cyrilzakka/clinical-trials huggingface dataset:
Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds

Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.

The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).

Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle.

Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 25 - 65 years
* Male or Female
* Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
* Good general health status
* Able to give informed consent

Exclusion Criteria:

* Clinically significant abnormalities of haematology or biochemistry testing
* Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time
* Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
* Allergy to local anaesthetics
* Active infection at the treatment site
* Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrolment
* Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
* Pregnancy/lactation
* History of keloid formation
* Systemic corticosteroids within last 12 weeks
* Diabetes or metabolic disorders
* A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
* Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.
* Participation in any other clinical trial one month prior to treatment and for the duration of the study.
Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers

62 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia

This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 80 years;
* New-onset stroke, confirmed by head CT or MRI;
* The course of disease between 1 to 6 months;
* With pharyngeal dysphagia shown by VFSS;
* Stable vital signs;
* Voluntary participation in the study.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
* Dysphagia caused by other diseases or reasons.
everlinQ endoAVF Post Market Study

Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age \>18 years old)
* Currently on chronic dialysis or expected to be started on chronic dialysis within 3 months of planned endoAVF creation
* Target treatment vein diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Venogram
* Target treatment artery diameter(s) for fistula creation ≥ 2.0 mm as measured via Duplex Ultrasound or Arteriogram
* Both radial and ulnar artery flow to the hand, as confirmed with Duplex Ultrasound and/or Allen's test (i.e.: palmar arch)

Exclusion Criteria:

* Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation
* Absence of perforator feeding the target cannulation vein(s) via Venogram
* Occlusion or stenosis \>50% of target cannulation cephalic or basilic vein
* Significantly compromised (≥50% stenosis) flow in the treatment arm
* Documented ejection fraction (EF) ≤35% in the last 6 months
* Pregnant women
* New York Heart Association (NYHA) class III or IV heart failure
* Hypercoagulable state
* Known bleeding diathesis
* Documented history of drug abuse including intravenous drugs within six months of AVF creation
* "Planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment
* Known allergy to contrast dye which cannot be adequately pre-medicated
* Known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated
* Evidence of active infections on the day of the index procedure
* Estimated life expectancy \< 1 year
* Patient is not willing to provide written informed consent, is not geographically stable and/or not willing to comply with required follow-up
* Patient with a target cannulation vein that is \> 6mm deep that would require a transposition procedure, defined as the elevation of a target cannulation vein AND the creation of a new AV fistula
* Patient is not willing to undergo a 2nd stage procedure as defined in Section 4.5.3 of the study protocol.
Sound Therapy for Tinnitus Relief in Cochlear Implant Users

The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
* At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
* Native speaker and fluency in the language used in the assessments (i.e. Dutch)

Exclusion Criteria:

* Additional handicaps that would prevent participation in evaluations
* History of psychiatric disorders or depression (on investigator's opinion)
* Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
* Pulsatile or diagnosed objective / middle ear tinnitus
Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.

Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Health Class 1-4
* Age 50-85 years
* Fluent in Swedish language
* Scheduled for primary hip replacement surgery due to arthrosis
* MMSE (minimental state test score \>= 25.

Exclusion Criteria:

* Patient refusal to participate in the trial
* Current autoimmune disease, including arthritis
* Ongoing smoking, snuff or other nicotine compound treatment
* Significant neurologic or psychiatric disorder (such as Alzheimer's disease, Parkinson's disease, Multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative MMSE score ≤ 24
* History of stroke with neurological sequelae.
* Current severe cardiac (NYHA\>IV) or renal (plasma creatinine\> 0.250 mmol/l) Coagulopathy making spinal anesthesia and intrathecal catheter placement impossible
* Terminal phase of a chronic disease.
* Patient on chronic steroidal therapy
* Poorly controlled diabetes mellitus.
* Presumed uncooperativeness or legal incapacity.
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth.

The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.


Eligibility Criteria:
Inclusion Criteria:

* Left-sided CDH
* Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth
* Gestational age at delivery ≥35.0 weeks
* Parental written informed consent

Exclusion Criteria:

* Right-sided or bilateral CDH
* Gestational age at delivery \<35.0 weeks
* Maternal contraindications: anterior placenta praevia, placental abruption
* High urgency caesarean section, with intended interval to delivery \<15 min
* Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension
* Twin pregnancies in which the infant diagnosed with a CDH is born first
* Multiple birth \>2 (triplets or higher order)
A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190

Fabry disease is a rare, X-linked inborn error of glycosphingolipid metabolism caused by an abnormal gene encoding the α-galactosidase A (αGLA) enzyme. The αGLA enzyme is ubiquitously expressed throughout the body and is responsible for the breakdown of glycosphingolipids, deficiency of which results in the accumulation of specific glycosphingolipids that are associated with the pathophysiology of the disease. Current treatment for Fabry disease is limited to the symptomatic management of pain, conventional management of complications, and methods to increase the availability of functional αGLA.

This clinical study aims to investigate the long-term safety and durability of αGLA in patients who have been dosed with a new gene therapy product (FLT190) in earlier clinical studies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have previously received FLT190
* Provision of full informed consent and able to comply with all requirements of the study including long-term follow-up for 60 months (5 years) post-treatment.

Exclusion Criteria:

* N/A
Effects of Nitrate in Vegetables on Blood Pressure in Subjects With Prehypertension

The purpose of this study is to examine the effect of different vegetables on cardiovascular function in subjects with moderately increased blood pressure. Specifically we are comparing the effects of vegetables with a high natural content of inorganic nitrate with those of vegetables with a low nitrate content.

Recent studies indicate that dietary-derived inorganic nitrate can affect blood pressure in humans by converting into nitric oxide bioactivity. Here we will study if vegetables that naturally contain high amounts of nitrate (green leafy vegetables) can lower blood pressure and whether any effect is attributed to the nitrate anion. High nitrate vegetables are compared with vegetables low in nitrate (e.g. tomatoes, sweet pepper). After a 2 week run in period where all subjects receive vegetables low in nitrate, the participants are randomized to one of three interventions. One third of the patients receive high-nitrate vegetables + a placebo pill (KCl), one third receives low-nitrate vegetables + placebo and the third group receives low-nitrate vegetables + a nitrate pill (KNO3). The nitrate content in the pill is precisely matched to the nitrate content in the high-nitrate vegetable group.

Eligibility Criteria:
Inclusion Criteria:

Age 50-70 years Systolic blood pressure \>130 at screening visit 2

Exclusion Criteria:

Systolic blood pressure \<120 or \>159 mm Hg at screening 2 Systolic blood pressure \> 169 mm Hg at screening 1 Chronic kidney disease Chronic rheumatic disease Insulin treated diabetes mellitus Atrial fibrillation Major cardiovascular event within 6 months Inflammatory bowel disease Malignancy, actively treated within 6 months Hepatitis Polycytemia Vera
Effects of Catheter Tip Location Relative to the Femoral Nerve on Sensory and Motor Function

To determine if the way local anesthetic, or numbing medication, is delivered through a tiny tube next to the nerves that go to the thigh affects the strength and sensation in the thigh.

Specific Aim: Research study to test the hypothesis that differing the location of the perineural catheter tip during a continuous femoral nerve block (anterior vs. posterior) impacts quadriceps muscle strength. These results will help define the optimal perineural catheter tip location relative to the femoral nerve used for continuous peripheral nerve blocks and help guide both clinical care and future research in this clinically-relevant area.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Willing to have bilateral femoral perineural catheters placed with a subsequent ropivacaine infusion and motor/sensory testing for 6 hours, requiring an overnight stay in the UCSD GCRC/CTRI to allow dissipation of local anesthetic infusion effects by the following morning

Exclusion Criteria:

* current daily analgesic use
* opioid use within the previous 4 weeks
* any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
* body mass index \> 30 kg/m2
* pregnancy
* incarceration
Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
2. Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
3. No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
4. Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
5. No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
6. At least 1 measurable lesion as defined based on RECIST v1.1 by investigator

Key Exclusion Criteria:

1. Has received docetaxel as monotherapy or in combination with other therapies.
2. Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (\> 50 mL/day)
3. Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
4. Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.

The primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.


Eligibility Criteria:
Inclusion Criteria:

* Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone.
* Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1.
* Have an absence of mucosal breaks in the esophagus, as defined by the LA classification, at the visit 1 endoscopy.
* Have provided Informed consent.

Exclusion Criteria:

Subjects with current or historical evidence of the following conditions are excluded from the study:

* Erosive esophagitis.
* Esophageal columnar metaplasia (Barrett's esophagus) of 1.0 cm or greater.
* Esophageal stricture.
* Primary esophageal motility disorder(s), i.e. diffuse esophageal spasm, achalasia.
* Systemic Sclerosis (scleroderma).
* Irritable Bowel Syndrome (IBS), i.e. upper abdominal discomfort or pain that in the opinion of the Investigator is likely to be due to IBS or fulfilling two or more of the criteria: relieved by defecation, associated with change in frequency of stools, associated with change in form (appearance) of stools.
* Inflammatory bowel disease.
* Zollinger-Ellison syndrome.
* Gastric ulcer, duodenal ulcer or duodenal erosions within the last 3 months

Subjects with i) history of significant or ii) current significant or unstable:

* Cardiovascular diseases or cardiac chest pain.
* Cerebrovascular diseases, such as cerebral ischemia, infarction, haemorrhage, or embolus.
* Diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable.
* Pulmonary, renal, pancreatic or liver diseases or any other serious disease as judged by the investigator to interfere with the evaluation of the current study.
* Malignant disease (except for minor superficial skin disease).
* Generalised bleeding disorders.
Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.


Eligibility Criteria:
Inclusion Criteria:

* mid-upper arm circumference (MUAC) \<11.5 cm

Exclusion Criteria:

* Children currently involved in another research trial or feeding program
* Children developmentally delayed
* have a chronic debilitating illness
* history of peanut or milk allergy
Microbial Community Transplantation on the Armpit/Foot

The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit/foot is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a doctor.


Eligibility Criteria:
Inclusion Criteria:

* Bad armpit or foot odour