cyrilzakka/clinical-trials huggingface dataset:
Effect of Auditory Stimulation on Spike Waves in Sleep

Background: Close relationship exists between sleep slow wave (SSW) and the generation of spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between excitatory depolarization ("Up-phase" of the SSW) and inhibitory hyperpolarization ("Down-phase" of the SSW). It has been shown experimentally that with increasing synchrony of slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in correspondence to the SSW "Up-phase" enhance the amplitude of the subsequent SSW. Conversely, tones delivered at the SSW "Downphase" have a disruptive effect on the following SSW.

Participants: Patients with epilepsy and spike waves in NREM-sleep.

Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by acoustic pulses applied at the "Up-" or "Down-phase" of SSW.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Rolandic epilepsy/BECTS
* Participants with ESES/CSWS
* Participants with generalized spike waves in sleep
* EEG within 6 months before study night consistent with the diagnosis

Exclusion Criteria:

* Clinically significant concomitant acute or chronic disease
* Seizure frequency \>1/week, history of convulsive status epilepticus or seizures provoked by sleep deprivation
* Severe sleep problems
* Treatment with corticosteroids, immunosuppressive or vagus nerve stimulation
Biomarkers in Dermal Interstitial Fluid for Early Diagnosis and Follow-up of Cardiovascular Diseases

Sampling of dISF and blood plasma for qualitative measurements.

Sampling of dISF will be performed to investigate biomarkers in dISF for early diagnosis and follow-up of cardiovascular diseases.

Eligibility Criteria:
Inclusion criteria:

Group 1: Chronic heart failure with stable therapy. NYHA classification III and IV. Age \> 60 years. Group 2: Age 18-40 years.

Exclusion criteria:

* Participating in another clinical investigation which may affect the study outcome according to clinical judgement.
* Previous use of sampling system used.
* Pregnancy or lactating.
* Any disease or condition that may be affected.
* Individuals who lack the ability to fully consent to participate in the study.
* Severe skin injury.
* Tattoo or piercing close to sampling area.
* Group 1: All forms of emergency care.
* Group 1: Non-stable therapy.
* Group 1: Sepsis.
* Group 1: BMI \> 30kg/m2.
* Group 1: Age \> 84 years.
* Group 2: Known heart or vascular disease.
* Group 2: Diabetes.
* Group 2: Kidney disease.
Stated-Preferences in Knee Arthroplasty

The primary objectives of this study are to apply best-practice stated-preference methods to quantify patient preferences for benefit-risk tradeoffs associated with arthroplasty treatment options for end-stage osteoarthritis of the knee. Duke will develop and administer stated-preference surveys to adult patients (Ages 40-80) with knee pain to collect preference data, estimate the relative importance of treatment features and outcomes, and estimate maximum acceptable risks for given benefits and minimum acceptable benefits for given harms. This study proposal describes plans for the patient stated-preference survey.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-80
* Knee Pain

Exclusion Criteria:

* Inability to read, understand and give effective English consent
Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)

This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged \>/= 18 years
* Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or Adenocarcinoma of the prostate
* At least 1 unidimensional measurable lesion (suitable for RECIST evaluation) or for patients without measurable disease, CA 125 levels \>/= 2 times the upper limit of normal (ULN) within 3 months and confirmed within 2 weeks prior to first infusion (ovarian cancer) or PSA value \>/= 5 ng/mL (HRPC).
* Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.
* Progression of disease (Ovarian Cancer) or symptomatic relapse after previous therapy (elevated CA125 levels alone are insufficient for inclusion) WHO performance status 0 to 1
* No clinical residual neuropathy (CTCAE Grade 0 at baseline)
* Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
* Adequate function of major organs and systems.
* Survival expectation =3 months
* Histologically or cytologically proven:

  1. Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of \>33%)

Exclusion Criteria:

* Symptomatic brain metastases requiring whole- brain irradiation
* Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment \>/= 5 years ago without relapse.
* Diabetes mellitus (even if controlled only by special diet)
* History of chronic hepatitis B or C, or known HIV infection
* Seizure disorder requiring medication (such as steroids or anti-epileptics)
* Inability to swallow oral medications
* Prior treatment with epothilones
* Concomitant use of neurotoxic drugs
* Concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy
Selection of Laryngeal Mask Airway in Patients With Slender Somatotype

The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.

One hundred and eighteen patients adult patients，actual body weight much less than ideal body weight will be assigned randomly to two groups (Actual weight Group or Ideal weight Group). Size selection was guided by the recommendations of manufacturer, patients will be based on the actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.

The success rate of first attempt，number of adjustments, insertion time, ease of insertion, overall success rate, oropharyngeal leak pressure and fiberoptic view will be recorded and compared. The occurrences of respiratory complications such as sore throat, hoarseness, and dysphonia will be observed and recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;
2. Patients' actual weight much less than ideal weight.

Exclusion Criteria:

1. Patients with gastroesophageal reflux disease;
2. Patients with predicted difficult airway;
3. Patients with preexisting airway diseases or significant upper airway infection.
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)

Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 and over
2. H/o closed head injury
3. Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
4. Must meet criteria for major depression as assessed by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual IV (DSM-IV) and a score greater than 10 on the Hamilton Depression 17 (HAM-D17) Scale

Exclusion Criteria:

1. Subjects with skull fracture
2. Subjects who meet DoD criteria for severe TBI
3. Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
4. Subjects who are medically unstable
5. History of active substance abuse x 1 month
6. Current psychotic illness
7. Evidence of frontal lesions on brain scan.
8. Individuals with a significant neurological disorders that could increase risk of seizures such as brain tumor, cerebral aneurysm, any h/o seizures and/or family h/o seizures
9. Dementia
10. Mini Mental State Exam score of less than or equal to 24
11. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire
12. Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit
13. History of treatment with rTMS therapy for any disorder
14. History of treatment with Vagus Nerve Stimulation (VNS)
15. History of treatment with Deep Brain Stimulation (DBS)
16. Cardiac pacemakers, implanted medication pumps, intracardiac lines,
17. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
18. Implanted neurostimulators
19. Known or suspected pregnancy
20. Investigators, personnel affiliated with this study, and their immediate families.
Use of the Stethoscope to Confirm Breathing Tube Placement

This study is intended to validate the use of neck auscultation with an electronic stethoscope during intubation to confirm tracheal tube placement.

It is hypothesized that the ability to confirm correct tube placement with this technique will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for confirming tracheal intubation.

Unrecognized esophageal intubation results in disastrous consequences. Fortunately, a variety of techniques have been cited to confirm placement of the endotracheal tube. However, even end-tidal CO2 monitoring, considered to be the gold standard, has been associated with false positive and false negative results. In addition, use of this monitor requires ventilation through the tube, resulting in gastric distention if the esophagus has been intubated.

When the lateral neck is auscultated during insertion of an endotracheal tube, there is a distinct difference between the sounds generated by a tube placed in the esophagus compared to a tube inserted into the trachea. Stethoscopes are readily available in any OR setting, and ventilation and release of cricoid pressure need not occur prior to confirmation of tube placement. However, this technique has yet to be validated.

A series of sounds heard at the lateral neck during both tracheal and esophageal intubation will be recorded using an electronic stethoscope. These sound files will be played to a group including both experienced and inexperienced intubators, who will be asked to identify which sounds represent tracheal and esophageal intubation. Overall accuracy will be determined for the group of listeners.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

* Anticipated difficult intubation
* Contraindication to esophageal intubation
Candidate Gene Association Study With Injury in Elite Male Youth Football Players

Understanding how candidate genes, previously associated with injury susceptibility, influence the incidence of muscle, bone, ligament, and tendon injuries across the development pathway of elite footballers may provide valuable insight into inherent injury predisposition to support the long-term development of every individual. Therefore, the aim of the present study was to investigate the association between candidate genetic variants and muscle, bone, ligament, and tendon injuries in elite football with sub-analysis of the influence of age and maturation on injury susceptibility.

Genetic variants in several candidate genes which code for structural constituents (COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722 and ACTN3 rs1815739), regulatory components (ACE rs1799752, ESR1 rs2234693 and MMP3 rs679620) and transcription factors (VDR rs2228570 and GDF5 rs143383) affecting the form, function and injury susceptibility of muscle, bone, ligament, and tendon tissue will be associated with overall injury, non-contact, bone, ligament, tendon and apophysitis injury risk in elite male youth and adult footballers.

Eligibility Criteria:
Inclusion Criteria:

* Elite Male Footballer Player Registered at Fulham Football Club

Exclusion Criteria:

* Female no longer registered at Fulham Football Club
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-55 years
* Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
* Patients able and willing to provide informed consent

Exclusion Criteria:

* Visible scar within the HIFU beam path that cannot be avoided
* Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
* Currently pregnant or desire to become pregnant in the future
* Pelvic malignancy
* Pelvic congenital malformation
* Acute pelvic infection
* Otherwise determined by a physician to be inappropriate for the study
Impact of Hepatic Impairment on the Pharmacokinetics of Deferasirox.

This study is to assess the pharmacokinetics of deferasirox in hepatically impaired patients compared to healthy volunteers.


Eligibility Criteria:
Inclusion criteria for those with hepatic impairment:

* Physical signs consistent with a clinical diagnosis of liver cirrhosis
* Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
* Otherwise considered healthy

Inclusion criteria for healthy volunteers:

• In good health.

Exclusion criteria for those with hepatic impairment:

* Clinically significant abnormal findings other than hepatic impairment
* Clinical evidence of severe ascites
* History of surgical portosystemic shunt
* Any evidence of progressive liver disease within the last 4 weeks

Exclusion criteria for healthy controls:

* Clinical evidence of liver disease or liver injury
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* Use of any prescription medication within 1 month prior to dosing

Other protocol defined inclusion/exclusion criteria may apply.
Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically/cytologically confirmed diagnosis of SCLC.
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be ≥ 18 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.

Exclusion Criteria:

1. Histology confirmed the mixed NSCLC components;
2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
7. Received live vaccination within 28 days before the first administration of the study drug;
8. 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.
9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
10. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
An Early Feasibility Evaluation of a Novel 3rdMolarTooth Bud Ablation Procedure

This single-arm prospective study will enroll a minimum of 7 and a maximum 10 subjects between the ages of 7 and 13 years of age with radiographic evidence of mandibular 3rd molar tooth bud development without enamel formation. Each subject will undergo a 3TBA procedure for each qualifying mandibular 3rd molar tooth buds. Each subject will receive treatment for qualifying mandibular tooth buds during the same session. Subjects will be followed for a minimum of 12 weeks post treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 7 and 13 years of age
2. Subject has radiographic evidence of at least one mandibular 3rd molar tooth bud

Exclusion Criteria:

1. Subject use of articaine is contraindicated (known hypersensitive to products containing sulfites).
2. Subject has any condition which, in the opinion of the Investigator, would prevent adequate performance of the procedure or affect the health and/or safety of the subject.-
Delayed Colorectal Cancer Care During Coronavirus Disease (COVID-19) Pandemic (DECOR-19)

To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.


Eligibility Criteria:
Inclusion Criteria:

* Members of renowned scientific societies with an interest in coloproctology

Exclusion Criteria:

* None
Safety and Performance of the Neuroform Atlas™ Stent System

The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018.

This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018.
* Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain

the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
* VAS pain score more than 5
* failed analgesic drug treatment

Exclusion Criteria:

* coagulopathy
* neurogenic bladder
* infection at site of procedure
Outcomes of Delivery in Patients With Dyspareunia

The focus of this pilot study is to determine if a woman who experiences pain during sexual intercourse has a higher risk of complications during labor and delivery secondary to pelvic floor dysfunction, anxiety and intolerance towards pelvic examinations. Furthermore, it is unclear whether women with prepartum dyspareunia experience an improvement following vaginal delivery. While physicians may expect that vaginal birth improves dyspareunia due to the stretching effect on pelvic floor, to date, there is insufficient evidence to support this claim. The Investigators plan to prospectively study 200 patients at our Institution, collect information regarding birth and follow them, via questionnaires, regarding their dyspareunia postpartum.


Eligibility Criteria:
Inclusion Criteria:

1. 200 nulliparous women admitted to the Labor and Delivery Department at the Hadassah Medical Center, above the age of 18.
2. Able and willing to read, understand, and sign the Informed Consent Form and questionnaire.
3. Agree to be contacted in the future to complete telephone questionnaires.

Exclusion Criteria:

1. Induction of labor
2. Placental abruption, placenta previa
3. Malpresentation
4. Non reassuring fetal heart rate upon admission
5. Any other contraindication for vaginal delivery
6. Multifetal pregnancy