cyrilzakka/clinical-trials huggingface dataset:
CPAP vs ASV for Insomnia

The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.

Patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. Following diagnostic polysomnography (PSG) testing, insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe. Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving optimal therapy at all times during this study. PAP adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use PAP therapy nightly during participation in this protocol. Baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.

Eligibility Criteria:
Inclusion Criteria:

* Primary complaint of insomnia when presenting at clinic
* Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
* Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
* Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a RDI ≥ 15 events/hour and AHI \< 5 events/hour
* Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB
* Able to fully understand study information in English and sign informed consent

Exclusion Criteria:

* Primary complaint of sleep-disordered breathing or issues with apneas during sleep
* Severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
* BMI \> 30 kg/m2
* Epworth Sleepiness Scale (ESS) score ≥ 10
* Frequent napping behavior, such as a few times a week or more
* Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial
* Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints
* Daily use of opiate medications
* Known contraindications to PAP therapy as listed in the indication for use
* Requires a CPAP (fixed) pressure \> 20 cm H2O
* Inability to comply with study procedures
A Phase II Study of Pemetrexed and Carboplatin in the Treatment of Esophageal Cancer

This is a study of an investigational agent, pemetrexed, in combination with a standard chemotherapy drug, carboplatin, for treatment of patients with metastatic esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically proven metastatic or recurrent esophageal cancer. Both adenocarcinoma and squamous carcinoma are eligible for the study. Patients with small cell carcinoma or sarcoma of the esophagus are not eligible for the study.
* Patients may have had no prior chemotherapy treatment for metastatic esophageal cancer. Patients may have had chemotherapy with 5-FU combined with definitive radiotherapy for curative intent in the adjuvant, neoadjuvant, or definite setting for locally advanced esophageal cancer, if no less than one year prior to trial enrollment. Patients may not have received pemetrexed in the past.
* Patients who have had radiotherapy for esophageal cancer must have completed radiotherapy at least four weeks prior to entry in the study.
* Patients need to have measurable disease.
* Lesions that are not considered measurable include the following:

  * Bone lesions
  * Brain metastases or leptomeningeal disease
  * Ascites
  * Pleural/pericardial effusion
  * Abdominal masses that are not confirmed and followed by imaging techniques
  * Cystic lesions
  * Tumor lesions situated in a previously irradiated area
* ECOG) performance status of 0-2.
* Life expectancy of \>=12 weeks.
* Patients must have adequate bone marrow function defined as: white blood cells (WBC) \>= 3000/mm\^3, absolute neutrophil count (ANC) \>= 1,500/mm\^3, hemoglobin \>= 9.0 g/dL, and platelet count \>= 100,000/mm\^3.
* Patients must have adequate liver function defined as: Bilirubin \<= 1.5 x institutional normal and ALT/AST \< 3 x institutional normal.
* Patients must have adequate renal function defined as: serum creatinine \<= 3.0 mg/dL and creatinine clearance \>= 45 mL/min.
* Radiation therapy for brain metastases should be completed at least four weeks prior to enrollment to this protocol.
* Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled symptomatic cardiac arrhythmia.
* Patients must be able to be compliant with premedications of dexamethasone, folic acid, and vitamin B12.
* For all sexually active women of child-bearing age, the use of adequate contraception (hormonal or barrier method of birth control) will be required prior to study entry and for the duration of study participation.
* Age \>= 18 years.

  * Written consent.
  * Ibuprofen (400 mg qid) can be administered with Alimta in patients with normal renal function (creatinine clearance \> 80 mL/min

Exclusion Criteria:

* Patients with third-space fluid (pleural effusions, ascites, etc.) uncontrolled by drainage.
* Pregnant or nursing females
* Patients who have had pre-existing neuropathy greater than or equal to grade 2.
* Patients with known active CNS metastases.
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter

The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

* At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.
* Age 18 years or older.

Exclusion Criteria:

* Previous typical CTI dependent right atrial flutter ablation
* Uncontrolled heart failure or NYHA function class IV
* MI within the past 2 months
* Any cardiac surgery (i.e. CABG) within the past 2 months
* Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
* Awaiting cardiac transplantation or other cardiac surgery within the next 6 months
* Documented thromboembolic event (including TIA) within the past 12 months
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Active illness or active systemic infection or sepsis
* Unstable angina
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation (eg, heparin or warfarin)
* Life expectancy less than 6 months
* Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
* Presence of a condition that precludes vascular access
* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
* Currently enrolled in another device, biologics, or drug study
* Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use
Right Ventricular Dysfunction in Cardiac Surgery Patients

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgery patients
* elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement

Exclusion Criteria:

* age \< 18
Surveillance Study of Acute Gastroenteritis in Hospitalized Children

Acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.


Eligibility Criteria:
Inclusion Criteria:

* acute gastroenteritis

Exclusion Criteria:

* immunodeficiency
* malnutrition
Randomized Comparison of Warfarin Dosing Quality Between the Hamilton Nomogram and a Commercial Computer System

Randomized comparison of warfarin dosing quality between the Hamilton nomogram and a commercial computer system.

Hypothesis: Mean TTR of patients managed with the commercial computer system is non-inferior to management with the validated Hamilton Nomogram.

Warfarin has a variable effect and many potential food and drug interactions. To have an optimal therapeutic effect the International Normalized Ratio (INR) needs to be maintained within the therapeutic target range. The time that a patient spends within the therapeutic target range is an intermediate quality indicator for patient outcomes and should be optimized. For this purpose, we use in our anticoagulation clinic the simple two-step Hamilton nomogram, which has been validated by Kim et al. who showed that the nomogram improved INR control for warfarin maintenance compared with expertise-based dosing in our anticoagulation clinic (see references). Computer systems are also known to outperform expertise-based dosing, but no direct comparison of a computer system with a simple nomogram has been assessed. In this single-center randomized controlled clinical trial we will compare the simple two-step Hamilton nomogram with the widely used computerized dosing management system DAWN AC regarding their effect on time in therapeutic range for patients on maintenance dosing with target range 2-3.

Eligibility Criteria:
Inclusion Criteria:

* On warfarin maintenance therapy
* INR target range 2-3
* At least 3 historical INRs on maintenance therapy
* At least 1 historical INR in the last 3 months

Exclusion Criteria:

* Participation in another study
* On multiple pill strengths
Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75 years of age;
2. Histologically confirmed squamous cell carcinoma;
3. locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
5. Able to eat a semi-liquid diet;
6. Less than 20% weight loss within 6 months;
7. Adequate hepatic function, renal function, hematologic function and coagulation function;
8. Documented informed consent.

Exclusion Criteria:

1. Distant metastasis;
2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
3. Prior thoracic irradiation, chemotherapy, or lobectomy
4. Known diseases or conditions that are contraindicated for radiotherapy or surgery;
5. Allergy to the research medications;
6. Pregnant women or women preparing for pregnancy;
7. Diagnosis of autoimmune disease or history of chronic autoimmune disease
8. Absence of informed consent because of psychological, family, social and other factors;
9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).
Effect of Different Conductive Media on the Efficacy of Electric Pulp Tester

Dental pulp tests are investigations that offer valuable diagnostic and treatment planning information to the dental clinician. EPT is a sensibility test that can be easily performed in clinical practice. Current study is to find the best conducting substance among readily available water-based gels and gel-based tooth pastes to evaluate the efficacy of electric pulp tester.

The study will be performed on dental students with written informed constant. The sample size of study is 100. There will two main groups of conductor materials used in the study: water-based gels (fluoride gel, electrode gel and chlorohexidine gluconate) and gel-based toothpastes (Colgate and Dentonic Ultrawhitening gel). All groups will be randomly applied to the same patient at a single visit. Two measurements will be recorded for each material and the average value of the two measurements will used. Then, the measurements will record, and a comparison will be made between different conductors.

Eligibility Criteria:
Inclusion Criteria:

* Healthy fully erupted teeth maxillary central incisors.
* Study subjects above 18 years.
* No systemic diseases and pregnancy

Exclusion Criteria:

* Carious, decayed and periodontally affected teeth.
* Taking anti-inflammatory drugs from last 2 weeks.
* Taking cortisone for the last 6 month
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems

Stress reactions in emergency physicians will be measures using cortol-awakening-reaction, heart-rate-variability and standardised stress questionnaires

In a field study with within-subject design, there will be conducted the hormonal and physiological stress strain of emergency physicians working in rescue helicopters or van on different days of service on different headquarters. The investigation of the parameter of stress will be conducted on two days of rescue service, on two days of clinical service and as a control on two days off. The quantification of the hormonal stress strain will be carried out with the cortisol awakening response, there will be conducted 3 saliva samples with identical interval after getting up within 30 minutes. While the labour time on the rescue service and on the clinical service and the whole day off, the heart rate variability will show the degree of physiological stress. This will be measured with a pulse-belt on the chest, which the participant will carry the whole day. In addition, participants will fill out a set of questionnaire on the first day of measurement.

Eligibility Criteria:
Inclusion Criteria:

* Medical Doctor working in rescue helicopter or van

Exclusion Criteria:

* Metabolic disease
* Autoimmune disease
* Heart disease
* Blood disease
* Mental disease
* Endocrinologic disease
* BMI\>30
* \>10 cigarettes/day
* Taking cortisone medication
TARGET Intracranial Aneurysm Coiling Registry

The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years or older.
2. Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
3. (NEW NANO arm ONLY) Target aneurysm is ≤7mm.
4. Patient has a Hunt and Hess Score of 3 or less.
5. Patient has a premorbid mRS of 3 or less.
6. Patient or patient's legally authorized representative has provided written informed consent.
7. Patient is willing to and can comply with study follow-up requirements.

Exclusion Criteria:

1. Patient is \< 18 years old.
2. Dissecting aneurysm.
3. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
4. Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.
5. (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of \<25% Stryker Target® 2nd generation Nano Coils.
6. Target aneurysm is fusiform.
7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese Subjects

This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) characteristics of insulin degludec (insulin 454) and insulin degludec/insulin aspart (IDegAsp) 50 - formerly SIAM), both explorative formulations, not similar to the proposed commercial formulation, in healthy male Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese passport holder
* Japanese-born parents
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Fasting blood glucose of below or equal to 6 mmol/L
* Healthy male subjects, who are considered to be generally healthy based on an assessment of medical history, physical examination and clinical laboratory data at screening, as assessment of medical history, physical exjudged by the Investigator

Exclusion Criteria:

* The receipt of any investigational drug within 3 months prior to this trial
* Subjects with a history of significant multiple drug allergies or with a known allergy to the trialproduct or any medicine chemically related to the trial product, as judged by the Investigator
Cognitive Behavioral Therapy for Sleep and Circadian Disturbances (CBT-I) in Treatment-Resistant Schizophrenia

Using a randomized controlled design, the project aims to test if cognitive behavioral therapy interventions specifically targeting sleep disorders can significantly lessen the burden of the disrupted sleep in patients with treatment resistant schizophrenia (TRS) and by proxy lead to a reduction in psychotic symptoms and improvement in quality of life.

We are including treatment-resistant patients with schizophrenia other nonorganic and chronic psychoses and in addition meeting the criteria of a sleep or circadian disorder. Included patients will be block randomized to either 8-10 sessions of CBT-I (active treatment) with a specific focus on sleep or 8-10 sessions of regularCBT with a specific focus on patients' psychopathology (treatment as usual) approx.1 session/week.

After 12 weeks the full battery of assessments will be repeated forboth groups. Primary analyses will be to identify group-difference in changes using repeated measure ANOVA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ICD-10 schizophrenia (DF20), chronic paranoid psychosis (DF22), schizo-affective disorder (DF25) or other non-organic psychosis (DF28-DF29)
* Treatment resistance according to TRRIP criteria
* Sleeping difficulties (minimum duration 3 months)
* ISI score \>14
* Stable psychopharmacological treatment the last month
* Only legal competent patient can participant

Exclusion Criteria:

* Psychiatric admission last six months (more than 1 week or resulted in significant changes in psychopharmacological treatment)
* Substance abuse to a degree that will interfere with participation.
* Diagnoses of sleep apnea/CPAP use
Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During Emergency PCI

This study is aimed to investigate if the bivaliruding with prolonged full dose infusion after PCI is superior to heparin alone in reducing 30-day mortality or major bleeding for patients with STEMI treated with emergency PCI. A total of 6000 STEMI patients will be enrolled and randomly assigned to receive bivalirudin or heparin during emergency PCI in a 1:1 ratio. This study will provide key evidence for peri-operative anticoagulant therapy decisions in STEMI patients.


Eligibility Criteria:
Inclusion Criteria:

* Any age;
* STEMI patients undergoing primary PCI with ST elevation≥1mm in≥2 contiguous leads or new LBBB with symptom onset 48h;
* Patients requiring staged revascularization of non-culprit vessels within 30 days may be enrolled. In such cases the same antithrombotic agents and PCI procedures must be used in the staged procedure consistent with the index procedure PCI, in particular the assigned antithrombin agent heparin vs. bivalirudin);
* Dual antiplatelet drugs must be administrated according to guidelines before PCI (loading doses and maintenance doses of aspirin and clopidogrel or ticagrelor);
* The subject or legal representative has been informed of the nature of the study, understood the provisions of the protocol, was able to ensure adherence, and signed informed consent.

Exclusion Criteria:

* Not suitable for emergency primary PCI;
* STEMI treated by thrombolysis;
* Patients received heparin, LMWH, fondaparinux, bivalirudin, or GPI within 48 hours before the index PCI;
* Mechanical complications (such as ventricular septal rupture, papillary muscle rupture with acute mitral regurgitation, etc.);
* Known allergy or contraindications to heparin, bivalirudin, aspirin, or both clopidogrel and ticagrelor
* Patients in whom the investigators consider inappropriate to participate in this study (eg, have participated in another drug/instrument study or undergoing another drug/instrument study).
Bone Augmentation Techniques in the Mandible Posterior Region

This study aims to compare the efficacy of two bone augmentation techniques in the posterior mandible. Twenty participants will undergo 40 surgical procedures at Espíritu Santo University (UEES) in Samborondon, Ecuador. Each patient will receive two types of bone grafts: one side will use autogenous cortical bone plates with a 50/50 mixture of autogenous bone and biomaterial (as described by Dr. Fouad Khoury), while the other side will use xenogenous cortical bone plates with the same mixture.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Bilateral Mandibular Posterior Edentulous with atrophy in 4, 5 or 6 Cawood and Howell stages.
* Patients who have good plaque control of less than 20%
* Patients between 18-64 years old

Exclusion Criteria:

* Systemically compromised patients
* Smoker patients
* Pregnant women, breastfeeding or use of oral contraceptives
* Patients who are taking medication that may affect healing and coagulation
* Patients with periodontal disease
* Patients who have undergone chemotherapy and radiotherapy