cyrilzakka/clinical-trials huggingface dataset:
A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

This study will assess the safety, tolerability and blood concentrations of lasmiditan and topiramate together compared to lasmiditan and topiramate separately. Information about any side effects that may occur will be collected.

Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start of the study and will remain through Day 14.

This study is expected to last approximately 25 days, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy males or females (of non-child bearing potential), as determined by medical history and physical examination
* Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

* Have known allergies to lasmiditan, topiramate, related compounds or any components of the formulation of lasmiditan or topiramate
* Have an abnormal supine blood pressure, defined as systolic blood pressure less than (\<) 90 or great (\>) 140 millimeters of mercury (mmHg) or diastolic blood pressure \<60 or \>90 mmHg at screening
* Have known or ongoing psychiatric disorders considered clinically significant by the investigator or demonstrate suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)
* Have a clinically significant abnormality in the neurological examination
* Have current or a history of orthostatic hypotension (\>20-mmHg drop in systolic blood pressure, or \>10-mmHg drop in diastolic blood pressure) with or without dizziness and/or syncope at screening or admission to the Clinical Research Unit (CRU) upon repeat testing
* Have an estimated glomerular filtration rate using Modification of Diet in Renal Disease \<60 milliliter per minute (mL/min) per 1.73 meter squared (m²)
* Have a history of glaucoma
* Have a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Bone and Inflammatory Outcomes - Nutrition and Exercise Trials

This study investigates whether dairy products will positively impact loading exercise-induced bone turnover and bone cell activity and/or the post-exercise inflammatory response in healthy young adults compared to a carbohydrate drink and/or water.

Introduction: Two million individuals at a cost of around 4.6 billion dollars a year in Canada suffer from osteoporosis. It is important to investigate strategies that can reduce bone loss and/or increase bone mass. Similarly, inflammation is associated with many different disease states, and investigating strategies to reduce systemic inflammation is prudent. Nutrition and exercise may be inexpensive and accessible strategies to improve bone health and inflammation and should be explored in different contexts and implemented. Our proposed research combines both nutrition and exercise along with the assessment of bone turnover and inflammatory markers in healthy young adults.

Design: Randomized controlled crossover trial

Participants: Healthy, university aged males and females.

Methods: During the study participants will complete 4 different acute exercise and nutritional supplement trials, in random order. The four trials are: 1) exercise+carbohydrate (CHO), 2) exercise+milk (Milk), 3) exercise+Greek yogurt (GY), and 4) exercise+water (W). The whole study will take a maximum of 16 weeks and each supplement trial will be separated by 2-4 weeks.

Outcomes: several markers of bone turnover and bone cell activity as well as markers of inflammation will be measured in the blood, before exercise and at different times post-exercise and post supplement consumption.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-30 years
* Normal BMI (18.5-24.9) kg/m\^2
* Low to moderately physically active (0-2 times/week)
* No allergy to dairy protein or lactose intolerance
* On no medication related to a chronic condition
* On birth control or naturally cycling with a regular menstrual cycle)

Exclusion Criteria:

* Regular smoker (cigarettes, e-cigarettes (e.g., vapes) or cannabis)
* Any chronic condition, inflammatory, or auto-immune condition
Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain

The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* nonspecific, chronic low back pain over 3 months
* Must have LBP of more than VAS 4

Exclusion Criteria:

* cancer, vertebral fracture, spinal infection, inflammatory spondylitis
* spinal operation
* radicular pain
* other musculoskeletal pain
* physicological or mental disorders
* allergic history to BV therapy or insect bite
Mother-infant Signalling During Breastfeeding

Primary hypotheses

1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)

Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.


Eligibility Criteria:
Inclusion Criteria:

Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of \>2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).

No current or recent involvement in other research studies that could potentially affect any of outcome measures.

Mother speaks and understands either English only or English and Malay (some questionnaires are in English)

Exclusion Criteria:

Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.

Mother smokes Mothers who do not exclusively breastfeed their infant

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Assisted Nerve Blocks

The study investigates assisted nerve blocks using an ultrasound machine.


Eligibility Criteria:
Inclusion Criteria:

* indication for nerve blocks

Exclusion Criteria:

* patient not able to provide the informed consent
* allergy to local anesthetics
Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a Multi-center Study

An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

This study aims to analyze the usefulness of rapid tests, especially: a) as a diagnostic test in people attending care for nonspecific, respiratory symptoms, in emergency services of referral hospitals b) as a diagnostic test in contacts of known patients. c) as a diagnostic test to differentiate influenza from COVID-19 in the circumstance of an overlap of both viruses in the community. d) In the 3 cases, the gold standard would be the RT-PCR test for influenza and for SARS-COV-2 performed in the usual laboratory following the officially approved technique in Mexico. If the test were in saliva, it would also be much more accepted and could come close to performing a test at home that would greatly facilitate the diagnosis. So it is important to see the performance of a saliva test.

As an observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Signed Informed consent
* Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.

Exclusion Criteria:

* Positive pregnancy test
* Lactation
* Decision of the responsible physician to remove patient from the study.
* Transfer of the patient to another hospital unit
Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery

The Study is a double-blinded, randomized, placebo-controlled trials. The Objective is to investigate the effect of single-high-dose glucocorticoid on surgical stress response and postoperative delirium among Elderly hip Fracture Patients undergoing surgery.

Patients with Hip Fracture are exposed for two traumas that can trigger a stress response. The first is the fall that causes the Fracture. The second is the surgery. In this study the intervention is dispensed early in the disease course - as soon as the Fracture has been diagnosed and booked for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for hip fracture
* Informed signed consent
* Danish speaking

Exclusion Criteria:

* Allergies towards contents of Solu-Medrol
* Insulin dependent diabetes
* Glaucoma
* In treatment for cancer disease
* Positive HIV, Hepatitis b or C status
* Lack of informed consent (eq. Severe dementia, coma, and others)
* Current treatment with systemic glucocorticoids (pr.os or intravenous) Immunoinflammatory disease (Except topical treated skin disease and respiratory disease)
* Current Immunosuppressive treatment
* Unable to participate in CAM-S measurement
* Peptic ulcera
Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy.

Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group

To evaluate and compare the swallowing and life quality swallowing on a group undergoing to speech pathology therapy (intervention) and a control group (no intervention).

Eligibility Criteria:
Inclusion Criteria:

* Head and neck squamous cell carcinoma
* Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy.
* Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable;
* 18 years old or older;
* informed consent signed before any specific procedure

Exclusion Criteria:

* Previous head and neck surgery
* Previous radiotherapy or chemotherapy
* Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma;
* Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy
* Patients with cognitive deficit which could not comprehend the speech pathology intervention.
Therapeutic Intervention Code in a Cognitive Geriatric Unit

The diagnostic and therapeutic progresses, associated with modifications in lifestyle and socio-cultural level of populations, have led to a remarkable increase in life expectancy. At the same time, the increasing medicalization of the individual has eroded the traditional boundaries between health and illness, normal and pathological state. This leads to the patient losing his sense of ownership of his own death. If most patients died at home before the Second World War, 75% of the population dies in hospital or institution at the present date.

Most hospitals and care institutions have developed codes, in multidisciplinary internal consultation, to address the interruption or lack of implementation of treatments that make no sense from a medical point of vue. This avoids therapeutic relentlessness.The code in place within the CHU Brugmann is:

* code A: no therapeutic restriction
* code B: not to be resuscitated
* code C: not to be intensively treated (no escalation in therapeutic treatments)
* code D: best palliative care (progressive de-escalation in therapeutic treatments).

These codes are established in consultation with the patient or his legal representative and are re-evaluated in a multidisciplinary way every week.

Planning a care path and therefore establishing a therapeutic code is particularly important for people with cognitive impairment and dementia because the progressive loss of cognitive abilities complicates the process of decision making.

A large part of the admissions are made via the emergency department. For these patients, no therapeutic plan has been established beforehand. However, the perception of the functional and cognitive status of the patient directly influences the intensity of care provided. Cognitive disorders are a risk factor for the exclusion of access to palliative care for the elderly patient.

The objectives of this study are:

* To establish a record of the therapeutic limitation codes in an acute cognitive geriatric unit
* To correlate the therapeutic limitation code with the comorbidities of the patients


Eligibility Criteria:
Inclusion Criteria:

Elderly patients with cognitive impairment admitted in the geriatric unit 83 within the CHU Brugmann between 01-01-2016 and 31-12-2016.

Exclusion Criteria:

None
Tailored Tobacco Quitline for Rural Veterans

The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:

1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.
2. Examine the impact of the intervention on tobacco use outcomes.
3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.

Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.

In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Eligibility Criteria:
Inclusion Criteria:

* Being a veteran
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VAMC or Coralville Clinic
* Live in a non-metropolitan area (based on RUCA codes)
* Be willing to make a quit attempt in the next 30 days
* Be capable of providing informed consent
* Have access to a telephone (land line or cell phone)
* Have a stable residence

Exclusion Criteria:

* Planning to move within the next 12 months
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized
This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years

This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.

This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years..

Part 2 of the study is open-label, Subjects completing 6 months of evaluations and study drug in Part 1 without serious study drug-related treatment emergent adverse events (TEAE) will be switched to INT131 1 mg PO QD and followed for an additional 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent before any study procedures
2. Male and female subjects aged 18-50
3. Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis
4. At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart

Exclusion Criteria:

1. Subjects with a history or presence of chronic disease of the immune system other than RRMS
2. Subjects with a diagnosis of primary or secondary progressive multiple sclerosis
3. Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults

The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.

The main questions it aims to answer are:

* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?
* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?

Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.

Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed.

Young, healthy, active men and women will ingest 30 grams of hydrolyzed collagen or a calorie matched beverage (maltodextrin) alongside vitamin C prior to performing high-intensity resistance training 2 - 3 times per week for 10 weeks.

The aim of this study is to investigate the effect of combining hydrolyzed collagen supplementation with resistance training in young men and women. If supplementation with hydrolyzed collagen leads to a greater change in tendon size, stiffness, and Young's modulus than resistance training alone, this will allow us to recommend this type of intervention to young athletes seeking to improve tendon health and/or athletic performance.

The experimental design and measurements will be the same in the Arm 1 and Arm 2 but the differences will be sex where participants in Arm 1 will be healthy young men while participants in Arm 2 will be healthy young women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young male or female
* No history of patellar tendon injuries in the past 6 months
* No history of lower limb musculoskeletal injuries in the past 6 months
* Non-smokers (including e-cigarettes)
* Free from cardiovascular and metabolic diseases
* Nullipara (a woman who has never given birth)

Exclusion Criteria:

* Age less than 18 years or higher than 40 years
* Being vegan or vegetarian (due to the mammalian source of collagen)
* Consumption of nutritional supplementation that purportedly affects muscle-tendon adaptation or recovery (i.e. protein powder, vitamin C, collagen)
* BMI over 30 kg/m2
* Previous anterior cruciate ligament injury where the patellar tendon was used as a graft