cyrilzakka/clinical-trials huggingface dataset:
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea

The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included. Approximately 160 subjects were recruited (80 per treatment arm) in the recent trial of eszopiclone. This size is expected to be able to discern an important difference of 80 minutes per night. In the current clinical population newly prescribed CPAP at Mount Sinai Hospital, the average compliance after 4 weeks of initiation of nCPAP was 4:01 (SD 2:59) hours per night. To be able to discern a difference of at least 1 hour (60 minutes) in usage per night, including entirely non-adherent patients who do not use treatment at all as 'zero hour' users, would require randomization of 264 patients (132 per group).

Our hypothesis for this study is that initial titration of CPAP treatment of OSA may be improved by initial prescription of a common hypnotic, zopiclone. To answer this question we intend to recruit 264 consecutive consenting subjects with OSA confirmed by a physician (ABSM or by a respirologist with extensive sleep medicine experience) with supportive polysomnography results who are willing to initiate long-term CPAP treatment.

Background: Obstructive sleep apnea (OSA) is a common sleep breathing disorder that is associated with serious complications. Continuous positive airway pressure (CPAP) is the treatment of choice for most patients but its use in the real world is limited by low patient adherence which may result in sub-optimal outcomes for some patients. A single hypnotic with low risk of adverse effects is a cost-effective intervention to augment the currently low adherence to CPAP, especially if only prescribed for a limited time. The hypnotic is generic zopiclone 3.75-7.5 mg at bedtime for up to 14 doses.

The clinical population targeted will be newly expert physician-diagnosed patients polysomnographically supported OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia. Outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included.

Eligibility Criteria:
Inclusion Criteria:

* MD diagnosis of obstructive sleep apnea
* No previous use of CPAP
* No concurrent use of hypnotic medication

Exclusion Criteria:

* Fatal comorbidities (i.e., life expectancy less than 6 months)
* Contraindications for CPAP use
* Pregnancy
* Liver Failure
Ropivacaine/Dexamethasone and 10% Lignocaine Injection in GPN Block for Intractable Cancer Pain

The study will compare the efficacy and safety of Ropivacaine/dexamethasone vs 10% lignocaine injection in distal glossopharyngeal nerve block for intractable cancer pain


Eligibility Criteria:
Inclusion Criteria:

* Patients with proven carcinoma of the oropharynx and supraglottic larynx with estimated survival of 3 months or more.
* Pain lasting for at least 2 weeks with an average intensity of 5 or more on an 11-point numeric rating scale (NRS) refractory to a combination strong opioids and NSAIDS

Exclusion Criteria:

1. Local infection or skin ulceration at the puncture site
2. Local anaesthetic allergy
3. Psychiatric illness that affected cooperation.
Understanding GRID Radiation Therapy Effects on Human Tumor Oxygenation and Interstitial Pressure to Increase Translation of Solid Tumor Therapy

To estimate the mean and standard deviation (SD) of the post-treatment decreases in the interstitial fluid pressure and hypoxia-specific PET-scan signal from GRID-treated tumors in patients with locally advanced squamous-cell carcinoma of the head and neck.

The possible effects of GRID radiotherapy on tumor oxygenation levels and interstitial fluid pressure within the tumors will be measured by assessing the trend and statistical significance of the difference in values for each condition obtained prior to and just after GRID exposure in each subject enrolled in the study. We expect that there may be a trend for increases in tumor oxygenation and decreases in interstitial fluid pressure which would indicate that more accurately timed additional chemotherapy and radiation therapy would improve overall patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 80 years of age
* Karnofsky performance status greater than 70 or ECOG ≥ 2
* Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension.
* History of adequate hepatic function (endoscopic or percutaneous drainage as needed):

  a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN
* Chemotherapy naive
* History of adequate renal and bone marrow function:

  1. Leukocytes ≥ 3000/uL
  2. ANC ≥ 1500/uL
  3. Platelets ≥ 100000/UI
  4. Serum Creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
* Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures
* Subjects with known presence of central nervous system or brain metastases
* Subjects with prior radiotherapy to the head and neck region
* Subjects will be excluded if deemed unable to comply with study procedures
Involvement of Translation Initiation Factors in the Immune Response in the Elderly

The investigators propose that the translation initiation factors eIF4E and eIF4GI may be involved in resolution of acute inflammation (regardless of age). Furthermore, the investigators suggest that differences in translation initiation factors state of activation may contribute to inflammation. Finally, the investigators hypothesize that differences in translation initiation factors state of activation may underlie the immune compromised state of the very elderly affording additional explanation for the heightened morbidity from infection in this group.

In the current study the investigators aim to test these hypotheses by measuring the levels of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly (85yrs\<) patients hospitalized at Meir hospital for acute infection and after their recovery (detailed in study design).


Eligibility Criteria:
Inclusion Criteria:

* elderly patients (65\<)
* hospitalized for acute infection (fever 38c\<, leukocytosis)

Exclusion Criteria:

* patients with dementia who can not sign informed consent of institutional Helsinki committee
* patient with active cancer with active chemotherapy treatment
Multicenter Study to Evaluate the Safety and Efficacy of Revanesse® Ultra Retreatment

To compare improvement with retreatment for all subjects undergoing correction of nasolabial folds (NLFs) in the initial SYM2014-02 study, who were retreated with Revanesse Ultra at Visit 6/Week 24 and to determine the safety of repeat injections of Revanesse Ultra. The retreatment phase was optional.

The subjects completing the initial phase of the SYM2014-02 study (NCT02987205) who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline, were offered the option for retreatment with Revanesse Ultra

Visit 6/Week 24 (± 7 days) optional open-label retreatment with Revanesse Ultra for subjects who had returned to baseline Wrinkle Severity Rating Scale (WSRS) score or as needed for optimal correction if WSRS scores had not returned to baseline; End of Study for subjects not being retreated

Visit 7/Week 28 (± 7 days) follow-up for retreated subjects

Visit 8/Week 52 (± 7 days) End of Study for retreated subjects

A telephone contact was performed at Week 40 (± 7 days) for retreated subjects to assess adverse events (AEs) and concomitant medications.

This report presents the results for all subjects who received optional open-label retreatment with Revanesse Ultra at Visit 6/Week 24.

This study was performed in compliance with Good Clinical Practice (GCP), including the archiving of essential documents.

Number of Subjects (Planned and Analyzed): Seventy-one subjects received retreatment.

Eligibility Criteria:
Inclusion Criteria:

Subjects from the SYM2014-02 initial study who were:

* Men or women at least 22 years of age with two fully visible bilateral nasolabial folds each with a WSRS score of 3 or 4 (moderate or severe) that may have been corrected with an injectable dermal filler.
* Subjects were eligible for retreatment when WSRS scores had returned to baseline for either or both NLFs (retreatment group).
* If scores had not returned to baseline, subjects were also eligible to be injected for either one or both NLFs as needed to achieve optimal correction (optimal correction group).

Exclusion Criteria:

-
Optimisation of High Flow Oxygen Therapy Settings During Hypoxaemic Respiratory Distress Based on Non-contact Measurement of Lung Volumes by Depth Camera

The goal of this clinical trial is to validate the interest of a strategy adjusting the flow rate delivered under high-flow oxygen (HFO) therapy according to the lung volumes measured by a new technique, in intensive care patients with hypoxemic respiratory distress (HRD).

The main question it aims to answer is:

"The use of a technique of measurement of lung pulmonary with adjustement to the flow rate can make it possible to limite intubation in patients with HRD in intensive care?" The participants will be the patients admitted in intensive care for HRD with the need for treatment with HFO.

This participants will be randomized in :

* the arm control: treated by high flow oxygen therapy according to standard procedures.
* or in the experimental arm : treated by high flow oxygen therapy with adjustement of ventilatory parametres based on lung volume measurements, obtained by the depth camera.

High-flow oxygen therapy (HFO) is a common technique for the management of patient with hypoxemic respiratory distress in intensive care.The variations in lung volumes induced by the HFO in patients is unknown in clinical routine, in the absence of the availability of a effective measurement technique.

The investigators research team validated a new non-invasive, non-contact technique for measuring lung volumes using depth camera. Using a stereoscopic camera, the patient's chest and abdomen are recognized by a artificial intelligence algorithms. The structures of interest of the chest and the abdomen are the identified and the variation in depth of these points in space allows both the integration of lung volume through automatic calibration procedures, the measurement of respiratory rate and comparaison of movement symetries.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypoxemic respiratory distress define by the following 4 criteria:
* Respiratory rate ≥ 25 breaths per minutes
* A ratio of the partial pressure of arterial oxygen (PaO2) to the FiO2 ≤ 300 mmHg while the patient is breathing oxygen at a flow rate of 10 liters per minutes or more
* A partial pressure of arterial carbon dioxide (PaCO2) not higher than 45 mmHg
* An absence of clinical history of underlying chronic respiratory failure

Exclusion Criteria:

* A do-not-intubate order
* Pregnant or lactating woman
* Cardiogenic pulmonary edema
* Exacerbation of asthma
* Hemodynamic instability with use of vasopressor at significant dose (norepinephrine \> 0.5 mg/h)
* A Glasgow Coma Scale of 12 points of less
* Contraindications to non-invasive ventilation
* Urgent need for endotracheal intubation
* High flow oxygen therapy started within 48 hours before inclusion
* Patient under legal protection or deprived of liberty
Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study

Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer

The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
2. Age ≥ 18
3. Able to receive chemoradiation therapy with Cisplatin.
4. Non-pregnant status in women of childbearing potential.
5. No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
7. Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
8. Able to give informed consent

Exclusion Criteria:

1. Age \< 18
2. Patients with a known active malignancy other than cervical carcinoma.
3. Pregnant and breastfeeding patients.
4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position

Laparoscopic surgery has become a standard of care for many gynecological surgeries due to its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg positioning will help displace CO2 from the sub diaphragmatic area thus reducing the diaphragmatic and phrenic nerve irritation causing pain.

A prospective randomized controlled study with 54 patients in each of the two arms. Group S (control) will undergo the standard laparoscopic procedure and the patients will be placed in supine head up position postoperatively. In group T (interventional); the patients will be positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia case unit (PACU) and will remain in this position for the first 24 hours postoperatively. Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected at arrival to PACU, \& 4, 6, 12 and 24 hours postoperatively. In addition, total amount of rescue pain and nausea medication used by the patient will be recorded. Data collected will be analyzed and compared between the two groups. The independent t- test will be used to compare postoperative shoulder pain, with NRS scores treated as continuous variable, between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age: 18 years to 60 years, American Society of Anesthesiologist physical status (ASA) 1 or 2
* Diagnostic or operative gynecologic laparoscopy {4 port sites, three 5 mm trocars (suprapubic, right and left iliac fossa) and one 10 mm trocar (umbilical)} between one and 3 hours duration.
* Abdominal incisions less than 1.5 cm.
* Steady abdominal insufflation pressure of 14 mm Hg following a gradual insufflation over a 5-minute period.
* Insufflation at a steady maximal flow of 30 l/min

Exclusion Criteria:

* Conversion to laparotomy.
* Abdominal insufflation pressure more than 14 mm Hg.
* Medical drug allergy to paracetamol, ketoprofen and/or tramadol.
* Presence of gastro-esophageal reflux (GERD)
* Pregnancy
* Patient with Thrombophilias and or at high risk of Deep Vein Thrombosis (DVT)
* Obesity body mass index (BMI) greater than 40
* One day surgery patients
Effect of Tadalafil (Cialis) on the Cardiovascular System of Spinal Cord Injury (SCI) Males

To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant hypotension in people with tetraplegia.

Tadalafil is a long-acting PDE-5 inhibitor, used to treat erectile dysfunction (ED). ED is a common issue for males with spinal cord injury (SCI).Patients with SCI are at risk of developing orthostatic hypotension, especially those with an injury at or above the T-6 level.An earlier study of the shorter-acting PDE-5 inhibitor sildenafil (Viagra) revealed that it can cause orthostatic hypotension, tachycardia and dizziness after administration in the SCI population, and suggested that caution should be used in prescribing sildenafil in this population, as blood pressure can drop significantly. There is potential for the significant hypotension seen with the short-acting medications to be much more problematic with the longer-acting tadalafil.

The study will be a prospective, randomized, double-blind, placebo-controlled cross-over design. This will be done by comparing the effects of administering tadalafil 20 mg and placebo on blood pressure (lying and sitting), and heart rate (lying and sitting). These measurements will be taken in the clinic setting prior to dosing, then repeated hourly for the first two hours post-dose, and again at four hours post-dose. The patient will repeat the measurements at home using an automated blood pressure apparatus at 12, 22,29 and 36 hours post-dose.In addition, the patient will record perceived dizziness on a visual analog scale ecah time the BP and HR are recorded.

Eligibility Criteria:
Inclusion Criteria:

* males 18 to 70 years old, with complete spinal cord injury (ASIA-A) between C-4 and T-6
* minimum 6 months post-injury

Exclusion Criteria:

* diabetic
* taking nitroglycerin
* ischemic heart disease or significantly abnormal EKG
* lower motor neuron dysfunction
* heroin or cocaine use
* history of adverse reaction to tadalafil or any other PDE-5 inhibitor
* any condition that may put the subject at risk, confound the study results, or interfere significantly with subject's ability to participate in the study
* have used any other (PDE-5) medications within 1 week of study medication administration
Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.

Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.

Eligibility Criteria:
Inclusion Criteria:

* Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
* Women with an intact uterus.
* No menses within the 12 months preceding screening visit and /or FSH \>30 IU/L.
* Endometrial thickness ≤ 5 mm.

Exclusion Criteria:

* Submucosal fibroid/s that applying pressure and affecting endometrial thickness
* Other medication that could affect estrogenic state.
Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.

It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).

The primary objectives of the study include:

1. Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
2. Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
3. Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.

The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Parturients
* Elective cesarean Delivery
* Term (\> 37 wks gestational age) as defined by ultrasound or last menstrual period
* Singleton fetus
* Vertex presentation
* Age \> 18
* BMI \< 40
* Height \> 5'2" and \< 5"8"
* Written informed consent

Exclusion Criteria:

* Placenta previa
* Multiple gestation
* Preeclampsia
* Gestational Diabetes or pre-existing diabetes
* Macrosomia (estimated fetal weight prior to delivery)
* Polyhydramnios
* Oligohydramnios
* Uterine fibroids
* More than 2 previous cesarean deliveries
* Suspected adherent placenta (acreta/increta/percreta)
* Planned general anesthesia