR was confirmed by IHC/PCR.
* with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
* Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.

Exclusion Criteria:

* Suffering from other malignant tumors at the same time.
* Others that the investigator consider that is inappropriate for this study.
Anterior Capsule Polishing Effect on Effective Lens Position

* The purpose of this study is to evaluate effects of anterior capsule polishing on effective lens position (ELP) and actual axial movement of the intraocular lens (IOL) by measuring anterior chamber depth (ACD)
* patients with bilateral age-related cataract undergo bilateral uneventful cataract surgeries with in-the- bag implantation of a single-piece hydrophobic acrylic foldable IOL (SN60WF). The anterior capsule was extensively polished using Whitman Shepherd Double-Ended Capsule Polisher in one eye randomly, and the other not. The ACD was measured 1day, 1 week, 1month, 3 months and 6 months with anterior segment Optical Coherence Tomograph (AS-OCT) postoperatively. The actual axial movement of IOL was defined as the root mean square (RMS) of the change in ELP at each visit.


Eligibility Criteria:
Inclusion Criteria:

* bilateral age-related cataract
* good overall physical constitution
* uneventful surgeries of both eyes with in-the-bag IOL implantation

Exclusion Criteria:

* history of intraocular surgery or laser therapy
* history of ocular trauma or ocular disease
* high myopia
* diabetes
* severe retinal pathology
* patients who could not return on time
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology

A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.

The objective of this prospective, two-arm, multicenter, post-market study is to evaluate safety through the incidence of reported device-related adverse events (AEs) through 30 days following use of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology in subjects undergoing indicated abdominal or thoracic procedures.

Eligibility Criteria:
Inclusion Criteria:

1. The subject must be 18-80 years of age
2. The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
3. The subject is undergoing an indicated primary abdominal or thoracic procedure where the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle) will be used per its Instructions For Use (IFU)

   * Thoracic procedures may include, but are not limited to, wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures.
   * Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection.
4. For thoracic subjects: the subject has a FEV1 ≥40%

Exclusion Criteria:

1. Subjects undergoing cardiac and vascular procedures
2. The procedure is an emergency procedure
3. The procedure is a revision/reoperation for the same indication
4. Any female subject who is pregnant

   a. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test (except for subjects who are surgically sterile or are post-menopausal for at least two years)
5. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)
6. The subject is unable or unwilling to comply with the study requirements or follow-up schedule
7. The subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
8. The subject has been diagnosed with a bleeding disorder and/or is undergoing active and not reversed anticoagulant treatment
9. The subject is concurrently enrolled in an investigational drug or device research study
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery

Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The paravertebral block has been successfully used in various surgical patient groups for purposes of anesthesia or postoperative pain management such as thoracotomy, breast surgery and abdominal surgery. The aim of this study is to compare the analgesic effects of erector spinae plane block and paravertebral block in patients undergoing video assisted thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Undergoing video assisted thoracoscopic surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
A Phase I/II Study of Active Immunotherapy With Cancer Stem Cells Vaccine for Colorectal Cancer

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring anti-tumor immunity.

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with colorectal cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the colorectal cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the colorectal cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-colorectal cancer CSC immunity induced by colorectal cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of colorectal cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with colorectal cancer CSC-DC.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18 and over
2. Performance status:Karnofsky 70-100%
3. Life expectancy:Greater than 6 months
4. Hematopoietic:Absolute neutrophil count at least 1000/mm 3,Hemoglobin at least 9 g/dL,Platelet count at least 100,000/mm\^3
5. Hepatic:Bilirubin less than 2.0 mg/dL No chronic or acute hepatic disease Renal:Creatinine less than 2.5 mg/dL
6. Cardiovascular:

   No chronic or acute cardiac disease (New York Heart Association class III or IV)
7. Pulmonary:

No chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease

Exclusion Criteria:

1. Patients receiving anticoagulation therapy.
2. Patients receiving any other investigational agents.
3. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV. 4、level 3 hypertension; 5、severe coronary disease; 6、 myelosuppression; 7、 respiratory disease; 8、 brain metastasis; 9、 chronic infections