cyrilzakka/clinical-trials huggingface dataset:
HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 Trial

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥45 years;
2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
4. informed consent.

Exclusion Criteria:

1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
2. patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
3. patients with peri-prosthetic fracture, open fracture or bilateral fractures;
4. patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
5. patients with acute myocardial infarction deemed to be clinically unstable, with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;
6. patients refusing consent; or
7. patients previously enrolled in HIP ATTACK-2.
Effects of a Cocoa Shot on the Human Brain

The Hershey Company is interested in investigating the effects of various chocolate beverages on brain physiology and cognitive function. The main substances in the drinks that are known to influence the brain are caffeine (and related chemicals such as theobromine) and flavonoids. Flavonoids are chemical found in plants and are most commonly associated with antioxidant activity. Caffeine, chemicals related to caffeine, and flavonoids are all naturally occurring and all potentially alter brain physiology. This study will evaluate changes in brain blood flow and cognition following the consumption of drinks with various combinations of the Primary Ingredients. Caffeine is likely to have peak effects within 1-hour of ingesting the chocolate while the flavonoids are likely to have peak effects 3-4 hours after ingestion. The study proposed here will evaluate ingredients in a 4-arm cross-over double-blind design in an attempt to understand the differential effects of these compounds in chocolate drinks.


Eligibility Criteria:
Inclusion Criteria:

* Consume 200-600 mg caffeine daily
* Willing and capable of signing the informed consent
* Willing to attend 4 testing sessions that will take 4-6 hours each AND will be at least 7 days apart
* Willing to abstain from caffeine for 24 hours before each testing session
* Willing to and able to have MRIs

Exclusion Criteria:

* As determined from the medical screening session

  * active neurological dysfunction (such as a major Axis I psychopathology, Alzheimer's disease, Parkinson's disease, prior history of stroke, epilepsy, or serious central nervous system (CNS) trauma)
  * attention deficit hyperactivity disorder (ADHD)
  * migraines
  * hypertension
  * diabetes
  * peripheral vascular disease
  * taking vasoactive medications (such as anti-hypertensive medications)
  * depression that has not been on a stable medical treatment for at least 4 weeks
* Pregnancy
* Color blindness
* Allergy to chocolate, peanuts, tree nuts, egg, soy, mike, wheat
* Individuals who are or potentially may be cognitively or psychologically impaired, or who otherwise have a limited capacity to provide consent
Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD

Secondary Objectives:

* To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
* To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
* To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
* To collect safety data on study participants

Participants enrolled in the study will be followed for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
* Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index \[EASI\], Scoring of Atopic Dermatitis \[SCORAD\], body surface area \[of AD involvement\] \[BSA\], Patient-Oriented Eczema Measure \[POEM\], and Dermatology Life Quality Index \[DLQI\]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database
* Able to understand and complete study-related questionnaires
* Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable

Exclusion Criteria:

* Participants who have a contraindication to the drug according to the country-specific prescribing information label
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments
* Patients currently participating in any interventional clinical trial which modifies patient care
* Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of UC for at least 3 months prior to baseline
* Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
* Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
* Participants must, if female, meet the contraception requirements

Exclusion Criteria:

* Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
* Participants must not have had a previous colectomy
* Participants must not have current evidence of toxic megacolon
* Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
* Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Determining the Reproductive Health of Men Post-COVID-19 Infection

Study rationale

1. An increasing proportion of the worldwide population is being infected with COVID-19.
2. There are ongoing and currently unanswered safety concerns about the effects of COVID-19 on reproductive health.
3. It will be immensely reassuring to rapidly report that COVID-19 has no detectable effects on male endocrine or sperm function. Conversely, if COVID-19 does impair male reproductive health, appropriate screening can be performed in couples trying to conceive, and further research can be undertaken.
4. The proposed study will be simple, rapid, and authoritative for the UK and worldwide.

Male infertility results from impaired sperm function, and account for half of all infertility. Fertility services have been reported to cost £325M annually in the UK(4) (REF). Testosterone deficiency is one of the most common hormonal problems affecting men, leading to osteoporosis, type 2 diabetes, obesity and depression(5).

Concerns have been raised about the potential effects of COVID-19 on male reproductive dysfunction (male infertility and testosterone deficiency). A recent study has suggested that COVID-19 may enter human cells by binding to receptors (special gates on cells that recognise a specific molecule) for angiotensin converting enzyme 2 (ACE2)(6) . ACE2 receptors are found at very high levels in the testes. Within the testes, ACE2 is found on developing sperm, the 'nurse cells' that help the sperm grow (Sertoli cells), and also on Leydig cells which are needed to make the male sex hormone testosterone. In summary, this evidence suggests that there is a plausible link why COVID-19 would cause male infertility and testosterone deficiency.

All fertility treatment in the UK is regulated by the Human Fertility and Embryology Authority (HFEA). The HFEA has prohibited on all non-cancer fertility treatment in the UK between April 15th and May 12th 2020 due to the COVID-19 epidemic. It is important to rapidly screen and report whether COVID-19 has any obvious effects in causing male infertility and testosterone deficiency. It must be noted that a recent study(1) reported that COVID-19 is not spread by human semen and therefore, semen processing should not risk staff to COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Men 18-50 years of age
* Already attending hospital for another reason
* Low risk of prior COVID-19 infection(EITHER Negative positive COVID-19 PCR test result within last 4 weeks OR no history suggestive of COVID-19 illness)
* High risk of prior COVID-19 infection(EITHER Prior positive COVID-19 PCR test result OR history suggestive of COVID-19 illness)

Exclusion Criteria:

* Men with current symptoms of COVID-19 infection
* Men currently self-isolating as per UK government advice for COVID-19 infection
* Needle-phobia
* Impaired ability to provide full consent to take part in the study
* History of co-morbidity likely to affect male reproductive function e.g. undescended testes, removal of testes, testicular cancer, drugs such as corticosteroids or testosterone therapy.
Different Positive Pressure Strategies in COPD Patients.

Chronic obstructive pulmonary disease (COPD) is characterized by a poorly reversible airway obstruction and consequent systemic manifestations. Its high prevalence and high number of diagnosed patients has become a challenge for health services due to the costs of diagnosis and treatment of these patients. Positive pressure and aerosol therapy are preferred therapies for the management of COPD symptoms, but their effects when associated are poorly studied. The objective of this study is to compare the effects of different positive pressure strategies associated with aerosol therapy through Pulmonary Scintigraphy and Electrical Impedance Tomography (EIT) in patients with COPD in the intercrise period. This is a randomized, crossover, blinded and allocated crossover type clinical trial in which patients with moderate to severe COPD will be allocated to three intervention groups with different strategies for positive pressure associated with aerosol therapy: control group 1 nebulization), group 2 nebulization with EPAP valve and group 3 nebulization with NIV bi-level pressure mode. The radioaerosol deposition pattern will be evaluated through Pulmonary Scintigraphy and regional pulmonary ventilation through EIT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage II (moderate) and III (severe) COPD according to the guidelines of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion Criteria:

* unable to understand or perform procedures that present rheumatic or orthopedic diseases or deformities / abnormalities in the spine that compromise the mechanics of the respiratory system; respiratory comorbidities such as asthma, bronchiectasis and sequela of tuberculosis, cardiovascular and neurological comorbidities; hemodynamic instability defined as heart rate greater than 150 bpm, or systolic pressure less than 90 mmHg; hypertension (blood pressure\> 149/89 mmHg) or hypotension (blood pressure \<90/60 mmHg) at the time of collection; pregnancy or suspected pregnancy; and any contraindications for the use of PEP.
Botanical Oils Study to Determine Genetic Differences in the Way Your Body Processes Fats in Edible Oils

A randomized, controlled, cross-over clinical trial of borage oil vs soybean oil to determine whether the metabolism and/or impact of medium chain-polyunsaturated fatty acids (MC-PUFAs) in botanical oil supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism.

The study will be a randomized, controlled, cross-over clinical trial of borage oil and soybean oil to determine whether the metabolism and/or impact of MC-PUFAs in botanical oil supplements are changed in relationship to specific genotypes in a SNP (rs174537) strongly associated with FADS1 activity and PUFA metabolism. Subjects previously genotyped at rs174537 will be given supplements and both blood PUFA (serum and erythrocyte membranes), urinary eicosanoids and eicosanoid release from whole blood (leukocyte generation) will be measured as biochemical determinants of genotype impact on supplement metabolism.

To evaluate the effect of genotype at the rs174537 locus on the metabolism of MC-PUFAs in borage and soybean oil to long chain polyunsaturated fatty acids (LC-PUFAs), including arachidonic acid, the investigators will utilize a double blind, randomized, crossover design. There will be three study groups based on the genotype of the healthy volunteer at rs174537. Individuals within each genotype will be consented and screened up to 8 weeks prior to randomization and the start of the intervention. Subjects will be randomized to begin with 4 weeks of either borage oil or soybean oil followed by an 8 week washout period, and then another 4 week period in which they take the second oil. Study visits will occur at 0, 2, and 4 weeks during each oil supplementation period, in addition to the consenting visit, for a total of 7 visits during the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Must agree to adhere to dietary requirements during the entire study
* Be willing to participate for the whole study
* Be willing to not take PUFA supplements outside of those provided by the study
* Agree not to take interfering medications during the duration of the study
* Agree to allow samples to be stored for future use

Exclusion Criteria:

* May not have diabetes, cancer, heart attack or vascular surgery within the past year, be diagnosed with heart disease, have uncontrolled high blood pressure, history of stroke, atherosclerosis, asthma, multiple sclerosis or chronic joint disease
* Gallbladder removal or gallbladder disease
* Use of tobacco products within the last six months
* Pregnancy or lactation
* Fasting triglycerides greater than 150 mg/dl
* Blood pressure greater than 130/90
* BMI equal to or greater than 30 or less than 19
* Fasting glucose greater than 125 mg/dl
* Have liver function values in the normal range
* Taking greater than 100 mg aspirin/day
* Taking NSAIDS or oral corticosteroids
* Taking montelukast-type allergy medications
* Having a pacemaker or a defibrillator
* Taking lipid lowering medications
Sensitive Troponin I in Out-of-hospital Cardiac Arrest

Troponin is a major diagnostic criterion of acute myocardial infarction (AMI) which confirms myocardial damage and necrosis. In out-of-hospital cardiac arrest (OHCA) patients its dynamics and diagnostic value is often controversial and has not been well described. Most of prior studies were retrospective, using first generation troponin assays and assessing only admission troponin. The aim of this work is to correlate dynamics of sensitive troponin I with urgent coronary angiography.

Patients resuscitated after OHCA will be prospectively divided in three groups based on the results of their urgent angiographies. Serial assessment of sensitive troponin I will be obtained over initial 48 hours.

We expect admission troponin will not be predictive of AMI. Over next hours troponin levels will be highest in patients with acute coronary lesion, lower in stable obstructive coronary disease and insignificant in non-obstructive coronary disease. We also expect significant difference in highest values and dynamics of troponin in sub-group with spontaneous reperfusion (TIMI flow 2 and 3) comparing to patients with coronary occlusion (TIMI flow 0 and 1). In patients with non-obstructive disease we expect troponin levels to correlate with duration of cardiac arrest, number of external electric shocks and cumulative dose of adrenaline administered.


Eligibility Criteria:
Inclusion Criteria:

* female and male over 18 years old
* comatose survivors after out-of-hospital cardiac arrest (OHCA)
* absence of an obvious non-coronary cause
* urgent coronary angiography at admittance
* less than 3 hours from OHCA to first troponin assessment at admittance

Exclusion Criteria:

* sub-acute myocardial infarction
* coronary spasms or in-stent thrombosis within first 48 hours after admission
* Coronary surgery or death within first 48 hours after admission
Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants

This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.

This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.

The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

Eligibility Criteria:
Inclusion Criteria:

* Pre-op knee score of \<70
* Scheduled to undergo primary total knee replacement with any of the following indication:

  1. pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
  2. One or more compartments involved.
* Need to obtain pain relief and improve function
* Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
* A good nutritional state of the patient
* Full skeletal maturity of the patient, patients who are at least 18 years of age.
* Patients of either sex
* Consent form read, understood, and signed by patient

Exclusion Criteria:

* Pre-op knee score greater than or equal to 70
* Infection
* Osteomyelitis
* Previous partial or total prosthetic knee replacement on the operative side
* Skeletal immaturity of the patient, patients who are less than 18 years of age.
* Sepsis
* Uncooperative patient or patient with neurological disorders who are incapable of following directions
* Osteomalacia
* Distant foci of infections
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
* Incomplete or deficient soft tissue surrounding the knee
A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women

The purpose of this study is to examine the feasibility of recruiting and providing a behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.


Eligibility Criteria:
Inclusion Criteria:

* GDM in last pregnancy
* BMI 30-40
* Age 18-40
* 1-5 years since last pregnancy
* Non-smoking
* English or Spanish speaking
* Planning to have a baby but willing to use birth control during the 3 month weight loss program

Exclusion Criteria:

* 3 or more miscarriages
* History of infertility
* Type 1 or Type 2 diabetes
* Any weight loss since last pregnancy (based on last pre-pregnancy weight)
* History of major psychiatric illness, drug abuse, or unsafe dieting practices
* History of bariatric surgery, major medical conditions that prohibit physical activity or dietary intervention (MD consent may be required)
Fibrinogen Concentrate In Children After Cardiac Surgery

The purpose of this study is to evaluate prospectively whether concentrate fibrinogen reduces blood losses, transfusion requirements and occurrence of clinical complications compared to cryoprecipitate in children after cardiac surgery with pump.

Cardiac surgery in children may be associated with excessive perioperative bleeding. Perioperative excessive bleeding is associated with need of transfusion with allogeneic blood products such as red blood cells, fresh frozen plasma, platelet pools, and cryoprecipitate. Furthermore, bleeding may result in re-exploration, which is associated with increased morbidity and mortality.Recent studies have shown that patients and children undergoing cardiac surgery with pump often experience a significant drop in their levels and function of fibrinogen, and it would be in part responsible for the bleeding. In most centre world-wide, it is common practice to treat bleeding in these patients with cryoprecipitate in order to substitute fibrinogen. Fibrinogen concentrate (Haemocomplettan P)may reduce perioperative bleeding, requirements of blood transfusion and clinical outcomes in children undergoing cardiac surgery with pump, compared to cryoprecipitate.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery with pump
* Age until 18 years
* Written informed consent
* Clinically important bleeding in intraoperative
* Fibrinogen lower than 1 g/L or TEG \< 7 mm

Exclusion Criteria:

* Previous coagulopathy (clinical history or INR \> 1.5)
* Low platelet count (lower than 100.000)
* Product allergy
* Urgent procedures
* Active infection