cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous CO2 Measurement - From Hospital to Home

Long-term non-invasive ventilation (LT-NIV) is the main treatment modality for chronic hypercapnic respiratory failure.To assess the adequacy of alveolar ventilation during sleep and potential sleep hypoventilation, nocturnal transcutaneous CO2 (PtcCO2) monitoring is necessary. There is an increased tendency to monitor patients at home, but there is a lack of robust data comparing the technical success rates between the home and inpatient setting of PtcCO2 monitoring. The primary aim of the current study was to evaluate the rate of successful nocturnal PtcCO2 monitoring in a home setting in a population of patients with chronic hypercapnic respiratory failure receiving LT-NIV. The secondary aim was to compare these data with PtcCO2 registrations performed during regular follow up of a similar population of patients in a hospital setting.

Patients scheduled for LT-NIV follow-up at Oslo University Hospital, Ullevål in the time-period January 2020 to December 2022 were prospectively identified. Follow-up monitoring occurred either at home or in the hospital. Two physicians blinded to the location of the monitoring, retrospectively classified the PtcCO2 as successful or unsuccessful, and identified the causes of failure for the latter.

Eligibility Criteria:
Inclusion criteria for both groups were:

1. LT-NIV treatment for at least 3 months,
2. that the monitoring was due to a scheduled follow-up appointment,
3. at least one follow-up visit at the hospital after LT-NIV initiation. Inclusion in the study required a signed consent from all participants.

There were three additional criteria for the home monitoring group:

1. home address in reasonable proximity to the hospital,
2. the subject/spouse/assistant/home health care provider was assumed capable of operating the equipment, and
3. the subject consented to undertaking the monitoring at home.
Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes

MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.

Morrow DA, Scirica BM, Karwatowska-Prokopczuk E, Skene A, McCabe CH, Braunwald E; MERLIN-TIMI 36 Investigators. Evaluation of a novel anti-ischemic agent in acute coronary syndromes: design and rationale for the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-elevation acute coronary syndromes (MERLIN)-TIMI 36 trial. Am Heart J. 2006 Jun;151(6):1186.e1-9.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with non-ST elevation acute coronary syndrome
* Ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry
* At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression, diabetes)

Exclusion Criteria:

* Persistent acute ST-segment elevation
* Successful revascularization during the qualifying hospitalization, prior to study entry
* Acute pulmonary edema, hypotension, or evidence of cardiogenic shock
* Clinically significant liver disease
* End stage kidney disease requiring dialysis
* Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs
* Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4
* Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control

Additional study entry criteria will be evaluated during initial screening.
Using Technology to Improve Eating Disorders Treatment

The purpose is to evaluate a technologically-enhanced, guided self-help program to reduce eating disorder outcomes in college-age women.

Colleges are faced with an elevated prevalence of eating disorders, yet less than 20% of students report receiving treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. Over the past 20 years, we have developed a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the eating disorder risk and diagnostic spectrum, using minimal person-based resources. The newest intervention in our suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a large-scale trial or via platform delivery. The aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, SB-ED, yields measurable and significant improvements in access, costs, and outcomes for eating disorder treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center).

Twenty-eight colleges will be randomly assigned to receive either SB-ED or referral to usual care. We will enroll at least 650 students from these campuses who screen positive for a DSM-5 clinical or subclinical eating disorder (excluding anorexia nervosa, which warrants more intensive medical monitoring). Outcomes will be measured at 6-months, 1-year, and 2-years following the completion of the online screen.

Eligibility Criteria:
Inclusion Criteria:

* Student at a participating college or university ages 18-30
* Screen positive for DSM-5 bulimia nervosa, binge eating disorder, or a subclinical eating disorder

Exclusion Criteria:

* Screen positive for DSM-5 anorexia nervosa
* No access to the internet
* Acutely suicidal
Interest of Procore Needle® for Diagnosis of Lung Cancer

The ProCore ultrasound biopsy needle, used primarily to obtain intra-abdominal tissue core biopsies, has not been widely used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). In this study the investigators are going to evaluate the utility of the ProCore needle for sampling mediastinal or hilar lymph nodes during EBUS-TBNA versus standard 22 gauge needle for diagnosis of lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* mediastinal lymphadenopathy \>10 millimeters
* lung cancer suspected

Exclusion Criteria:

* coagulopathy contraindication for midazolam contraindication for bronchoscopy
The Effect of Delivery Mode on Inter - Couple Relationship, Sexual Function and Pelvic Floor Activity

Pregnancy and delivery have a major impact on couple's inter personal relationship. Different modes of delivery have different effect on pelvic floor function, and it is known that instrumental vaginal deliveries have the worse effect, though various common anatomical injuries have been described following vaginal delivery. Pelvic floor dysfunction has the potential to ameliorate sexual function, and the investigators hypothesis is that the impact of delivery on pelvic floor disorders following delivery will have a direct effect on sexual malfunction and interpersonal relationship. The purpose of this study is to evaluate the effect of delivery mode of primiparous women on inter couple relationship , their sexual function and the female pelvic floor activity. The couples will be followed from the second trimester of the pregnancy by validated specific questionnaires, assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function. After delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery. Apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor.

Pregnant women in their first pregnancy and their husbands will be recruited from 14th week of gestation. The couples will be followed by validated specific questionnaires, such as Couple Satisfaction Index (CSI), Isreali Sexual Behavior Inventory (ISBI), Pelvic Floor Distress Inventory (PFDI)and Pelvic Floor Impact Questionnaire (PFIQ) assessing the couple's satisfaction of their marriage, intimacy in their relationship, their sexual behavior and pelvic floor function. After delivery, the parameters of the parturition will be recorded, and the couples will be interviewed 6 months following delivery. Apart from questionnaires, sample of the participated women will be assessed by ultrasound examination of the pelvic floor, demonstrating the continuity of pelvic floor muscles and their function.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in their 1st pregnancy
* Married couples in their 1st marriage

Exclusion Criteria:

* Chronic GIT disease
* Endometriosis
* Chronic GUT disease
* Psychiatric disease
* Known sexual dysfunction
Assessing Concentrations of Methadone and Its Metabolites

An observational proof of concept method comparison study. Comparing Liquid Chromatography -Mass Spectroscopy to a new Quantitative Lateral Flow Immunoassay with an Optical Reader.

CARI Health, Inc.'s long-term goal is to address the problem of high dropout rates of patients receiving medication for opioid use disorder (MOUD; e.g., methadone) treatments, which has increased with the prevalence of fentanyl use, with an innovative point-of-care (PoC) device to enable science-based personalized dosing for patients receiving methadone treatment for opioid use disorder (OUD). The proposed solution consists of a customized analysis device that incorporates proprietary methadone detection technology for quickly measuring methadone and metabolite levels in the blood and calculating the methadone/metabolite ratio (MMR).

To accomplish this long-term goal, the investigators aim to first quantitatively measure methadone doses taken and ethylidene-dimethyl-diphenyl pyrrolidine (EDDP) detection using lateral flow assays. At this stage, the investigators are not testing a device. They are first assessing whether methadone metabolism can be evaluated using lateral flow assays, which are simple paper-based diagnostic strips. The tests work similarly to a home pregnancy test, where a sample (like blood, urine, or saliva) flows along a test strip and interacts with antibodies or other molecules that capture the target substance. No clinical decisions will be made, no treatment will be applied, and no dosing will be changed based on the results learned in this study.

Eligibility Criteria:
Inclusion Criteria:

Age 18-70. A prescription for methadone at a dose of 10mg or more for at least 7 days. Participants may be taking the methadone to treat an OUD or for pain. Taking methadone as prescribed during the last 4 days before consent to participate in the study.

Has been prescribed at least 1 day of take-home doses.

Exclusion criteria for methadone group includes:

Age \<18 or \>70. A condition preventing or complicating blood collection. Conditions may include dermatological (skin) condition, bleeding diathesis, immunodeficiency, recent blood donation, anemia, end stage renal disease, liver cirrhosis, cancer, congestive heart failure, bleeding diathesis, tuberculosis (TB), active severe depression (e.g., suicidal ideation), or mania symptoms.

Tattoo or piercing close to sampling area. Under a conservatorship.
Evaluation of Using Different Screwed Abutment Height

A prospective randomized controlled clinical trial will be conducted. Study groups will be assigned as described above. The patients will be randomly divided into two groups in order to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant System, Institut Straumann AG, Basel, Switzerland).

48 patients will be selected with partial edentulism in the maxilla or mandible, requiring two dental implants in the posterior areas (molars and premolars).

Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12) and all the implants will be placed by residents of the International Master in Oral Surgery and Master in Periodontics of the same University.

Study groups

Group 1: Two stage approach (cover screw in first surgery and healing abutment in second surgery) (12 patients)

Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two subgroups according to different trans-epithelial height abutment:

* Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
* Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)

Clinical Parameters and Outcomes

* Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed tomography superposed with digital cast models).
* Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
* Probing depth, bleeding on probing and keratinized mucosa width will be measured in the follow-up visits in 3 different points in buccal (Mesial, center and distal).
* VAS Scale: The visual analog scale or visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Overall, healthy subjects
3. Females and males of at least eighteen-years
4. Requiring a minimum of two implants (molar and/or premolar teeth)
5. Adequate oral hygiene (less than 15% FMPS)
6. Able to follow instructions and attend a regular compliance
7. Enough bone to place a standard implant of 4.1 mm diameter.

Exclusion Criteria:

1. Acute local infection
2. Occlusal overload with parafunctional activity (assessed clinically)
3. Large occlusal discrepancies
4. Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical attachment loss in two consecutive visits within 1 year)
5. Smokers (more than 10 cigarettes/day)
6. Drug and/or alcoholic dependencies
7. Medical conditions contraindicating implant surgery
8. History of head and/or neck radiation
9. Bisphosphonate therapy
Study on the Efficacy and Safety of Enhanced Recovery After Surgery （ERAS）in Gastrointestinal Cancer

At present, there are more and more reports about enhanced recovery after surgery（ERAS）in China, but there is no ERAS treatment standard for gastrointestinal cancer, and there are many factors limiting the development of ERAS. In recent years, due to the development of minimally invasive technology, the establishment of evidence-based medicine model and the development of MDT, it makes a good solid foundation for the clinical application of ERAS. The implementation of ERAS requires the cooperation of surgeons, anesthesia management, nursing, rehabilitation and other teams. As an individualized treatment mode, ERAS focuses on the optimization of treatment for different individuals in order to acquire the best benefit of patients. Therefore, the concept of ERAS is still in the process of continuous improvement and development in China, hoping to explore the Chinese ERAS clinical pathway for gastrointestinal cancer. The purpose of this study is to optimize the clinical pathway of ERAS in the perioperative period of gastrointestinal cancer, and to evaluate the effectiveness and safety of ERAS in gastrointestinal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent
* Preoperative pathology confirmed gastric cancer or colorectal cancer
* Age: 18-70 years, men or women
* According to NCCN guidelines, it is not Stage IV tumor
* Perform radical gastrectomy or radical colon cancer surgery (CME) or radical rectal cancer surgery (TME);
* ASA I-III
* Receive no radiotherapy or chemotherapy before operation
* The subjects can describe the symptoms objectively and keep the follow-up plan

Exclusion Criteria:

* Preoperative pathology confirmed no gastric cancer / no colorectal cancer (such as rectal neuroendocrine tumor, lymphoma, etc.)
* Stage IV or Radical resection can't be performed
* Emergency operation
* Can't cooperate with clinical data collection
* General condition is intolerable to operation
* Serious diseases, including heart function ≥ level II, respiratory function insufficiency, liver and kidney function insufficiency, and blood system diseases
* Patients participate in other clinical trials at the same time
* Pregnant or perinatal women
* Other malignant tumors
* History of mental illness
* Had a history of severe trauma within 4 weeks before admission
* Less than 6 months after other level 4 operations
Effects of Rifaximin on Gut Microbiota and Emotion

A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.

This study is a randomized, triple-blind, placebo-controlled, interventional trial aiming to elucidate the impact of rifaximin-induced gut microbiota alteration to the psychobiological functioning of healthy men. The intervention will be performed in a parallel group design where one group will receive rifaximin (Targaxan 550 mg) twice daily for two weeks (treatment arm), while the other group will receive placebo (placebo arm).

Primary objective: to test the effect of rifaximin on stress sensitivity and fear-related processes

Secondary objective: to determine the mediating and/or moderating factors that underlie rifaximin-induced psychobiological changes

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Proficiency in English and/or Dutch
3. Healthy with no intestinal and/or psychological complaints
4. Access to a -18°C freezer (i.e. ordinary household freezer)
5. Male participants
6. Age 18-50 years
7. BMI 18.5-25 kg/m2

Exclusion Criteria:

1. Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
2. Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial
4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
5. Hypersensitivity to the active substance rifaximin, to any rifamycin (e.g. rifampicin or rifabutin) or any of the excipients
6. Current or recent medication use
7. Use of antibiotics within three months preceding the study
8. Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
9. Previous or current substance/alcohol dependence or abuse (\>2 units per day or 14 units per week)
10. One or more diagnoses based on the mini international neuropsychiatric interview (MINI-S)
11. One or more diagnoses based on ROME IV for gastrointestinal disorders
12. Smoking
13. Night-shift work
14. Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.)
15. Use of pre- or probiotics within one month preceding the study
16. Previous experience with any of the tasks used in the study (not including questionnaires)
17. Color vision deficiency (colorblindness)
18. Magnetic Resonance Imaging (MRI) contraindications, including claustrophobia, severe back problems, conditions that would interfere with MRI scanning (e.g. cochlear implant, metal fragments in eyes, metallic body inclusion, or other metal implanted in the body), and if the participant does not want to be informed of incidental findings that might be found during imaging.
The Ability Of The PD2i Cardiac Analyzer To Predict Risk Of Ventricular Tachyarrhythmic Events

This is a prospective study to evaluating the ability of the PD2i Cardiac Analyzer to predict the risk of serious heart rhythm abnormalities in high-risk patients that do not already have an Implantable Cardioverter Defibrillator.

The annual incidence of sudden cardiac death in the United States has recently been estimated at 450,000. Most of these patients die from ventricular tachyarrhythmias. Currently, there is a limited ability to predict reliably which patients are at risk for these events. Implantable cardioverter defibrillators (ICDs) are highly effective at treating the arrhythmias that cause sudden death. Multiple clinical trials demonstrating the efficacy of ICDs for the primary prevention of sudden death have been completed, leading to a relaxation of the selection criteria for their use, and therefore a potentially large expansion in the pool of patients eligible for these devices. This has major economic implications for the health care system, and has led to a need for better prospective identification of patients who are or are not at high risk for sudden death.

The existence of beat-to-beat changes in heart rate, termed heart rate variability HRV), has long been recognized by physiologists. However, over the past 15 years, it has been determined that HRV is not a random phenomenon but can be influenced by the brain through the autonomic nervous system.

Promising work in the analysis of HRV may provide a means of predicting which patients are at risk for sudden death. HRV analysis utilizes mathematical modeling of ECG data to gain insight into the subtle variations in heartbeat patterns which occur from beat-to-beat.

The development of a system that could better identify the patients at risk of arrhythmic events would have a significant impact on clinical and economical fields. This study will test software developed by Vicor Technologies that can potentially identify patients at risk of arrhythmic events. It works as a generic digital-electrocardiogram (ECG) device, as it would normally be used by technical personnel in the routine care of outpatients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Left Ventricular Ejection Fraction (LVEF) \<35%
* Prior myocardial infarction
* Symptomatic congestive heart failure
* Referred for EP testing and/or prophylactic ICD implantation

Exclusion Criteria:

* Currently has implanted pacemaker or ICD
* Current atrial fibrillation/flutter or atrial fibrillation/flutter requiring cardioversion within the previous 6 months
* Cardiac surgery or percutaneous revascularization, MI, unstable angina, or CVA within the previous 30 days
* Antiarrhythmic drug therapy other than a beta-blocker within the previous 6 months
* Previous episode of sustained VT/VF or cardiac arrest, except in the setting of acute myocardial infarction or other reversible cause
* Life expectancy of less than one year from any non-cardiac cause
* Expected cardiac transplantation within 6 months
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy

Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thyroid surgery

Exclusion Criteria:

* ASA physical class III or IV
* age \> 75 years
* pregnancy