cyrilzakka/clinical-trials huggingface dataset:
Acute Cycling on Executive Control

This study will examine whether 10-minute bouts of cycling at various intensities will impact executive functioning (i.e., cognitive ability) as assessed by the antisaccade (AS) task through a total of five visits. An antisaccade is a rapid eye movement away from a visual target. The ability to suppress making an eye movement towards a visual target gauges inhibitory control (i.e., a domain of executive functioning). In the initial visit, participants' exercise capacity will be assessed through a maximal effort cycling test. Intensities for the cycling bouts (i.e., high, moderate, low) in subsequent sessions will be based upon this maximal effort cycling test. In visits 2 through 5, participants will complete an AS task, followed by a 10-minute bout of cycling, and then complete the AS task again. The order of cycling intensities will be randomized between participants. Differences in the AS task (i.e., reaction time and accuracy) will be compared between and within cycling conditions.


Eligibility Criteria:
Inclusion Criteria:

* Able to read, write and understand English
* Full time student enrolled at Western University
* Able to perform a ten-minute exercise task at a light intensity without health implications
* Have email or phone number for contacting purposes

Exclusion Criteria:

* Do not have a medical condition that prevents you from exercise (e.g. heart attack in the past year, heart disease, irregular heartbeat, etc.)
* Do not have history of eye injury or neurological impairment
* Do not have an orthopaedic limitation
* Are not pregnant
Exercise and Diet Program for Schizophrenia Patients Who Are Taking Atypical Antipsychotic Medications

In this study the investigators will recruit patients with the diagnosis of schizophrenia that are taking atypical neuroleptics and that are willing to participate in an exercise and diet program. The investigators will measure weight and abdomen circumference.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* Atypical neuroleptics

Exclusion Criteria:

* Medical illness preventing exercise
Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections. As an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and C. acnes infection is not always obvious. Unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. Given high rates of positive C. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive C. acnes cultures for clinical decision making remains uncertain.

The purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder PJI with indolent organisms (C. acnes and CNS).


Eligibility Criteria:
Inclusion Criteria:

1. all patients undergoing single-stage revision arthroplasty with all implants exchanged,
2. all patients undergoing single-stage revision arthroplasty with some implants retained,
3. all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer

Exclusion Criteria:

1. patients with polymicrobial infection,
2. patients with infection by organisms other than P. acnes or Coagulase Negative Staphylococcus,
3. patients with clinical suspicion of infection but negative cultures,
4. patients with no preoperative or intraoperative signs of infection and only 1 positive culture.
Long-term Effect of TMS in Primary Progressive Aphasia

There are very few treatments for neurodegenerative disorders, and the efficacy of these treatments is generally modest. Recent studies have shown a short-term positive effect of non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) in primary progressive aphasia (PPA). PPA is a clinical syndrome associated with Alzheimer's disease and Frontotemporal degeneration. The aim of this study is to compare the effect of TMS and language therapy versus language therapy and sham TMS in patients with PPA during 6 months. A prospective, randomized, controlled, double-blind and parallel clinical trial will be conducted. The changes in brain metabolism using FDG-PET, language, neuropsychiatric symptoms, and daily-living activities will be assessed. Connectivity changes using electroencephalography will also be examined. In addition, a subgroup of patients will be assessed with multimodal MRI (structural and functional), and blood biomarkers. As a result of this project, valuable information about the long-term efficacy of non-invasive brain stimulation in PPA will be obtained, as well as the mechanisms of the therapy and clinical and neuroimaging factors associated with therapy response.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PPA (Gorno-Tempini et al. 2011 criteria supported by neuroimaging)
* CDR
* Language is the most prominent symptom

Exclusion Criteria:

* Clinical Dementia Rating scale \> 1
* History of epilepsy or epileptiform activity in EEG
* Another disorder causing aphasia
* Any contraindication for TMS
* Pregnancy
* Medical disorder with a life expectancy of less than one year
* Malignancy in the last two years
* Alcohol or drug abuse
* Major psychiatric disorder
* Inability to communicate (mutism)
* Use of anticonvulsants, benzodiazepines, donepezil/galantamine/rivastigmine, memantine, antidepressants and neuroleptics is permitted if they are at stable doses in the last three months.
Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children

The goal of the clinical trial study is to test the effect of the individual complex physiotherapy intervention program in the children actively playing soccer with flatfoot or valgus foot.

The aims are:

1. see if the medial longitudinal arch will by actively more higher after the intervention
2. see if the type of the foot will change toward more neutral type after the intervention
3. see if the transfer of the centre of body mass through the foot during the gait will directed in more neutral line after the intervention

The participants will undergo clinical assessment of short kinesiology assessment visually in underwear and barefoot. Then Participant will be tested for balance test in narrow stance with open and closed eyes, and single.leg stance with open eyes on the pressure mat. Finally, participant will walking in self-selected normal speed through the gait pressure mat. Eaxh procedure will be measured twice, before the program start and after the 4 weeks when the program finish. Researchers will compare these two measurement for the changes.

The aim of the study was to evaluate the effect of the neurophysiology-based (NB) intervention program in sporting children with foot problems. The NB intervention composed from evidence based and neurophysiology-based methods: 1) Janda´s sensorimotor stimulation, 2) Dynamic neuromuscular stabilisation concept (DNS), 3) Toe and foot muscle strengthening, 4) foot support base related exercises, and 5) somatic-sensory facilitation techniques. The proposed NB intervention lasted 4 weeks with each 45minutes long session twice a week. Each session was leaded by experienced physiotherapist in clinical practice gym, in one-to-one regime to ensure quality of the exercising, using progressive steps and some additional balance pads and small ball. The research assessments were conducted pre- and post-intervention (T0 and T4) and consisted of personal data and health questionnaires (name, date of the birth, laterality, shoe size, diseases, injuries and surgery), clinical examining (standing posture, core stabilisation function in supine position, foot posture index), laboratory testing (postural stability and normal walking on pressure mat). Data were edited, analysed and compared pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* age 9-10 years
* playing football at least for one year and train twice a week
* FPI above 5
* CSI above 45.1%

Exclusion Criteria:

* acute pain, injury
* injury of musculoskeletal system (past 6 months)
* infectious disease
* cardiovascular, metabolic, neurologic or orthopaedic diseases
* active wearing the orthotic devices or aids or barefoot shoes
* previous surgery on the lower limbs or pelvis
A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) properties of NN1250 (insulin degludec) in Japanese subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese subject aged 20-70 years (both inclusive)
* Japanese passport holder
* Japanese-born parents
* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Treated with insulin for at least 3 months
* Body Mass Index (BMI) maximum 33.0 kg/m\^2
* Glycosylated haemoglobin A1c (HbA1c) maximum 10.0%
* Fasting C-peptide below 1.0 nmol/L

Exclusion Criteria:

* Use of oral antidiabetic drugs (OADs) and/or glucagon like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
* Supine blood pressure at screening (after resting for 5 min) minimum 180 mmHg for systolic and/or minimum 100 mmHg for diastolic
Mood Lifters Online for Graduate Students and Young Professionals

Mood Lifters is a revolutionary mental wellness program that teaches scientifically validated strategies in a supportive group setting. This study will test two new versions of the program designed specifically for graduate students and young professionals.

Participants will need to attend 12 hour long virtual weekly meetings on Zoom that focus on helpful mental health strategies and skills. Participants will be encourage to practice what the participants learn at home in order to improve their mood or mental wellness. Additionally, participants will complete a series of measures (approx. 1-1.5 hours) prior to, at the end of the program, 1 month after the program and 6 months after the program.


Eligibility Criteria:
Inclusion Criteria:

* Participants ages 22-32 (must identify as either a graduate student or a young professional)

Exclusion Criteria:

* Active suicidality, mania, or psychosis
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female subjects 18 years of age and older
2. Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
3. Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
4. Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
5. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

1. Previous exposure to OTL38
2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
3. History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
4. History of allergy to any of the components of OTL38, including folic acid
5. A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
6. Clinically significant abnormalities on electrocardiogram (ECG) at screening.
7. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
8. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
9. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
10. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
11. Known sensitivity to fluorescent light
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.

To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced solid tumors；
2. At least one extracranial measurable lesion;
3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
5. Life expectancy≥3 months;
6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.

Exclusion Criteria:

1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
2. Subjects who have received previous drugs with the same target;
3. Subjects with active infections requiring systemic treatment;
4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
5. Subjects with uncontrolled or severe cardiovascular disease;
6. Severe lung disease;
7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
8. Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
9. Subjects who use or require long-term use of hormonotherapy before screening;
10. Subjects who have had other malignancies within the past 5 years;
11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
13. Abnormal virological examination during screening; History of immune deficiency;
14. Uncontrolled systemic diseases;
15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
17. Subjects with a history of severe allergy or known allergy to this product and its excipients;
18. Subjects who cannot follow the study protocol to complete the required study visit and dosing;
19. Subjects with a history of alcohol or drug abuse;
20. Lactating female patients;
21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator;
22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.

Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.

Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.

Concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.

The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass

Exclusion Criteria:

* history of cardiac surgery
* hematocrit \<33%
* platelet count \<100,000/ml
* allergy to tranexamic acid
* recruited in other studies
Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff

Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission occurs through droplets, with a R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2 months among hospital staff, without any supposed anti-Covid treatment 19.


Eligibility Criteria:
Inclusion Criteria:

* Army Training Hospital staff

Exclusion Criteria:

* Individuals who have already been confirmed Covid-19 positive
* Individuals taking preventive anti-Covid-19 therapy or considering participating in anti-Covid-19 therapy study
* Individuals on hydroxychloroquine
* Pregnant or breastfeeding women
* Non-permanent staff during the study period
* Individuals identified for a detachment outside the metropole during the study period
Uganda Birth Cohort Study

The UBC was a USAID-funded longitudinal prospective cohort study of pregnant women (n= 5030) aged 15-49 years from rural North and South-Western regions of Uganda, conducted between 2014 and 2016. The aim of the UBC study was to observationally follow pregnant women and their newborns until 2 years of age and compare changes over time in communities that were part of an ongoing USAID project called the Community Connector (CC) compared to those communities that were not included in the Community Connector project.

This study aimed to assess the role of livelihoods, agriculture and nutrition in improving maternal and child nutrition and health in rural Uganda in communities that were a part of an ongoing program that was un-related to the study. The overall aim of this study was to understand the effect of participating in an ongoing program that provided support on nutrition, agriculture, water, hygiene and sanitation and the change over time in the nutritional status of mothers and children under two years of age. The specific objectives of this observational study were as follows:

1. To compare health and nutrition status of pregnant women in communities participating in the Community Connector project to those that were not participating in the program
2. To assess the aflatoxin levels in pregnancy and test its association with birth outcomes and early life growth as measured by weight and length
3. To assess environmental enteropathy in pregnancy and test its association with birth outcomes and early life growth
4. To assess access to coverage and adherence to information/messages and engagement in Community Connector project's activities
5. To determine heterogeneity in program exposure and variability in household and agro-ecological characteristics and its relationship with maternal and infant health and nutrition status

Eligibility Criteria:
Inclusion criteria:

Inclusion into pregnancy surveillance:

* Participant is a woman aged 15-49 years
* Participant intends to reside in the study area through the enrollment period
* Participant provides informed consent herself or through a legal guardian

Inclusion into main study:

* Pregnancy is confirmed by urine pregnancy test
* Mother is aged 15-49 years
* Mother intends to reside in the study area through completion of follow-up
* Mother intends to deliver in the study area
* Mother provides informed consent (potentially as an emancipated minor)

Exclusion criteria:

-None