cyrilzakka/clinical-trials huggingface dataset:
Simultaneous Fluorodeoxyglucose Positron Emission Tomography (PET) and Magnetic Resonance (MR) in Visual Snow Syndrome

Visual snow syndrome (VSS) is a neurologic condition where patients experience tiny flickering dots in their entire visual field. It has been reported that the brain consumes more glucose in the lingual gyrus (a subdivision of the occipital cortex) and that this also shows increased volume of grey matter (neurons and supporting cells). In this study, the investigators apply fluor-18 fluorodeoxyglucose positron emission tomography with magnetic resonance imaging (18F-FDG PET/MR) in patients with VSS and compare this to healthy controls. Aside from an analysis in each brain volume element (voxel), the accuracy of classifying groups based on a volume-of-interest (VOI) analysis of both PET and MR is studied, Lastly, this is also compared to a visual assessment of the PET and MR images.

Aim : Prospective measurement of brain glucose metabolism and structural integrity in the brain of subjects with visual snow syndrome (VSS). Voxel-based and volume-of interest comparison to age matched healthy controls retrospectively obtained on the same simultaneous PET/MR imaging system.

Hypothesis : 1/ VSS patients show overactivation of parts of the visual system, in particular the lingual gyrus, which is likely related to larger volume of the gyrus on structural imaging. 2/ Discrimination of VSS patients versus controls can be done by visual read of FDG PET and/or volume-of-interest based discriminant analysis.

Methods : Recruitment through neurology practice specialised in VSS, detailed history taking and assessment of in/exclusion criteria, scanning with simultaneous18F-FDG PET/MR Signa GE Healthcare.

Analysis : visual assessment, group-based voxel and volume-of-interest based analysis (FDG PET, volumetry T1 MRI) with appropriate statistics and corrections for multiple regional comparisons. Discriminant analysis on VOI based data. Dual observer scoring of visual data and assessment of accuracy, sensitivity and specificity of visual image analysis compared to clinical final diagnosis.

Eligibility Criteria:
GROUP 1: VSS Patients

Inclusion Criteria:

* M/F, age 18-85,
* diagnosis of VSS by an experienced neurologist : dynamic, continuous, black and white tiny dots in the entire visual field lasting longer than 3 months, with at least two additional visual symptoms

Exclusion Criteria:

- other underlying neurological conditions inclusive ophthalmological examinations

GROUP 2 : Controls

Inclusion Criteria:

* age 18-85 years, M/F, in general healthy condition
* normal neurological examination, Mini-Mental State Examination (MMSE) ≥ 28, Beck's Depression Inventory (BDI) score ≤ 9, and a normal structural volumetric MRI.

Exclusion Criteria:

* history of major internal pathology, neurological and/or psychiatric disorders (including psychosis, depression, and anxiety),
* history of frequent migraine attacks, substance abuse or current use of any central acting medication
* first-degree relatives with dementia.
Fluoxetine as a Quit Smoking AID for Depression Prone

To test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improves the depression-prone smoker's ability to quit.

DESIGN NARRATIVE:

The research was a treatment-matching study to test whether adding fluoxetine pharmacotherapy to behavioral cessation treatment improved the depression-prone smoker's ability to quit. The investigators randomized 144 smokers with a prior history of depression and 206 smokers who lack such a history to a double-blind treatment with either 60 mg fluoxetine or placebo, while they underwent cognitive behavioral treatment to quit smoking. The main study outcome was biologically verified abstinence 6 months after treatment. The administration of placebo and fluoxetine began 3 weeks before the quit smoke date and continued for 2 months post-quit date (totaling 11 weeks on drug/placebo). Cognitive behavioral treatment were weekly before quitting and biweekly after quitting. There were monthly follow-up evaluations for six months after the quit date. The research tested both the Selective Benefit Hypothesis and the Generalized Benefit Hypothesis of fluoxetine's effects. The hypothesis of the mechanism of action was that the drug diminished compulsive smoking behavior, obsessional cigarette craving, and nicotine withdrawal dysphoria that occurred independently of depressive vulnerability.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
An estimated 144 smokers with a prior history of depression and 206 smokers who lacked such a history.
Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin

Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

A Randomized, open label, single dose, crossover phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

Eligibility Criteria:
Inclusion Criteria:

* A healthy adult within the range of 19 to 65 years old at the time of screening
* Body Mass Index(BMI)=17.5\~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)
* Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
* Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged
* The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the Institutional Review Board(IRB)-approved consent form signed by the parties in writing

Exclusion Criteria:

* One with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
* One with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
* Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 times the upper limit of the normal range
* Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
* Take part in other clinical trials within two months
* Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg
* The great history of alcohol or drug abuse within 1 year
* Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
* More than 20 cigarettes a day smoker
* Taking medication of a prescription drug or nonprescription within 10 days,
* Within two months the whole blood donation have, within one month of the apheresis donation have
* Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character
* Pregnant women and lactating mothers
* Described lifestyle in this protocol can comply with or can not
* One with other investigator judge to unsuitable
SHAPES: Supporting Multimorbid Older People

The Smart \& Healthy Ageing through People Engaging in Supportive Systems (SHAPES) Innovation Action is a Horizon 2020, EU-wide project looking at how technology can enable the older population to live healthier lives at home. It involves the development, piloting and deployment of a large scale, EU-standardised open platform. This platform will integrate with a wide-range of technological, organisational, clinical, educational and societal solutions seeking to facilitate long-term healthy and active aging.

Within this project are 7 pilot themes investigating various potential uses of the platform, in Northern Ireland we are leading on medicines control and optimisation.

This pilot is focused on identifying, managing and improving deficiencies in adherence to medicines and treatments of older individuals living with permanent or temporary reduced functions or capabilities due to chronic, age-related illnesses and living at home. Digital Solutions (including blood pressure monitors, pulse oximeters, weight scales and glucometers) will be used to enable self-monitoring of the individual's physiological parameters. Data will also be used to develop an algorithm to help predict decompensations in participants with heart failure and dynamic personal ranges will also be developed. In the future this may enable early opportunities to adjust medicines and treatments so as to deliver safer and more effective use of medicines in-home, however, in this pilot there will be no changes to treatment.

The target population is composed of older individuals (+65 years) living at home with heart failure and/or diabetes. We aim to recruit 30 people (for 3 months) to our pilot in Northern Ireland. We are working closely with colleagues in Spain, Czech Republic, Cyprus and Germany to run similar pilots within their healthcare systems.


Eligibility Criteria:
Inclusion Criteria:

* Northern Health and Social Care Trust service user
* ≥60 years
* Diagnosed with heart failure and/or diabetes mellitus (treatment includes regular self-monitoring of blood glucose)
* Lives at home or in supported living accommodation (category 1 or 2).

  * Category 1 - self-contained accommodation for the more active elderly, which may include an element of scheme supervisor support and/or additional communal facilities
  * Category 2 - scheme supervisor supported self-contained accommodation for the less active elderly, which includes the full range of communal facilities
* Has stable self-reported Wi-Fi connection at home
* Has access to an appropriate android smartphone or tablet
* Android device running version 8 or above; supports Wi-Fi; supports BLE; front facing camera for facial recognition
* Self-reported stable disease state, the participant feels well enough to take part in the pilot
* Self-reported confident user of smartphone/tablet

Exclusion Criteria:

* Participant report of cognitive impairment
* Wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)
A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

This 2 arm study will compare the resection rate of liver metastases and safety of surgery in patients with metastatic colorectal cancer and primarily unresectable liver metastases receiving treatment with Avastin in combination with 5-FU, leucovorin and oxaliplatin with irinotecan (FOLFOXIRI) or without irinotecan (mFOLFOX-6) as first line treatment. Patients will be randomized to receive Avastin (5mg/kg iv every 2 weeks) in combination with each of these two standard neoadjuvant chemotherapy regimens. The anticipated time on study treatment is until surgery, disease progression, unacceptable toxicity or patient refusal, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* unresectable liver metastasis secondary to cancer of colon or rectum;
* scheduled for standard first line chemotherapy;
* ECOG performance score of 0 or 1;
* condition feasible for major abdominal surgery after first line treatment.

Exclusion Criteria:

* diagnosis of metastatic disease \>3 months prior to study entry;
* evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of celiac lymph nodes;
* prior systemic or local treatment of metastatic disease;
* prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to study entry;
* history or evidence of CNS disease unrelated to cancer.
Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?

Nitrous oxide (commonly known as 'laughing gas') is often used during dental and other outpatient procedures, because it is easy to administer, is short-acting and rapidly clears from the body following the procedure.

The investigators hypothesize that use of Nitrous oxide during GI endoscopy may enhance patient comfort during the procedure and speed-up post-procedure recovery, while minimizing the fatigue and mental fogginess some patients report the day after receiving standard sedative and narcotic drugs used routinely for the procedure.

The investigators are interested in determining if adding Nitrous Oxide to commonly used sedation drugs will decrease fatigue, mental fogginess, and nausea/vomiting, as well as determine when the patient felt fully recovered from the effects of all sedatives given for the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant patients age 18 and older
* Patient's presenting for upper endoscopy or colonoscopy under endoscopist- directed nurse sedation.
* Patient is willing and able to consent and comply with study procedures.

Exclusion Criteria:

* Age \<18
* Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
* Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
* Allergy to the proposed anesthetic agents (e.g. nitrous oxide, midazolam, fentanyl, diphenhydramine)
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy

Background: Stress is the critical method for survive of reacting to a condition including a threat, challenge or physical and psychological challenge. Stress either physiological or biological is an organism's response to a stressor such as an environmental condition. Stimuli that alter an organism's environment are responded to by multiple systems in the body. The hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system are major systems which the body reacts to the stress. It has been reported that cancer patients receiving chemotherapy perceived a lot of stress. It has been believed and well known that stress-related illness is one of the reasons contributing to the increase in long-term sick leave during the last decade in many countries.

Purpose: The aims of this study are to evaluate the effects of aromatherapy on cancer patient receiving chemotherapy: 1) for physical effects by meridian electrical conductance, heart rate variability (HRV), vital sign, visual analogue scale (VAS) for pain; 2) for psychologic effects by State-Trait Anxiety Inventory (STAI).

Materials and methods: This is a prospective, pre post comparison study. A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. The characteristics data will be collected in all participants. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes. Meridian electrical conductance, HRV, vital sign, VAS for pain, and STAI were evaluated and compared before and after aromatherapy.

Expected outcomes: It is expected to understand more about the effects of aromatherapy on the meridian system, HRV and emotional status by undertaking 30 minutes session aromatherapy intervention for cancer patients receiving chemotherapy. The results may suggest aromatherapy as one of the affiliated programs of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients in chemotherapy
* Subjects who are aged from 20 to 70 years-old

Exclusion Criteria:

* Subjects who are unable to read and sign the consent form
* diagnosed with a major illness (such as acute myocardial infarction, stroke, paralysis, and major organ transplantation)
* being pregnant
Audio Data Collection for Identification and Classification of Coughing

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1, 3, 4 and 5:

* Females and males over 18 years old
* Willing to share demographic data with the sponsor of the study
* Willing to follow app use instructions during the course of the study
* Willing to complete survey instruments as described in study procedures
* Willing to provide electronic informed consent
* Able to read and understand the English language well enough to complete electronic informed consent

Cohort 2:

Any person present in the vicinity of a HealthMode Cough Monitoring Device

Exclusion Criteria:

No exclusion criteria

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Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained \>400m 6MWD preoperatively, twice as many of \<400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.

The investigators propose a randomized controlled trial of nutrition prehabilitation alone vs nutrition prehabilitation with supportive exercise in patients with malnutrition and 6MWD \<400m before elective colorectal surgery. The primary objective, and therapeutic target, will be achievement of minimal clinical important difference for the 6MWD (14m for within group comparisons and 19m between groups). Ability to adhere to the interventions will be monitored. The findings of this study will guide optimal treatment for this vulnerable population by exploring the role of nutrition alone vs. nutrition with exercise to optimize surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older;
* Patients with cancer scheduled for primary colorectal resection;
* Patients with 6MWD at baseline less than 400 m;
* Patients with Patient-Generated Subjective-Global Assessment (malnutrition assessment) score equal or greater than 9.

Exclusion Criteria:

* Patients with history of premorbid conditions that contraindicate exercise including dementia, -Parkinson's disease or previous stroke with paresis;
* Metastatic cancer;
* Patients who do not speak English or French and cannot be accompanied by someone who speaks English or French;
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD)
* Central foveal thickness (CFT) of \> 250 microns as assessed by OCT (see below)
* Diagnosis of retinal vein occlusion in the past 9 months
* Age over 50 years

Exclusion Criteria:

* History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit
* Inability to make study visits
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
* Pregnancy or lactation
* Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset
* Any intravitreal injections within 12 weeks of study onset
* Prior retinal vein occlusion
* History of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset
* History of cerebrovascular event or myocardial infarction within 3 months of study onset
The Development and Evaluation of a Single Session Intervention for Parent Distress Tolerance

The purpose of this study is to study different ways to help parents cope with strong emotions. The study team will be looking at how two different treatments help parents learn to manage strong emotions. These treatments are one session and are completed online, without a therapist, like an online training or class.


Eligibility Criteria:
Inclusion Criteria:

* Live in the United States.
* Parent of a child aged 6-17 years old who has received at least one counseling or mental health treatment session from a provider in the last 6 months will be eligible to participate.
* Parent is not currently receiving psychotherapy or counseling for a mental health concern (or received such in the past six months).
* Parent reported poor distress tolerance (DT). Poor DT will be defined as a score of less than 54 on the Distress Tolerance Scale.
* Due to language limitations of the primary researcher, parents will be eligible if they comfortably speak and read in English.
* Parents must have a mobile device (e.g., laptop, tablet, smart phone, etc.) or desktop computer and internet access sufficient for the delivery of the study assessments and intervention online.

Exclusion Criteria:

* Failure to meet any of the inclusion criteria.
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease

This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points

Exclusion Criteria:

* Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
* Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.