cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Two Repeat Doses of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

This study's objective is to evaluate if RT001 is safe and well-tolerated following two (2) sequential applications.

Revance is conducting this Phase 2 clinical study to establish the safety of two (2) sequential doses of RT001 Topical Gel at Baseline (Day 0) and Week 4 for the treatment of moderate to severe LCLs at rest.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a woman of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study
* Previous treatment with botulinum toxin (any serotype)
BIOFLOW III Satellite-Italy Orsiro Stent System

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry. The sample size maybe increased in order to reach the subgroup sizes (Diabetes, small vessel, AMI and CTO).

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. Results will contribute to the collection of clinical evidence for the clinical Performance.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age

Exclusion Criteria:

* Subject did not sign informed consent
* Pregnancy
* Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint not reached yet
A Study Comparing Two Magnetic Resonance Imaging (MRI) Contrast Agents in MRI of the Brain

This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days

Exclusion Criteria:

* Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams
Evaluation of the Stability of Osseointegrated Implant in Amputees

The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implant section that protrudes from the soft parts.

The benefits of using an osseointegrated prosthesis are the improved sensory feedback (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis to the abutment, greater control of the prosthesis and the absence of heat, pain, and pressure sores.

The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good growth of bone and muscle mass. The aim of this study is to evaluate the stability of the osseointegrated implant in trans-femoral and trans-humeral amputees.

The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and follow-up.

The secondary outcome: evaluation of the quality of life improvement in patients through clinical score and satisfaction survey.


Eligibility Criteria:
Inclusion Criteria:

* BMI\<35 kg/m2
* Problem in using socket

Exclusion Criteria:

* Diabetes;
* Peripheral vascular diseases;
* Psychiatric problems;
* Pregnancy;
* Rheumatoid arthritis;
* Neurovascular diseases;
* Neurological deficits;
* Amputation of the contralateral limb;
* Infections in progress;
* Immunosuppression;
Status Asthmaticus on the PICU; Intravenous Salbutamol

Although IV salbutamol is frequently used in children in a wide range, pharmacodynamic data are scarce. To date, there is an insufficient evidence base to guide initial and subsequent dosing recommendation for its IV use in children. Especially the need for a loading dose needs to be addressed. Therefore, pharmacodynamic and kinetic data are needed to guide initial dosing strategies of IV salbutamol in children. To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the loading dose, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Between 2-18 years of age at moment of inclusion
* Admitted to PICU for Severe Acute Asthma or Severe acute (viral) wheeze
* Requiring administration of IV salbutamol

Exclusion Criteria:

* Patient is outside of specified age range
* Patient has already received a -loading dose- of IV salbutamol in the general hospital
* Lower airway infection with consolidation on a chest X ray -Patient has Down's Syndrome
* Patient has a congenital/acquired heart defect that interferes with normal asthma treatment
* Patient has a primary/secondary immunodeficiency
* Patient has a pre-existing chronic pulmonary condition, known to mimic asthma: Cystic fibrosis, Bronchopulmonary dysplasia, Bronchiolitis obliterans
A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

This will be an open, two arm, parallel group, randomised, controlled investigation of the ANSeR Software System as a stand-alone neonatal seizure recognition decision support tool. Term neonates requiring EEG monitoring will be stratified by recruiting site and then randomised to receive either EEG monitoring with the ANSeR Software System or EEG monitoring without the ANSeR Software System.

It is proposed that the rate of true detections (sensitivity) of investigation personnel using the ANSeR Software System in clinical practice will be at least 25% higher than that of investigation personnel not using the ANSeR Software System in routine clinical practice. In addition we expect the specificity of investigation personnel using the ANSeR Software System to be no worse than 10% less than that of investigation personnel not using the ANSeR Software System. This should result in more appropriate and timely use of antiepileptic drugs (AED).

Randomisation Immediately following enrolment in the investigation, each participant will be randomly assigned to receive either EEG monitoring with the ANSeR Software System or without the ANSeR Software System. Randomisation will be stratified by recruiting site with a 1:1 allocation ratio to each group. Block randomisation with varying block sizes will be used and the randomisation and allocation will be performed centrally using a web-based electronic system.

Blinding As this is an investigation of a medical device (software), the investigation personnel will be aware of which group the participant is assigned to. The expert panel who are the diagnostic reference standard will be blinded to group allocation. The biostatistician will also be blinded to group allocation during the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* Neonates 36 weeks - 44 weeks corrected gestational age in whom EEG monitoring is indicated because they are deemed to be

  * at high risk of seizures or
  * are experiencing seizures

Exclusion Criteria:

* • No parental/guardian consent
Epididymal U.S Findings in Asthenozoospermic &Correlation With L.Carnitine Level

To evaluate the epididymal findings by U.S and study its correlation with seminal parameters including L.carnitine level in infertile males

infertility is a relatively common problem affecting about15-20% of reproductive aged couples. Historically, the cause of infertility was falsified attributed to the female partner, while the male factor, which is either primary or a co factor in 40-60% of cases, has largely been ignored Thus, it is important to evaluate men at the same time with women.(2) The epididymis is an elongated structure, posterolateral to the testis within the scrotal sac. Its primary function is the collection, maturation and transport of sperm from rete testis to the ductus deferens.(1)(3) Testicular spermatozoa are nonfunctional and lack the ability to naturally fertilize an oocyte .After, spermatozoa reach the epididymis they undergo a complicated maturation process leading to biochemical, physiological and functional changes resulting in a functional spermatozo on that is able to successfully fertilize an oocyte (3)(4)(8) Sperm dysfunctions are recognised as the most significant cause of male infertility and many may think that sperm dysfunction is only as a result of defective spermatogenesis. However, it can also be the result of an inadequate epididymal maturation process due to improper epididymal function (6)(7)(8) Scrotal sonography is commonly used for evaluation of the infertile male. While abnormalities of the epididymis like( cysts and calcifications ) are frequently observed during sonographic assessment and their presence has uncertain importance (1)(10)(12)(13) Measurement of acetyl carnitine content of human seminal plasma could be used as a marker of epididymal maturation. Carnitine is present in the epididymis at higher concentrations than in other body tissues in the rat

Eligibility Criteria:
Inclusion Criteria:

* 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) Age from 18 to 55 years.

Exclusion Criteria:

* Extreme age
* Single
* Recent L carnitine intake
* Undesended testis
* Genetic cause of inferitility
* Patients with clinical Varicocele
* Azoospermic patients
Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

The purpose of study to assess the short-term efficacy and safety of probiotic E.coli Nissle 1917 strain comparing to lactulose and rifaximin in patients with mild (Stage 1-2) or minimal hepatic encephalopathy


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement or radiological study;
* presence of minimal or mild (Grade 1-2) HE as defined by West Haven criteria;
* two or more documented episodes of HE in the last 6 months, in addition to at least one episode in the last 3 months;
* subject is capable and willing to comply with all study procedures;
* signed inform consent.

Exclusion Criteria:

* history of taking L-ornithine- L -aspartate, zinc, metronidazole, or neomycin, antibiotics, probiotics and yogurt consumption within 6 weeks;
* subject has a history of allergy or intolerance to lactulose and/or rifaximin;
* alcohol intake during the past 6 month or during follow up;
* recent (6 weeks) gastro-intestinal bleed;
* hepato-cellular carcinoma or liver transplantation;
* renal insufficiency;
* significant comorbid illness such as heart or respiratory failure;
* concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection;
* any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies;
* subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments.
Gene Regulation by Thiazolidinediones

The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Agrees to use a barrier method of birth control for the duration of the study

Exclusion Criteria:

* History of inflammatory bowel disease
* Has taken prescription or over the counter medications in the two weeks prior to enrollment
* History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS
* Fasting LDL \>160 mg/dl
* History of smoking in the year prior to enrollment
* Pregnant or breastfeeding
Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA

Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients.

The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.

This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia.

Main indicators:

VAS score at 30 min after operation.

Secondary indicators:

VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old
* ASA Ⅰ-Ⅲ
* patients undergoing functional endoscopic sinus surgery under general anesthesia.

Exclusion Criteria:

* Significant hypertension (diastolic blood pressure \> 100mmHg) or hypotension (systolic . blood pressure \< 100mmHg).
* severe mental, cardiovascular, kidney or liver disease.
* previous history of alcohol or drug abuse.
* long-term use of painkillers before operation.
* contraindications for any drugs used in the study.
Study of Fibromyalgia Treated With Milnacipran

The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are:

1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
2. Fibromyalgia patients may have different sites of innervation.
3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.
4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.


Eligibility Criteria:
Inclusion Criteria:

* Female age 18-70
* fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites.
* VAS score greater that 40mm at Screening and Randomization visits.

Exclusion Criteria:

* History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator.
* Allergy to lidocaine
* Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
* Women who are pregnant, breastfeeding or trying to become pregnant
* Active cancer with the previous two years except treated basal cell carcinoma of the skin.
* presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or QST
* Co-existing conditions that can produce chronic widespread pain
* Presence of uncontrolled or severe depression
* Patients with Worker's Compensation, pending Worker's Compensation,
* any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above.
* presence of uncontrolled narrow-angle glaucoma
Peripheral Bypass Trial for Completion Control

The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle


Eligibility Criteria:
Inclusion Criteria:

* Chronic Limb-Threatening Ischemia as defined by presence of Peripheral Artery Disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration\>2 weeks duration (ref Global Guidelines)
* Atherosclerotic infra-popliteal PAD
* Adequate distal anastomotic target (crural, tibial or popliteal below the knee with one single run-off) between knee and ankle distal to the stenotic/occluded segment.
* Available autogenous vein conduit based on preoperative vein mapping.
* Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.

Exclusion Criteria:

* Bypass with artificial conduit or cryopreserved allografts
* Bypass for non-atherosclerotic lesions
* Life-expectancy less than 2 years
* Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.
* Any condition that the investigator believes should exclude participation.
* Excessive risk for adverse events during open surgery as judged by the investigator.
A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation

The spinal cord is a very important part of the central nervous system. fMRI can be applied to observe functional status of the human spinal cord. Under different conditions, the investigators will see different types of fMRI signals within the spinal cord. In resting state, the investigators might see active/inactive signals, too.


Eligibility Criteria:
Inclusion Criteria (for healthy people):

* Chinese male residents
* right handed
* no history of psychological/psychotic problems
* no history of important diseases

Exclusion Criteria (for healthy people):

* with factors which make subjects unsuitable to receive MR examination
* history of important diseases

Inclusion Criteria (for patients):

* Chinese male patients with ischemic stroke (CT/MRI scan confirmed)
* right handed
* at least 1.5 months from onset of stroke
* ability to follow complex commands

Exclusion Criteria (for patients):

* hemodynamic instability
* history of dementia
* inability to give consent because of impaired cognition or receptive aphasia
* diseases in spine/spinal cord
* with factors which make subjects unsuitable to receive MR examination