cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.

To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.

Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.

Eligibility Criteria:
Inclusion Criteria: chronic respiratory failure

* Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% \>10%)

Exclusion Criteria:

* Under 18 years old.
* Presence of severe uncontrolled cardiac comorbidity.
* Impossibility to achieve adaptation to therapy in the training session.
SFDI in High Energy Lower Extremity Fracture

This is a non-randomized prospective study of 20 patients with high energy lower extremity fractures evaluating feasibility and acceptability of SFDI, a real-time optical imaging technology.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* High energy lower extremity fracture
* Provision of informed consent

Exclusion Criteria:

* Upper extremity fracture
* Metatarsal fractures
The Effect of a Pre-Clinical Practice Simulation Using Virtual Reality Stress and Anxiety Levels

This study is designed as a randomized controlled trial to examine the effect of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice.

Nursing education is a field that requires the integration of both clinical and theoretical training, as it is a practical discipline (Ryan et al., 2010; Özçelik \& Ayhan, 2021). Therefore, nurse educators must continuously innovate their teaching and learning methods at every stage of their students' educational journey (Fealy et al., 2019). The use of simulation in nursing education has been implemented for the past 50 years (Foronda et al., 2017). Simulation practices can reflect the characteristics of the real world, providing students with safe learning environments where they can practice until they achieve skill competence through feedback and self-correction (Aebersold, 2018; Shorey \& Ng, 2021). With the advancement of simulation technology over time, it is observed that the realism and authenticity of simulated environments have increased.

Upon reviewing the literature, no studies were found that evaluate the impact of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice. Therefore, this study is planned to be conducted on nursing students. The results of this study are expected to contribute to educators in enhancing, planning, and managing the effectiveness of clinical education.

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the students before and after the clinical practice, the study will conduct with various data collection forms.

These forms are; Student Identification form, Spielberger's State and Trait Anxiety Inventory, Student Satisfaction and Self-Confidence in Learning Scale and Perceived Stress Scale for Nursing Students will be used, and Visual Analog Scale will be used to assess the general self-confidence of the students. Patients will randomize.

The Virtual Reality (VR) group in group- I (n=41), and group II (n=41) will be the control group. We have three stage. In first stage; anxiety levels will be measured for both groups. In second stage; Student Satisfaction and Self-Confidence in Learning Scale and anxiety levels will evaluated for the Virtual Reality (VR) group in group- I. In third stage; anxiety levels and Stress levels will be measured for both groups in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Being a second-year student at Gülhane Nursing Faculty of Health Sciences University
* Agreeing to participate in the study

Exclusion Criteria:

* Not completing any stage of the study
* Wanting to withdraw from the study
* Having previously taken the surgical disease nursing course
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients

The aim of the study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

The aim of this study is to investigate the effectiveness of Aripiprazole long-acting injection in recent onset and chronic schizophrenia patients

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards
* men and women aged 19 and under 60
* a person who is being given an atypical antipsychotic.
* Patients should be able to reasonably cooperate with the questionnaire to be used for the study
* a person who fully understands the purpose of the study and signs the consent
* stable outpatient before screening without changing the volume of antipsychotics for at least two weeks

Exclusion Criteria:

* a person who has a serious and unstable physical condition either now or in the past
* A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling or unable to use acceptable contraception until the clinical trial is complete.
* a person suffering from severe drug allergies or complex and severe drug reactions
* Patients who have taken clozapine in the last 60 days
* subjects showing significant risk of suicide or significant risk of violent behavior based on past history or investigator's judgment
Focal Therapy Using HIFU for Localised Prostate Cancer

To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®).

Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment.

A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.


Eligibility Criteria:
Inclusion Criteria:

* Age≥ 50 years
* Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination)
* PSA ≤10 ng / mL
* Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex).
* Gleason score ≤ 7 (3+4)
* Flowmetry \> 12 mL / sec for a voided volume of 125 mL
* PVR \<100 mL
* Patient with normal anal and rectal anatomy.
* Patient with a condition corresponding to a classification of ASA 1 or 2.
* Patient signing ICF and agreed for following monitoring

Exclusion Criteria:

* Patient with an ASA score 3.
* Patient in clinical stage T1a, T1b, T2b, T2c or T3.
* Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real
* Metastatic lymph node or metastasis discovered by MRI and bone scan.
* Patient previously treated for his prostate cancer by hormone therapy.
* Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick
* History of inflammatory bowel disease
* Rectal fistula.
* History of pelvic radiotherapy.
* History of bladder cancer.
* History of bladder neck sclerosis or urethral stenosis.
* Patient with an implant located less than 1 cm from the treatment zone (stent, catheter).
* Urogenital infection.
* Latex allergy
* Contraindication to MRI (pacemaker,metal prosthesis ...)
* Patient participated in another clinical study within 30 days.
* Illiterate patients
* Legally incapable patients
Impact of Health Lifestyle on Body Weight

Pharmacotherapy becomes an important and effective approach to improve body weight. However, it still remains unclear how to manage potential fluctuation after its cessation. Lifestyle change is the foundation and included as a part of clinical routine in real-world, therefore, we plan to conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from treatment. In addition, body weight related results will be described.

Novel pharmacotherapy is emerging, leading to substantial and sustained improvement in body weight compared with placebo in clinical trials. However, there is no evidence on management of body weight in real world setting after cessation of treatment. Body weight fluctuation is a pivotal difficulty for obese subjects who left off pharmacotherapy. It would be interesting to investigate the impact of real-world health lifestyle and its compliance in this clinical situation and probe into factors affecting compliance. Therefore, we will conduct a prospective observational study to assess the impact of health lifestyle along with its compliance on body weight in Chinese people who live with obesity or overweight and are off-pharmacotherapy trial. The aim of this study is to examine the impact of health lifestyle along with its compliance on body weight related parameters in 6 months at 3 monthly intervals from pharmacotherapy cessation. In addition, body weight related results will be described.

Eligibility Criteria:
Inclusion Criteria:

* All patients who completed a pharmacotherapy trial
* Those who consent to this FU study

Exclusion Criteria:

* Those who do not consent to this study
AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression

The study will evaluate the safety and efficacy of AV-101.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration.
* Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode.
* Meet the threshold on the total HAMD-17 score of \> 20
* If female, a status of nonchildbearing potential or use of an acceptable form of birth control.
* Body mass index between 18 to 40 kg/m2.
* Other criteria may apply

Exclusion Criteria:

* History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
* Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within 6 months prior to screening.
* Women who are pregnant or breastfeeding or a positive pregnancy test at screening or baseline.
* Currently taking a prohibited adjunct therapy. Such drugs must be washed out for at least 4 weeks prior to baseline.
* Current diagnosis of moderate or severe substance use (including alcohol) disorder (abuse or dependence, as defined by DSM-5), with the exception of nicotine dependence, at screening or within 6 months prior to screening.
* In the opinion of the investigator, the subject has a significant risk for suicidal behavior
* Has received electroconvulsive therapy, or had repetitive transcranial magnetic stimulation in the current episode.
* Has received vagus nerve stimulation at any time prior to screening.
* Any current or past history of any physical condition, which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg

The purpose of this study is to compare the safety and pharmacokinetic characteristics of fixed-dose combination of MP-513 10mg and metformin XR 750mg administered in a high fat fed state versus fasting state to healthy male volunteers.

1. Randomized, open-label, single-dosing, two-treatment, two-sequence, two-period, crossover design
2. Wash-out period: 14 days from the first dosing
3. Drug concentration analytical device: UPLC-MS/MS

Eligibility Criteria:
Inclusion Criteria:

* A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening test.
* Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW) within ±20%
* An individual who has been given and fully understood detailed explanations about this study, decides to participate in the study of his own will, and provides written informed consent to comply with instructions.

Exclusion Criteria:

* History or presence of any clinically significant diseases in the hepatobiliary, renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular, urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and, particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).
* History of any gastrointestinal disease that may affect absorption of the study drug (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgeries (except for simple appendectomy or hernia repair).
* Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same class as ingredients or to other drugs
* Vital signs in a sitting position corresponding to at least one of the following criteria: systolic blood pressure ≥ 140 mmHg or \< 90 mmHg, or diastolic blood pressure ≥ 95 mmHg or \< 60 mmHg.
* Serum creatine \> upper limit of reference range
* Required to refrain from food intake for at least 24 hours during the study period due to surgery or religious reason.
* History or presence of drug abuse.
* Administration of drugs that either induce or inhibit drug metabolizing enzymes, such as barbitals, within 1 month prior to the first dosing.
* Intake of food or beverage containing grapefruit or cranberry within 1 week prior to the first dosing.
* Administration of any ethical drugs or traditional Korean herbal medicines within 2 weeks or any over-the-counter drugs or vitamin products within 1 week prior to the first dosing
* An individual who participated in another clinical trial and was administered any investigational product within 3 months prior to the first dosing.
* Whole blood donation within 2 months, apheresis donation within 1 month, or blood transfusion within 1 month prior to the first dosing.
* An individual who drinks excessive amounts of alcohol or who cannot stop drinking alcohol from 24 hours prior to hospital admission through to hospital discharge.
* Having smoked 10 cigarettes/day or more on average over the past 3 months.
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot

The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation

* Written informed consent from parents/care givers and patient assent if age appropriate
* Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:

  * Treatment of VTE
  * Treatment to reduce the risk of recurrence of VTE

Exclusion Criteria:

* Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
* Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
* Previous participation in this study.
High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology

The primary objective of the study is to determine whether dietary intervention to increase fiber and decrease fat reduces C. difficile infection recurrence in a cohort of oncology patients.

This is a randomized study. A total of 124 individuals with either acute leukemia or lymphoma and a first or second occurrence of C. difficile infection will be enrolled. Participants will be randomized to Arm 1 (Diet intervention) or Arm 2 (No diet intervention). Participants in Arm 1 will be assessed for food preferences and will be provided lists of high fiber and high saturated fats. Participants will be able to choose foods from the high fiber food lists and groceries will be provided once per week to support each participant's meal plan. Participants will be asked to limit foods on the high saturated fats list. Food consumption with a 24 hour recall and weight will be monitored and stool samples will be collected one time per week for 6 weeks. In Arm 2, participants will be asked to provide 24 hour food recall and stool samples. Individuals in both arms will be monitored for stool consistency and any antibiotics or chemotherapy drugs taken. Participation will last 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a malignant neoplasm at the at Children's Hospital Colorado or the University of Colorado Hospital
* Diagnosis of first time or first recurrent CDI as defined by clinical criteria within the past 21 days
* Informed consent obtained and signed. For minors, the consent will be completed by a guardian and the study participant will sign the assent form. Only the consent form is required of adults.
* 9 years old or older
* 40th to 100th percentiles of saturated fat intake and below the 50th percentile for fiber intake based on a food frequency questionnaire.
* Ability to comply with study procedures for the entire length of the study.
Community-based Precise Management for Patients With Coronary Artery Disease

The community-based precise management for patients with coronary artery disease study is a prospective, cluster-randomized, open-labeled trial. The purpose of this trial is to test whether a community-based precise management and rehabilitation model under the hierarchical medical system could help improve the cardiovascular risk factors control in patients with coronary artery disease. Additionally, the trial will also evaluate the impact of the model on major cardiovascular adverse events in patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prior myocardial infarction
* or receiving percutaneous coronary intervention or coronary artery bypass graft;
* or coronary artery stenosis≥50% defined by coronary angiography or coronary CT angiography

Exclusion Criteria:

* Refuse to sign the written informed consent;
* Patients without the ability to take care of themselves;
* Mental disorders;
* Alcoholics or drug addicts;
* Cannot be followed up for any reasons;
* Life expectancy\<1 year due to non-cardiovascular reasons.
Monitoring of Intubation and Ventilation During Resuscitation

Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac arrest. Endotracheal intubation is the gold standard for airway control, but several studies have shown high rates of unrecognized placements of the tube in the esophagus instead of in the airway out-of-hospital. This is lethal. There are no failproof technique for recognising such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the lungs with ventilation changes the impedance (resistance to alternating current) through the thorax. This impedance is already measured routinely by the defibrillators used during CPR. We propose that we can measure ventilation volumes and also discover failed intubations by monitoring this impedance during CPR with the possibility of giving feedback on both to the rescuers.

On the anesthesiologist manned ambulance in Oslo ventilation volumes during CPR will be controlled with a ventilator, the tidal volume varied in random order between 500, 700 and 100 ml, and the volumes be measured continuously as will the impedance between the defibrillator electrodes. In case of failed CPR, the patient will be declared dead. Thereafter the lungs will be ventilated with 700 ml followed by removal of the endotracheal tube, placement of an endotracheal tube in the esophagus and ventilation of this tube, again with monitoring of the impedance.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest

Exclusion Criteria:

* \<18 years old trauma pregnancy
Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy Response

In adult kidney transplant recipients a therapy-responder and non-responder phenotype by antibody mediated rejection will be precisely defined according to clinical and histological characteristics such as creatinine, proteinuria and Banff-classification. Twenty-five patients will be selected each in the therapy-responder and non-responder group. Their stored Formalin Fixed Paraffin Embedded (FFPE) biopsies will be (re)-classified according to the most recent Banff classification. Using Nanostring Technology the gene transcription of therapy-responders versus non-responders will be analyzed and compared to serological and clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant patients at the University Hospital of Zurich between 01.01.2008 - 31.12.2016 with histologically suspected or confirmed ABMR
* Written consent for further use of data for research purposes

Exclusion Criteria:

* Age at transplantation \< 18 years
* Combined organ transplantation (incl. Kidney-Pancreas, Kidney-Liver, Kidney-Heart)
* Incomplete laboratory and/or clinical data
* Recurrence of the initial disease
* Insufficient Biopsy Material for NanoString Analysis
* Documented refusal of further data analysis for research purpose
Spectrum of Epididymis and Vas Deferens Anomalies Among Children With Cryptorchidism

: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

Background: Epididymal and vas deferens anomalies are not rare among children with cryptorchidism. They may affect fertility following orchiopexy.

Material and Methods: Data was collected retrospectively from six centers providing care for patients with undescended testicles from September 2017 to February 2019. All patients whose congenital anomalies of the epididymis or vas deferens were discovered incidentally during operative intervention for cryptorchidism and where photographs of the anomalies were taken were included.

Eligibility Criteria:
Inclusion Criteria:

- All included cases had photographic documentation.

Exclusion Criteria:

* cases without photographic documentation.
CICATRIX in the Treatment of Recent Post-surgical Scars

The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.


Eligibility Criteria:
Inclusion Criteria:

* Recent (less than 48 hours) post-surgical wound

Exclusion Criteria:

* Post-surgical wound with sepsis
* Usage of steroids within 30 days
* Malignant neoplastic conditions
* Alcoholism
* Handicap and/or psychiatric condition preventing treatment accomplishment.