cyrilzakka/clinical-trials huggingface dataset:
Pharmacological and Behavioral Treatment of Insomnia

to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.

DESIGN NARRATIVE:

The study examined the relative efficacy of a pharmacologic, cognitive behavioral, and conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia. Sixty-three medication-free, chronic sleep-onset insomniacs completed evaluations, baseline sleep diaries, daytime functioning and mood inventories and home-based objective sleep assessments (OSA). Subjects were then randomized to one of four interventions: 1) six week Zolpidem intervention (D for drug); 2) six week multifactor behavioral intervention (B for behavioral); 3) six week conjoint Zolpidem and multifactor behavioral intervention (DB); and 4) placebo medication intervention (P for placebo). The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Differences in Atorvastatin Metabolite Ratios as a Diagnostic Tool in Detecting Atorvastatin Induced Myotoxicity

The primary objective of the study is to investigate whether differences in atorvastatin metabolite ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

The primary objective of the study is to investigate whether differences in atorvastatin metabolites ratios might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. A muscle biopsy is also collected and investigated.

Eligibility Criteria:
Inclusion Criteria:

* Suspected atorvastatin induced muscle adverse events
* Signed informed consent
* 18 years of age or older
* Able to donate blood samples
* Ongoing treatment with atorvastatin (not necessary if patients only donate a muscle biopsy)
Optimizing Regulation of a Cochlear Implant in Patients With Functional Contralateral Audition.

360 million people in the world suffer from debilitating hearing deficiency. The cochlear implant is indicated in certain patients with severe profound deafness. The principle of the cochlear implant is to directly stimulate auditory nerve fibres by electrodes inserted in the cochlea. The steps in auditory rehabilitation are the surgical insertion of the cochlear implant, activation, and follow-up regulation. There is no formal consensus to define the exact modalities for regulation during activation or follow-up, but the principles are respected according to centres that regulate cochlear implant. Bimodal audition is the fact of having a cochlear implant and a contralateral hearing aid. In patients with cochlear implants, having binaural bimodal audition improves their auditory vocal performance in silence and in noisy environments. It needs to be considered when a second cochlear implant is not indicated for the contralateral ear. It has been shown that by allocating frequencies different from the default frequencies attributed by the manufacturer, intelligibility and perception of music are modified. The investigators therefore with to study this working hypothesis and to develop a simple protocol for the reallocation of frequencies in order to optimise auditory performance in the everyday lives of patients with implants by using an evolutionary algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided consent
* Patients over 18 years old
* Profound post-lingual deafness with a cochlear implant and a functional contralateral ear (normal audition or mild to severe deafness but with a hearing aid).
* Patients fitted with one of the following cochlear implants with the most recent processor: Cochlear, Med-El, Neurelec Oticon or Advanced Bionics.
* Patients with at least 6 months experience with the cochlear implant and using both aids for at least 6 hours per day.

Exclusion Criteria:

* Persons without health insurance cover
* Adults under guardianship
* Pregnant or breast-feeding women
Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial

Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.


Eligibility Criteria:
Inclusion Criteria:

1. over 19 years old, male and female
2. patients who have plan to get esophagogastroduodenoscopy (EGD)

Exclusion Criteria:

1. ASA class III or IV
2. Allergies to propofol, sulfites or eggs
3. patients who had surgery for esophagus, stomach or duodenum
4. inpatients
5. patients who had sleep apnea, gastroparesis or achalasia
6. patients who are taking sedative drugs more than 6 months
7. pregnancy
8. hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
9. psychiatric or neurologic problems (ex. epilepsy or dementia)
Effect of a Respiratory Training Program on Woodwind and Brass Players

This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments. Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks.

This project will study the effect of a respiratory training program on woodwind and brass players, using an inspiratory muscle training equipment. The goal is to understand whether it is possible to develop the inspiratory muscles of wind players through regular and planned training. Fourteen young wind players will be selected, in which 7 will be male and 7 will be female, playing different instruments: transverse flute (1), oboe (2), saxophone (4), horn (4), trumpet (1), trombone (1) and tuba (1). Inspiratory muscle training will be performed with the POWERBreath Plus Medium Resistance, and will consist of 30 maximal inspirations, twice a day, for 5 weeks. The participants will be instructed on the use, handling and cleaning of the equipment. The participants will be instructed to use the equipment in a comfortable position, with a good posture, and will be instructed on how they should execute the inspiratory training: inhale to the maximum limit, with intensity, and exhale slowly and relaxed. An explanation will also be given about the calibration of the POWERbreathe, and the initial resistance level will be established based on the calculation of 50% of the Maximal Inspiratory Pressure of each participant, previously measured. Participants will also be instructed on how to increase the resistance level of POWERbreathe. The increase would be 1/4 of a level, whenever they no longer feel tired after a 30-inhalation workout. A questionnaire will be applied before, during and after the inspiratory training and they will be asked to record the daily use of the equipment in an online form, created for the purpose of recording its use by each participant. Assessment will be executed with the standard Borg Scale and the modified Borg scale. Surface electromyography (sEMG) of the right sternocleidomastoid, the right scalene muscles, the diaphragm and the right rectus abdominis will also be tested. Maximal inspiratory pressure and spirometry testing, specifically volume of forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) and FEV1/FVC ratio will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* 10 years of musical experience

Exclusion Criteria:

* lung disease
Amnion Bilayer and Stem Cell Combination Therapy on Thin Endometrium Infertile Patients

Severe infections or trauma to the endometrial lining causes permanent scars that disrupt the menstrual cycle and lead to conceive failure. Transplantation of biological graft seeded with stem cells is purposed to regenerate and recover the capability of the endometrial lining back into its cycles. Initially, the techniques to isolate and culture the endometrial cells and amnion epithelial stem cells were developed, then the endometrial cells form patients with thin endometrium. Tissue were obtained from hysteroscopic biopsy, weight between 100 µl, while up to 20 µl from the thin endometrium. Tissue were digested using collagenase-1 and cultured using DMEM-F12 added wit epidermal growth factor. Endometrial cells will be characterized to SSUD2, ICAM and BRCP1. Amnion epithelial stem cells (hAESC) will be isolated using collagenase-1 and hyaluronidase. Characterization towards TRA-1-60, SSEA-4, Oct 3/4, and Nanog. In the future, the cells will be co-culture on amnion bilayer, and stained using IHC against α-cadherin, estrogen receptor α, progesterone receptor. Endometrial receptivity (HOXA10, LIF (early secretory) adhesion, VEGF, osteopontin (SPP1) to indicate the pinopodes will be identified using qPCR.The SPP1, target of MIR424 expressed during the receptive phase.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thin endometrium without scar
* Patients with acute thin endometrium post-therapy (medicamentosa)
* Patients who are willing to participate in the study

Exclusion Criteria:

* Patients with thin endometrium due to TB
* Patients with cancer in the reproductive system
Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal to stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.

The investigators are planning to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.

The investigators plan to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.

Investigators will search for patients who had a REBOA catheter placed in the study period in the clinical documentation system (openMEDOCS) and the database of the German trauma registry. Documentation will include hemodynamic parameters, transfused blood products, complications, basic demographics and mortality up to thirty days after REBOA placement.

The investigators will then try to find patients with similar trauma mechanism and severity of trauma in the German trauma registry and match them with their REBOA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non-compressible torso hemorrhage following major trauma with REBOA placement
* age\>18 years
* REBOA placement during the initial resuscitation

Exclusion Criteria:

* age\<18 years
* missing data
The Diagnostic Performance of BMO-MRW and RNFL Thickness and Their Combinational Index Using Artificial Neural Network

This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT. SD-OCT exam will be performed to all patients in this study.

spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg, Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter which measures the minimum distance between Bruch's membrane opening to internal limiting membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different from RNFL thickness measurement but only software implemented in OCT device calculates BMO-MRW as well as RNFL thickness. The investigators are going to compare these two parameters and find out the relationship between two parameters.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years with a clear cornea and clear ocular media
* BCVA ≥ 20/40
* Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0

Exclusion Criteria:

* uveitis
* secondary glaucoma
* corneal abnormalities
* non-glaucomatous optic neuropathies
* previous trauma
* ocular surgery or laser treatment
* any other eye disease except glaucoma.
Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy

Acute stress-induced (takotsubo) cardiomyopathy or broken heart syndrome presents like a heart attack, classically is triggered by intense emotional or physical stress and can have serious health consequences. In the current study the investigators wish to establish whether there is a genetic predisposition making certain people more susceptible to this condition. This could also have implications for their families.

Acute stress-induced (takotsubo) cardiomyopathy presents like a myocardial infarct, is triggered by intense emotional or physical stress, and can have catastrophic and potentially fatal consequences. Despite data linking takotsubo cardiomyopathy with conditions that have a recognized genetic predisposition (such as mental health and neurological problems), a systematic and comprehensive characterisation of the genetic-epidemiologic factors in takotsubo is lacking. The researchers propose to further investigate this disorder by collecting blood from probands and characterising the genotype of patients with takotsubo cardiomyopathy in a large scale, nationwide genome wide association study. The investigators will also archive DNA for identification of future candidate genetic variants. Ultimately, understanding the underlying predisposition of this poorly understood neuro-psycho-cardiac disorder is essential if we are to move this field forward.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have been diagnosed with Takotsubo cardiomyopathy in Scotland between 2010 to date.
* Familial cases elsewhere in the world who would be willing to participate.

Exclusion Criteria:

* Unwillingness to participate
Remifentanil Propofol Infusion in Pediatric Spinal Surgery

Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics of these drugs are well understood, and that knowledge has led to the development of computer controlled infusion pumps that can administer the drugs based upon pharmacokinetic models. Computer controlled infusion schemes automatically adjust the drug administration based upon pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers the dosage of a computer controlled infusion it is obvious that manually imitating a similar scheme may be difficult.This study will evaluate manually controlled infusion schemes using the models built into the Applied Medical Visualizations (Medvis) display and compare the manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.

During Total intravenous anesthesia (TIVA), the anesthetic propofol and the opioid remifentanil are often used together. Previous studies have demonstrated the synergy between these combinations of medications. From these data, drug interaction models have been developed to pair drug effect-site concentrations with event markers of interest to the clinical anesthesiologist. For example, the amount of remifentanil and propofol typically required during the induction of anesthesia to cause loss of responsiveness to verbal or moderate stimuli has been studied. Likewise, the blood concentration levels present during emergence from anesthesia have been explored describing levels typically present for patients to return to consciousness.

The purpose of this study is to retrospectively analyze the infusion doses of both remifentanil and propofol for pediatric patients undergoing spinal fusion surgery at CHOP. These data will be applied to the pharmacokinetic models to determine the predicted effect site concentration, and the relationship of that concentration to the 50% and 95% doses as predicted by the model.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female patients age 0 to 18 years old
2. Spinal surgery at CHOP between 4/1/07 and 3/31/08
3. Complete CompuRecord Anesthesia documentation
4. Use of Propofol and Remifentanil infusions as primary anesthetic technique

Exclusion Criteria:

1. Chronic opioid or benzodiazepine medication use prior to surgery
2. Use of other anesthetic infusions (i.e. Ketamine/Fentanyl) during TIVA
3. Use of Neuraxial opioids
4. Use of other Induction medications (i.e. Sodium Thiopental)
Phase 2 Evaluation of Multi-modality Algorithm for Non-metastatic Adenocarcinoma of Pancreas or Ampulla

Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).

All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.

All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.

After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.

Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.

Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
* Fitness for chemotherapy in judgement of treating physician
* Bilirubin \< 4 (any means of biliary drainage acceptable)

Exclusion Criteria:

* Medical or mental illness precluding provision of informed consent
* Pregnancy
* Active infection for which neutropenia would pose high risk of mortality
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK

To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS \& Nevanac) to help control pain following Photorefractive Keratectomy (PRK).

Laser Vision Correction is the most commonly performed elective surgical procedure in the United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular technique, a growing number of surgeons have switched to surface ablation techniques, including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3, epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During this healing process, patients often complain of moderate to severe ocular pain, and delayed healing may result in an increased risk of infection or corneal haze4.

Over the past decade, a variety of methods have been used to assist with reducing pain following surface laser procedures. Topical Nonsteroidals have been shown in a number of studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also been shown to assist with the reduction of pain following PRK. Oral pain medications, such as Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options for pain control.

In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by the FDA. Nevanac was approved with a a TID dosing schedule.

Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically used on a QID dosing schedule.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PRK for myopia or hyperopia

Exclusion Criteria:

-