cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery

It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

Recruitment to this study was terminated (on February 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. The decision to end recruitment to the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Smokers motivated to stop smoking scheduled for elective surgery

Exclusion Criteria:

* Current or recent depression
* Current or recent suicidal ideation
* Uncontrolled or unstable clinically significant medical condition
Treatment of IBS in Primary Health Care.

The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.

Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.

Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.

In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.

The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".

Descriptive statistics will be used.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.

Exclusion Criteria:

* Patients \< 18 years or \> 65 years.
Safety and Effectiveness of the KOKO Device to Treat Primary Abnormal Postpartum Uterine Bleeding or Hemorrhage

The purpose of this study is to evaluate the safety and effectiveness of the KOKO™ device in the control and reduction of primary abnormal postpartum uterine bleeding or hemorrhage.

This IDE study is designed to evaluate the effectiveness and safety of the KOKO™ device to treat primary abnormal postpartum uterine bleeding or hemorrhage. The study is literature controlled.

Eligibility Criteria:
Inclusion Criteria:

* Adult Female, 18 years of age or older at time of consent.
* Subject is able to understand and provide informed consent to participate in the study.
* Diagnosis of abnormal postpartum uterine bleeding (500 - 999 ml for vaginal birth) or postpartum hemorrhage (1000 - 1500 ml for vaginal or Cesarean birth) with suspected atony within 24 hours after vaginal or cesarean birth.
* EBL, to be determined when investigator is ready to have the KOKO packaging opened: Vaginal birth: 500 - 1500 ml EBL or Cesarean birth: 1000 - 1500 ml EBL.
* Failed first - line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Note: Uterotonic administration may continue concomitant with and post KOKO use.

Exclusion Criteria:

* EBL \>1500ml, to be determined when investigator is ready to have the KOKO packaging opened.
* Delivery at a gestational age \< 34 weeks or, if multiples, uterus is judged \<34 weeks size.
* For cesarean births: Cervix \< 2.5 cm dilated before use of KOKO.
* Abnormal postpartum uterine bleeding or hemorrhage that the investigator determines to require more aggressive treatment, including any of the following:

  1. hysterectomy;
  2. B-lynch suture;
  3. uterine artery embolization or ligation;
  4. hypogastric ligation.
* Known uterine anomaly.
* Ongoing intrauterine pregnancy.
* Placental abnormality including any of the following:

  1. known placenta accreta;
  2. retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior cesarean and placenta previa);
  3. retained placenta without easy manual removal.
* Known uterine rupture.
* Unresolved uterine inversion.
* Subject has undergone intrauterine balloon therapy, uterine packing or use of other negative pressure system(s) for tamponade treatment of this episode of abnormal postpartum uterine bleeding or hemorrhage prior to use of the KOKO™ device.
* Current cervical cancer.
* Current purulent infection of vagina, cervix, uterus.
* Diagnosis of coagulopathy.
Evaluation of the Effects of Two Dietary Supplement Formulations on the Lipid Profile in Mild Hypercholesterolemia

A single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet.

The study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the Mediterranean diet. The participants will be divided into three groups:

Group A: Test Product A (study product) Group B: Test Product B (comparative product) Placebo group: placebo

The following visits are scheduled during the study:

T-2 (day -35) - Screening visit, 5 weeks before T0 T-1 (day -28) - Enrollment visit, 4 weeks before T0 T0 (day 0) - Randomization visit, baseline T1 (day 56) - Interim visit, 8 weeks after T0 T2 (day 112) - Final visit, 16 weeks after T0 After the first 8 weeks of the study (double-blind), all three groups will continue with only Product A for an additional 8 weeks. This experimental design aims to highlight whether any differences between Test Product A and Test Product B observed during the first 8 weeks can be minimized when both arms receive the same treatment. Additionally, the effect of Product A will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. This may also provide insights into the potential achievement of a plateau. Regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with Test Product A.


Eligibility Criteria:
Inclusion Criteria:

* Prevention of cardiovascular disease
* Low cardiovascular risk (\< 5%)
* Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2
* Signature of informed consent.

Exclusion Criteria:

* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5)
* diabetes mellitus
* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism
* Hypertension treatment not stabilized for at least 3 months
* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease
* Any medical-surgical treatment that may limit adherence to the study protocol
* Pregnant and/or breastfeeding women
Brain Activation During Accommodation to Painful Stimulation With FMRI

Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI) investigations of pain have provided substantial insight into the workings of the human brain. To date, however, the vast majority of studies have dealt with short painful stimulations. This work will expand the investigators knowledge of how longer stimulations are processed by comparing the activation pattern from a two minute painful stimulation with that of an 30-second painful stimulus. The investigators hypothesis that accommodation to the longer stimulation will be evident by either decreases in signal intensity in brain areas known to process pain, or by increasing activity in brain areas thought to be responsible for the modulation of painful perception.

Background: Over the past 14 years, BOLD FMRI studies have non-invasively shown that pain activates a matrix of areas, but that this activation decays during stimulation, possibly reflecting the body's ability to "accommodate" to the stimulation. The majority of these use short applications of pain lasting 1 to 30 seconds. However, investigators are now using stimulations much longer than the periods that were typical a few years ago. The effect of signal decay on the activation maps generated by these longer tasks is not known. Because the signal change in many of the subcortical areas involved in pain processing is low, errors in analysis due to neglecting the signal decay may induce significant artifact.

Materials and Methods: Using transcutaneous electrical nerve stimulation, 20 healthy volunteers will experience two different painful stimulations: a repeating 30-second long stimulation and a constant 2 minute stimulation. The brain activity for each will be determined and compared. In addition, the signal decay during each painful stimulation will be quantified and compared.

Significance: Investigators are using longer stimulations periods in an attempt to understand how the brain processes "real- life" pain instead of the artificial on-off pattern of earlier studies. However, significant attention has not been paid to the possible effect of accommodation on the stimulus and how this may impact the activity pattern found. In addition, proof of activation of pain-control areas like the periaquaductal gray while inverse changes are occurring in pain-perceiving areas has not been sought. This study will address both of these issues with a single BOLD FMRI experiment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50
* Right-handed
* Male or female
* Healthy individuals not taking any medication.

Exclusion Criteria:

* Pregnancy
* Diagnosed with any treated or untreated medical or neurological conditions
* Using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. Oral contraceptives are permitted
* Using any over-the-counter medications including aspirin, Tylenol, or herbal supplements
* Using any illicit substances
* Contraindications to magnetic resonance imaging.
Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease

In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.

NOTE: All sites have been selected for this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with dry eye disease
* Signs and symptoms of dry eye disease
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with study procedures
* Willing and able to provide consent

Exclusion Criteria:

* Active ocular infection or inflammation
* History of eyelid, conjunctiva or corneal surgery within the past year.
* Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
* Contact lens wearer
* Significant ocular surface or eyelid abnormalities, recent ocular trauma
* Certain corneal surface abnormalities
* Use of medications for treatment of dry eye or medications that cause dry eye
* Systemic disease that results in dry eye
Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation

As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. The aim of the present study is to compare different methods for visualization of the esophagus to prevent this complication.

Percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. Importing images from pre-acquired 3-D CT or MRI scans into the 3-D mapping system with superimposition of the electro-anatomical map is increasingly used. Despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. To prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. Another possibility of visualization of the esophagus is to perform the CT after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the LA and may be scanned by CT . It has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. However it is not clear whether the position of the esophagus in relation to the left atrium is changing over days.

The aim of the present study is to evaluate whether visualization of the esophagus by placing a conventional gastric tube before performing the CT scan and visualization and integration of the esophagus into the 3-D electro-anatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship during the radiofrequency ablation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrial fibrillation undergoing radiofrequency ablation
Accuracy of Pulse Oximeters With Profound Hypoxia

This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

Generally, benign breast tumors are excised under the local anesthesia. But such action was so invasive that every patient would experience the physiological and psychological stimuli unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its "easy come,easy go" property during short-lasting operations than isoflurane. We purposed that sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane with relative less alteration in hemodynamics, less postoperative side effects and easily-control the depth of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Chinese
* Diagnosed benign breast tumor patients
* 18-64 yrs

Exclusion Criteria:

* Allergic to any interventional drugs
* Organic dysfunction
* Long-lasting PACU staying
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

Group A (Subjects with Hepatic Impairment):

* male or female between 18 and 65 years of age
* subjects must have a Child-Pugh total score of 7 to 9
* subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study
* subjects must have a body mass index (BMI) of 18 to 35 kg/m2

Group B (Healthy Subjects):

* male or female between 18 and 65 years of age
* subjects will match subjects with hepatic impairment for sex, BMI, cigarette smoking habit, and age
* subjects must agree to use 1 highly effective method of contraception during the study and for 90 days after the completion of the study

Exclusion Criteria:

Group A (Subjects with Hepatic Impairment):

* subjects who are not clinically stable or who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
* subjects who have a history of alcohol abuse within 1 year or illicit drug abuse within 2 years
* subjects who smoke more than 10 cigarettes per day
* subjects who have fluctuating or rapidly deteriorating hepatic function
* subjects who have significant renal dysfunction
* subjects who have HIV, or active hepatitis B
* subjects who have previous solid organ or bone marrow transplantation

Group B (Healthy Subjects):

* subjects who have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* subjects who are unwilling or unable to discontinue use of any inhibitors or inducers of CYP3A
* subjects who have a history of alcohol or illicit drug abuse within 2 years
* subjects who smoke more than 10 cigarettes per day
* subjects who have HIV, hepatitis C, or active hepatitis B
A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery

This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of liposomal bupivicaine that is reputed to have a much longer duration of action compares to bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also been studied in other procedures and demonstrated reduction in opioid use and median length of stay (LOS).

Currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. As Exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if TAP blocks with Exparel™ have an advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result in reduced length of stay contributing to significant hospital cost savings. Secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). Given there are no published data on the efficacy and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot study.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing planned exploratory laparotomy
* TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
* Consent for TAP block signed by patients preoperatively by anesthesiology

Exclusion Criteria:

* All pregnant patients
* All patients under 18 years of age
* minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
* medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease