cyrilzakka/clinical-trials huggingface dataset:
Remifentanil Dosing Regimes for Anesthesia in Bariatric Surgery: Characteristics of Early Recovery

Early recovery characteristics are important for patients' safety and operating room turnover. Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Introduction: The population of overweighted patients is increasing dramatically, therefore physicians face them in their daily practice (1-2). There are many guidelines showing the dose counting methods of intravenous anesthetics, but none of them are perfectly good for morbidity obese patients (3). Early recovery characteristics are important for patients' safety and operating room turnover (4).

Aim: Our aim was to compare fundamental methods for dosing remifentanil during morbid obesity surgeries: a manual infusion and a target-controlled infusion (TCI). Throughout study, patient's recovery time was tracked and compared between the groups.

Methods: 31 patients were evaluated who underwent bariatric surgery in Hospital of Lithuanian University of Health Sciences. All of them had received sevoflurane/remifentanil anaesthesia. Remifentanil infusion was randomly assigned to a manual (control group) or to a TCI (case group) method. We had evaluated patients' hemodynamics (arterial blood pressure, heart rate, saturation), spontaneous breathing and airway reflexes recovery time, time of extubation, eye opening, recovery of orientation and start of the following oral command. Also we had registered concentrations of remifentanil in the blood (according to automatic infusion pump) while using TCI method.

Eligibility Criteria:
Inclusion Criteria:

* Morbid patients to whom, according guidelines (BMI \> 45 or BMI \> 35 and chronic disease) bariatric surgery is indicated.
* Patient's approval.

Exclusion Criteria:

* Patients, younger than 18 years old.
* Patients who are higher than III ASA class.
* Patients who have higher sensibility to medications that are used during anesthesia.
* Patients with phycological disorders.
* Patients who can not fully communicate because of language barriers.
* Patients with surgical complications.
* Patient's disapproval.
Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas

This study aims to collect perioperative diagnosis and treatment information of patients undergoing abdominal surgery at plateau and plain areas , collect blood and others samples for laboratory testing when necessary, analyzing the data to clarify the incidence and risk factors of pulmonary complications in patients undergoing abdominal surgery at different altitudes, so as to reduce the risk of pulmonary complications and even death in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old；
2. scheduled for elective abdominal surgery under general anesthesia；
3. ASAⅠ-Ⅲ

Exclusion Criteria:

1. Patients and their family members refused to be enrolled；
2. patients were unable to communicate because of language disorders such as dementia and hearing impairment；
3. patients were admitted to ICU 48 hours before operation；
4. preoperative diagnosis of ARDS, aspiration pneumonia, pulmonary embolism or pulmonary edema or other acute respiratory diseases；
5. mechanical ventilation within one week before operation；
6. death or discharge within 24 hours after operation；
7. second operation due to postoperative complications
A Single-centre Study of Entonox Versus Midazolam Sedation in Gastroscopy

This study aims to determine whether Entonox (gas and air) is at least as good as intravenous midazolam in providing analgesia and sedation during gastroscopy. Entonox is used as an adjunct in lower gastrointestinal procedures but is not routinely used in gastroscopy, and there is only one similar published study to date, which was performed in children. The main advantage of Entonox over midazolam is the quick recovery time following withdrawal of the agent, which enables patients to return to independent normal life. The investigators would like to be able to offer Entonox to patients as an option for sedation during gastroscopy, this study is being conducted to determine if it is a safe and feasible option.


Eligibility Criteria:
Inclusion Criteria:

* Male/female aged 18 years or over
* Confirmed clinical requirement to undergo diagnostic gastroscopy
* Suitable for sedation
* Able to provide informed consent

Exclusion Criteria:

* History of chronic respiratory or significant cardiac disease
* Requirement for longer procedure eg Barrett's surveillance
* Previous known adverse reaction to Entonox
* Entonox use in previous 4 days
* Known current vitamin B12 or folate deficiency
* Unable to provide consent
* Any known contraindication to Entonox:
* Gas trapped in a part of the body where its expansion may be dangerous, such as air lodged in an artery or artificial traumatic or spontaneous pneumothorax (collapsed lung).
* Decompression sickness (the bends) or following a recent dive
* Air encephalography
* Severe bullous emphysema
* Myringoplasty
* Gross abdominal distension
* Recent severe injuries to the face and jaw
* Current or recent head injuries
* If the patient has recently had any eye surgery where injections of gas have been used
Evaluation of Improvements in Patient-reported Quality of Life

Local intervention trial for the evaluation of improvements in patient-reported Quality of Life and treatment satisfaction, in breast cancer patients (BCP), as a result of flexible treatment planning supported by REBECCA-collected real-world data, in comparison with standard care

Local intervention trial which will evaluate the potential of using real-world patient measurements collected by the REBECCA system for improving the patient-reported quality-of-life, through just-in-time support consultations, during the first 12 months after radiology and/or chemotherapy treatment. The effects of the REBECCA-assisted treatment on QoL, in relation to baseline, will be compared against standard

The use of REBECCA-collected patient information by BCP-supervising health professionals (based on the continuous REBECCA real-world measurements), aims to estimate to which extent it:

- Improves the quality of the provided treatment at 12 months, resulting in an improved QoL, in comparison with standard treatment practice

It will also evaluate that:

* The observed improvements will persist long-term, at least till the point of the 18-month follow-up evaluation
* The observed QoL improvements will be associated with REBECCA's Functional Life Index improvements, as evaluated through the continuous REBECCA real world measurements. This will act as an assessment of the RWD use for safer and more effective post-treatment management of interventions with first line chemo/radiotherapies in breast cancer.
* The observed QoL improvements will be associated with REBECCA's PROM Index improvements, as evaluated through the continuous REBECCA real world measurements.

Eligibility Criteria:
Inclusion Criteria:

* Before patient registration, written informed consent must be given according to national and local regulations.
* Participants have had histologically proven stage I-III breast cancer undergoing endocrine treatment (with or without prior chemotherapy) no more than 12 months prior to randomization.
* Be between 18 and 75 years of age.
* Have increased life expectancy beyond the initial 3 months post-treatment initiation.
* Have the ability to understand protocol, participate in testing and willingness to sign a written informed consent.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

* Patients that are not willing to sign an informed consent form
Therapeutic Drug Monitoring for Individualized Clozapine Therapy

The purpose of this study is to evaluate the factors affecting the occurrence of adverse drug reactions (glucose and lipid metabolism abnormality, changes in liver function index and sleeping tendency) and clinical effects in schizophrenia patients with clozapine treatment

1. The baseline tests (sleeping tendency assessment, clinical symptom and cognitive assessments, clinical laboratory tests, genotyping, exploratory biomarker tests, etc.) are conducted to the schizophrenia patients before initiation of the clozapine dosing.
2. On day 15 and 57, the changes from baseline clinical symptom and cognitive function are assessed after clozapine treatment. Also, the occurrence of adverse drug reactions are evaluated. In addition, blood sample collections are performed for the assessment of clozapine and its metabolite levels.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed with schizophrenia spectrum disorder and are expected to use clozapine for more than 57 days to treat or prevent recurrence of schizophrenia
2. Patients who are 19 years or older
3. Patient who understands the contents of the clinical research and provide their written informed consent forms

Exclusion Criteria:

1. Patients taking a drug that the researcher deems inappropriate before clozapine administration
2. Patients who can not use an appropriate contraceptive method during the study period
3. Patients whom the researcher deemed inappropriate for clinical research participation
A German Multicenter Study on Toxoplasma Gondii in First-episode Schizophrenia

Environmental risk factors for the development of schizophrenia include infections during the perinatal period or later in life with Toxoplasma gondii (TG) being one of the candidate agents. A recent review (Torrey and Yolken, 2003) on TG in schizophrenia and other serious mental disorder reported higher antibodies to TG in patients compared to controls in 18 of 19 studies, one having been conducted by the investigators group. In a second, independent study on first-episode schizophrenia (n=56) and control subjects (n=32), sera were sampled and standard instruments used to assess diagnoses and psychopathology, respectively to screening controls.

For the total sample, contacts with animals during pregnancy and age emerged as a non-significant predictors of TG IgG titers. Means of patients' and controls' TG IgG titers did not differ significantly but variances did; a subgroup of patients' titers reached much higher levels than those of controls. Patients in the high TG IgG subgroup were older (p=0.001), also they were older when psychiatric symptoms appeared, more individuals had regular animal contacts during pregnancy, or rural upbringing including regular animal contact, more consumption of raw meat, and a higher absolute treatment response (all trend levels). Regarding the short term course of patients, the investigators detected decreasing IgG titers in several individuals A power analysis demonstrated that results fell short of significance due to lack of statistical power. Based on the power analysis, the investigators propose an opel label, multicenter study at three regionally different sites within Germany (Halle, Hamm, Heidelberg). The investigators intent to study 173 first-episode patients with schizophrenia, schizoaffective, and schizophreniform disorder and 173 matched controls.

The investigators hypothesize that - according to the heterogeneity of the illness - a subgroup of patients will exhibit higher TG IgG titers compared to the remaining patients and to controls; that this subgroup will have had regular contact with animals during pregnancy and early life as well as developmental delays; and that clinical improvement, response to treatment, and subjective well-being will run parallel with TG IgG decrease.

Patients shall be assessed on admission to hospital, at discharge and at 6- and 12-month-follow-up with respect to TG antibody titers, symptomatology, neuropsychology, predictors of outcome, quality of life, and neurological soft signs. In controls two assessments shall be performed, 12 months apart. All foreseen assessments will be performed using standard measurement instruments with sound reliability and validity such as the SCID and the PANSS. Exposure to cats, other warm-blooded life-stock, and raw meat will be assessed using a special questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Key inclusion criteria will be a first episode of schizophrenia, schizoaffective or schizophreniform disorder.

Exclusion Criteria:

* Exclusion criteria will be major organic and substance induced disorders, refusal or withdrawal of IC.
Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung

2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT screening study and who are scheduled for follow-up diagnostic imaging study, biopsy, clinical consultation or surgical appointment at one of the participating hospitals.

The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer.

Study duration: Expected patient enrollment to be completed within 12 months after study initiation. Patients will be followed for a minimum of 12 months from the date of enrollment. The study duration is approximately 2 years.

Participant duration: The day of blood collection. Participants will follow their regular standard of care schedule as recommended by existing guidelines; no extra visits are planned. Follow up data will be obtained from the electronic medical record within at least 12 months of follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients, aged 50 to 80 years
* Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or subsequent) and are referred to undergo further diagnostic procedures for the detection of lung cancer
* Has undergone LD-CT screening exam within last 90 days and allows for blood sampling within this period
* Subject may not have undergone any invasive diagnostic procedure in relation to the suspicious nodule
* Able and willing to provide informed consent

Exclusion Criteria:

* Prior history of diagnosed lung cancer
* History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer within the past 10 years
* Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)
* Immunosuppressive medication
* Deemed not able to participate in the study by the investigator
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy, male and nonpregnant female subjects, 18 years of age or older.
2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
3. Subjects with the presence of telangiectasia at Baseline
4. Subjects with the presence of facial erythema associated with their rosacea at Baseline

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea
3. Standard exclusion criteria.
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure

The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.

Endothelial function is known to be impaired in patients with chronic heart failure (CHF) and impaired endothelial function has been reported to be associated with an increased mortality risk in those subjects. Although systemic exercise training has been demonstrated to improve endothelial dysfunction in patients with CHF, elderly patients with severely impaired exercise capacity could not engaged in usual exercise training using ordinal ergometer. Those patients are able to join stretching or very light resistance training. On the other hand, passive pedaling using strength ergometer has been reported to be useful in patients with severely impaired exercise capacity, but the safety and the efficacy of passive pedaling on endothelial function in old patients with CHF has not been previously reported.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic heart failure
* Elderly patients aged ≧65 years
* Patients with severely reduced exercise capacity and cannot continue exercise with usual cycling ergometer for 5 minutes

Exclusion Criteria:

* Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension)
* Active infectious disease
* Malignancy
* Chronic obstructive pulmonary disease
* Dialysis
* Severe aortic valve disease
* With any hip, knee, ankle joint pain
* Hemiplegia
* Current smoker
Individualized Exploration of Aerobic Exercise-assisted Treatment of Depression

The goal of this project is to quantify the relative effectiveness of aerobic exercise monitored by smart wristbands in assisting the treatment of depression and improving cognitive function. It aims to explore the mechanisms through which aerobic exercise exerts its effects using imaging genetics and other methods, and to identify suitable populations for exercise, ultimately providing personalized clinical exercise prescriptions. This study will intervene from a behavioral perspective and also seeks to motivate participants to change and improve their physical activity habits.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-45 years (including 18 and 45), no gender restriction;
2. Meets the diagnostic criteria for depressive disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV);
3. Outpatients or inpatients; Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 14; Mood Disorder Questionnaire (MDQ) screening negative to exclude bipolar disorder patients; and Clinical Global Impressions-Severity (CGI-S) score ≥ 4;
4. Maintained on antidepressant treatment for at least 4 weeks or not using antidepressant treatment;
5. Written informed consent obtained from the patient.

Exclusion Criteria:

1. Diagnosed with other mental disorders, including schizophrenia, bipolar disorder, alcohol or substance abuse/dependence, eating disorders, etc.;
2. Individuals with intellectual disabilities or who are unable to cooperate for other reasons, or those lacking or having incomplete civil capacity during the onset of illness;
3. Suffering from neurological or organic brain diseases (such as stroke, cerebral hemorrhage, brain tumors, Parkinson\&#39;s disease, epilepsy, etc.) and a history of severe traumatic brain injury;
4. Suffering from conditions with high exercise risk, such as hypertension or heart disease;
5. Currently undergoing systematic psychological therapy;
6. In the 3-minute step test, males with a recovery heart rate \&gt;131 and females with a recovery heart rate \&gt;140;
7. Physically restricted individuals unable to participate in physical exercise;
8. Physical Activity Readiness Questionnaire (PAR-Q) score ≥ 2;
9. Pregnant women or individuals with contraindications to MRI examinations;
10. Individuals with severe suicidal tendencies or at risk of harming others.
Reducing Sedentary Behaviors Among Colorectal Cancer Survivors

Interview colorectal cancer survivors and use this input to create a brochure intended to guide reduction of sedentary behaviors in this population. Have colorectal cancer survivors review and comment on a draft of the brochure. A third group of colorectal cancer survivors will wear an Actigraph activity monitor for one week, then receive feedback on their activity level with the brochure. After one month this group will be surveyed by telephone regarding their use of the brochure, and their physical activity level.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Early (stage 1 or 2) colorectal cancer
* 6 months or greater post treatment
* Does not follow guidelines for physical activity
* Average at least 6 hours a day of sedentary behaviors

Exclusion Criteria:

-
Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

This study will compare the efficacy of indacaterol versus placebo (i.e., rescue medication only) and tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD) who have not received maintenance COPD medication for at least 12 months prior to entry (described hereafter as "maintenance naïve", see inclusion criteria).

The purpose is to provide efficacy data comparing the long-acting beta-2 agonist, indacaterol, with short-acting rescue therapy in maintenance-naive patients belonging to GOLD 2011 Groups A and B.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable Chronic Obstructive Pulmonary Disease (COPD) Groups A or B according to GOLD 2011.
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥50% and \<80% of the predicted normal, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) \< 0.7
* Patients with no record of receipt of maintenance medication for COPD.
* Patients with a mMRC dyspnea score ≥1 at Visit 2.
* Current or ex-smokers who have a smoking history of at least 10 pack years.

Exclusion Criteria:

* Patients who have not achieved acceptable spirometry results at run-in, in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
* Patients who have had 2 or more COPD exacerbations that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 12 months prior to Visit 1.
* Patients who have had a respiratory tract infection.
* Patients requiring long-term oxygen therapy (\>12 hours a day) on a daily basis.
* Patients with a) any history of asthma, or b) onset of respiratory symptoms prior to age 40 years.
* Patients with allergic rhinitis who use a H1-antagonist or intra-nasal corticosteroids intermittently. Treatment with a stable dose is permitted.
* Patients with concomitant pulmonary disease (e.g., lung fibrosis, sarcoidosis, interstitial lung disorder, pulmonary hypertension) or active pulmonary tuberculosis
* Other protocol-defined inclusion/exclusion criteria may apply.
Primary Prevention Study: Study on Obesity, Cardiovascular and Psycho-Social Characteristics in the City of Merzig

Cardiovascular risk factors and psycho-social characteristics will be determined in obese and non-obese patients in the setting of primary medical care.

Cardiovascular risk factors and psycho-social characteristics will be determined using a questionnaire in primary care physician offices in the city of Merzig, Germany. We will recruit all people (age\>18y) with a body-mass index (BMI) \> 30 kg/m2 plus patients in the two following participating physician offices: Praxisnetz and Merzig. Cardiovascular risk will be assessed using the PROCAM (Munster Heart Study), ESC (European Society of Cardiology) and Framingham risk scores. Psycho-social factors will be recorded according to the methodology of the INTERHEART study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or \> 18
* BMI \> 30 kg/m2
* Presenting to a participating primary care physician

Exclusion Criteria:

* Age \< 18