cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands

The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.

* At least 5, but not more than 20 participants will be enrolled in the study.
* Each wart is randomly assigned a test product prior to the start of the study
* Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants
* The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.
* Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.
* Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.
* Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients with 2+ warts being seen at a Dermatologist's office
* 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers
* Warts must have been present for at least 2 months
* Wart size must be between 2 mm-15 mm in diameter
* Participants must be in good general health
* Participants must be able to speak and read in English.
* Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.
* Subjects must be able to understand and execute the instructions presented in pictorial form.

Exclusion Criteria:

* Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).
* Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.
* Known allergies to common topical antimicrobials or the individual ingredients in either test product.
* Participation in a clinical study in the past 7 days or participation in another clinical study
* Unwillingness to perform requirements of the study
* Any medical condition that should preclude participation in the study, at the discretion of the physician
* Missed ≥ 6 of the treatments in a 4 week study period
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:

  * Primo implant of a valve shunt-based derivation system, or as a
  * Replacement of another valve -based shunt system, or
  * Endoscopic ventriculostomy (EVT) failure
* Patient having given his/her informed consent prior to inclusion in this study, as per local regulations

Exclusion Criteria:

* Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body
* Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system
* Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system
Evaluation of Contrast-Enhanced Ultrasound to Detect Endoleaks After Endovascular Aortic Aneurysm Repair

This study will be a cross-sectional survey of interobserver variability associated with contrast enhanced ultrasound (CEUS) to detect endoleaks using computed tomographic angiography (CTA) as the practice standard. The investigators will enroll 40 consecutive patients undergoing endovascular abdominal aortic aneurysm repair (EVAR). At the first follow-up visit after the procedure, participants will undergo two abdominal ultrasound examinations with and without contrast, and one CTA. Analyses will be conducted to examine interobserver variability in the detection and characterization of endoleaks using contrast-enhanced ultrasound (CEUS). Other endpoints include examination of sensitivity and specificity of CEUS compared to CTA, and characterization of the number and types of endoleaks detected.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age or greater;
2. Diagnosed with abdominal aortic aneurysm and has undergone or is scheduled to undergo endovascular repair procedure.
3. Has not completed the first scheduled post-treatment follow-up exam
4. Voluntary participation and signature of IRB-approved informed consent.

Exclusion Criteria:

1. Inability to consent (includes non-English speaking patients)
2. Has already completed the first scheduled post-treatment follow-up exam.
3. Clinical instability;
4. Pregnancy / breast feeding;
5. Known allergy to perflutren;
6. Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts (based on manufacturer recommendations for use);
7. Recent heart attack (\<6 months), unstable angina or uncontrolled cardiopulmonary disease
8. Clinically unstable or recent worsening congestive heart failure (based on FDA warning)
9. Serious ventricular arrhythmias or at high risk for arrhythmias
10. Respiratory failure (based on FDA warning)
11. Severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature (based on FDA warning)
12. Any reason judged by the investigators to hamper inclusion.
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* Obese adults 30 - 65 years old (inclusive);
* Women of child-bearing potential must be using adequate contraception;
* BMI between 30 and 40 kg/m2 (inclusive);
* Diagnosis of OSA syndrome with Apnea/Hypopnea Index (AHI) of 15 or greater;
* Unwilling or unable to comply with CPAP treatment;

Exclusion Criteria:

* Known allergy or hypersensitivity to phentermine or topiramate;
* Sleep disorder other than OSA syndrome;
* Women who are pregnant, breast feeding, or intend to become pregnant during the study;
* Presence of unstable angina or heart failure corresponding to NYHA functional class III or IV;
* History of myocardial infarction or coronary revascularization within the past year; any history of stroke;
* Presence of any clinically significant abnormality on electrocardiogram;
* Use of any prescription CNS stimulants;
* History of cholecystitis or cholelithiasis unless treated by cholecystectomy;
* History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
* Weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 months;
* Previous bariatric surgery;
* Shift workers or any subjects with a circadian rhythm disorder;
* Professional drivers or commercial pilots;
* History of nephrolithiasis;
* More than one lifetime episode of major depression;
* History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder; history of any psychiatric hospitalization;
* History of a seizure disorder; concurrent use of any anticonvulsant drug (other than assigned study drug);
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)

The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.

This is a prospective, multi-center, observational, self-control study assessing screened and consented subjects undergoing instrumented posterolateral fusion for degenerative disc disease (DDD) at 1 to 2 contiguous levels between L1 and S1.

Patients diagnosed with DDD will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. Subjects who are successfully screened and sign an informed consent will undergo PLF surgery utilizing PureGen, Alphagraft ProFuse Demineralized Bone Scaffold (DBS), and ZODIAC, Illico, or Xenon Fixation system (pedicle screw and rod fixation system)

Subjects will be followed at 6 weeks, 3, 6, 12 and 24 month post-operative visits. Standard radiographs will be taken at these visits to evaluate fusion rate and quality. Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) self-assessment questionnaires and neurological exams will be administered to measure pain and function scores. A computerized tomography (CT) scan will be taken at the 6-month to further assess rate and quality of fusion. A conditional 12 and 24 month post operative CT may also be taken. Procedure related and PureGen related adverse events will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lumbar degenerative disc disease in up to two contiguous levels between L1 and S1
* Subjects with back and/or leg pain indicated for posterior stabilization with or without decompression at any level and posterolateral fusion (PLF)
* Unresponsive to conservative treatment for at least 6 months
* Radiographic evidence of primary diagnosis

Exclusion Criteria:

* More than 2 levels requiring posterolateral fusion
* Spondylolisthesis greater than Grade I
* Prior failed fusion surgery at any lumbar level(s)
* Systemic or local infection in the disc or cervical spine, past or present
* Active systemic disease
* Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing
* Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified
* BMI greater than 40
* Use of post operative Spinal Cord Stimulator (SCS)
* Known or suspected history of alcohol and/or drug abuse
* Involved in pending litigation or worker's compensation related to the spine
* Pregnant or planning to become pregnant during the course of the study
* Insulin-dependent diabetes mellitus
* Life expectancy less than duration of study
* Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires
* Undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs.
* Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)
Tissue Kallikrein Preventing the Restenosis After Stenting of Symptomatic MCA Atherosclerotic Stenosis

The study aims to determine whether tissue kallikrein (TK) is efficacy for preventing the long-term in-stent restenosis (ISR) after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery (MCA) M1 segment

A series of studies have confirmed the kallikrein-kinin system (KKS), including kallikrein, kininogen and kinin, plays an important role in the regulation of inflammation secondary to acute and chronic ischemic brain injury. Some researchers found that hTK gene delivery can inhibit the formation of neointimal induced by the common carotid artery ligation in mice. Further study revealed hTK gene transfection in VSMC lead to increased secretion of TK and inhibition of VSMC proliferation. In addition, it was also observed that the serum TK levels were coincident with the carotid artery stenosis. The more severe the stenosis is, the higher the serum TK level is, and the serum TK decreased after carotid artery angioplasty and stent placement. These results suggest that KKS play an important regulatory role in vascular remodeling and TK may exert a beneficial influence in the process of ISR

Eligibility Criteria:
Inclusion Criteria:

1. TIA or stroke in the MCA territory refractory to aggressive anti-platelet and regular statin therapy in 3 months
2. Symptomatic MCA M1 segment stenosis ≥ 70% confirmed with DSA
3. Successfully treated with PTAS without acute surgical complications in 12 hours after operation
4. All patients provided fully informed consent

Exclusion Criteria:

1. Using angiotensin-converting enzyme inhibitors
2. Severe cardiopulmonary dysfunction, chronic liver disease (A / G inversion, ALT increased 2-fold greater than normal), abnormal renal function (serum creatinine greater than 1.5 times normal)
3. Allergies, the history of allergy to multi-drug
4. The history of cerebral hemorrhage, brain tumors, brain trauma, cerebral embolism and other brain lesions
5. During pregnancy or breast-feeding
6. Not expected to complete follow-up
Non-attendance Prediction Models to Pediatric Outpatient Appointments

Non-attendance to pediatric outpatient appointments is a frequent and relevant public health problem.

Using different approaches it is possible to build non-attendance predictive models and these models can be used to guide strategies aimed at reducing no-shows. However, predictive models have limitations and it is unclear which is the best method to generate them. Regardless of the strategy used to build the predictive model, discrimination, measured as area under the curve, has a ceiling around 0.80. This implies that the models do not have a 100% discrimination capacity for no-show and therefore, in a proportion of cases they will be wrong. This classification error limits all models diagnostic performance and therefore, their application in real life situations. Despite all this, the limitations of predictive models are little explored.

Taking into account the negative effects of non-attendance, the possibility of generating predictive models and using them to guide strategies to reduce non-attendance, we propose to generate non-attendance predictive models for outpatient appointments using traditional logistic regression and machine learning techniques, evaluate their diagnostic performance and finally, identify and characterize the population misclassified by predictive models.


Eligibility Criteria:
Inclusion Criteria:

* pediatric outpatient appointments

Exclusion Criteria:

* appointments generated for system benchmarking or appointments with missing data
APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)

The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 80 years
* Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
* Ability to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
* Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
* Had medialization thyroplasty before
* Had injection medialization laryngoplasty in the past two years.
* Presence of structural vocal fold lesions such as polyp or nodules
* Status post total cordectomy
* Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
* Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
* Severe coagulopathy
KOMATE Registry: Korean Multicenter Angioplasty Team

The investigators will enroll the patients who underwent PCI and was based on real world clinical practice to collect the data regarding demographic, clinical, procedural information and clinical outcome using case report forms.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients older than 19 years
* 2. Patients who undergo percutaneous coronary intervention

Exclusion Criteria:

* 1. Refuse to participate
* 2. Pregnant women or women with potential childbearing
Neurostimulation for Cognitive Rehabilitation in Stroke

Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.


Eligibility Criteria:
Inclusion Criteria:

* Ischaemic chronic stroke
* Mild/Moderate Cognitive impairment
* Informed consent

Exclusion Criteria:

* National Institute of Health Stroke Scale (NIHSS) ≥ 16 points
* Severe cognitive comorbidities (dementia, depression)
* transcranial direct current stimulation criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system
NEUROR: Exploring the Neural Basis of Reasoning

Decades of research have long established that people's reasoning can be biased by their intuitions and deviate from logical norms. Popular dual process models that characterize thinking as an interaction between intuitive and deliberate thought processes have presented an appealing explanation for this observation. Within this account logical reasoning is traditionally considered as a prototypical example of a task that requires effortful deliberate thinking. In recent years, however, a number of findings obtained with new behavioral paradigms have questioned the traditional dual process characterization. A key observation is that people can process logical principles in classic reasoning tasks intuitively without deliberation.

The fast or intuitive logic findings have far stretching theoretical implications for dual process theories and our view of human rationality. However, the nature of this newly discovered fast logical reasoning is not clear. One limitation is that its neural basis has not been explored. The primary goal of this project is to address this shortcoming in a functional magnetic resonance imaging (fMRI) study. In the study adult participants will solve classic reasoning problems (i.e., variants of the bat-and-ball problem) in the scanner. Half of the trials will be traditional "Slow" trials in which participants get ample time to deliberate (i.e., 20 s). The other half of the trials will be "Fast" trials in which people do not get sufficient time to deliberate (i.e., 4 s deadline) and need to rely on intuitive processing.

All participants in the fMRI study will be healthy adults aged between 18-45. In addition to contrasting correct responders' brain activation during fast and slow trials, we will also contrast the fast and slow activations for correct and incorrect responses. This will allows us to identify brain regions associated with both correct and incorrect fast and slow logical responses and reach our study objective.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* signed informed consent form
* medical, neurological, neuroradiological healthy
* social security number
* use of contraception for female subjects

Exclusion Criteria:

* standard contra-indication for MRI examination (pacemaker, metallic implants/dental braces, claustrophobia, pregnancy)
* chronic drug or alcohol user
* cognitive disorders linked to cardiovascular accidents
* chronic neurological or psychiatric disorder
* history of major illness (diabetes, metabolic, cancer, immunological)
* use of medicines that can potentially interfere with cerebral imaging (psychotropic drugs, hypnotics, anxiolytics, neuroleptics, anti-parkinson drugs, benzodiazepines, steroidal anti-inflammatory drugs, antiepileptics, anti-histamines, central analgesics and muscle relaxants)
* dyschromatopsia
* pregnant female
* non-MRI compatible tattoo
The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns

This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools.

Intervention group: During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.

Control group: Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.

Eligibility Criteria:
Inclusion Criteria:

* Connected to a mechanical ventilator (intubation or nasal CPAP),
* Term newborns (born at 37-42 weeks),
* No neurological disorders,
* No congenital or acquired hearing malformations,
* The family consents for their infant to participate in the study,

Exclusion Criteria:

* Diagnosis of asphyxia,
* Use of sedatives or analgesics,
* Congenital anomaly,
* Underwent an extra invasive procedure or surgical intervention,
* Parents with congenital hearing problems.