cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study on the Timing of Multiple Sclerosis (MS) Symptoms

The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (RR-MS) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.

Fluctuations in MS symptoms in women with RR-MS might be affected by a variety of factors. To determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. After an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. Compensation ($10 gift card) is sent after each monthly diary is received. The diary includes a list of symptoms and a rank scale for the women to show subtle changes in MS symptoms. The calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. We anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* females
* diagnosed with relapsing-remitting multiple sclerosis

Exclusion Criteria:

* male
* no diagnosis of relapsing-remitting MS
* diagnosis of any other autoimmune disease or fibromyalgia
* peri-, post-, or surgically menopausal
* pregnant within past year or nursing
* history of chemotherapy
* on experimental medications
* treatment with steroids in the last 30 days
Bioavailability of Prochlorperazine Suppositories, 25 mg

The purpose of this study is to compare prochlorperazine plasma concentrations produced after administration of the test formulation with those produced after administration of a marketed reference product.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by lack of clinically significant abnormalities in health assessment performed at screening

Exclusion Criteria:

* Positive test results for HIV or Hepatitis B or C
* History of allergy or sensitivity to Prochlorperazine or related drugs
Using VR to Assess the Efficacy of a Motivational Interviewing Intervention to Increase Bystander Behaviors

With the present project, we will a evaluate a new, motivational interviewing (MI) intervention for increasing bystander behaviors to prevent sexual violence. In the intervention, motivational interviewing will be used to build each participant's unique motivation for engaging in bystander intervention behaviors. To assess the efficacy of the intervention, we will utilize the Bystanders in Sexual Assault Virtual Environments (B-SAVE), a virtual reality measure of bystander behaviors, along with self-report measures examining relevant bystander behaviors and attitudes. We will also examine key moderators of intervention efficacy to provide valuable knowledge (e.g., whom the intervention is most effective for) for further tailoring of the intervention.

This study will provide a comprehensive examination of Motivate-The-Bystander and provide information about whom the intervention is most effective for. Specifically, at T1, participants will be randomly assigned to the MTB condition, a motivational interviewing intervention designed to increase participants' bystander intervention behaviors, or an assessment only control condition. All participants will complete a battery of self-report measures, including our three proposed moderators (gender, alcohol use, and rape myth acceptance). Participants assigned to the MTB condition will also engage in a motivational interviewing intervention designed to build each participant's unique motivation for engaging in bystander intervention behaviors. Approximately two months later, at T2, participants will complete a battery of self-report measures assessing their bystander behaviors and attitudes over the past two months. Then, all participants will complete the B-SAVE, where they provide open ended verbal responses to a series of sexually risky and non-risky interactive scenes they witness in the virtual environment.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-25, English speaking

Exclusion Criteria:

* Non English speaking.
Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline

The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain plasticity, physiological biomarkers and behavioral outcomes, including cognitive and physical functions, from pre- to post-training; (2) understand the neural mechanisms of cognitive recovery following two hybrid interventions using the functional magnetic resonance imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to identify the correlations between brain activity, biomarkers and behavioral measures.

Cognitive decline after stroke is highly associated with functional disability. Empirical evidence shows that exercise combined cognitive training may induce neuroplastic changes that modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive trainings can facilitate cortical activity and physiological outcome measures and further influence on the cognitive function after stroke. We aim to investigate the effects of two hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind randomized controlled trial. A target sample size of 75 participants will be recruited. Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training, dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60 min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes in functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers, cognitive functions, physical function, daily functions and quality of life.

This study may differentiate the effects of two hybridized trainings on cognitive function and health-related conditions and detect appropriate neurological and physiological indices to predict training effects. This study capitalizes on the groundwork for non-pharmacological intervention of cognitive decline after stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke occurring at least 6 months prior to enrollment
2. Age range from 20 to 80 years
3. MMSE score \< 28 or MoCA\<25
4. Able to follow the study instruction
5. Adequate cardiopulmonary function to perform aerobic exercise
6. Able to walk with or without assistive devices

Exclusion Criteria:

1. Unstable medical history (e.g., recent myocardial infarction) that might limit participation
2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis)
3. Current participation in another interventional trial
4. Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers, et al)
5. Pregnant woman
DS-5565 Phase III Study for Post-herpetic Neuralgia

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

\[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo.

\[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.

Eligibility Criteria:
Inclusion Criteria:

* PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening
* At screening, a pain scale of ≥ 40 mm

Exclusion Criteria:

* Previous use of neurolytic block
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)

The study evaluates the combination of immunotherapy of PD-1 antibody and chemotherapy and neoadjuvant short-course radiotherapy in locally advanced colon cancer (LACC). Patients are randomly assigned into two prospective groups: treatment group and observerment group. In treatment group, a total of 60 patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the surgery. In observerment group: a total of 60 patients will receive 4 cycles of CAPOX chemotherapy, then receive the surgery. The rate of pathologic complete response （pCR）, long-term prognosis and adverse effects will be analyzed.

This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy，to compare the efficacy of neoadjuvant short-course radiotherapy combined with CapOX chemotherapy and PD-1 immunotherapy in locally advanced colon cancer. We will consecutively enrolled patients who were diagnosed with locally advanced colon cancer with T4 stage or bulky nodes. A total of 120 patients will be Randomized 1:1 to the treatment group and observerment group. In observerment group, patients will receive 4 cycles of CAPOX (Capecitabine: 1000mg/m2 d1-14 q3w; Oxaliplatin: 130mg/m2 d1 q3w)chemotherapy, then receive the surgery, followed by 4 cycles of CAPOX. In treatment group, patients will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOXand PD-1 antibody(Serplulimab,300mg d1 q3w), then receive the surgery,followed by 4 cycles of CAPOX.

Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmed adenocarcinoma
2. clinical stage T4 and/or bulky nodes
3. the distance from anal verge more than 15 cm
4. without distance metastases
5. age \>=18 years old, female and male
6. KPS \>=70
7. without previous anti-cancer therapy or immunotherapy
8. with good compliance
9. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
6. allergic to any component of the therapy
Continuous Infusion of Remidazolam for Colonoscopic Polypectomy in Elderly Patients

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy.

To observe the sedative effect of continuous infusion of remidazolam in elderly patients undergoing colonoscopic polypectomy, and to screen the optimal dose of remidazolam, in order to provide a more reasonable and safe sedative and analgesic drug regimen for elderly outpatients undergoing colonoscopic polypectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 years old;
* ASA Level I - III;
* Operation time: 15min\~1h;
* BMI18.0-29.9；

Exclusion Criteria:

* Emergency surgery;
* Patients with high risk of gastric satiety and reflux aspiration;
* Allergies to benzodiazepines and opioids;
* Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
* Abnormal liver and kidney function;
* Previous drug use history;
* Recently participated in other clinical studies;
* Patients who cannot cooperate with communication.
Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.

The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .

Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Non-specific LBP for at least three months
* Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale

Exclusion Criteria:

* Pregnancy;
* Any contraindication to ACP or having undergone treatment in the previous six months
* Having undergone spinal surgery in the previous six months;
* Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
* Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);
Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion

This study will test the central hypothesis that postmenopausal women will demonstrate increased oxygen extraction in active leg muscle during leg cycling exercise while receiving an infusion of Esmolol, a fast-acting β1 selective antagonist, when compared to premenopausal women

This study will test the central hypothesis that postmenopausal women will demonstrate increased oxygen extraction in active leg muscle during leg cycling exercise while receiving an infusion of Esmolol, a fast-acting β1 selective antagonist, when compared to premenopausal women. β1 selective antagonists (or "β1 blockers") are used to lower heart rate and improve O2 supply-to-demand balance in patients with coronary artery disease. By using esmolol to attenuate the central sympathetic response to exercise (increased heart rate and cardiac output) we can examine peripheral mechanisms of O2 delivery. The current project will evaluate how older postmenopausal women adjust active muscle O2 supply to an acute reduction in systemic O2 delivery during large muscle dynamic exercise when compared to younger premenopausal women.

Eligibility Criteria:
3.1 Inclusion Criteria

1. Capable of giving informed consent
2. Premenopausal women ages 18-35 years OR post-menopausal women ages 55-70 years
3. Satisfactory medical history and physical exam, as determined by a CRC clinician
4. Not currently taking medications affecting heart rate or contractility
5. Fluent in written and spoken English

3.2 Exclusion Criteria

Participants who will not be studied are those who:

1. Are less than 19 years of age or more than 70 years of age
2. Are pregnant or lactating
3. Are prisoners or institutionalized individuals or unable to consent
4. Diagnosed renal failure (Creatinine \>2.0 mg/dl)
5. Diagnosed liver disease (ALT and AST 2 times normal)
6. Diagnosed Reynaud's disease
7. Have uncontrolled diabetes
8. Have uncontrolled hypertension
9. Have a left ventricular ejection fraction \< 40%
10. Have a recent history of unstable angina or myocardial infarction (\<6 months), unstable angina, or use of nitrate medications within past 2 weeks

10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers) 11. Diagnosed bleeding or clotting disorder or recent blood transfusion 12. Have asthma, history of thyroid issues or hyperkalemia 13. Known use of recreational drugs 14. Methylphenidate use
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections

The objective of this study is to determine whether there is a relationship between interferon-gamma levels and the incidence of viral respiratory infections in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care (nasal steroids, antihistamines) over a 1-year period. The hypotheses to be tested are 1) interferon-gamma levels will be significantly increased 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care, 2) the incidence of viral respiratory infections will be reduced at 3, 6, 9 and 12 months in allergic children treated with allergy immunotherapy as compared to those treated with standard medical care.

This study will consist of five visits. Visit 1 will occur after subjects complete an initial clinical evaluation for allergy at this site. Subjects will select their treatment (allergy immunotherapy as compared to standard medical care) prior to enrollment in this study.

Visit 1 will include informed consent, review of inclusion and exclusion criteria and phlebotomy for the determination of serum interferon-gamma levels. At the end of this visit, diary cards to capture the frequency of symptoms of viral respiratory infections will be distributed. Visits 2-5 will occur 3, 6, 9 and 12 months after visit 1 and will include review/exchange of diary cards, and phlebotomy for determination of serial serum interferon-gamma levels.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years of age
* History of allergic rhinitis as confirmed by previous allergy skin testing conducted within the past year
* Subjects assigned to the allergy immunotherapy must be prescribed therapy according to national recommendations using FDA-approved allergy extracts supplied by Greer Laboratories

Exclusion Criteria:

* Concurrent difficult to control asthma or an underlying immune deficiency
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study B

This is a prospective, non-randomized, longitudinal study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.

Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. This sub-study involved the assessment of the placement of the ShapeMatch® Cutting Guides intraoperatively and post-operatively. An assessment of post-operative patient outcomes compared to pre-operative status was also analysed.

Protocol Attached in documentation.

Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or non-pregnant female between the ages of 50-90.
* The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
* The patient has a primary diagnosis of osteoarthritis (OA).
* The patient has intact collateral ligaments.
* The patient is able to undergo MRI scanning of the affected limb.
* The patient has signed the study specific, HREC-approved, Informed Consent document.
* The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria:

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* The patient has had a high tibial osteotomy or femoral osteotomy.
* The patient is morbidly obese (BMI ≥ 40).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
* The patient has a fixed flexion deformity ≥ 15°.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* The patient has a cognitive impairment, an intellectual disability or a mental illness.
* The patient is pregnant.
* The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
* The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Relation Among Shear Stress Distribution, Stent Design, and Subsequent Vessel Healing After Drug-eluting Stent Implantation (SHEAR DES)

The purpose of this study is to evaluate the differences of wall shear stress distribution among different types of drug-eluting stents and its impact on vessel healing evaluated by intravascular optical coherence tomography evaluation.

Background: Distribution of wall shear stress (WSS) may be different according to stent designs. The impact of WSS after stent implantation may impact future vessel healing after current generation drug-eluting stents implantation. Although previous studies used IVUS (intravascular ultrasound) and angiography to determine WSS from computational fluid dynamics (CFD) simulations, new methods using higher resolution OCT (optical coherence tomography) are warranted to further evaluate the impact of stent design on WSS with current generation drug-eluting stents.

Methods: For these purpose, we will enroll a total of 30 patients with stable angina who are scheduled for percutaneous coronary intervention. Those patients were randomized to thin-strut (81μm) 2-link Promus element (PE: n=10), thin-strut (81μm) 3-link Xience Prime (XP: n=10), or thick-strut (145μm) 2-link Nobori stents (NO: n=10) and underwent OCT and coronary CT angiography (CTA) after stenting. Post stent WSS was calculated using CFD simulations based on patient-specific reconstructed 3D arteries created by the fusion of OCT and CTA data, normalized using WSS in the proximal unstented region. Also, follow-up angiography and OCT are performed for the assessment of vessel healing as well as WSS distribution 8months after stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old.
* Indication of PCI with Xience prime, Nobori, or Promus element.
* Clinical diagnosis of stable angina, unstable angina or silent ischemia with reference vessel diameters ranging from 2.5-3.5mm.
* Underwent CT angiography before PCI.
* To agree to review and record all the clinical course in this research protocol.

Exclusion Criteria:

* Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
* Low ejection fraction (LVEF\<=30%), an impaired liver function, and renal dysfunction (eGFR\<=40)
* Severe calcification
* Stent restenosis
Dietary Inorganic Nitrate and the Enteral Microbiome

A growing body of data shows that the enteral microbiome has an effect on cardiovascular diseases. Exogenous inorganic dietary nitrate mediates cardioprotective effects and has been shown to have an influence on the oral microbiome. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet.

Whether dietary nitrate influences the enteral microbiome and downstream metabolites like short-chain fatty acids (SCFA) and TMAO will be investigated in the present study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 years
* no regular medication intake
* no chronic diseases

Exclusion Criteria:

* Regular systemic drug intake
* Active smoking
* Chronic diseases
* Acute diarrhea or vomiting
* Short gut syndrome
* Pregnancy or breastfeeding