cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Plus Nerve Stimulator Versus Nerve Stimulator Guided Lumbar Plexus Block

Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Some case series have demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks and axillary brachial plexus blocks under ultrasound than with conventional techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the popliteal fossa compared with single injection, nerve stimulator-guided block using either a tibial or peroneal endpoint. Despite this impressive profile, the application of the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar plexus block is traditionally performed using surface anatomical landmarks and nerve stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its deep anatomic location and the "acoustic shadow" of the overlying transverse processes. Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the lumbar paravertebral region with the ultrasound beam being insonated through the intertransverse space (ITS) and directed medially toward the intervertebral foramen (PMTS-ITS) may overcome the problem of the "acoustic shadow" and allow clear visualization of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus blocks has not been studied extensively and its advantages are not validated in a clinical study. Thus, we designed this prospective, randomized, subject and assessor blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus block combined with nerve stimulation and a conventional technique on time required to readiness for surgery in patients undergo knee arthroscopy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18-70yr
* American Society of Anesthesiologists physical status I-II
* Patients scheduled to undergo knee arthroscopy surgery
* Ultrasound visibility score equal or great than 10

Exclusion Criteria:

* Body mass index more than 35 kg/m²
* Pregnant or lactating women
* Allergy to local anesthetics
* Coagulopathy, on anticoagulants
* Malignancy or infection at puncture site
* Significant peripheral neuropathy or diabetic peripheral neuropathy
* Language barrier
* Neuropsychiatric disorder
* Severe cardiac or respiratory diseases
* Pathology or previous surgery or trauma to the lower limb
* Analgesics intake, history of substance abuse
* History of spinal surgery or deformity
* Ultrasound visibility score less than 10
* Participating in the investigation of another experimental agent
The Influence of Gonadal Hormone Suppression on Adipocyte Lineage and the Microbiome

This research study plans to learn more about the role of female sex hormones on adipose tissue (or fat) and the gut microbiome (or the organisms that are in your digestive tract). The rationale for this study is that the rate at which women gain fat (especially in the stomach region) increases after menopause. It is thought to be due to the loss of estrogen because post-menopausal women who take estrogen gain less weight than those who do not take estrogen. Gut bacteria process estrogen and help determine the types of estrogen that circulate in the body. These bacteria can be changed with lifestyle factors such as diet, and may therefore, also affect the risk of diseases that are more common in women after menopause i.e., cardiovascular disease and cancer. In this study the investigators will obtain fat biopsies before and after 6 months of ovarian hormone suppression to measure how the fat cells change with the loss of female sex hormones (e.g., medical menopause). The investigators will also obtain stool and urine samples before and every month during the study to measure changes in the microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment into the parent protocol (COMIRB 16-1479 - The impact of estrogen status on the biological function of brown adipose tissue in women measured using quantitative PET/CT; PI - Edward Melanson, PhD)
* Participation in GnRHag intervention

Exclusion Criteria:

* Known allergy to lidocaine or other numbing medication
* Uncontrolled bleeding disorder or inability to withhold aspirin/NSAIDs or other blood thinning medications for 7 days prior to biopsy procedure.
The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study

Scar is an unpleasant symptom that commonly appear after orthopedic surgery, especially the joint procedure. Due to the wide motion range, skin around joint has excessive tension that may increase risk for wide or conspicuous scar formation of surgical wound. Noticeable scar can negatively impact the quality of life and psychosocial development. However, scar management is overlooked in early recovery period easily. Patients commonly start to turn their attention to the surgical scar after the completion of rehabilitation or the resolution of disease or unbearable symptom. It is always beyond the best period of scar treatment, 3 to 6 months after wound healing. This study is aimed to observe and evaluate the scar formation with or without aggressive management in pediatric population within 6 months after wound healing.

This is an observational, case-control study. Patients will be invited to participate and allocated to scar dressing group if they plan to use scar dressing. After gaining the written inform consent, participants will be asked to fulfill the patient diary, including the record of scar dressing use, patient scar assessment scale and satisfaction assessment, with parents' help. In regular group, patients are retrospectively selected by matched factors, such as demographics data. Scar-related data, including scar pictures, vancouver scar scale assessment and complication, are collected from medical history in both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 5 to 18 years
2. Had orthopedic surgery 3 weeks ago and within 6 weeks
3. Had incision sites around the knee
4. All surgical wounds healed completely
5. Length of surgical wounds between 2 and 15 centimeters
6. Planed to treat incisional scar with scar dressing, adhesive tapes, or adhesive strips

Exclusion Criteria:

1. Surgical wound infection
2. Atopic dermatitis or sensitive skin
3. Not able to make return visits regularly
4. Participation was not appropriate determined by physician
Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* patients with orofacial cleft, who undergo routine cleft repair

Exclusion Criteria:

* missing datasets
* no signed consent for research
Comparison of Various Measures for Anticipating Difficult Laryngoscopy

Demographic features and eight diagnostic variables were evaluated for difficult laryngoscopy (DL) predictivity. These were retrognathia, presence of buck teeth, modified Mallampati test (MMT), upper lip bite test (ULBT), sternomental distance (SMD), interincisor distance (IID), thyromental distance, and neck circumference. DL was identified by Grade III-IV view during laryngoscopy according to the Cormack-Lehane (CL) classification.

Creating a regression model among selected bedside tests for predicting difficult laryngoscopy )defined as Grade III or IV view during laryngoscopy according to Cormack-Lehane classification) is the primary objective. Recruiting of 145 ASA I-II adult patients who would have an elective surgery under general anesthesia were planned.

Criteria for exclusion were: a history of craniofacial surgery or restriction of cervical mobility, edentulous patients, pregnant women, patients who did not have a proper mouth opening (\< 3 cm), and those who might require awake intubation or rapid sequence induction, cancellation of the surgery or change in the anesthetic strategy.

The selected tests and clinical situations were:

The presence of retrognathia (reduced temporomandibular joint-incisor distance) Buck teeth Modified Mallampati test (MMT) in the sitting position without phonation. A scale ranging between 1 and 4 points is used and scores of 3 or 4 are considered as predictors of DL. Upper lip bite test (ULBT) performed in a neutral position. ULBT is graded as 1-3 according to the extension ability of lower incisors.

Sternomental distance - The distance between the mentum and upper border of the manubrium sterni when the head is fully extended and the mouth is closed.

Thyromental distance (TMD) - The distance between mentum and the thyroid notch when the head is fully extended.

Interincisor distance (IID) - The distance between upper and lower incisors when the mouth is fully opened.

Neck circumference (NC) - It was measured at the level of the cricoid cartilage, perpendicular to the cervical axis.

The patients are premedicated with 0.03 mg/kg and oxygenated with the help of a bag-mask. Anesthesia is induced by consequent administration of 2 mcg/kg fentanyl, 1 mg/kg lidocaine, 2 mg/kg propofol, and 0.7 mg/kg rocuronium bromide thereafter. Two minutes after induction, the laryngoscopy is performed

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Candidate for elective surgery under general anesthesia

Exclusion Criteria:

* History of craniofacial surgery or restriction of cervical mobility,
* Edentulous patients
* Pregnancy
* Patients who do not have a proper mouth opening (\< 3 cm)
* Patients who might require awake intubation or rapid sequence induction.
Effect of Critical Patients Mobilization on Respiratory and Peripheral Muscle Strength and Functional Capacity.

To analyze changes on respiratory muscle strength, peripheral and functional capacity of critically ill patients with clinical and surgical etiology, breathing spontaneously and bedridden, within 48 hours of admission to the intensive care unit (ICU) and if there are correlations among these variables. This is an observational study. Respiratory muscle strength will be assessed through the maximum inspiratory pressure (MIP) and maximal expiratory pressure (MEP) and peripheral muscle strength, by the Medical Research Council score (MRC) and hand grip test and functional capacity through the Functional Independence Measure (FIM) and Physical Function ICU Test Score (PFIT-s) in the period between 24h and 48h of hospitalization in the adult ICU. For descriptive purposes, the sample will be stratified according to clinical and surgical characteristics. Correlations will be determined using the Pearson test, with significance level of p \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Breathing spontaneously
* Length of stay in ICU greater than 24 hours
* Adherence to study

Exclusion Criteria:

* Patients with poor prognosis or palliation;
* Preexisting neuromuscular diseases;
* Immobility or restriction to bed prior to admission;
* Nonunions and amputations;
* Osteomioarticular, cognitive or neurological impairment;
* Non-cooperation;
* Specific contraindications to the application of evaluation methods;
* Hemodynamic or respiratory instability within 48 hours of ICU admission preventing evaluation muscle strength and functional capacity.
CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)

Parkinson's disease is a common condition particularly affecting older people. Falls are a very frequent complication of the disease affecting 60% of people with Parkinson's every year. As the population ages, the number of people living with Parkinson's disease and the occurrence of complications will increase. The loss of the chemical dopamine in the brain causes walking in Parkinson's to become slower, unsteady and irregular. People with the condition are therefore at a very high risk of falling. To some extent, people can compensate for these changes by paying more attention to their walking. However, Parkinson's also diminishes memory and thinking ability. This decreases people's ability to pay attention to their walking, especially when doing something at the same time.

Cholinesterase inhibitor (ChEis) are drugs that are currently used to treat people with memory problems in Parkinson's. The effect of these drugs on falls in Parkinson's has been tested to show that treatment has the potential to almost halve the number of falls.

This trial aims to definitively determine whether cholinesterase inhibitors (ChEi), can prevent falls in Parkinson's and whether this treatment is cost effective. 600 participants with Parkinson's disease will be enrolled from hospitals throughout the UK. Participants will be randomly assigned to either receive the drug (ChEi) via a patch or receive a placebo (dummy) treatment via a patch.

Neither the researchers nor the participants will know which group they are in. Participants will take the medication for 12 months and record any falls that they experience in diaries. If successful, this treatment in Parkinson's disease, would tackle one of the most disabling complications of the disease and positive findings will provide robust evidence to change clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease.
* Modified Hoehn and Yahr stage 1-4 disease as determined at baseline visit.
* Have experienced a fall in the previous year.
* Able to walk ≥10m without aids or assistance.
* 18+ years of age.

Exclusion Criteria:

* Previous ChEi use in 12 months prior to enrolment.
* Hypersensitivity to rivastigmine
* Dementia diagnosed according to MDS criteria (6).
* Inability to attend or comply with treatment or follow-up scheduling.
* Non-English-speaking patients (cognitive tests performed in English).
* Falling ≥4x per day.
* Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential.
* Pregnancy and/or breastfeeding
Study to Evaluate the Effect of Multiple Doses of BIIL 284 BS on the Pharmacokinetics of Prednisone in Healthy Male Subjects

Study to evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of prednisone


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated prior to participation into the study
* All participants in the study should be healthy males, aged 18-50 years old inclusive
* All participants should be within (+- 20%) of their ideal body weight (Broca-Index)
* Non-smokers (subject who have never smoked) or ex-smoker for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for 1 year)
* Ability to comply with the concomitant therapy restrictions as detailed in Clinical Trial Protocol (CTP)
* Subjects will be off all prescription drugs. O.T.C. drugs must be discontinued for at least two weeks prior to participation in the study. If throughout the study, subjects need any O.T.C. medication, the investigator will call the clinical monitor and this will be reviewed on a case-by-case basis. Restrictions for different medications are described in CTP
* Subjects will have no evidence of clinically relevant concomitant disease based upon complete medical history, full physical examination, chest-x-ray (if not done in previous 6 months), ECG and clinical laboratory tests

Exclusion Criteria:

* Viral respiratory tract infection or a respiratory tract infection within the six weeks preceding dosing with study medication
* Small or difficult to locate arm or hand veins that would impair the clinicians ability to draw blood samples or to place a venous catheter
* Subjects with a known drug or alcohol dependence (absence of dependency for 10 years) or who drink more than 60 g of alcohol per day, history of significant allergic reactions to drugs or sensitivity to aspirin or positive drug screen
* Use of investigational new drug in the preceding month or six half-lives (whichever is greater) prior to the first screen at Visit 1
* Donation of blood during the month preceding Visit 1
* Subjects receiving hyposensitization therapy who are not on a stable dose for the last three months before Visit 1
* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* Subjects with known history of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects with eosinophilia \> 7 %
* Subjects who received any other drugs, which might influence the results of the trial during the weeks prior to dosing with study medication
* Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before dosing with study medication
Establishment of an ELISA for the Recognition of Procalcitonin Variants in Patients With Hyperprocalcitonemia.

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. However, it is unknown if this applies also in humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.

Procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. More than 20 years ago it has been shown that dipeptidylpeptidase-4 (DPP-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids.

Within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice: They observed that binding of truncated procalcitonin to the CRLR/RAMP1-receptor on vascular endothelium lead to phosphorylation and destruction of VE-cadherin, an essential part of adherens junctions. Consequently, paracellular leakage of proteins and fluid from blood vessels developed.

It is unknown if these effects also apply to humans. By using an ELISA-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data. Futhermore, they want to examine if the procalcitonin-variants have influence on cytokine levels and surface antigens on immune cells by performing multiplex immunoassays and FACS-analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patients with diagnosis...
* Sepsis or,
* SIRS after cardiothoracic surgery or,
* adipositas or,
* granulomatosis with polyangiitis/microscopic polyangiitis or,
* pre-eclampsia
* healthy control subjects
* written informed consent

Exclusion Criteria:

* participation in an interventional study trial within the last 3 months
* relationship to study investigator
Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study

Estimate the proper thyroid screening method during pregnancy. Evaluate if maternal subclinical hypothyroidism treatment during pregnancy result in improved pregnancy outcome and cognitive function in the children.

The investigators conducted a single-blinded trial in which pregnant women at a gestation of less than 12 weeks, usually 6 to 8 weeks, provided blood samples for measurement of thyrotropin, free thyroxine(FT4) and thyroid peroxidase antibody (TPOAb). Women were assigned to a screening group in PUMCH (in which measurements were obtained immediately) or a control group in HMCHH (in which serum was stored and measurements were obtained shortly after delivery). Each group enrolled 1000 pregnant women separately. Women with positive findings in the screening group were given individualized levothyroxine treatment and regular follow-up. Compare the pregnancy outcomes, IQ at 2-3 years of age in children of women with subclinical hypothyroidism between two groups.

Eligibility Criteria:
Inclusion Criteria:

* All of the pregnant women who receive prenatal care in PUMCH and HMCHH
* Sign the consent form
* agree to follow-up the pregnancy outcome and child

Exclusion Criteria:

* the pregnant women who do not agree to enter the study
Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies\[9-11\] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury.

Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing heart surgery on cardiopulmonary bypass
2. Patients aged 18 years to 80 years

Exclusion Criteria:

1. Inability to give informed consent
2. Cardiogenic shock
3. Cardiac arrest on current admission
4. Left ventricular ejection fraction less than 30%
5. Current atrial fibrillation
6. Preoperative use of inotropics or mechanical assist device
7. Patients with significant hepatic dysfunction (Prothrombin\>2.0 ratio)
8. Patients with known renal failure with a GFR\<30 mL/min/1.73 m2
9. Patients with significant pulmonary disease (FEV1\<40% predicted)
10. Recent myocardial infarction (within 7 days)
11. Recent systemic infection or sepsis (within 7 days)
12. Severe stroke (within 2 months)
13. Significant peripheral arterial disease affecting the upper limbs
14. Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
15. Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery