cyrilzakka/clinical-trials huggingface dataset:
Treatment Comparison for Undergraduate College Students With Traumatic Brain Injury

Up to 28% of undergraduate college students report a suspected history of traumatic brain injury. Following traumatic brain injury, college students fail and repeat more courses and have lower grade point averages. Further complicating this problem may be the fact that college students lack knowledge of traumatic brain injury definition, its associated symptoms, and individuals involved in post-injury management. In this project, the investigators propose to compare the use of an established treatment model (i.e., the Dynamic Coaching Model) to a novel protocol (i.e., the Apprenticeship Approach) that includes explicit instruction about traumatic brain injury in college students with this population. The investigators will use a group comparison design to examine the efficacy of this instructional component. This work incorporates findings from educational psychology and speech-language pathology (e.g., the included instructional materials adhere to the principles of adult learning). As such, this work will advance the field's basic understanding of currently recommended treatment components and will systematically examine the effects of incorporating explicit instruction into an existing treatment model.


Eligibility Criteria:
Inclusion Criteria:

* a documented history of mild, moderate, or severe traumatic brain injury no more than 36 months prior to study initiation
* speak English as a primary language
* at least 18 years of age
* demonstrate no barriers related to hearing, vision, reading, or technology that prevent successful experimental task completion.

Exclusion Criteria:

* no documented history of mild, moderate, or severe traumatic brain injury
* injury occurred more than 36 months prior to study initiation
* do not speak English as a primary language
* are not at least 18 years of age
* demonstrate barriers related to hearing, vision, reading, or technology that prevent successful experimental task completion.
Thermogenic Properties of Zantrex-3

Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of a combination of yerba mate, guarana, caffeine and damiana. The combination has previously been shown to decrease gastric emptying and its weight controlling effects may be related to increased satiety and thermogenesis.

Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic factors and subjective appetite sensations.

Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized, double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate (HR) and appetite ratings were assessed every half hour.


Eligibility Criteria:
Inclusion Criteria:

* Healthy,
* BMI: 23-30 kg/m2,
* Weight stable (within +/- 3 kg) two months prior to study inclusion,
* Non-smoking,
* Nonathletic (\< 10 h hard physical activity), \*The subjects followed a normal Danish habitual diet with rare use of hot spices

Exclusion Criteria:

* Change in smoking status,
* Daily or frequent use of medication,
* Suffering from metabolic diseases,
* Suffering from psychiatric diseases,
* Suffering from any other clinical condition, which would make the subject unfit to participate in the study,

  * use of dietary supplements or frequent use of medication
  * blood pressure above 160/90 mmHg
Safety and Efficacy of Daratumumab in Patients With Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Spectrum Disorders

The objectives of this time-to-event study are to assess the efficacy and safety of Daratumumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive. NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord, optic nerves, and area postrema. It is usually mediated by the pathogenic AQP4-IgG. Antibody-secreting cells (ASCs) have been recognized as essential sources of AQP4-IgG. CD38 is a glycoprotein that is highly expressed on ASCs. Daratumumab, a CD38-directed monoclonal antibody, has been shown to decrease the levels of autoantibodies in lupus, myasthenia gravis, or autoimmune encephalitis. This randomized controlled study aims to evaluate the therapeutic potential of daratumumab in NMOSD.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants ≥ 18 years old.
2. Diagnosis of NMO or NMOSD.
3. Anti-AQP4 antibody seropositive.
4. Historical relapse of at least 1 relapses in the last 12 months or 2 relapses in the last 24 months with at least 1 relapse in the 12 months prior to the screening.
5. Expanded Disability Status Scale score ≤ 7.5.
6. Patients must give written informed consent.

Exclusion Criteria:

1. Use of intravenous steroid pulse therapy or intravenous immunoglobulin or plasma exchange/adsorption within 3 weeks prior to Screening.
2. Use of tocilizumab, satralizumab, belimumab, ofatumumab within 1 months prior to Screening.
3. Patients treated with oral immunosuppressive agents other than steroids (e.g. azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclosporine in the 3 months prior to allocation.
4. Use of rituximab or inebilizumab within 6 months prior to Screening.
5. Patients infected with hepatitis B or C virus, or human immunodeficiency virus, or those having active infectious diseases.
6. Patients with a severe chronic infection or a history of recurrent infections.
7. Patients with a history of radiation treatment (whole body irradiation or lymphoid irradiation) or stem cell transplantation.
8. Patients who are pregnant or breast-feeding.
9. Patients who are participating in other clinical trials for NMOSD.
10. Patients diagnosed with cancer.
Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
* Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

* Cancer
* Medicines that suppress the immune system
* Dialysis
Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis

This study will help to determine the immediate and long term effects of Mulligan mobilization with and without myofascial release on pain, grip strength and function in patients with lateral epicondylitis

Tennis elbow patients usually experience diminished grip strength, decreased functional activities, and increased pain, all of which can have a significant impact on everyday activities. Tennis elbow can also be caused by excessive elbow use. The following is a description of the basic clinical manifestation of tennis elbow, as well as the most commonly reported symptoms of people suffering from the condition: Tennis elbow is easily identified and confirmed with a test that produces discomfort, palpable tenderness over the lateral epicondyle facet, resisted wrist extension, resisted middle finger extension, and passive wrist flexion. Tennis elbow is a common elbow disease caused by excessive use. Furthermore, despite some difficulty, the patient must be able to extend his or her wrist and middle finger. The goal of this study is to find out how Mulligan Mobilization with and without myofascial release affects pain, grip strength, and function in people with lateral epicondylitis in the short and long term.

Mulligan mobilisation and myofascial release have both been shown to be effective treatments for lateral epicondylitis. The purpose of this study is to look into the short-and long-term advantages of myofascial release and Mulligan mobilisation. No research has been conducted to evaluate whether mulligan mobilisation with or without myofascial release benefits people with lateral epicondylitis in terms of pain, grip strength, and overall function. This study will not only help therapists come up with treatment goals for lateral epicondylitis, also known as tennis elbow, but it will also add credibility to the existing body of literature.

Eligibility Criteria:
Inclusion Criteria:

1. Age group 20 years to 40 years ,both males and females
2. Diagnosed cases of lateral epicondylitis by senior physiotherapist
3. Acute and sub-acute cases
4. Numeric Pain Rating Scale 4 and above
5. Positive cozen test, Mills test, middle finger extension test

Exclusion Criteria:

* H/o

  1. Active medications.
  2. Dermatitis, malignancy or hazardous to myofascial release.
  3. Recent trauma, fracture
  4. Prior surgeries of elbow, tendon ruptures
  5. Any Neurological conditions like nerve compression
  6. Swelling around the elbow joint
Meta-analysis of Stannous Fluoride Dentifrice and the Effects on Dentine Hypersensitivity

The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.


Eligibility Criteria:
Subjects were excluded from this study for the following reasons;

* severe periodontitis
* at discretionary of the Principal Investigator
Dynamic Carbon Dioxide (CO2) Administration for Sleep Apnoea

Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA).

Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities.

As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing.

There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels.

We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month;
* An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive.

Exclusion Criteria:

* Pregnancy,
* Myocardial infarction,
* Unstable angina or cardiac surgery within the previous three months.
Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma

The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
3. No systematic treatments for neuroendocrine carcinoma are received before enrollment;
4. ECOG ≤ 2;
5. Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
6. Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
7. Have ability to sign a written informed consent.

Exclusion Criteria:

1. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
2. Previous use of HDAC inhibitors;
3. Allergy to related drug components;
4. Have a medical history of immune deficiency diseases, or organ transplantation;
5. Have uncontrolled or significant cardiovascular disease;
6. Abnormal liver function (total bilirubin \> 1.5×upper limit of normal); Transaminases (ALT/AST) \>2.5×upper limit of normal (\>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine \> 1.5×upper limit of normal);
7. Pregnancy ;
8. Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;
9. Any serious mental or cognitive disorder;
10. Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;
11. Any other condition which is inappropriate for the study in the opinion of the investigators.
Research of Automated Maculopathy Screening Based on AI Techniques Using OCT Images

The investigators expect to develop an algorithm that can interpret OCT images and automated determine whether the macula is normal or not by using OCT image-based deep learning techniques. And investigators wish to develop software applications that will help better screen and diagnose macular diseases in resource-limited areas.

The investigators will apply deep learning convolutional neural network by using ImageNet for an automated detection of multiple retinal diseases with OCT horizontal B-scans with a high-quality labeled database. Datasets, including training dataset, testing dataset and validation datasets, will be built by ophthalmologists of the First affiliated hospital of Nanjing Medical University according to the standardized annotation guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All patients attending the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University within 5 years and who received known, clear diagnoses with digital retinal imaging (including OCT, fundus digital photographs and fundus fluorescein angiography, at least with OCT images) as part of their routine clinical care, will be eligible for inclusion in this study.

Exclusion Criteria:

* Hardcopy examinations (i.e., photos of paper reports of OCT imaging performed at other hospitals) will be ineligible.
* Data from patients who have previously manually requested that their data should not be shared, even for research purposes in anonymised form, and have informed the Ophthalmology Department of the First Affiliated Hospital of Nanjing Medical University of this desire (even in previously conducted studies or other on-going studies in this hospital), will be excluded, and their data will not be upload to the cloud platform before research begins.
* Data from eyes tamponed with silicone oil or gas (i.e., C3F8) will be ineligible.
* Data with poor image quality, such as incomplete images, inverted images, blurred or cracked images and images with a very weak signal (i.e., vitreous haemorrhage), will be ineligible.
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* HbA1c maximum 10 % by central laboratory analysis
* Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination

Exclusion Criteria:

* Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
* Cardiovascular disease (CVD) defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to Visit 1
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
* Known or suspected hypersensitivity to trial products or related products
Emergency Ventilator Splitting Between Two or More Patients (COVID-19)

The purpose of this study is to develop a safe, easily scalable, and simple method to split a single ventilator for use amongst two or more patients, thus serving as a capacity bridge to save patient lives until manufacturers can produce enough ventilators.


Eligibility Criteria:
Inclusion Criteria:

* Phase I

  * Undergoing routine thoracic surgery which will include the use of a dual lumen endotracheal tube at Stanford.
* Phase II

  * Able to give consent
  * On venovenous extracorporeal membrane oxygenation for reason other than COVID-19
* Phase III

  * Able to give consent
  * Infected with COVID-19 and will likely require mechanical ventilation.

Exclusion Criteria:

* Phase I

  * Significant cardiac comorbidities
  * Liver disease
* Phase II

  * Significant cardiac comorbidities
  * Pre or Post-transplant patient
  * Infection with COVID-19
* Phase III

  * Co-infection with disease aside from COVID-19
  * Severely ill requiring high ventilator requirements and not stable for ventilator splitting
Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors During a Standardized Meal Test in Patients With Diabetes Mellitus Type 1 and Type 2

Measurement algorithm control and optimization with subsequent performance evaluation of Sanmina biosensors in monitoring of glucose, heart rate (HR), and SpO2 in patients with type 1 and type 2 diabetes during a standardized meal experiment.

* This study is a combined, open label, prospective, comparative single-center study.
* The study is separated in 3 consecutive study parts. The first 2 study parts include 12 patients each. In the third study part 36 patients will be enrolled. Study part 1 and 2 will be used for optimization and control of the measurement algorithms of the Sanmina biosensors. During the third study part with enrolment of 36 patients, the precision and accuracy of the final Sanmina biosensor algorithm will be demonstrated. The study conduct for all 60 participants of all 3 study parts will be exactly the same. In all groups of participants, the Sanmina finger clip and wearable non-invasive monitoring biosensor will be individually introduced and assigned. During the study visit at the study site, a standardized meal will be given to the participants. At eleven time points before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Sanmina finger clip and wearable non-invasive monitoring biosensor. The measurement time points are -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The measurements will be compared to capillary blood glucose measurements by YSI Stat 2300 and StatStrip (glucose), and parallel measurements of the heart rate and the pO2 using a patient monitor. Further the exact skin colour will be evaluated using a skin colour card.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetic subjects or healthy probands
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;
* Anatomically suitable finger in discretion of the investigator

Exclusion Criteria:

* Does not meet inclusion criteria;
* Any conditions that may hamper good visual contact between the finger or wrist and sensor, such as raised birthmarks, scars, tattoos;
* Pregnancy;
* Nursing mothers;
* Any skin scratch(es), damage, over dry, long nails on the measured finger;
* Unsuitable finger with the device might be excluded if recognized during the trial;
* Medication containing nitrates
Visual Stimulus Competition

In this study, we will use behavioral methods to investigate several types of interactions that occur when visual stimuli conflict, such as when objects are presented nearby to each other, or to separate eyes. We will target purely sensory aspects by using simple geometric shapes: letters and lines. Our outcome measure will be performance thresholds.

Participants will be shown visual stimuli on displays and be asked to identify some aspect of the stimuli: their orientation and/or color, the existence of binocular suppression, etc.

In different blocks, stimuli will be manipulated in different ways to characterize basic aspects of visual processing. For example, the contrast, color, and/or spatial layout of stimuli will be varied.

Eligibility Criteria:
Inclusion Criteria:

* Normal Vision
* English language

Exclusion Criteria:

* Less than 20/20 in either eye
* Vision-affecting abnormalities (amblyopia, keratoconus, etc.)
* Ortho-K lenses