cyrilzakka/clinical-trials huggingface dataset:
Prevention of Severe Hypoglycemia in Type 1 Diabetes

Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. Symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.

The unifying objective of the proposed unblinded randomized prospective study is to determine whether hypoglycaemia awareness in Type 1 diabetes can be restored by rigorous avoidance of hypoglycaemia addressed by one of the following interventions:

1. A non-targeted approach whereby pre-prandial glycaemic targets are raised from 4.5-7mmol/L to 7.2-8.3mmol/L and hypoglycaemia is rigorously avoided without specific alterations in subcutaneous insulin regime5
2. Optimisation of subcutaneous insulin regime employing pre-prandial short-acting insulin analogue in combination with once daily insulin Glargine targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles
3. Insulin delivery by external pump (continuous subcutaneous insulin infusion) targeted to prevent periods of hypoglycaemia identified by 24 hour glucose profiles

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes
* recurrent severe hypoglycemia within the preceding 6 months
* attending the Newcastle Diabetes Centre

Exclusion Criteria:

* previous use of rapid- and long-acting insulin analogs used in an multiple daily insulin injection regimen
* previous use of continuous subcutaneous insulin infusion pump
* alcohol or drug abuse
* seizures unrelated to hypoglycemia.
Premedication by Midazolam for Emergency Surgery

Preoperative anxiety is a subjective and painful experience and may have adverse psychological consequences and complicate anesthetic management. The aim of the study is to show the effect of premedication by midazolam on preoperative anxiety assessed by a visual analog scale and by measuring salivary cortisol levels. This study was a monocentric, prospective, blind randomized placebo controlled clinical study. Sixty patients, aged 18 to 79 years, to undergo elective surgery under general anesthesia with tracheal intubation must be enrolled and randomized to receive midazolam (0.02mg/kg) or placebo. The primary outcome is the reduction in anxiety assessed by a visual analog scale. The secondary outcomes are the reduction in salivary cortisol levels, the overall level of anxiety and the evaluation of respiratory and hemodynamic adverse effects of midazolam.


Eligibility Criteria:
Inclusion Criteria:

* major patient undergoing elective surgery under general anesthesia with tracheal intubation
* Anesthesia state 1 and 2
* preoperative fasting for 6 hours
* information and signed consent
* social security
* non pregnant women

Exclusion Criteria:

* anesthesia state above 3
* midazolam sensibility
* pregnant or breastfeeding women
* ICU patients
* no consent
* pediatric surgery
* no social security
* no tracheal intubation
* required premedication in placebo group or midazolam sensibility in premedication group
Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery

The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.

The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.

The NEVAL protocol is a descriptive study conducted in order to confirm the clinical evidence of safety and performance of NEVELIA®, as described in the literature on equivalent products.

This dermal substitute consists of an inner biodegradable dermal substitute made of bovine collagen (collagen of type I), covered with an outer silicone membrane. Its porosity and the speed of degradation allow the act of recolonization by the fibroblasts and initiation of the vascularization process within 3 weeks. The application procedure requires removement of the silicone layer and wound covering with an ultra-thin epidermal graft, possibly meshed. This surgical procedure is well-known and permits an ultra-thin epidermal graft.

All the patients will be treated with NEVELIA®, prior to autologous skin grafting within 3 weeks after its application. Then, three follow-up visits will be planned: post operatively, at 6 and 12 months.

The objectives are:

* Primary objective: To assess the type and frequency of complications
* Secondary objectives:

  * To assess the take rate of NEVELIA®
  * To assess the take rate of skin graft
  * To assess the satisfaction rate of physician and patient,
  * To assess the quality of the healed skin,
  * To assess the rate of re-operation at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Patient geographically stable,
* Patient requiring dermal reconstruction after third-degree burns, reconstructive surgery or trauma surgery;
* Patient who signed the non-opposition form;
* Patient able to be followed up to 12 months.

Exclusion Criteria:

* Patient with clinical signs of wound infection;
* Allergic patient or with known allergy to bovine collagen or silicone;
* Patient with life-threatening conditions;
* Patient receiving a treatment that may affect wound healing;
* Patient with an autoimmune or immunosuppressive disease;
* Patient with a suspected neurological disease as Creutzfeldt-Jakob disease;
* Patient simultaneously participating in another study;
* Pregnant or nursing woman.
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life

The prevalence of chewing dysphagia in the domestic rehabilitation department ward was about 53.61%.Nasal tube retention of about 31%, due to nasogastric tube feeding, often overlooked oral hygiene, easy to cause respiratory tract infection. At the same time, oral hygiene will also affect the effectiveness of swallowing treatment, is worthy of attention to health problems.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of first stroke with nasal tube retention
2. Language therapist providing swallowing treatment
3. Caregiver providing oral care to patients

Exclusion Criteria:

1. Oral cancer
2. head and neck cancer
Association of Digital Aid Use With Infant Sleep and Maternal Mental Health

The goal of this study is to better understand the use of the Huckleberry app, a pediatric sleep guidance app and the impacts on infant sleep and maternal mental health.

This study aims to understand the impact of the Huckleberry app, a scalable low-cost solution to problematic child sleep patterns, on pediatric sleep and maternal mental health, especially in the Medicaid population.

A secondary aim for this study is to determine if Medicaid Accountable Care Organizations (ACO) goals are improved according to stakeholder interviews.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old
* Has a child between the age of 0-12 months
* Receives healthcare through UMass Memorial Health
* Is a part of the Medicaid Accountable Care Organizations (ACO) population

Exclusion Criteria:

* Lacks capacity to consent
* Does not understand English
* Does not have internet access on their smartphone or at home
* If the infant is in Department of Children and Families (DCF) custody or is admitted into the Neonatal Intensive Care Unit (NICU)
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults

GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females
* Age: 18 to 55 years, inclusive
* A female subject who is non-childbearing potential or using acceptable contraceptive methods.
* Adequate organ systems function
* Able to swallow and retain oral medication
* Able to understand and comply with protocol requirements and instruction and is likely to complete the study.

Exclusion Criteria:

* Cannot participation if subject has a clinically relevant abnormality, medical condition, or circumstance that makes them unsuitable for the study per the study doctor.
* History of drug or other allergy which, in the opinion of the Investigator, contraindicates participation.
* Use of an investigation drug within 28 days or 5 half-lives.
* Blood donation in excess of 500mL within 56 days prior to dosing or intends to donate within 30 days of the post-treatment follow-up visit.
* Presence of or suspected iron deficiency
* Positive stool for occult blood
* Female subject who is lactating
* Positive urine drug screen
* Positive for HIV antibody, hepatitis C antibody or hepatitis B surface antigen
* Use of tobacco-containing products within the past 12 months prior to screening
* History of drug or alcohol abuse or dependence within 6 months of screening
* History or presence of uncontrolled emesis
* Positive purified protein derivative (PPD) skin test for tuberculosis
Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients

This study aims to compare the neuromuscular blockade responses in patients undergoing elective surgery under general anesthesia, with a focus on the use of statins. The study will assess the depth of neuromuscular blockade, recovery time, and postoperative residual curarization using Train-of-Four (TOF) monitoring, with the primary goal of determining whether statin use alters the neuromuscular blockade management.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* ASA classification I, II, III
* BMI 18-30
* Statin use for at least 3 months or no prior statin use
* Elective surgery requiring general anesthesia with endotracheal intubation
* Signed informed consent for participation in the study

Exclusion Criteria:

* ASA classification IV or higher
* BMI \<18 or \>30
* History of liver or renal insufficiency (creatinine \>1.6, liver function tests \>2x normal)
* Neuromuscular, psychiatric, or neurological disorders
* Pregnancy
* Use of drugs affecting neuromuscular function (e.g., anticonvulsants, aminoglycosides)
* History of malignant hyperthermia
* Respiratory disorders, including sleep apnea
* Allergy to anesthetic drugs used in the study
Sample Collection Study to Assess Prevalence of Gene Mutations: Establishing Population Norms

This is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. Subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. Once IRB approved informed consent is obtain, subject demographic information, history of sun exposure and samples will be collected.

This is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. Subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. Once confirmation of participation is confirmed subjects will undergo the informed consent process.

Once consented the subject will have their medical history reviewed, concomitant medications and demographic information recorded, complete a sun-exposure questionnaire, have photoaging characteristics (such as melasma, wrinkles, AK lesion(s)) recorded, record their assessment of photoaging, have skin samples collected non-invasively and complete the local skin reaction and local tolerability assessments. A select number of subjects will also have a facial photograph taken.

If the location to be sampled contains a lesion, then the collection should occur as close as possible to the target area. The site staff and/or subject will be responsible for collecting the skin samples.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females at least 21 years of age presenting to the clinic for medical consultation;
2. In good health, determined by no clinically significant findings from medical history,
3. Willing to complete all study procedures required by the protocol; and
4. Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

1. Have any skin disorder including acne, rosacea, psoriasis, atopic dermatitis and active skin cancer(s) that appear in the facial area where sample collection will be taken and could confound the results of the trial;
2. Has a suspicious lesion (i.e., actinic keratosis lesion) in an area that is expected to be sampled and requires further medical follow-up,
3. Pregnant or breast feeding,
4. Hospitalization within 4 weeks before enrollment,
5. Previously provided samples for this study,
6. Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study,
7. Documented substance abuse, any other significant medical condition that would indicate an unreasonable risk to the potential study participate or potential interference with the procedures, or would negatively affect the study subject's reliability and compliance with the study schedule of events, and
8. Chemical peel or treatment with a laser in the facial area within 3 months prior to enrollment.
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.

The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.

Eligibility Criteria:
Inclusion Criteria:

* Female Subjects \>18 years of age
* English or Spanish speaking/reading
* Must be able to provide informed consent
* Undergoing urogynecologic procedures or surgery

Exclusion Criteria:

* Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
* Inability to return for follow-up visits
* No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
* Lack of telephone
* Known allergy to either antiseptic agent
* Prisoners will not be eligible to participate in this study
Safety and Efficacy of Fentanyl Citrate in Children

Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically ill children with mechanical ventilation

Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with midazolam in children with mechanical ventilation.

Design: Double-blind randomized controlled study

Patients: Patients age 2 months through 18 years who are admitted in Seoul National University Hospital pediatric intensive care unit, and applied with mechanical ventilation.

Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline) is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing pharmacist knows that.

Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent. The start time of study is when the continuous infusion of midazolam and blind reagent are begun. Assigned research nurse check Comfort behavior scale of the patient every hour regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours after begining. If there is any adverse effect or unexpected event, however, the study can be early terminated.

Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response, crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot be evaluated 'crying', however, we use 6 components among total of all 7 components, except 'crying'.

Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the situation which study cannot last in, such as withdrawal of consent, necessity of drugs which can affect the level of consciousness of the patient, emergent interventional procedure, etc.

Eligibility Criteria:
Inclusion Criteria:

* children mechanically ventilated
* age : from 2 months to 18 years

Exclusion Criteria:

* children with neurologic disease
* children with drugs which can affect the level of consciousness
* children with renal disease
* children with hypotension (systolic blood pressure \< 70 + (2 x age in year) mmHg)
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure

This is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）.

Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.

Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects


Eligibility Criteria:
Inclusion Criteria:

1. Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily.
2. Age: ≥ 18 years and ≤ 65 years.
3. Body weight: ≥ 40kg;
4. Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and Treatment of Liverfilture (2018 Edition)): base on chronic liver disease, acute jaundice deepened and coagulation dysfunction caused by various inducements, manifested as extreme fatigue, with obvious gastrointestinal symptoms such as anorexia, vomiting, abdominal distention, etc; Progressive deepening of jaundice, serum TBil ≥ 171 μmol/L or increase ≥ 17.1 μmol/L daily or ≥10 × upper limit of normal value; with bleeding tendencies or manifestations (bleeding spots or ecchymosis), or 20%\<PTA ≤ 40% (or 1.5 ≤ INR\<2.6), and other reasons excluded.

Exclusion Criteria:

1. Subjects with primary or metastatic liver cancer.
2. Subjects with severe esophageal/gastric varices and high risk of bleeding, with positive red signs, or with previous active bleeding, as indicated by gastroscopy or imaging examination results.
3. Serum creatinine was greater than 132.6 μmol/L.
4. Subjects with serious uncontrolled infections, including sepsis, septic shock, severe pneumonia (refers to the diagnostic criteria of the American Society of Infectious Diseases/American Thoracic Society for adult severe pneumonia in 2007), abdominal infection (exist Peritonitis manifestations or white blood cells in ascites\>0.1 × 10 9/L after reasonable antibiotic treatment), etc;
Transcriptomic Analysis and Optical Coherence Tomography Combined for Patients with Basal Cell Carcinoma

The goal of this observational study is to learn if tape strip for transcriptomic (RNA) analysis and optical coherence tomography (OCT) combined can optimize noninvasive management of basal cell carcinoma (BCC) patients.

The main question of the study is to examine if the combination of these two techniques, transcriptomic and OCT, can improve noninvasive detection of human BCCs.

All included patients will undergo 1) an OCT scan and 2) a tape strip collection for transcriptomic analysis from the same BCC.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years with clinical suspicious BCC for inclusion in the study and BCC histopathology diagnosis for inclusion in our analysis.

Exclusion Criteria:

* Patients with a BCC in areas not amenable to OCT (e.g., around the eye).
The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion

Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.


Eligibility Criteria:
Inclusion Criteria:

* ≥1 CTO lesion amenable to PCI.
* Stable and stabilized coronary artery disease
* Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia.
* CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).

Exclusion Criteria:

* Expected survival \<1 year.
* Renal failure on dialysis.
* Stable non-CTO lesions treated within one month.
* Declined informed consent.
* Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45;
* No chronic symptomatology;
* No acute symptomatology during the last 72 hours before intervention;
* No pathologies

Exclusion Criteria:

* Age below 18 or over 45;
* Pregnancy;
* Menopause;
* Abuse of alcool during the last 48 hours;
* Chronic pain;
* Acute pain during the last 72 hours;
* Conclamate pathologies;
* Use of drugs during the last 72 hours ;
* Use of ortothic devices during the last 3 months;
* Any type of surgery;
* Osteopathic treatment during the last 3 months.