cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Erector Spinae Plane Blocks

The purpose of this study is to determine the feasibility of using the ultrasound-guided erector spinae plane blocks to provide additional pain relief to patients with rib fractures in the Emergency Department (ED) and Intensive Care Unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older.
* Patients with one or more acute traumatic rib fractures.

Exclusion Criteria:

* Inability to position appropriately.
* Unconscious or heavily sedated.
* Patients who are critically ill such that care should not be delayed for regional anesthesia.
* Patients under the age of 18 years old.
* Vulnerable populations including prison inmates and pregnant patients.
* Overlying skin infection, wound, or dressing/equipment (i.e., Chest tube).
* Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
* Known or documented allergy to ropivacaine or other amide local anesthetic.
First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults


Eligibility Criteria:
Key inclusion Criteria:

* Signed informed consent
* Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
* Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
* Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
* Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
* Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively

Key exclusion Criteria:

* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations


Eligibility Criteria:
* Genders eligible for Study: Both
* Age: between 18 and 55 years
* Healthy volunteers are accepted

Inclusion Criteria:

* Subjects tested positive for HIV-1 infection (HIV-infected subjects).
* Subjects that are tested negative for HIV (Healthy subjects).
* Either on stable antiretroviral therapy or not on antiretroviral therapy.
* CD4 cells \> = 200 - 750/µl.
* Subjects must be in good general health except for HIV infection.
* Women must not be pregnant and use an acceptable method of contraception.

Exclusion Criteria:

* Impairment of immunologic function (other than HIV infection).
* History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure.
* Uncontrolled serious infection.
* History of or active autoimmune disease.
* History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
* History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years.
* High risk of developing a myocardial infarction or coronary death.
* History of intravenous drug abuse (within the last 12 months).
* Known allergy to egg or aminoglycoside (gentamicin).
* History of anaphylaxis or severe allergic reaction.
* Subjects undergoing treatment for tuberculosis infection or disease.
* Chronic administration of systemic immuno-suppressants.
Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:

  * SCC
  * BCC
  * Lentigo maligna melanoma (Dubreuilh melanoma)
  * Carcinosarcoma
* Acceptable tumor locations include the following:

  * Skin (facial, scalp, extremities, torso)
  * Lips
  * Eyelids
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form

Exclusion Criteria:

* Subject has a tumor with histology of one of the following:

  * Keratoacanthoma
  * Merkel cell carcinoma
  * Sarcoma other than carcinosarcoma
* Metastatic disease (according to the TNM staging system - M1 patients are excluded)
* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.
Goat or Cow Milk Based Infant Formula GMS

This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
2. Infants with a birth weight of \>2500 g to \<4500 g
3. Infants ≤11 days of age at enrollment; birth constitutes Day 0
4. Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study

Exclusion Criteria:

A participant who meets any of the following criteria will be excluded from participation in the study:

1. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
2. Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
3. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
4. Infant that has received oral or parenteral antibiotics prior to enrollment
5. Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:

   1. Solid foods and juices
   2. Vitamins and/mineral supplements, as the study product provided is nutritionally complete
   3. Pre- and probiotics
6. Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
7. Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.

The comparison of two lipid emulsion product will be performed. Patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. If the patient needs total parenteral nutrition (TPN) treatment after surgery for at least 5 days and meets all criteria, then he/she will be enrolled and randomized to ether of the groups, SMOFlipid or Lipovenoes MCT. During the treatment period, efficacy variables and safety variables will be measured. Life quality evaluation will also be performed through questionnaires collection.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25 \~ 75 years old
2. Postoperative (gastrectomy) patients required parental nutrition for at least 5 days
3. Signed informed consent form

Exclusion Criteria:

1. Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
2. Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is \>2.26 mmol/l (\>200 mg/dl) the subject must not be included
3. Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
4. Severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as S-creatinine value of \>3mg/dL (250 µmol/l), or dialysis/hemofiltration therapy
5. Over weight (BMI\> 30kg/m2)
6. Severe blood coagulation disorders
7. Inborn abnormality in amino acid metabolism
8. Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
9. Known diabetic ketoacidosis 7 days prior to randomization.
10. Acute shock
11. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
12. Pregnancy or lactation
13. Chemotherapy within 7 days before start of the trial
14. Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study
15. Already accept parental nutrition therapy.
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine

This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent provided by the participant
2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
3. Willing to receive influenza vaccination
4. Older cohort has received their influenza vaccine for the previous influenza season

   -

Exclusion Criteria:

1. Immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily)
2. Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
3. Participant has received a community available influenza vaccine for the approaching influenza season
4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

   -
Physical Activity and Fatigue in Myasthenia Gravis

Danish patients with myasthenia gravis are asked to answer a validated and international questionnaire about physical activity. Also background questions about their disease and comorbidity are asked. To validate the data about physical activity from the questionnaires 69 patients are asked to wear an accelerometer for 7 days to measure activity level.

Secure digital mails are sent to around1500 patients qua their civil registration number (CPR number) (each resident of Denmark has a permanent unique civil registration number that is provided at birth or immigration to Denmark). The mail contains a link for the software REDCap (© 2018 Vanderbilt University), recommended by Rigshospitalet. REDcap is a secure web application for building and managing online surveys and databases. Patients are, in REDcap, informed about the project, and if interested, asked to sign the included informed content and answer six validated and translated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Danish resident.
* Alive.
* Minimum age 18 years.
* Registered in the Danish Patient Register with diagnosis code 70.0 (ICD-10) or 733.09 (ICD 8).
* Subscribing E-boks (the Danish system for receiving secure digital emails).

Exclusion Criteria:

* I fulfilling the inclusion criteria, then no exclusion criteria
Postacute Sarcopenia: Supplementation With β-hydroxyMethylbutyrate After Resistance Training

A randomized, double-blind, placebo-controlled, parallel study to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance. Treatments compared will be β-hydroxymethylbutyrate (β-HMB) with a resistance training program or placebo with a resistance training program.

Sarcopenia is a geriatric syndrome characterized by the loss of skeletal muscle mass and strength that occurs with advancing age; it is related to frailty, falls, worsening quality of life, and death in chronic and elderly patients. Diagnosis of sarcopenia is based on clinical criteria: presence of low muscle mass and the presence of low muscle function and/or low physical performance. The latest developments indicate that dietary supplementation combined with resistance exercise could be an option to improve muscle mass and function.

The objective of the study is to assess the effects of β-hydroxymethylbutyrate (β-HMB) combined with a resistance training program, after an acute process in older patients with sarcopenia in terms of muscle mass, muscle strength and physical performance.

Design: A randomized, double-blind, placebo-controlled, parallel study with two intervention groups. The investigators shall compare placebo against an intervention with β-HMB in patients performing a resistance training program after an acute process (post-acute period) during 12 weeks. There will be 16 patients in each arm of the study. Additionally a one year follow up visit will be performed.

Eligibility Criteria:
Inclusion Criteria:

* male or female ≥60 years old
* sarcopenia diagnosis and case-finding criteria following European Working Group On Sarcopenia in Older People (EWGSOP)
* being discharged from post-acute care geriatric unit for rehabilitation treatment
* ambulatory prior to the recent acute process
* cognitive situation that let them to understand and follow an active physical rehabilitation program (Mini-Mental Status Examination ≥21/30)
* voluntary participation and being able and willing to provide an informed consent

Exclusion Criteria:

* potential participants will be excluded if they have active malignancy (exception basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix)
* major lower limb surgery over the past 6 months (knee or hip arthroplasty)
* contraindication for resistance training
* performed regular exercise in the last 6 months
* use of any medications interfering with the nutritional intervention
* serious clinical conditions that compromises and endanger the patient's life
* contraindication, intolerance or allergy to β-hydroxymethylbutyrate
Genotype and Phenotype Registry: Enrollment of Normal Control Subjects for Current and Future Research

Registry program for volunteers who are willing to serve as control subjects in future research studies.

The registry is a collection of volunteers willing to participate as control subjects in research studies. Control subjects are people who do not have a specific disease; therefore they can serve a critical role as a comparison with people who have the disease or other characteristic being studied. Once registered, participants will be notified about studies they may be able to participate in as a control.

Participation requires:

1. signing a consent form
2. answering a short health survey
3. providing a DNA sample via a mouthwash kit

The registry allows scientists to select study participants based on whether or not they have a specific genetic change that may be relevant to a disease under investigation. Having the ability to access controls when needed is an extremely valuable resource that will speed up scientific discoveries.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* over age 18

Exclusion Criteria:

* under age 18
Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD

The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.

Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is, therefore, a need for more representative RCTs and real-life observational studies to inform existing guidelines and help optimise asthma outcomes.

Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP.

Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios:

1. before a diagnosis of COPD is made
2. unlicensed use as monotherapy, or in combination with long-acting bronchodilators

The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥40 years at index prescription date
* COPD diagnosis:

  * diagnostic code, and
  * ≥2 prescriptions for COPD therapy in baseline year (at different points in time)

    * For the ICS increase cohort (i.e. IPDA) ≥1 of these prescriptions must be for ICS therapy.
    * Commence ICS therapy at any time (even if before COPD diagnosis is made)

Exclusion Criteria:

- A diagnostic read code for any other chronic respiratory disease (except asthma)