cyrilzakka/clinical-trials huggingface dataset:
Oral Versus Intravenous Tranexamic Acid

The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are:

Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing?

Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing?

Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).

Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon.

While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing.

In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total hip arthroplasty (THA) through a posterior approach
* Patients undergoing total knee arthroplasty (TKA)
* Patients between 18-80 years of age

Exclusion Criteria:

* Patients with \>80 years of age
* Patients with a BMI over 40
* Patients undergoing general anesthesia
* Patients with a history of major ipsilateral joint surgery
* Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)
* Patients with a history of bleeding disorders
* Patients with platelets less than 100/nl
* Patients with new-onset/active atrial fibrillation
* Patients with a history of myocardial infarction in the past year
* Patients with a history of a stroke in the past year
HA-WBRT vs SRS in Patients With Multiple Brain Metastases

This study compares the effectiveness and safety of two radiation treatment techniques for patients with multiple brain metastases.

For patients suffering from multiple brain metastases whole brain radiation therapy still constitutes a standard therapy. However, because of the risk of neurocognitive side effects as well as reduced local tumor control, employment of stereotactic radiosurgery (SRS) is becoming more common. The disadvantage of SRS alone may be poor intracranial tumor control because of frequent appearance of new distant brain metastases after therapy. In recent years hippocampal avoidance whole brain therapy has been shown to minimize treatment related side effects while reducing the rate of distant intracranial failure.

In this study patients will be randomized to receive either hippocampal avoidance whole brain radiation therapy with integrated tumor boost (HA-WBRT+SIB) or stereotactic radiosurgery. The investigators hypothesize that HA-WBRT+SIB can improve intracranial tumor control compared to stereotactic radiosurgery, while avoiding additional neurocognitive side effects.

Eligibility Criteria:
Inclusion Criteria:

* At least 4 and not exceeding 15 brain metastases not exceeding a combined total volume of 25ml and not previously treated with radiotherapy
* KPI ≥ 70, ECOG ≤ 2
* Age ≥ 18 years, Male or female

Exclusion Criteria:

* Neuroendocrine, SCLC, germinoma or lymphoma histology
* Brain stem metastasis
* Life expectancy \< 3 months
* Suspicion of meningeosis carcinomatosa
* Previous WBRT
* Inability to participate in radiologic follow-up, contraindication to MR imaging (e.g. not MRI compatible pacemaker, severe claustrophobia)
* Inability to participate in neurocognitive function testing, insufficient German language skills, aphasia, graphomotor impairment, insufficient vision, insufficient attention span
* Pregnancy, nursing or unwillingness to prevent pregnancy using effective methods of contraception during treatment
* Known abuse of medication, drugs or alcohol
* Known severe dementia (z-score \< 2) or major cognitive function disorder that is not caused by intracranial tumour
* Known clinical depression or psychotic disorder
Genetic Analysis of Thyrotoxic Periodic Paralysis

Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. This study, we aim to find the susceptibility genes that associate with TPP. Both candidate genes approach and genome wide association study have been conducted.

This study is a genetic association study. It included 50 cases of TPP patients and 80 cases of male, hyperthyroid patients who didn't have hypokalemia as a well characterized controls. After informed consent were obtained, genomic DNA from leukocyte were extracted. Pooled DNA were constructed and whole genome scan using 10K GeneChip microarray were genotyped on pooled genomic DNA.

Eligibility Criteria:
Inclusion Criteria:

TPP

* Hyperthyroid patients from any causes
* Evidence of hypokalemia (k\<3.5 mg/dl)from intracellular shift (Urine K\<15 mg/dl, TTKG\<2)
* Episodic paralysis

Exclusion Criteria:

* Hypokalemia from GI or renal loss
Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder

The purpose of this study is to increase knowledge and insights with regard to physical activity behavior in adolescents with Autism Spectrum Disorder.

Low levels of physical activity (PA) in adolescents with Autism Spectrum Disorder (ASD) increase the risk for both physical and mental health problems during adolescence and subsequent adulthood. To enable the identification of adolescents with ASD at risk for developing an inactive lifestyle and to inform the future design of high-quality, evidence-based and ASD-specific PA interventions and programs, several gaps of the current literature need to be addressed.

1. To date, no PA and cardiorespiratory fitness (CRF) tests have been validated in adolescents with ASD, causing an inability to accurately assess and interpret these two important health markers.
2. There is a lack of knowledge regarding PA correlates in this population, resulting in difficulties to identify adolescents with ASD at risk of developing an inactive lifestyle.
3. It is still unknown why adolescents with ASD are predominantly inactive and qualitative research of the perspectives of adolescents with ASD towards PA participation in order to understand their PA behavior is scant.

Therefore, the aims of this project with regard to adolescents with ASD are:

1. To examine the concurrent validity of two self-report PA instruments and the concurrent validity and test-retest reliability of a submaximal CRF test.
2. To determine potential complex and multiple (interactions between) correlates of PA, using a comprehensive assessment protocol.
3. To explore the perspectives of adolescents with ASD concerning the barriers and facilitators of PA participation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent
* ASD diagnosis according to the DSM-IV/5
* Proficient knowledge of Dutch

Exclusion Criteria:

* A physical disability hampering the administration of the standardized tests (e.g. unable to sit on a bicycle/perform a motor skill test in standing position)
* Participants with an intellectual disability (defined as an intelligence quotient \< 70)
* Participants with severe medical problems (e.g. severe metabolic disorders, oncological disease, diabetes), because of safety reasons
* Wave 1 participants only: the use of antipsychotics, because of safety reasons in the context of performing a maximal exercise test
* Participation in another clinical trial
* In case of pregnancy
Efficiency of the Imaging Strategy for the Management of Pneumonia

For patients with suspected pneumonia presenting to the emergency room, the imaging strategy most often involves a frontal and lateral chest x-ray despite poor diagnostic input. Indeed, the radiography is not very sensitive and specific for the diagnosis of pneumopathy compared to the scanner. However, the scanner remains the gold standard, the major constraint of which concerns the irradiation to which the patient is exposed. The new scanners allow ultra-low-dose scans with better sensitivity than standard radiography with an equivalent dose of radiation. In addition, the ultra-low-dose scanner helps prevent diagnostic errors and unintended treatments. A low-dose CT scan for suspected pneumonia has been possible in the Strasbourg emergency department since March 2019. The investigators therefore hypothesize that a diagnostic strategy involving the performance of a low dose CT scan in the event of suspicion of pneumopathy in the emergency room makes it possible to improve the adequacy of the diagnosis made by the initial imaging examination and the diagnosis on discharge from hospitalization, to reduce respiratory or hemodynamic complications and to reduce the prescription of antibiotic therapy that is not suitable for the patient. course of the imaging result validated by a panel of emergency physicians and infectious disease specialists based on medical records in accordance with the recommendations.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Emergency consultant subject with a final diagnosis of pneumonia, diagnostic code J18 and J15 with imaging: standard radiography or low dose scanner from 03/01/2019 to 02/29/2020
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Absence of emergency imaging
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Palliative Radiotherapy Protocol in Head and Neck Cancer

Phase II prospective study or Palliative Radiotherapy of 25 Gy in 5 fractions, Intensity Modulated, for frail patients with incurable head and neck cancer. Comprehensive Quality of life (QLQ-C30, head and neck module, QLQ C15 PAL) and toxicity data (CTCAE v 4.0) collected.

Patients deemed too frail for radical treatment or incurable because of tumour extension, as determined by an experienced tumour board, were eligible for this study of palliative radiotherapy delivered by intensity modulation, 25 Gy in 5 daily fractions over one week. This study was conducted in two academic centers.

Eligibility Criteria:
Inclusion Criteria:

* Able to give an informed consent
* Able to complete QOL questionnaires
* Deemed incurable by an experienced tumour board or unwilling to receive a radical course of radiation therapy
* Presence of measurable disease
* Biopsy proven squamous or salivary cancer of the head and neck region
* Expected survival of at least 2 months.

Exclusion Criteria:

* Pregnancy
* No previous RT to the neck and no plan to receive concomitant chemotherapy
* Special histology (Lymphoma, small cell cancer, metastasis from a site other than the head and neck region)
* Unavailable for follow-up
Influence of Preprandial Metformin Administration on Carbohydrate Absorption

Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption.

It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake.

To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI ≥30 kg/m2)
* Dysglycemia (HbA1c≥ 6,0 %)
* No anti diabetic medication

Exclusion Criteria:

* No obesity (BMI \< 30 kg/m2)
* No dysglycemia (HbA1c \<6,0%)
* Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)
* Anemia (Hb \<12 g/dL)
* Organ failure
* Inflammatory Bowel Disease
A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy

Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a CRT device \> 6 months previously according to current and conventional CRT indications
* Device optimization \> 1 months previously
* Aged 18yrs or older
* Able to attend outpatient follow up

Exclusion Criteria:

* Recent MI (\<2 months)
* Women who are pregnant or planning pregnancy
* Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
* Upgrade procedure is contraindicated for safety reasons.
* Class IV inotropic agents
* Patient unwilling to comply with required follow-up protocol including randomization scheme
Convalescent Plasma for Patients With COVID-19: A Pilot Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks.

The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Eligibility Criteria:
Inclusion Criteria:Fulfilling all the following criteria

1. Aged between 18 and 60 years, male or female.
2. Hospitalized participants with diagnosis for COVID 19 by Real Time - Polymerase Chain Reaction.
3. Without treatment.
4. Moderate cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)".
5. Confusion, Urea, Respiratory rate, Blood pressure-65 (CURB-65) \>= 2.
6. Sequential Organ Failure Assessment score (SOFA) \< 6.
7. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Patients with prior allergic reactions to transfusions.
3. Critical ill patients in intensive care units.
4. Patients with surgical procedures in the last 30 days.
5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).
6. HIV diagnosed patients with viral failure (detectable viral load\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).
7. Patients who have suspicion or evidence of coinfections.
8. End-stage chronic kidney disease (Glomerular Filtration Rate \<15 ml / min / 1.73 m2).
9. Child Pugh C stage liver cirrhosis.
10. High cardiac output diseases.
11. Autoimmune diseases or Immunoglobulin A nephropathy.
12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
Mi Band Step Challenge to Improve Body Composition in Overweight University Students

This is an eight-month research project using one group pretest-midst-posttest design. This study is based on self-efficacy and self-regulation of Social Cognitive Theory. The investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above at one university campus. Participation is completely voluntary. After pretesting, a 12-week "Mi Band Step Challenge" will be launched immediately. Participants will be assessed with the validated instruments of International Physical Activity Questionnaire (IPAQ)-Taiwan short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and self-regulation questionnaires. Mi Band activity trackers will be used to monitor step counts. An ioi 353 body composition analyzer will be used to assess body composition. Data will be analyzed using generalized estimating equation (GEE).

The expected outcomes of this study include: (1) "Mi Band Step Challenge" will be developed based on the theory, which is expected to be effective. If this is true, the intervention can be packaged and applied at different types of colleges and universities with overweight students. (2) "Mi Band Step Challenge" has the potential to be used for the reference of the healthy weight - physical activity, which is embedded in the School Health Promotion Program executed by the Ministry of Education. (3) The result of this study can serve as an example for the promotion of evidence-based health care.


Eligibility Criteria:
Inclusion Criteria:

* University students with a body mass index of 24 kg/m2 or above at one university campus.
* No physical limitations that would prevent them from performing physical activity.
* Not currently pregnant women.
* Having a smart phone that would allow them to connect to a Mi Band.

Exclusion Criteria:

* The university student who expects to be absent for more than 2 weeks or expects a suspension or transferring to another school during the implementation of the intervention.
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes

The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores （eat more, drink more and urinate more）, weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled.


Eligibility Criteria:
Inclusion Criteria:

* 10-18years ord Type 1 DM.
* Able to read and write Chinese.

Exclusion Criteria:

* Communication and cognitive impairments.
Weight Management for Improved Pregnancy Outcomes

This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Eligibility Criteria:
Inclusion Criteria:

* BMI 30 or more
* Less than 20 weeks gestation
* member of Kaiser Permanente Northwest (NW)
* receive pre-natal care at Kaiser Permanente NW
* speaks English

Exclusion Criteria:

* no current treatment for cancer
* no bariatric surgery
* no current renal disease
* no multiple birth anticipated
* no hyperemesis requiring hospitalization
* no diabetes (type 1 or 2)
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects

The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.

1. Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
2. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
3. Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Age 18-70 years
* For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period

Exclusion Criteria:

* Severe cardiac disease

  * History of myocardial infarction
  * Cardiac arrhythmia
* Previous stroke or cerebral haemorrhage and any other structural cerebral disease
* Active cancer or cancer diagnosis within the past five years
* Uraemia defined as s-creatinine above 3 times upper reference value
* Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval
* Epilepsy
* Use of antiepileptic drugs for any purposes
* Clinical important hearing impairment
* Use of active implantable medical device including

  * Pacemaker and Implantable Cardioverter Defibrillator (ICD-unit)
  * Cochlear implant
* Use of following drugs

  * Chemotherapeutic drugs of any kind
  * Methotrexate
  * Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
* Abuse of alcohol (defined as consumption of \> 250g alcohol (in Danish: 21 "genstande")) per week or abuse of any other neuro-active substances
* Infection at the site of device-implantation
* Any haemorrhagic disease
* Diving (snorkel diving allowed) or parachute jumping
* Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason
* Persons operating MRI scanners.
* Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military).
* Persons working at broadcast stations for television or FM/DAB radio.
* Persons performing extreme sport.