cyrilzakka/clinical-trials huggingface dataset:
Twin Pregnancy Cohort

The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.

The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.


Eligibility Criteria:
Inclusion criteria:

* Pregnant women
* Delivery of a twin pregnancy
* Gestational age \>25 weeks
* Age \>18 years

Exclusion criteria:

* Singleton pregnancy
* Miscarriage
Nutritional Status and Quality of Life in Older Adults

The aim of this study is to determine the nutritional status, and factors affecting malnutrition in older people staying in hospitals.

Objectives:

* To recruit a sample of older people in hospital
* To collect information on nutritional status, satisfaction with food-related life and experience with access to food in hospital.
* To assess the staffing attitudes to nutritional care of the older adult
* To undertake an audit of therapeutic ('special') diets served in hospitals, with respect to their nutritional adequacy and wastage
* To investigate predictors and correlates of malnutrition within the hospital setting and compare these relationships with those previously identified in care homes and the community.
* To make recommendations for practice to improve the nutritional status of hospitalised older adults.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 75 years old
* Male or female
* Duration of stay is more than 24hrs
* Able to eat normally
* Able to read and write English
* Able to be weighed standing or sitting OR accurate weight available since admission

Exclusion Criteria:

* Age below 75 years old
* Newly admitted patient (less than 24hrs)
* Certain medical conditions likely to affect digestion/ absorption of nutrients (researchers will assess)
* Unable to provide informed written consent
* Patients on gastric surgical wards or suffering from gastritis
* Patients currently taking laxatives
* Unable to be weighed and no measured weight available (self report weight is not adequate)
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)

Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.

Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.

In spite of the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in hemorrhagic shock and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.

Based on encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with hemorrhagic shock will safely reduce secondary injury, and improve survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 18 yrs or \< 50 yrs
2. Blunt or penetrating trauma leading to presumed hemorrhagic shock
3. Pre-hospital or ED systolic blood pressure \< 90
4. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital or Baylor University Medical Center Emergency Department, Level I Trauma Centers in Dallas, Texas

Exclusion Criteria:

1. Those who would receive the study drug \> 120 minutes after the traumatic event
2. Time of injury is unknown
3. Known indication for IV estrogen
4. Known contraindication for estrogen
5. Estimated age \<18 or \> 50 years
6. Cardiopulmonary Resuscitation (CPR) prior to randomization
7. Known incarceration
8. Severe hypothermia (suspected T \< 28° C)
9. Drowning or asphyxia due to hanging
10. Burns total body surface area (TBSA) \> 20%
11. Isolated penetrating injury to the head
12. Known inclusion in another interventional trial related to this traumatic event prior to randomization
13. Known legal do not resuscitate (DNR) orders in place prior to randomization
14. Recognized spinal cord injury prior to study drug administration
Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty

Current measurement techniques of edema are not adapted or not convenient for assessment in the post surgical environment. Developement of a convenient, quick and reliable method could be useful to facilitate edema evaluation in this context.

Eligibility Criteria:
Inclusion Criteria:

* knee replacement surgery

Exclusion Criteria:

* pacemaker
* cardiac defibrillator
* other metallic implant than knee arthroplasty
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer

The purpose of this study has 2 aims:

Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.

Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.

Eligibility Criteria:
Inclusion Criteria:

1. Fluent in English or Spanish;
2. At high risk of developing colorectal cancer;
3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics
5. Access to either smart phone or computer; and
6. Currently physically inactive.

Exclusion Criteria:

Any criterion not met under inclusion.
Amygdala MRI-TIS for Depression

The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be aged between 18 and 65, with no gender restrictions;
* A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
* HAMD-17 score of 17 or higher;
* Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
* Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form.

Exclusion Criteria:

* Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy;
* Participants must not have a history of seizures or prior episodes of epilepsy;
* The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
* Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention;
* Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
* The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
* Pregnant or breastfeeding;
* Participants who are concurrently engaged in other clinical interventional trials;
* Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

To evaluate the outcome of a prednisolone and low dose methotrexate based protocol in Down syndrome children with ALL (DS-ALL) in an Asia-wide study. The treatment protocol was modified based upon backbone of Taiwan Pediatric Oncology Group (TPOG)-ALL protocol in which risk classification will be guided by level of flow minimal residual disease (MRD) instead.


Eligibility Criteria:
Inclusion Criteria:

* Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)
* Newly diagnosed ALL according to WHO 2016 classification.
* Age \< 21 years old at time of enrollment.
* ECOG performance status (PS) score of 0-2.
* Written informed consent obtained from legally acceptable representatives.

Exclusion Criteria:

* Second malignancy.
* Philadelphia positive ALL.
* Mature B-ALL.
* Mixed phenotype acute leukemia.
* Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (\< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study.
* Renal dysfunction with creatinine \>2x upper limit of normal (ULN). Patients whose creatinine has improved to \<2x ULN before treatment commencement can enrol subject to discretion of site PI.
* Liver dysfunction with direct bilirubin \> 5x ULN.
* Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:

  1. History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years.
  2. Ongoing uncontrolled hypertension.
  3. Ongoing uncontrolled diabetes mellitus.
  4. Ongoing uncontrolled infection.
  5. History of congenital or acquired immunodeficiency including HIV infection.
  6. History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.
  7. CNS hemorrhage.
  8. Psychiatric disorder.
  9. Other concurrent active neoplasms.
* Pregnant or lactating women.
* Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.
Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in COPD Patients

The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.

The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during effort, in COPD patients. However, the test need a 30m corridor.

The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows that 3MST can be used to determine oxygen desaturation.

The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and the 3MST.

50 patients will be included in this study.

Patients realize two 6MWT and two 3MST, with rest between each test.

Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are notified before and after each test, distance or number of steps are noted.

Eligibility Criteria:
Inclusion Criteria:

* stable COPD patients hospitalized for pulmonary rehabilitation program

Exclusion Criteria:

* acute exacerbation of COPD
* incapacity to realize the tests
* absence of written informed consent
A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1

This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.


Eligibility Criteria:
Inclusion Criteria:

The volunteer must satisfy all the following criteria to be eligible for the study:

* Men and women aged 18-50
* Resident in or near Oxford for the duration of the vaccination study
* Able and willing (in the Investigators' opinions) to comply with all study requirements
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
* Willingness to use effective contraception for 4 weeks from the date of vaccination
* Agreement to refrain from blood donation for 4 weeks from the date of vaccination
* Written informed consent

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

* Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
* Previous receipt of any recombinant adenoviral vectored vaccine
* Previous receipt of MVA-NP+M1
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
* Any history of anaphylaxis in reaction to vaccination
* History of cancer (except basal cell carcinoma and cervical carcinoma in situ)
* History of serious psychiatric condition
* Any chronic illness requiring ongoing or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening.
* Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
* Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)
* Pregnancy, lactation or willingness/intention to become pregnant during the study
* Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study.
* No response / confirmation from GP regarding previous medical history
Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors

To study the effects of green coffee supplement on adropin, irisin, vaspine, systemic inflammation and oxidative stress in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, adropin, irisin, vaspine, systemic inflammation and oxidative stress will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40 treatment is over

Exclusion Criteria:

* Taking any kind of supplement for weight reduction
* pregnancy or lactation
* Professional athletes
Sleep Quality Among Children And Adolescents With Type 1 Diabetes Mellitus

Sleep is an important health behavior for children and adolescents due to the impact it has on both mental and physical development. Although sleep is considered a resting period, it is also a period when the brain work to encode and consolidate memories into more stable representations for long term recall . Unfortunately, pediatric sleep disorders affect 25 - 40% of youth and several studies showed that children with chronic illness experience more problems with initiating and maintaining sleep than their non- chronically ill children .

Type 1 diabetes mellitus (T1DM) affects the quality of sleep in children and adolescents as well as their caregivers. Sleep disturbances in patients with T1DM may negatively impact their ability to manage their diabetes .


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 6 to 15 years .
* diagnosed with T1DM for at least 6 months
* attending the pediatric diabetes outpatient clinic at Sohag University Hospital.
* Age and sex matched control group for acute non-serious illnesses

Exclusion Criteria:

* Children and adolescents with associated neurological or psychiatric disorders .
Factor XIII in Major Burns Coagulation

Prospective observational study in which FXIII levels and coagulation tests and cicatrization are measured during the 30 days after the thermal trauma.

This is a prospective observational pilot study in which the levels of FXIII and coagulation, anticoagulation, fibrinolysis, endothelial tissue damage and cicatrization are at the arrival of the patient to hospital, 24 hours before the first surgical intervention, 24h After the first surgical intervention, at 7 days after the first intervention and at 30 days after the thermal trauma, in this moment the healing will also be evaluated. All burn patients who meet the proposed inclusion criteria will be included and entered into the Burn Unit of the Vall d'Hebron University Hospital from the start of the study until reaching a minimum of 20 cases or a temporary term of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Burned patients with a burned body surface of 20% or more
* Over 18 years of age

Exclusion Criteria:

* ABSI (Abbreviated Burns Severity Index) greater than or equal to 12
* Associated polytrauma
* Coagulation deficit previously known
* Treatment with anticoagulants
* Electrocution burns
* Admission into the unit after hour 6 after thermal trauma
* The refusal of the patient, familiar or responsible to participate in the study
Pharmacodynamic and Safety of MBA-P01 in Healthy Male Volunteers

To determine the pharmacodynamic and safety of MBA-P01 in Healthy Male Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Male adults aged between 20 and 45 years

Exclusion Criteria:

* Subjects not appropriate for participating in this study according to the investigator's opinion
Cereals and Intestinal Function

The aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.

In the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. Before and after intervention parameters of intestinal function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI \<25 kg/m2
* daily alcohol consumption \<20g (men) or \<10g (women)

Exclusion Criteria:

* food allergies or intolerances
* instable body weight
* BMI \<18,5 kg/m2 or \>25 kg/m2
* bariatric surgery within the last 5 years
* intake of antibiotics within the last month or during the study
* daily alcohol consumption \>20g (men) or \>10g (women)
* pregnancy and/or lactation period
* viral or bacterial infection during the last three weeks
* increased inflammatory markers of unknown reason
* chronic or acute disease of gastrointestinal tract
Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the Helicobacter pylori treatment.

This multicenter randomized controlled clinical trial was conducted to compare the eradication efficacy and health economic benefits of individualized regimens based on HP drug resistance mutation gene detection (multiple PCR method), individualized regimens based on HP traditional drug sensitivity testing (E-test method) and empirical regimens in the treatment of Helicobacter pylori in patients with chronic gastritis. This study will compare the efficacy of individualized and empirical drug sensitivity regimens, and conduct cost-effectiveness analysis to provide pharmacoeconomic guidance for clinical decision-making. At the same time, it will provide reference for the reasonable pricing of H.pylori drug sensitivity test and considering the health benefits brought by its inclusion in medical insurance.

Eligibility Criteria:
Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

Exclusion Criteria:

* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.