cyrilzakka/clinical-trials huggingface dataset:
A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza

The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years of age or older
* Good general health without significant physical examination findings or clinically significant abnormal laboratory results
* Available to participate for entire study period
* Acceptable laboratory parameters
* Willingness to have blood stored for up to 10 years for use in additional assays to evaluate immune responses to influenza or the alphavirus vector if such assays become available
* Willingness to refrain from donating blood while participating in the study
* Willingness to delay receipt of 2008-2009 licensed influenza vaccination until after completing study visit 6 procedures (study week 8)
* Signed inform consent obtained before screening and before enrollment

Exclusion Criteria:

* Venous access deemed inadequate for th phlebotomy demands of the study
* Receipt of any other vaccine within 30 days prior to enrollment
* Use of any investigational agent within 30 days prior to enrollment
* Receipt of immunoglobulin or other blood products within 60 days prior to enrollment
* Use of cytotoxic medications within 6 months prior to enrollment
* Use of systemic corticosteroids within 6 months prior to enrollment (except that participants who have completed a course of prednisone, at up to 20 mg per day for up to 7 days, at least 1 month prior to enrollment are eligible for enrollment)
* History of serious adverse reactions to any vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain
* History of autoimmune disease or splenectomy
* History of malignancy within the last 3 years (except that participants with a diagnosis of basal cell carcinoma of the skin are eligible for enrollment)
* Psychiatric condition that may interfere with the ability to comply with the protocol requirements or to understand informed consent. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years.
* History of medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
* Any condition which leads the investigator to believe that the particpant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for further participation.
Movement Analysis of Stroke Patients When Walking on a Treadmill

In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the analyses. One of the systems which can be used to perform motion analysis on a treadmill is the GRAIL. This GRAIL (Gait Real-time Analysis Interactive Lab) consists of an advanced treadmill with force sensors. Patients can walk on this treadmill with an imposed speed (fixed-speed) or at a speed determined by the patient itself (self-paced). Because not everyone is used to walk on a treadmill it is important to know if a person's walking pattern is different when he walks over ground compared to walking on the treadmill. Based on these insights, decisions can be made regarding interventions including treadmill training or this findings can be taking into account during further analysis of walking patterns on a treadmill. For this study stroke patients would be invited for an assessment on the treadmill (1 assessment moment). The movement pattern of these patients would be compared in different conditions:

* (Forward and backward) Walking at comfortable walking speed on the GAITRite
* Walking at comfortable walking speed on the treadmill in fixed speed mode
* Walking at comfortable walking speed +0.2 m/s (faster walking) on the treadmill in fixed speed mode
* Walking at comfortable walking speed on the treadmill in self-paced mode
* Backward walking at comfortable walking speed on the treadmill in fixed speed mode (only if patients are eligible to do so)

Hypotheses based on this study protocol:

* Do stroke patients walk different over ground compared to treadmill walking
* Do stroke patients walk different during treadmill walking self-paced compared to fixed speed
* Do stroke patients walk different during treadmill walking fixed speed comfortable walking speed compared to fast walking
* Is there a correlation between upper extremity impairment and arm swing


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.

Exclusion Criteria:

* Traumatic brain lesions (car accident, fall with bike, ...)
* Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance

  * Bilateral stroke
  * Cerebellar stroke
  * Orthopedic surgery lower limbs in the past
  * Cognitive or language impairments that prevent the patients from understand simple orders
Positron Emission Tomography in Prostate Cancer

RATIONALE: Diagnostic procedures, such as positron emission tomography using carbon-11 acetate, may help find metastases from prostate cancer and may help predict whether prostate cancer will come back after treatment.

PURPOSE: This clinical trial is studying how well positron emission tomography using carbon-11 acetate works in finding metastases and predicting recurrence in patients with prostate cancer who are at risk for recurrence after treatment.

The overall goal of this project is determination of the role of PET in patients with newly diagnosed medium- and high-risk prostate cancer in whom the standard clinical and imaging workup is negative. Thus, the incremental value of PET will be determined in this important group.

Eligibility Criteria:
Inclusion Criteria

* Newly diagnosed prostate cancer
* Has completed conventional staging examinations, including biopsy with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy AND conventional staging examinations negative
* Candidate for curative radical prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
* Deemed to be at medium or high risk for recurrence after initial curative treatment, as defined by 1 of the following criteria:

  * Gleason score 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
  * Gleason score ≥ 8 AND PSA \< 10 ng/mL
  * Gleason score ≥ 8 AND PSA \> 10 ng/mL
  * Any Gleason score AND PSA \> 20 ng/mL

Exclusion Therapy:

* Not a candidate for treatment by surgery or radiation therapy with curative intent
* Inability to give informed consent
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years
nCD64 vs. Neutrophil/Lymphocyte Ratio for Predicting In-hospital Outcome in AE-COPD

Neutrophil CD64 versus Neutrophil/Lymphocyte ratio (NLR) as markers predicting in-hospital outcome in acute exacerbation of COPD

Acute exacerbation of COPD is among the most frequent reasons for hospitalisation. Approximately 4% of the general population in the western world is admitted with an acute respiratory disease at least once a year and nearly one fifth of hospital visits is due to acute exacerbation of COPD. Early identiﬁcations and management of AE-COPD is an important issue in clinical practice. AE-COPD is accompanied with various worsening respiratory symptoms and deterioration in lung function. Also the frequency and severity of attacks is associated with increased mortality.

During exacerbation, the inﬂammation in COPD is ampliﬁed in comparison with stable periods. The increased level of inﬂammatory markers is associated with lung function decline. As infection, is the main cause leading to clinical AECOPD, white blood cell counts and ESR are the common markers to show the existence of infection in patients with COPD. Recently, other bio markers are used. Authors have found that the high-affinity Fc receptor-CD64 is expressed by monocytes and only weakly on resting neutrophils. The high-expression of neutrophil CD64 (nCD64) is an early step in the host- immune response to bacterial infection. Studies have shown that the nCD64 might be used as a bio-marker for early-onset sepsis or bacterial infection. However, authors agreed that the value of the nCD64 in COPD prognosis is unknown.

As most of novel bio-markers that identify the severity of acute exacerbation in COPD, are time consuming and expensive, there is a need to use more simple tests. The Neutrophil-lymphocyte ratio is a rapid, easy and cost-effective method derived from routine complete blood count tests in clinical practice. The NLR could be an important marker that assess inﬂammatory status in patients with COPD and could identify early, acute exacerbation. However, this bio marker has not been widely used in the diagnosis of AECOPD.

The purpose of the present study is: 1- To measure the values of the neutrophil CD64 and NLR in patients with AECOPD and stable COPD, 2- to correlate between nCD64, NLR and the usual routine bio-markers as white blood cell count and erythrocyte sedimentation rate, 3- to investigate the role of nCD64 and NLR as predictors for short term hospital outcome in this group.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as AECOPD and stable COPD ( random selection by 1:1 cross over). A diagnosis of COPD was made by a clinical history, examination and spirometer (forced expiratory volume in 1st second/forced vital capacity (FEV1/FVC)ratio of \<0.7). The severity of COPD was graded according to the Global Initiative for Chronic Obstructive Lung Disease guidelines.

Exclusion Criteria:

* history of current respiratory disorders other than COPD, malignancy, systemic auto-immune disorders, recent surgery and severe endocrine, hepatic or renal diseases. Patients with pneumonia, cardiovascular and metabolic diseases
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma

RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.

OBJECTIVES:

Primary

* Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.

Secondary

* Determine preliminarily evidence of biologic activity of this regimen in these patients.
* Determine the toxic effects of this regimen in these patients.

STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. With a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed\* diagnosis of 1 of the following:

  * Poor prognosis brain tumor

    * Relapsed or progressive disease
    * No curative therapy exists
  * Neuroblastoma

    * Recurrent disease NOTE: \*Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease
* Patients with brain stem glioma must have symptoms lasting \< 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs

PATIENT CHARACTERISTICS:

Age

* 21 and under

Performance status

* Karnofsky 50-100% OR
* Lansky 50-100%

Life expectancy

* More than 2 months

Hematopoietic

* Hemoglobin ≥ 9.0 g/dL
* Platelet count \> 75,000/mm\^3
* WBC \> 2,000/mm\^3
* Absolute neutrophil count \> 1,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 mg/dL
* SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac)
* Alkaline phosphatase ≤ 2 times normal
* No active hepatic disease ≥ grade 3

Renal

* Creatinine \< 1.5 mg/dL OR
* Creatinine clearance ≥ 70 mL/min
* No active renal disease ≥ grade 3

Cardiovascular

* No active cardiac disease ≥ grade 3

Pulmonary

* No active pulmonary disease ≥ grade 3

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation

  * Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.\^®) program
* No active psychiatric disease ≥ grade 3

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Prior biologic therapy allowed

  * No prior thalidomide

Chemotherapy

* Prior chemotherapy allowed

  * No prior temozolomide

Endocrine therapy

* Concurrent steroids allowed

Radiotherapy

* Prior radiotherapy allowed

Surgery

* Prior surgery allowed

Other

* Concurrent antiseizure medications allowed
* No other concurrent investigational agents
Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

This trial is planned to collect relevant clinical data to evaluate the prevention efficacy and safety of Tangningtongluo tablets on the non-proliferation period of diabetic retinopathy.

After being informed about the study and potential risks,all patients giving written informed consent will undergo a 1-week screening period to eligibility for study entry.At week 0,patients who meet the eligibility requirements will be randomized into two groups(experimental group and control group)in a 1:1 ratio to Tangningtongluo tablets(4 tablets,tid,po.) or Calcium dobesilate capsules(1 capsule,tid,po.).

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with the diagnosis of type 2 diabetes.
* 2. Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
* 3. Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
* 4. Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
* 5. HbA1C ≤ 9%.
* 6. Age between 18 and 75 years old
* 7. Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP).

Exclusion Criteria:

* 1. Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy.
* 2. Patient who has been treated with full retinal laser photocoagulation.
* 3. Patient with difficulty in evaluating fundus images with refractive medium turbidity.
* 4. Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
* 5. Patient with other serious diabetes complications, such as diabetes gangrene.
* 6. Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
* 7. Female patient with pregnancy, or prepare for pregnancy, or lactating.
* 8. Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
* 9. Liver and renal function (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 x Upper limit of normal (ULN)and Cr\> above 1 x Upper limit of normal (ULN)). The diabetic nephropathy stage was 4 and above.
* 10. Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
* 11. Patient participated in other clinical researches within a month.
Metabolic Effects of Lac-Phe

The goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of Lac-Phe on appetite and glucose concentrations in healthy volunteers with obesity (BMI 28-35).

The main questions it aims to answer are:

* Does Lac-Phe reduce appetite in humans?
* Does Lac-Phe have glucose-lowering properties in humans?

During the study, participants will:

* receive an intravenous infusion of Lac-Phe on one study day and a NaCl infusion on another study day.
* drink a standard mixed meal
* eat an ad libitum meal test
* answer appetite questionnaires
* indirect calorimetry
* blood samples for hormone and substate analyses


Eligibility Criteria:
Inclusion Criteria:

* A body mass index (BMI) between 28-35 kg/m2
* Older than 18 years of age
* Hgb within a normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)
* Females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device).

Exclusion Criteria:

* Medications affecting glucose metabolism (e.g., Saxenda).
* Anemia
* Diabetes
* Ongoing cancer or other acute/chronic serious diseases (PI will determine)
* Inability to understand Danish or English
* Deemed unsuitable to participate by the PI and co-investigators.
Pilot Study on the Use of Hydrocortisone, Vitamin c and Tiamine in Patient With Sepsis and Septic Shock

Due to the high incidence, mortality and short and long term complications of sepsis and septic shock, it is necessary to look for strategies to try to minimize this impact.

Based on the current literature, we can affirm that the decrease in ascorbic acid levels in patients with sepsis and septic shock is directly proportional to the evolution to multiorgan failure and inversely proportional to survival. After assessing the safety in the administration of ascorbic acid as well as the decrease or almost abolition of its impact at the renal level after the association of thiamine, and the synergy provided by the administration of hydrocortisone, it is decided to implement the "Metabolic Resucitation Protocol" and assess its impact on our septic patients

Eligibility Criteria:
Inclusion Criteria:

* Patients\> 18 years of age with diagnosis of septic shock and multiorgan failure admitted to our Unit
* Entry into the ICU once diagnosed with sepsis and / or septic shock. The first 24 hours after admission to the ICU will be established as an inclusion limit
* Written informed consent.

Exclusion Criteria:

* Patients under 18
* Pregnancy
* Coexistence of other types of shock at admission
* Limitation of therapeutic effort or ICT (Conditional Intensive Therapy) upon admission to the ICU. It refers to patients in whom, prior to admission to the ICU, it was decided not to perform any or some of the usual treatment measures for sepsis, or in which a time limit is established in which in case of non-response they would withdraw intensive measures. This limitation will be indicated by your treating physician and if it exists, the patient would be excluded from the study.
* Patient with a history of previous intake of ascorbic acid, thiamine or corticosteroids in the month prior to admission to the ICU
* Patients considered immunodeficient (More than 10 mg of prednisone or its equivalent per day in the last 2 weeks, immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome).
Trial of JMKX003801 in Healthy Participants

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants


Eligibility Criteria:
Inclusion Criteria:

* The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol;
* Healthy adult males and/or females, 18 to 45 years of age;
* Body mass index (BMI) ≥ 19 and ≤ 28.0 (kg/m2) ,weight ≥45kg (female) or ≥50kg (male) .

Exclusion Criteria:

* Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, or any other diseases judged by investigators that will be interference to the results of this study;
* Use of any over-the-counter (OTC) medication, prescription medicine, Chinese herbal medicine , within 2 weeks prior to the time of informed consent signed;
* Pregnant or lactating women;
* Other conditions unsuitable for the trial judged by the investigators.
Community Interest in Vision Screening Technology

Virtual reality (VR) is a relatively new, emerging field within healthcare. Studies have analyzed public perceptions of virtual reality in healthcare using social media, but few have actually demonstrated and educated these modalities to communities. Because vision care can be costly and inaccessible, especially in communities with few physicians, this study aims to evaluate whether communities would be open to new technology. For example, it has been determined that 80% of vision loss is preventable with adequate screening technology, a key factor in ameliorating the economic and emotional burden of eye disease. Therefore, through demonstrations and educational presentations by medical students, gaps in understanding perceptions, willingness to adopt, and general demographics of those seeking better eye care will be understood.

This study is critical to show healthcare leaders that communities seek new, lower cost, and more accessible technologies for vision care. This study will also be used to expand use of the technology in other communities and prove a use case for it. Ultimately, this can help benefit communities to ensure that all are receiving proper vision care and to address common conditions in a timely manner.

If participants agree to participate, individuals will be educated about vision care and the use of virtual reality technology by a medical student or trained volunteer using a VR headset. This entire process will take about 5 minutes. Participants will be allowed to take breaks and medical students and/or volunteers will be nearby to answer any questions they may have throughout the study. There will be no results given to patients during the study nor will they be advised to use any information to inform future healthcare decisions. The purpose of the study is demonstrative.

After the demonstration, a survey will be given to each participant about their experience with the VR technology along with demographic information. This will be kept confidential and will only be accessed by those approved. The survey will take approximately 5 minutes. In addition, we will offer educational materials on the conditions that the vision tests are used to screen for.

Eligibility Criteria:
Inclusion Criteria:

* Males and females of any race
* At least 18 years of age
* Participants must be able to understand and provide verbal and written consent. Only participants who undergo the demonstration of the technology and consent to the study after full explanation will be included in research.

Exclusion Criteria:

- People who have undergone intraocular surgery less than six months ago, and potential contraindication for visual field test that include anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or another implantable device, severe vertigo or balance.