cyrilzakka/clinical-trials huggingface dataset:
Variability of Infant LP Insertion Site Based On Procedural Experience

The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.


Eligibility Criteria:
Inclusion Criteria:

1. Less than or equal to 12 months of age
2. Availability of a study sonographer to perform bedside ultrasound

Exclusion Criteria:

1. Prior history of LP in preceding 72 hours
2. Known spinal cord abnormality (i.e., tethered cord, spina bifida)
3. Clinically unstable patients (acuity level 1)
Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD

The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T\&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.


Eligibility Criteria:
Inclusion Criteria:

* Active MNV secondary to nAMD, going along with clinically significant vision loss
* Patients aged 50 years or older of all sexes
* Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT
* signed informed consent for this study prior to the screening visit
* If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria)

Exclusion Criteria:

* Any other cause of macular oedema
* Structural damage to the macula precluding a visual potential
* Optical media opacities not allowing an accurate performance of the protocol examinations
* Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery
* Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage
* Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea
* History of IVT with anti-VEGF or corticosteroids at any time in the study eye
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
* Significantly worse functional prognosis in the other eye or only eye
* Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment
* Pregnant or lactating women
* Any systemic auto-inflammatory and auto-immune disease requiring treatment
* Treatment with high-dose corticosteroids (Prednisone equivalent \>5mg/day), immunosuppressive or immunomodulatory or anti-proliferative agents for any reason
* Inability or contraindications to undergo the investigated intervention
DiaCon Dual-Hormone Closed-Loop Glucose Control

The ultimate T1D treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. Such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. Currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. Most closed-loop systems consist of an insulin pump, a CGM, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the CGM values. For daytime blood glucose control, however, we believe that the system needs to be further advanced. Consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages.

We hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.


Eligibility Criteria:
Inclusion Criteria:

* T1D ≥ 2 years
* Insulin pump therapy with rapid-acting analog insulin ≥ 1 year
* HbA1c ≤ 8.5% (69 mmol/mol)
* Ability and willingness to comply with all protocol procedures

Exclusion Criteria:

* Pregnancy or nursing
* Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
* Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l)
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
* History of coronary artery disease or congestive heart failure
* Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
* Allergy to glucagon or lactose
* Pheochromocytoma
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
* Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Participation in a clinical trial within 30 days prior to the first dose of study drug.
* For Part 1 subjects:
* Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus
* For Part 2 Subjects:
* Clinical history or evidence at screening of medically significant bleeding
* History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions
* A platelet count \<LLN, or INR \>ULN, or aPTT \> ULN at Screening
* Ongoing daily use of nonsteroidal anti-inflammatory drugs
* For Part 3 subjects:
* AST and/or ALT \>ULN at Screening
* For Part 4 subjects:
* History of glaucoma
Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)

The purpose of the study is to verify the efficacy of using trendelenburg maneuver to predict fluid responsiveness in patients with extracorporeal membrane oxygenation


Eligibility Criteria:
Inclusion Criteria:

* patients with ECMO and mechanical ventilator support
* hypotension (MAP\<65mmHg)
* required volume expansion by clinical judgement of the intensivists

Exclusion Criteria:

* severe hypotension with high dose of vasopressors
* severe valve regurgitation
* cardiac arrhythmia
Nutrition Under Noninvasive Ventilation

Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Admission to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023;
* Noninvasive ventilation treatment for acute respiratory failure of any cause;
* Duration of noninvasive ventilation treatment of more than two days;
* Informed consent signed.

Exclusion Criteria:

* Patients under 18 years of age;
* Duration of noninvasive ventilation treatment of less than two days.
Comparison of the Immediate Effects of a Hypopressive Abdominal Exercise Program Versus a Proprioceptive Neuromuscular Facilitation Stretching Program on Hamstring Flexibility in Adults With Short Hamstring Syndrome

A Randomised Controlled Trial was conducted to assess increases in hamstring flexibility using two different methods, one group of participants who were stretched with PNF techniques and the other group who performed Hypopressive Abdominal Techniques (HAT). Flexibility scores of both groups were obtained and compared using pre and post measurements of a single intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participants with less than 75° in the straight leg raise test.

Exclusion Criteria:

* History of hamstring injury within the last year.
* Pharmacological treatment or history of neurological, orthopaedic, growth or autoimmune disorders.
* Training to improve flexibility in the week prior to the intervention.
* Hypertension.
* Pregnant women.
* Inability to perform hypopressive abdominal techniques.
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.

Study to evaluate the effect of pf-06651600 on pharmacokinetics of single dose sumatriptan.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes BP and pulse rate measurements, clinical laboratory tests, and 12-lead ECG.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), diabetes or of the contraindications as per the USPI for IMITREX.
* 10-year risk of atherosclerotic cardiovascular disease (based on ASCVD Risk Estimator) ≥7.5%.
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Systemic therapy with any of the medications that are MAO-A inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. Concomitant use of any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide), or other 5-HT agonist (Section 6.5) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
* Known participation in a clinical trial of PF-06651600 within 60 days prior to the first dose of investigational product; participation in any clinical trial of PF-06651600 and the participant experienced AE that led to discontinuation or had an SAE that in the judgment of the investigator were PF-06651600-related.
Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II.

Exclusion Criteria:

* Patient refusal
* Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy)
* Contraindications to dexmedetomidine or remimazolam administration
* Allergy to dexmedetomidine or remimazolam
* Baseline MOAA/S score of 4 or less
* Pregnancy
* Other conditions considered unsuitable by the investigators
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn singleton infant
* Full-term (\>= 37 weeks gestation)
* Birth weight between \>= 2500 and \< =4500 g
* 14 ± 3 days of age on enrollment
* Infant's mother has elected not to breastfeed
* baby has been exclusively formula fed a minimum of 3 days prior to enrollment
* Study explained and written information provided with Parent/Caregiver
* Informed consent signed (parent/legal representative)

Exclusion Criteria:

* Congenital illness or malformation affecting infant feeding and/or growth
* Suspected or known allergy to cow's milk protein
* Significant pre-natal and/or post-natal disease
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
* Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
* Infant has received probiotics in the seven days prior to enrollment
* Infant currently participating in another clinical study
* Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Safety and Efficacy Study of Orally Administered DS102 in Healthy Subjects

The purpose of the study is to investigate the safety, pharmacokinetics and food effect of DS102 (up to 2000mg single and multiple daily doses) and placebo in healthy participants.

DS102 capsules will be orally administered for up to 4 weeks, and will be compared against placebo.

The study will enrol approximately 56 adult subjects.

There will be 7 cohorts enrolled, each consisting of 8 subjects.

Cohorts 1 - 4 will be orally administered up to 2000mg single doses of DS102 on Day 1.

Cohorts 5 - 7 will be orally administered up to 2000mg multiple daily doses of DS102 for 28 days.

The primary objective is to assess the safety and plasma pharmacokinetics of single and multiple daily oral doses of DS102.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and is aged between 18 and 45 years inclusive.
* Subject's body mass index (BMI) is between 18.0 and 30.0 kg/m2 inclusive.
* Subject is a non-smoker, has been a non-smoker for 3 months prior to screening and has a negative urine cotinine test at screening.

Exclusion Criteria:

* Subject has had a clinically significant illness in the 4 weeks before screening.
* Use of prescribed medication in the 2 weeks before dosing or over-the-counter preparations (including vitamins and supplements) for 1 week before dosing
* Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse (DOA) test at screening or Day -1.
* Subject with a history of alcohol abuse in the opinion of the Investigator, or who currently drinks in excess of 28 units per week (males) or 21 units per week (females), whereby a unit consists of 10ml or 8mg of pure alcohol, or who have a positive alcohol urine test at screening or Day -1.
* Subject has participated in any other clinical study with an investigational drug/device within 3 months before the first day of administration of study treatment.
* Subject has a positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibodies at screening.
* Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
* Subject has donated blood or blood products within 3 months before screening.
* Subject has known hypersensitivity to any ingredients of the study treatment.
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.

Eligibility Criteria:
Inclusion Criteria (Potential study participants must meet the following criteria):

* Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
* At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
* Normal blood chemistries and blood cell counts
* At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria (Potential study participants will not be eligible with the following):

* Previous chemotherapy treatment for melanoma
* Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
* If surgical removal of all lesions would be possible and could be curative
* Any melanoma tumors greater than 10cm x 10cm in size
* Known condition resulting in a suppressed immune system
* Female subjects who are pregnant
A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)

.Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty

Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups.

Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period.

Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.

According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).

Eligibility Criteria:
Inclusion Criteria:

- hip arthroplasty

Exclusion Criteria:

* patient with resence of neurological and psychiatric disorders
* minor patient