cyrilzakka/clinical-trials huggingface dataset:
The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries

To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form

Exclusion Criteria:

* Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma

This is the first study which evaluates the different staging modalities 18F-2-fluoro-2-deoxy-D-glucose PET/CT (PET/CT) and diagnostic ultrasound (US) in a single patient cohort with malignant melanoma (MM). Previous analyses are ambivalent regarding the modality of choice. These analyses, however, compared separate patient cohorts for each modality.

Inclusion criteria were a primary staging or re-staging of suspected or confirmed MM with one or more PET/CT and/or one or more US. Exclusion criteria were the non-existence of a malignancy or a malignancy other than MM, alone or in combination with an MM.

The analysis includes the calculation of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). This was done individually for PET/CT and US, and in PLA also for the combination of these two radiological modalities. Furthermore, US was divided into US as a whole (wUS), peripheral lymph nodes (pUS) and/or abdomen (aUS).

The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in all three analyses. As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* the existence of malignant melanoma (MM) as primary tumour or metastases

Exclusion Criteria:

* the non-existence of a malignancy,
* a malignancy other than MM, alone or in combination with an MM
A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

In this Phase 3 study, eligible participants will be randomized in a 1:1:1 ratio to receive once-weekly subcutaneous XW003 (high or dose) or active comparator dulaglutide as add-on to metformin treatment for 52 weeks, including a dose-escalation period.

Eligibility Criteria:
Inclusion Criteria:

1. Ability and willingness to participate in the study, give written informed consent, and comply with the study specific requirements and all protocol procedures
2. Sex: male or female; Age: 18 to 75 years, inclusive
3. BMI: 20.0 kg/m\^2 to 35.0 kg/m\^2, inclusive
4. Have been diagnosed with T2DM for at least 3 months and treated with a stable dose of metformin (≥1500 mg/day) in addition to diet and exercise during the 8 weeks prior to screening.
5. HbA1c ranging from 7.5% to 11.0% at screening, inclusive
6. FPG ≤13.9 mmol/L at screening

Exclusion Criteria:

1. History of type 1 or other types of diabetes mellitus
2. Use of insulin during the 6 months preceding screening
3. History of proliferative diabetic retinopathy, diabetic maculopathy, diabetic neuropathy, or diabetic foot during the 6 months prior to screening.
4. History of acute or chronic pancreatitis or high-risk factors for pancreatitis
5. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
6. History of stomach surgeries or disorders associated with slowed emptying of the stomach during the past 6 months.
7. History of heart attack, stroke or congestive heart failure of Grade 3 or 4 in the past 6 months.
De-labeling of Patients With False Diagnosis of Penicillin Allergy

The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.

Penicillin allergy is the most common of self-reported drug allergies and un-verified penicillin allergy is a significant and growing public health problem. 10% of all patients report penicillin allergy. However, there is large discrepancy between reported penicillin allergy and true allergy. Despite its high prevalence, greater than 90% of such patients are in fact able to tolerate the medication without allergic reactions.

In this study patients having a penicillin allergy label will be investigated to confirm or to exclude the allergy diagnosis. The diagnostic value of the allergen test panel and the allergologic work-up will be evaluated. Clinical parameters as well as immunological will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are referred to the department of Pulmonary medicine with clinical history suspected of having penicillin allergy.
* The control group will be healthy adult volunteers with no history of any personal or family history of drug allergy, atopy, inflammatory or autoimmune diseases.

Exclusion Criteria:

* Systemic reactions such as DRESS, any internal organ involvement
* Clinical history of Type II-III hypersensitivity reaction
* Severe Type IV hypersensitivity reaction such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, vasculitis, acute generalized exanthematous pustulosis
* Chronic idiopathic urticaria on antihistamine maintenance treatment/anti-IgE treatment
* Medication which can affect the test outcome
* Active signs of an underlying disease such as uncontrolled asthma
* Cardiac disease with increased risk of serious anaphylaxis
* Pregnancy/Breastfeeding
* Reaction within the last 4-6 weeks
Feasibility of Total Mastectomy in Ambulatory Care

Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .


Eligibility Criteria:
Inclusion Criteria:

* All patient with an indication of breast non conserving surgery

Exclusion Criteria:

* Standard contra-indication for ambulatory care.
* Also bilateral surgery and immediate breast reconstruction.
Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games

In this study the clinical relevance of the use of commercially available virtual reality games in the rehabilitation of balance will be assessed in children with cerebral palsy. It will be investigated how different commercially available platforms (i.e. Xbox One + Kinect and Nintendo Wii + balance board) will affect the compensations of children with cerebral palsy to preserve their balance. The effect of 1 training session will be assessed as well as the effect of a long-term training of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. children diagnosed with cerebral palsy (spastic type)
2. age: 8-11 years and 11 months
3. bilateral CP (diplegia) \& unilateral CP (hemiplegia)
4. GMFCS level 1 \& 2
5. able to independently stand still for 2 minutes
6. sufficient cooperation to participate in the measurements and training

Exclusion Criteria:

1. No informed consent
2. surgery of the lower limbs that affects mobility
3. Botulinum-toxin A treatment within 6 months prior to inclusion in the study
4. vestibular deficits, benign vertigo, ADHD or instable epilepsia

For typically developing children:

Inclusion criteria;

1. age: 8-11 years and 11 months
2. no history of neurologic, musculoskeletal or other impairments that could affect mobility
Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients

34 adult (\>18 years) cancer pain outpatients with Opioid base therapy because of pain and breakthrough pain or extreme pain on movement will be included in this prospective, randomized, double-blind crossover study.

Over a period of 3 weeks patients will go through 3 treatment arms, each one lasting one week: Group A receives morphine drops and Placebo spray, Group B receives ketamine/chitosan spray nasal and Placebo drops and Group C receives morphine drops and ketamine/chitosan spray nasal.

Primary endpoint is time to onset of action of intranasal ketamine compared with morphine drops. Secondary endpoint is the median numeric rating scale (NRS) improvement after using the spray or morphine or the combination of ketamine spray and morphine drops.


Eligibility Criteria:
Inclusion Criteria:

* Cancer pain in outpatients with:
* Opioid based therapy due to pain
* Breakthrough pain or
* Extreme pain on movement
* Age \>= 18 years

Exclusion Criteria:

* Patients unable to give written informed consent
* Patients unable to understand how to handle and document the use of the study medication
* Known drug allergies or intolerance to ketamine
* Known drug allergies or intolerance to morphine
* Known allergy to crustacea or chitosan
* Patients using snuff at a regular basis
* Recreational drug addiction or abuse
* Serious intranasal or epipharyngeal Problems (Septum wall defects, cancer)
* Mental/psychiatric disorder
* Patients with renal failure (clearance \< 30 ml/min)
* Pregnancy and breast feeding mothers
* Patients not understanding German
* Patient having arterial hypertonia with measured values \> 180/95
Minimally Invasive Tongue Suture For Obstructive Sleep Apnea

This is a pilot study to determine the usefulness of a newly developed, minimally invasive tongue suture procedure for people with obstructive sleep apnea.

Obstructive sleep apnea is a common sleep-breathing disorder characterized by repetitive complete cessation of breathing due to pharyngeal obstruction. Untreated, it has been strongly associated with daytime sleepiness, hypertension, depression, coronary artery disease, stroke, and even death. It is estimated that up to 25% of men and 9% of women may suffer from this condition. One proposed mechanism of pharyngeal obstruction is that the posterior tongue is susceptible to collapse when supine during sleep, which causes further collapse of the soft palate and related structures. Treatment includes continuous positive airway pressure (CPAP), mandibular advancement devices, and various surgical options. There are many surgical options for treating tongue base collapse, many of which are morbid with significant pain and discomfort involved. Silhouette Sutures (Kolster Methods, Inc.) are designed to hold and grip soft tissues using intermittently placed dissolvable cones spaced by knots. It has been used widely for years for facial cosmetic procedures with excellent results and safety record. This is a pilot study evaluating the practicality and efficacy of using Silhouette Sutures in an innovative, minimally invasive technique that obviates the need for more aggressive and morbid procedures for obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

Five patients will be recruited during a period of one year, or until a total of five patients have been recruited and have taken part. Patients must have undergone a formal overnight polysomnogram with documented obstructive sleep apnea within the past 2 years with no significant change in their weight or symptoms. They must have tried or refused all available nonsurgical options (CPAP or mandibular advancement devices), and must be ideal candidates for traditional upper airway surgery. Based on the polysomnogram results and specific entry criteria, patients will be recruited. All patients will undergo a full ENT examination and a fiberoptic laryngoscopy, examining the nasal cavity, palatal structures and tongue position, both in the sitting and supine positions (a routine part of the ENT examination).

Entry criteria include the following:

* men and women ages 18 to 65
* supine Park tongue position 3+ or greater
* tonsil size 2 or less
* Mueller's 2+ or less
* Friedman Stage II/III
* BMI ≤ 30
* AHI ≥ 5

Exclusion Criteria:

* Prior pharyngeal surgery
* History of radiation to the head and neck
* Dysmorphic facies or craniofacial syndrome
* ASA class IV or V
* Major depression or unstable psychiatric disorder
* Pregnancy
* Illiteracy (unable to complete required forms)
* No phone # or mailing address, or plans to change in 3 month period
* Any upper airway surgery within three month period
Early Assessment of the Response to Neo-adjuvant Chemotherapy in Breast Cancer Patients With FDG-PET

18F-FDG PET, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches.

We propose to conduct a prospective study to evaluate early therapeutic response using 18F-FDG PET before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients.

Variation of 18F-FDG PET uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy.

The purpose is to estimate the capacity of 18F-FDG PET to differentiate responder and non-responder patients.

Further study details as provided by Centre Oscar Lambret

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Breast cancer treated by neo-adjuvant chemotherapy (T\>2cm)
* Measurable lesions ,assessed clinically and by ultrasound
* Delay minimum between biopsy and PET: 15 days
* PS-WHO: 0

Exclusion Criteria:

* T\<2cm
* Inflammatory breast cancer (T4d)
* Diabetic patients unbalanced (glycemia\>1.40)
* Pregnant or lactating women
Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders

The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states.

Protein turnover is a cyclic process with a net loss of protein in the fasting state and a net gain in the fed state contributing to nitrogen balance. These physiologic processes are impacted during infection; whole-body protein catabolism exceeds protein synthesis, resulting in net loss of whole-body protein. Patients with urea cycle disorders suffer episodes of periodic hyperammonemic crisis, often in association with intercurrent infections. The immediate cause of this decompensation is the increase in endogenous protein catabolism that is the endpoint of a cascade triggered by intercurrent illness. This increase in protein catabolism leads to elevations of serum amino acids and ammonia production, which cannot be eliminated by a dysfunctional urea cycle.

It is well known that infectious illnesses play a significant role in precipitating metabolic crises in urea cycle defects, presumably by triggering a cascade of events involving the release of inflammatory cytokines that lead to increased protein catabolism. Cytokines have also been implicated as distant mediators of oxidative stress. However, the correlation between oxidative stress, cytokine levels, and severity of a crisis is currently unclear.

The primary purpose of the proposed study is to characterize the oxidative stress and inflammatory cytokine status in UCD during baseline and decompensated states. The investigators will undertake measurements of selected markers of oxidative stress and cytokines in serum and urine during baseline and decompensated states in subjects with UCD in order to establish their prognostic value as biomarkers for disease severity and/or predictors of metabolic decompensation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or highly-likely diagnosis of one of the eight UCDs as established for the Longitudinal Study (5101) (See section 4.2 Inclusion Criteria, Table 4 for diagnostic criteria for patients with UCD)
* Enrolled in Longitudinal Study of Urea Cycle Disorders (RDCRN UCDC #5101)

Exclusion Criteria:

* UCD patients who have undergone orthotopic liver transplantation
* Significant chronic medical co-morbidity that might confound the analysis as determined by the site investigators.
* Significant co-morbidities include but are not limited to:

  * diabetes, liver failure + cirrhosis
  * renal failure
  * cardiac disease
  * chronic inflammatory diseases
  * asthma requiring daily long-term control medications
  * significant respiratory disease.
Longitudinal Endpoint Assessment of Disease Burden in HD

LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.

The LEAD-HD study will be offered via HSG's online observational research platform called myHDstory®. This direct to patient study will collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older;
* Be willing and able to provide informed consent electronically;
* Self-report, when answering as a participant, that you have been diagnosed with HD by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for HD but have not been clinically diagnosed with HD (prodromal HD);
* Have the ability to answer online questions or direct someone else to enter answers for them;
* Have the ability to ambulate independently and take care of some of your personal needs;
* Have the ability to read and understand English;
* Be willing to create a unique identifier based on personal demographic information;
* Reside in the United States or its territories. Surveys can only be completed in the US. If you move outside of the US, you will no longer be able to participate;
* Own or have access to an electronic device and secure internet connectivity

Exclusion Criteria:

-
DIATOR-Diabetes Intervention With Atorvastatin

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

The objectives of this study were as follows:

* To assess the effect of atorvastatin on pancreatic beta-cell function as measured by C-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes,
* To assess the effect on metabolic control as measured by HbA1c and insulin requirements,
* To assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes,
* To assess the effect on risk factors of diabetic complications as indicated by changes in lipids and CRP, and
* To assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level.

Study duration: 18 months

Eligibility Criteria:
Inclusion Criteria:

* Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
* Age 18 to 39 years, inclusive
* Male patient or female patient using adequate contraceptive methods
* Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA

Exclusion Criteria:

* History of a malignancy
* Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated more than ten percent above the upper limit of normal, elevation of AST or ALT more than 3 times the upper limit of normal
* Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
* Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
* Pregnant or nursing women or women intending to become pregnant
* Known or suspected allergy to atorvastatin or any component of thr trial product
* Known myopathy, myalgia or myositis with a serum-CPK above 3 times the upper limit of normal
* Patients who had a severe blood loss (\>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
* Any significant laboratory abnormality
* A serum LDL-cholesterol above 150 mg/dL at time of screening
* Unwillingness to comply with study procedures
Advancement of Modified Bubble CPAP

This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia.

This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to fit older children, will create a safe form of respiratory support that may help to decrease respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress will be evaluated for use of the modified bCPAP device as treatment for their respiratory distress (in addition to their routine care, i.e. antibiotics, nutrition support)

Eligibility Criteria:
Inclusion Criteria:

* Age 1mo-5y Hypoxia and/or respiratory distress Hypoxia- Oxygen saturation \<92% despite 2LPM nasal cannula support Modified TAL's Respiratory Score \>3

Exclusion Criteria:

* Pneumothorax
* Congenital lung disease
* Cyanotic heart disease
* Nasal trauma/facial injury/congenital anomaly (cleft) that makes bubble CPAP nasal interface unusable
* Nasal tissue injury
* Active nosebleed
* Recent abdominal surgery or significant abdominal distension
* Agonal respirations
* GCS \<3
* Imminent death within the next 1-2hou