cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.


Eligibility Criteria:
Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m\^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Weight at least 110 lbs

Exclusion Criteria:

* Use of contact lenses within 14 days, or planned use during the study
* Use of any ocular eye medications within 30 days, or anticipated use during the study
* Anticipated use of any artificial tears product during the study
Acute and Chronic Nicotine Modulation of Reinforcement Learning

The purpose of this study is to use functional magnetic resonance imaging (fMRI) to investigate the acute and chronic effects of nicotine on motivational behavior and prediction error-related neural activation. Nonsmokers (n = 24) and smokers (n = 24) will undergo fMRI scans on two separate occasions while performing a decision-making task that will elicit prediction error signals in the mesocorticolimbic pathway of the brain. Nonsmokers will be scanned once following an acute dose of nicotine and once following placebo administration. Smokers will be scanned once following smoking as usual and once following 24-hours of smoking abstinence, in order to measure the effects of nicotine withdrawal. The study team hypothesizes that acute nicotine will increase the prediction error signal in nonsmokers compared to placebo, and that nicotine withdrawal will decrease the prediction error signal in smokers compared to the normal satiated condition. Furthermore, nonsmokers (during the placebo condition) will have greater prediction error activation than smokers (during the satiated condition). The results of this study will inform whether the initiation and maintenance of smoking behavior could be facilitated by the effects of nicotine on reinforcement learning.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for all subjects:

1. generally healthy
2. between the ages of 18-55
3. right-handed

Inclusion criteria for nonsmokers:

1. smoked \< 50 cigarettes of a brand delivering ≥ 0.5 mg nicotine (FTC method)
2. have not smoked in ≥ 6 months
3. afternoon expired CO concentration ≤ 5 ppm and/or morning urinary NicAlert \< 100 ng/ml

Inclusion criteria for smokers

1. smoke ≥ 10 cigarettes/day of a brand delivering ≥ 0.5 mg nicotine (FTC method)
2. smoked ≥ 2 years
3. afternoon expired CO concentrations ≥ 10 ppm and/or morning urinary NicAlert \> 100 ng/ml

Exclusion Criteria:

1. inability to attend all required experimental sessions
2. significant health problems (e.g., current and uncontrolled liver, lung, or heart problems, current or past seizure disorder, serious head trauma)
3. lifetime diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
4. meet DSM-V criteria for past or current substance dependence other than nicotine
5. use of psychoactive medications as indicated by self-report
6. use of smokeless tobacco, nicotine replacement therapy, or desire to change smoking behavior while in the study
7. positive urine drug screen for illicit drugs or positive breath alcohol concentration
8. presence of conditions that would make MRI unsafe
9. having vision that cannot be corrected to 20/40
10. among women, nursing or a positive pregnancy test
11. inability to achieve learning criteria in training session
Extending Urine Analysis By Direct Mass Spectrometry

The aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is done directly from the urine sample (without an intermediate bacterial culture).The primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a comparison of the length of hospital stay.

Urinary tract infections (UTI) have a high incidence rate and are one of the main reasons for initiating an antibiotic therapy, both, in the ambulatory and hospital setting. Mass spectrometry and improved sample preparation allows same-day identification of the causing agent of an UTI. This could shorten the time of suboptimal and potentially harmful empirical therapy. Additionally adverse effects from and the development of resistance against the applied antibiotic agent could be diminished. Matrix Assisted Laser Desorption Ionization (MALDI)- Time of Flight (TOF) Mass Spectrometry (MS) (MALDI-TOF MS) is already the preferred identification method in an increasing number of laboratories since it outperforms biochemical identification by speed and precision. This study tries to evaluate this new method to identify the causing agent of an UTI and evaluates its clinical implications.

This research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry. This patient material is conventionally processed and not retrieved particularly for study purposes. Health-related personal data is collected from patients on the wards of the Clinic for Internal Medicine at the University Hospital Basel that have a urine sample analysed during the study period. No health-related personal data is particularly collected for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients of the Clinic for Internal Medicine at the University Hospital Basel with a suspected UTI and a minimum of one urine sample sent to the clinical microbiology laboratory.

Additionally at least one of the following:

* Patients consented to the general (i.e. "hospital-wide") use of their data and samples for research purposes.
* Patients consented to be enrolled in this study (by being informed about this study and signing the study specific consent form).
* Patients who are exempted from the need for a consent by way of an exception in agreement to the decisions of the competent ethics committee.

Exclusion Criteria:

* Minors or persons who declined the general use of their data and samples for research purposes (hospital wide consent) and declined or did not decide on the study specific consent form are not included.
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects

This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and female subjects;
* Body Mass Index 30-40 kg/m2;

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Characterization of Anti-HLA Alloimmunization After Pulmonary Valve Homograft Insertion

This is a prospective, monocentric, observational cohort study whose main objective is to describe the number and rate of patients who developed DSAs (Donor Specific Antibody) at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Lung homograft is used in a large number of complex malformations. It is accepted that homografts may induce immune reactions in the recipient, but no immunological studies have been carried out to characterize the recipient's immune reactions to the homograft and their potential impact on valve function. In this project, the authors propose to study the immunizing character of cryopreserved lung homografts by identifying the appearance of antibodies directed against the HLA, DSA (Donor Specific Antibodies) molecules of the graft (lung homograft) at 1 month and 6 months after its surgical implantation.The primary objective will be analyzed by describing the rate of patients who developed DSA at 6 months post-surgery with implantation of a cryopreserved lung homograft.

Eligibility Criteria:
Inclusion Criteriafor control patients:

* Patient receiving a cryopreserved pulmonary valve homograft
* Patient aged 14 or over
* Signature of consent by adult patients/parents/guardians and assent by children

Inclusion Criteriafor patients with lung homograft :

* Patientsreceiving a cardiac surgery with extracorporeal circulation and without lung homograft

Exclusion Criteria for both group

* Emergency surgery patient
* Pregnant women or childbirth within the last 6 months
* Transfusion during the surgery or within the last 6 months
* Patient with DSAs detected before the surgery
* Patient with anti-HLA antibodies (non-DSAs) detected before the surgery
Wound Contamination During Orthopaedic Surgery

In the present study we will compare bacteriological findings and the incidence of SSI in relation to laminar airflow (LAF) ventilated ORs, conventional (also called displacement or mixed) ventilated ORs and conventional ventilated ORs with the addition of tables equipped with units providing a local LAF over the surgical instruments.

The hypothesis is that there exist a correlation between number and types of airborne bacteria and bacteria in the surgical wound and on surgical instruments at the time of wound closure.

The scientific literature on the relationship between airborne bacteria and wound contamination during different conditions is scares. A study from 1982 (Whyet et al.), demonstrated that the most important and consistent source of contamination of the wound during clean surgery (in this case hip implant surgery) was via air. The study concluded that approximately one third of bacteria in the wound were caused by direct air contamination whereas the remaining number of bacteria were transferred to the wound by indirect routes such as via contaminated instruments.

The present study includes patients undergoing hemiarthroplastic surgery due to hip fracture.

During the surgery active air sampling, for microbial analysis, will be done within 30 cm from the wound.

Passive sampling of instrument tables, to measure number of depositing bacteria on the surface during the procedure, will be performed by placing sterile filters on the table surfaces before initiating the surgical procedure and collecting them at the end.

Skin and wound sampling will be performed with sterile flocked nylon swabs. The method for skin and wound sampling was decided based on a literature review and discussions with the department of Clinical microbiology at Sahlgrenska University hospital. Both aerobe and anaerobe bacteria will be analyzed.

The wound will be measured and number of personnel, door openings and clothing, at each procedure will be recorded.

Patients included in the study will be interviewed after 6 weeks and 1 year, to evaluate incidence rate of SSI.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip fracture surgery treated with hemiarthroplasty implant and that are subsequently cared for at participating ortho-geriatric unit

Exclusion Criteria:

* Patients that will not give their informed consent.
* Patient that, at the time of surgery, have an infection in any part of the body, hospital or community acquired.
* Patients receiving fracture fixation with pins only
Atypical Antipsychotic-induced Mitochondrial Dysfunction in Patients With Schizophrenia

Schizophrenia is a serious mental disorder with a global prevalence of 1%. The main cause of this condition is dysfunction in the signaling of neurotransmitters dopamine, serotonin, glutamate and Gamma-aminobutyric acid .According to recent research, a disturbed cellular energy state caused by mitochondrial dysfunction is thought to be a factor in the development of schizophrenia.

The aim of the treatment of schizophrenia is to reduce symptoms and is mainly based on the monoamine hypothesis. Atypical antipsychotics are the first-line of treatment.

Certain typical and atypical antipsychotic medications have been shown in prior preclinical research to decrease mitochondrial respiratory chain complex I activity. In contrast to individuals who were drug-naive, Casademont et al. found a significant decrease in complex I activity with haloperidol and risperidone in one cross-sectional observational study. Also, there is evidence suggesting that mitochondrial dysfunction is linked to the extrapyramidal side effects seen with antipsychotics.

To date, there are no randomized controlled trials that assess the effect of these drugs on mitochondrial functions. Hence, the present randomized controlled trial has been planned to evaluate and compare the clinical and biochemical markers of mitochondrial dysfunction in schizophrenia patients treated with the atypical antipsychotics risperidone and aripiprazole.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the DSM-5 criteria for diagnosis of schizophrenia.
* Treatment naıv̈ e patients or patients who had not taken any antipsychotic drugs for at least 4 weeks before recruitment.
* Patients of either sex between the ages of 18 and 60 years.
* Legally authorized representative (LAR) of patients consenting to participate in the study by signing the informed consent form.

Exclusion Criteria:

* Patients diagnosed with other psychiatric disorders including schizoaffective disorder or schizophrenia with somatoform disorders.
* Highly agitated patients who need immediate indoor-based treatment.
* Patients with known mitochondrial disorders (MELAS, LHON, Leigh syndrome, KearnsSayre syndrome, MERRF etc.)
* Patients with history of comorbidities like cardiovascular, renal, hepatic, neurological, respiratory or endocrinal diseases or malignancies.
* Patients with history of substance abuse.
* Pregnant or lactating mothers.
Vitamin D in Treating Patients With Prostate Cancer

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

OBJECTIVES:

Primary

* To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

* To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.
* To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

* To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
* Arm II: Patients receive 6,000 IU of vitamin D3 once daily.
* Arm III: Patients receive 8,000 IU of vitamin D3 once daily.
* Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the prostate
* 25(OH) D3 level \< 80 ng/mL

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status 0-2
* Creatinine ≤ 2.0 mg/dL
* Corrected serum calcium ≤ 10.5 mg/dL

Exclusion criteria:

* History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
* Hypersensitivity to cholecalciferol or one of its components

PRIOR CONCURRENT THERAPY:

* No other concurrent vitamin D supplementation
Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group for a Period of 6 Months During the COVID-19 Pandemic

This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.

Prior to conducting any of the screening tests, the Investigator or his designee will explain the trial fully to the prospective patient and provide him with a copy of the Patient Information Leaflet/Informed Consent Form.

If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file.

The screening questionnaire will be completed. The patient's suitability for the trial will be confirmed by the inclusion/exclusion criteria .

Following completion of the Baseline Questionnaire, patients will receive the Daily Questionnaire. This is designed to assess if they have developed symptoms associated with COVID-19 infection.

If a participant responds that they are not feeling well, a series of follow-up questions will be asked regarding what symptoms they are currently experiencing.

The Daily Questionnaire will be asked of patients every day throughout the Observation Period of 6 months.

At the end of the Observation Period, all patients will complete a series of questionnaires relating to the conduct of the study and tools employed.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient followed in the medical oncology department of Paris Saint-Joseph Hospital Paris in France
* Patient Having regular access to smartphone and internet sufficient to support study demands
* French-speaking patient
* Affiliation to the social security network
* Willing and able to provide given oral, free, informed and express consent

Exclusion Criteria:

* Patients unable or unwilling to perform all requested study tasks
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Pregnant or lactating patient
Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge

The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing major abdominal surgical procedures performed by laparotomy
* patients undergoing major urological surgical procedures performed by laparotomy
* patients undergoing major gynecological surgical procedures performed by laparotomy
* age ≥ 18 years
* signed informed consent

Exclusion Criteria:

* pregnant women
* esophageal disease
* aortic valve disease
* allergy to gelatin
* BMI \> 35
* beta blocker treatment, antiarrhythmic treatment, arrhythmia, pace-maker,
* presence of an arterio-venous shunt or of any other vascular disease on upper limb
Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea

Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient services

Exclusion Criteria:

* Inpatient services
The Effects of Bed Exercises on Anxiety, Pain, Early Ambulation and Mobilization in Patients Undergoing Major Surgery

In this study, the effects of bed exercises on pain, anxiety, early ambulation and mobilization in major surgery patients were aimed. The research was experimental and a total of 120 patients participated. Data were collected using an information form, anxiety scale, and pain scale. Exercise was applied to the patients in the experimental group (15 minutes) and no intervention was applied to the control group. Descriptive statistics, correlation tests and t-test were used. Cronbach's alpha coefficients were checked for the scales.

Major surgery are operations that can cause morbidity and mortality. Worldwide, approximately 230 million major surgical interventions are performed each year. Major surgery is a stressful experience and causes life-threatening fear and anxiety by increasing the level of anxiety. The most important of these fears is the pain that may occur after surgery. More than 75% of patients who experience postoperative pain in the Western world report that they experience moderate to severe pain. In our country, this rate is over 90%. If pain management is inadequate, patients' quality of life is adversely affected. In pain management, nurses can use non-pharmacological methods such as massage and exercise in addition to pharmacological applications.

Leg-arm exercises done in bed are aimed at protecting the muscle strength of individuals. Turning in bed, leg-arm exercises, raising the heels and feet, inverting the arms, moving from right to left, reverse arm and leg movements are performed. Also 6-8. Early ambulation is recommended. If these applications are made, early recovery and rapid discharge can be achieved. Since pain and anxiety delay early recovery in patients undergoing major surgery, effective pain management is very important. In this study, we aimed to examine the effects of in-bed exercises on anxiety and pain in patients undergoing major surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Ability to communicate verbally and not having a cognitive problem,
* Defining pain severity of 4 and above,
* Willing to participate in the study,
* Having undergone major surgery.

Exclusion Criteria:

* The absence of open wounds and cellulite in the area to be applied,
* The absence of thrombophlebitis,
* The absence of deep vein thrombosis,
* The absence of inflammatory diseases.