cyrilzakka/clinical-trials huggingface dataset:
Preventive Treatment of Episodic and Chronic Migraine

This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.

Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Migraine with or without aura or chronic migraine.
* Subject age 18 to 70.
* At least 2 migraine attacks per month.
* Willing ang able to give written informed consent.
* Willing and able to complete the entire course of the study and to comply with study instructions.
* Willing to taper and discontinue their current preventive medications.

Exclusion Criteria:

* Subject is pregnant, lactating or planning a pregnancy in the next year.
* Subject is female of child-bearing potential and not taking adequate forms of birth control.
* Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
* Previous failure of four or more adequate trials of preventive medication.
* Currently on any form of antidepressant for depression and not able to discontinue.
* Currently demonstrating medication overuse headache.
* Currently has uncontrolled narrow angle glaucoma.
* Currently taking monoamine oxidase inhibitors.
* Subject has a history of seizures.
* Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans

This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled "Transforming Prevention into Action" aimed at effectively engaging patients and their families to improve their health and medical care.

This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.

Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese. However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts. Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations. When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system. Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans. Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals. Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).

Eligibility Criteria:
Inclusion Criteria:

1. OEF/OIF/OND Veteran
2. Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system
3. Interested in starting a physical activity program in the next 30 days
4. Access to a computer with an internet connection and a working USB port.
5. A smartphone running a compatible iOS or Android operating system.
6. Younger than Age 65

Exclusion Criteria:

1. Veteran self-reports that a health care provider has told the patient that it is currently unsafe to exercise in an unsupervised or unmonitored setting. (Can become eligible with written medical clearance).
2. History of eating disorders or a BMI \< 20
3. Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.
Effect of the Auricular Acupunture of the Lower Limbs on the Equilibrium Response Evaluated by Static Stabilometry

By using a static stabilometry platform, the investigators believe the possible verification of the efficiency of auricular acupuncture points that correlates with regions of our body that may interfere with static equilibrium.

The present work aims to analyze the effect of the stimulation of atrial points of the lower limbs on the equilibrium response evaluated by static stabilometry.

Balance is an extremely relevant subject because of the large and increasing incidence of falls mainly in the elderly population. This leads to a significant social impact since falls can lead an elderly to increasing dependence on the family and can be the cause of depression and reduce their quality of life. Studies have already demonstrated the efficacy of acupuncture stimulation in the treatment of vertigo and also for the improvement of postural control. For this, the option of auricular acupuncture was chosen because it is a non-invasive and safe method. Thus, the objective of this study will be to analyze the effects of atrial stimulation of the lower limbs on the equilibrium response by static stabilometry. Participants in this study were 40 healthy individuals aged between 18 and 30 years who will be divided into two groups: GA (acupuncture group) (n = 20) and CG (control group) (n = 20). The acupuncture group will be stimulated unilaterally according to the motor preference side of each individual in the points referring to the three joints of the lower limb (knee and ankle hip). The control group will not receive stimulation. Balance evaluations will be performed before the stimuation (initial), 20 minutes after the initiation of the protocol (second evaluation) and 5 minutes after the second evaluation, with eyes open and closed. Participants will be positioned standing with their arms along their body, mouth closed not with force and parallel feet. Statistical analysis will be performed by means of a one-way analysis of variance (ANOVA) and the differences between the data will be evidenced by Holm Sidack's post-test. Values of p≤0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* 40 healthy individuals between the ages of 18 and 30

Exclusion Criteria:

* Disorders of the central nervous system
* Joint pathologies
* Peripheral neuropathies
Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain

Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.

Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.

Eligibility Criteria:
Inclusion criteria:

* Individuals between the ages of 18-65
* Individuals with low back pain for at least 3 months for the first group
* Not undergoing surgery related to the lumbar region
* Cases without lumbar steroid injection in the last 3 months
* Not having visual and hearing loss
* Having low back pain
* Cases without neurological problems
* Cases without tumor and infection in the lumbar region
* Exclusion criteria:
* Individuals under the age of 18
* Individuals with low back pain for less than 3 months for the first group
* Not having a musculoskeletal or neuromuscular disease that limits mobility,
The Feasibility of Early Time-Restricted Eating in a Student Population

This study proposes to investigate the effect of a self-selected early time-restricted eating window in University students.

There were over 2.3 million students registered at Higher Education institutes in the UK. Early adulthood is a critical time for establishing self-care habits which will ultimately influence health outcomes later in adulthood and studies suggest that the overall health of students is poor relative to that of their age-matched peers not in education. Therefore, the investigators would like to assess the feasibility of adopting a novel, nutritional intervention in this important, understudied population.

Previous research has shown Early Time-Restricted Eating can reduce daily energy consumed and improve markers of health over time, in a range of populations. Therefore, the investigators are investigating how often participants can eat within an early 8 hour eating window, starting no earlier than 8am (finishing calorie intake by 4pm), or no later than 10am (finishing calorie intake by 6pm). The investigators will be measuring how often the participants can adhere to this eating window between Monday to Friday, with the study lasting 4 weeks in total. This is a feasibility study, so this study will investigate whether this intervention is achievable and what social barriers may exist which reduce adherence to this eating window. Participants will visit the laboratory on 3 occasions (at the start, halfway point, and at the end of the intervention) to measure any changes in health markers across the intervention. The lab visits will involve providing a finger-tip blood sample, and measuring body mass, blood pressure, and waist-to-hip circumference. Outside of the laboratory, participants are required to record their eating window on a mobile app and an investigator-created trial sheet. Further measures outside of the laboratory will include a weekly questionnaire and motivational correspondence via mobile text message.

Eligibility Criteria:
Inclusion Criteria:

* Registered student

Exclusion Criteria:

* Not taking any medication which is known to affect appetite
Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)

In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.

The new coronavirus (COVID-19) \[1\] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. In the early clinical practice of treating severe H1N1, it was clinically concerned, and combined with conventional treatment, and achieved good results.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>=18 years;
2. Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
3. The patient himself participated in the study voluntarily, agreed and signed the informed consent.

Exclusion Criteria:

1. Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
2. Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
3. Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
4. Women who are breastfeeding or pregnant;
5. Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
6. Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
7. Patients who have participated in other drug clinical trials within 3 months before the screening test;
8. The investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)
Sexual Health Texting Intervention to Support Adolescent Females

This study aims to use a text messaging intervention to prevent unintended teen pregnancy and transmission of sexually transmitted disease. The study will be informed by a formative qualitative phase (February 2014 - January 2015) which will include individual qualitative interviews and focus groups with teens to elucidate and explore the barriers to effective contraceptive use and sexually transmitted disease (STD) prevention and to obtain feedback on the developed intervention. The second efficacy phase will randomize subjects to the texting intervention or to usual care.

Adolescents, particularly those from disadvantaged backgrounds, are disproportionally affected by both unintended pregnancies and STDs. While youth only represent a quarter of the sexually active population in the US, they account for almost half of all new STDs and the rate of unintended pregnancies among sexually active teens is almost double the rate of all sexually active women. Teen mothers experience higher rates of negative social outcomes including school dropout and children of teens are more likely to have low birth weight, lower academic achievement and more likely to perpetuate the cycle of teen pregnancy themselves. Both unintended pregnancies and STDs are much higher among racial/ethnic minority populations. Contraceptive methods considered most effective for pregnancy prevention do not protect against STDs and HIV transmission. Dual protection methods include being on an effective and consistent form of contraception and having an effective STD prevention method in place, preferably consistent condom use. Non-penetrative sexual practices can be substituted.

There are many barriers to providing sexual health education and services in the context of primary care visits. A recent study of pediatricians found that 61% of pediatricians reported discussing contraception, use of condoms and/or STDs with patients at preventive care visits. Most providers (76%), however, believed they did not have sufficient time to provide such counseling in the visit. The problems are even more acute in resource-limited safety net settings. Therefore, a two-tiered approach may prove to be useful, where providers initially address reproductive health issues in the visit but where additional support outside the visit provides additional information, support, motivation and connection to services. An innovative intervention using texting technology may prove to be a cost effective method of providing support between visits.

Eligibility Criteria:
Inclusion Criteria:

* biologically female;
* between 13 and 18 years of age;
* not currently pregnant or trying to become pregnant;
* have texting capability; and
* able to read/write/speak in English.

Exclusion Criteria:

* not meeting inclusion criteria outlined above
Cognitive Disorders in Hereditary Spastic Paraplegia Type 4

Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized.

Our primary objective is to describe a pattern of cognitive impairment in Hereditary Spastic Paraplegia type 4 using 18-FDG-PET metabolic imaging.

As secondary objectives, we wish to study the presence of correlations between neuropsychological tests, clinical examination, 18-FDG-PET data and general and genetic data of the pathology. We also wish to investigate correlations between genotype and phenotype.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age, living in the Grand Est region (France)
* Patient with a pathogenic or probably pathogenic variant (class 4 or 5) in the SPAST gene.

Exclusion Criteria:

* dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests.
The Seniors COvid-19 Pandemic and Exercise Study

The purpose of this study is to evaluate different types of exercise programs (virtual group-based exercise program; personal exercise program; wait-list control) across 12-weeks on the physical and mental health of older adults during the current Covid-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* 65+ years old
* be able to speak and read English
* one participant in the study per household (Spouses, significant others, or family members can take part in the exercise programs with the study participant; however, they will not be able to provide data and won't be remunerated for participating)
* not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
* participants must be able to access the internet at home via a personal smartphone, tablet (e.g., ipad), or computer (device used must have camera capabilities)
* low active individuals (i.e., less than 150 minutes of moderate-to-vigorous physical activity per week)
* currently living in Canada

Exclusion Criteria:

* age of less than 65 years
* unable to read and speak in English
* inability to participate in moderate-to-vigorous physical activity (including a lack of ability to receive doctor's clearance for participating in physical activity)
* lack of internet access which does not allow them to access online materials
* device used to access the internet does not have a camera/video capabilities
* active individuals (e.g., participate in greater than 150 minutes of moderate-to-vigorous physical activity each week)
* living outside Canada
* not the first person from a household to enroll in the study
Oxycodone Concentration in the Blood After Oral Premedication

Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy testpersons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg

Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy test-persons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg 20 female patients between 30 and 60 years will be included after informed consent. They will have day-surgery. The patients will receive 5 mg oxycodone if weighing less than 60 kg and 10 mg if weighing over 60 kg. Serum samples will be taken 1, 2,3,4, and 5 hours after medication intake and serum concentrations will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* Females \<100kg, non-opioid tolerant, day surgery and informed consent

Exclusion Criteria:

* In complying to inclusion criterias
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)

The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic, locally recurrent (local recurrence not amenable to surgical resection of curative intent), or locally advanced (T3 or T4, any N, M0) adenocarcinoma of the breast.
2. Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines
3. Initiating treatment with TmAb
4. Clinically measurable disease (by RECIST for patients with metastatic disease).

Exclusion Criteria:

1. Male gender.
2. Less than 18 years of age.
3. Life expectancy \< 12 weeks.
4. Only site of metastases is liver.
5. Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
6. Currently receiving PmAb or lapatinib for treatment of MBC.
7. Having received TmAb as adjuvant therapy within the previous 6 months.
8. Required to receive another radiopharmaceutical during the first week of the study.
9. Hypersensitivity to monoclonal antibodies.
10. Left Ventricular Ejection Fraction (LVEF) \< 50% at baseline (within 42 days of study registration) as determined by either echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) scan.
11. Hematology and/or biochemistry parameters outside acceptable ranges:

    * absolute neutrophil count \<1,500 cells/mm3,
    * platelet count \<100,000 cells/mm3,
    * hemoglobin \<9 g/dL,
    * total bilirubin \> upper limit of normal (ULN) (unless subject has documented Gilbert's Syndrome),
    * aspartate aminotransferase (AST) \[serum glutamic oxaloacetic transaminase(SGOT)\] and alanine aminotransferase (ALT) \[serum glutamic pyruvate transaminase(SGPT)\] \>2.5 × ULN,
    * serum creatinine \>2.0 mg/dL or 177 μmol/L,
    * alanine aminotransferase (ALP) \>2.5 x ULN.
12. Known pregnancy or lactating female (e.g. positive serum beta-human chorionic gonadotropin (B-hCG) pregnancy test).
13. For women of childbearing potential, failure to agree to use a highly effective form of contraception (patient and/or partner, e.g., surgical sterilization) or two effective forms of contraception (a reliable barrier method in conjunction with spermicidal jelly, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment.
14. Any condition, which in the investigator's opinion would not make the patient a suitable candidate for inclusion in the trial.
15. Participation in another clinical trial.
16. Inability to provide informed consent.