cyrilzakka/clinical-trials huggingface dataset:
Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia

This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer.

This is a prospective randomised study investigating the use of chromoendoscopy and confocal laser endomicroscopy for the detection of preneoplastic neoplasm in patients at high-risk of gastric cancer. Patients are randomised to undergo upper endoscopy using either confocal laser endomicroscopy or standard whitelight endoscopy to investigate for gastric preneoplastic and neoplastic lesions.Results are compared to histopathologic diagnosis made on biopsies obtained during endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is Chinese
2. The subject is greater than 50 years of age
3. The subject satisfies one or more of the following criteria:

   * has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms include bloating, epigastric discomfort and early satiety
   * has a family history of gastric cancer
   * has a medical condition for which an OGD is indicated.
4. The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
5. The subject must be willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
2. The subject with liver cirrhosis.
3. The subject with previous total or partial gastrectomy.
4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy.
5. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study.
6. The subject is currently on anti-coagulant therapy such as warfarin. Patients on aspirin, ticlopidine and clopidogrel must undergo a one-week washout period before enroling in the study.
7. The subject has a history of bronchial asthma, or a known allergy to fluorescein.
8. The subject is unwilling or unable to provide signed informed consent.
Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies

This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.

The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.


Eligibility Criteria:
Inclusion criteria

* With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.
* With 1 or more MS diagnosis for 12 months prior to the index date \[inclusive\].
* Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date \[inclusive\].
* Include patients who were 18 years or older on the index date.
* Include patients continuously enrolled in pharmacy and medical benefits from the index date \[inclusive\] to 6 months/12 months post-index date.

Exclusion criteria

• Patients with 1 or more claims of index drug within 12 months prior to index date.
Clinical Trial to Assess the Effectiveness of I+Med's DayDrop Advanced Ophthalmic Drop

Clinical trial conducted with the aim of evaluating changes in the signs of dry eye through the change in the amount of tears produced, measured through the Schirmer test. It will be performed in 45 patients diagnosed with mild/moderate dry eye who meet the inclusion/exclusion criteria. Follow-up will be 12 weeks with a maximum of 4 visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes over 18 years of age.
* Patients diagnosed with mild-moderate dry eye who meet the following characteristics: Schirmer test ≥3 and ≤ 10 mm; BUT test ≥5 and ≤ 10 seconds and OSDI ≥13 and ≤ 33.
* Patients without other ophthalmologic pathologies.
* Have ability to self-administer drops.
* Have ability to understand the Patient Information Sheet.
* Sign the Informed Consent.

Exclusion Criteria:

* Patients diagnosed with severe dry eye.
* Ingestion of parasympathomimetic or antipsychotic medications .
* Glaucoma.
* Previous cataract surgery.
* Systemic treatment with corticosteroids or topical treatment with any ophthalmic medication except artificial tears in the week prior to the start of study treatment.
* Ocular infection or clinically significant inflammation.
* Ocular surgery in the 3 months prior to the study.
* Sjögren's syndrome.
* Stevens-Johnson syndrome.
* History of allergic conjunctivitis.
* Pregnancy or planned lactation.
Improving Sleep Quality in ICU Patients

Sleep architecture is deeply altered in intensive care unit (ICU patients). Among factors involved in poor sleep quality are environmental factors, such as light and noise, which are an unavoidable consequence of cares.

The aim of the study is to evaluate the benefit of earplug and sleep mask on sleep architecture and quality in ICU patients.

It is well demonstrated that sleep architecture is deeply altered in intensive care unit (ICU patients). The consequences of this alteration are multiple: neuropsychological complication such as delirium, long-term sequels such as post-traumatic stress disorders, alteration of the circadian fluctuation of various hormones with well demonstrated deleterious impact, alteration of the immune response that may promote nosocomial infections and, finally, a decrease of respiratory muscle endurance that may compromise weaning from mechanical ventilation.

Various mechanisms contribute to sleep alteration in ICU patients, including intrinsic factors linked to disease severity, factors related to therapies such as mechanical ventilation and sedation, and environmental factors. Among environmental factors, light and noise are an unavoidable consequence of cares that strongly contribute to sleep alteration in ICU patients. It is of notice that few studies have focused on strategies to protect ICU patients against noise and light such as the systematic use of earplug and sleep mask. Although the benefit of earplug and sleep mask on sleep quality has been demonstrated in healthy subjects submitted to an environment similar to ICU, it has never been evaluated in ICU patients.

The aim of the study is to evaluate the benefit of earplug and sleep mask (designated as "protective strategy) on sleep architecture and quality in ICU patients.

Eligibility Criteria:
Inclusion criteria :

* Admission in the ICU with expected duration of stay \> 48hrs.
* Level of sedation \< 4 on Ramsay scale.
* Interruption of sedation \> 12 hrs
* Analgesia with a maximal dose of morphine \< 0.01 mg/Kg/h
* Vasopressive therapy not exceeding 0.3 mg/Kg/min for epinephrine and 10 mg/Kg/min for dopamine.
* Informed consent by patients or next of kind.

Exclusion criteria :

* Known sleep disorder (apnea syndrome, narcolepsy, restless leg syndrome).
* Central nervous disease that might impact sleep architecture or the interpretation of EEG recordings.
* Severe liver encephalopathy (stage 3 or 4)
* Ongoing sepsis
* Pregnancy.
* Age \< 18 yrs.
* No health insurance.
Breathing Device for Orthostatic Hypotension (OH)

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease blood pressure drops on standing in patients with orthostatic hypotension.

Orthostatic hypotension is commonly described, especially in an elderly population. Using data from a national hospital inpatient database, Shibao et al. have reported that the annual hospitalization rate for orthostatic hypotension was 233 per 100000 among patients older than 75 years. Orthostatic hypotension is associated with an increased risk of falls, increased risk of coronary heart disease and mortality.

Orthostatic hypotension is defined as a fall in systolic blood pressure of at least 20 mmHg within 3 minutes upon standing 3. Patients with orthostatic hypotension commonly experience lightheadedness or syncope. In normal individuals, changes in posture do not results in significant changes in blood pressure due to physiological compensation for the gravity-mediated pooling of blood in the lower limbs with upright posture. Unfortunately, in patients with impairments of the autonomic nervous system, one or more of these adaptive mechanisms fail, and an orthostatic fall in blood pressure results.

In this pilot study, we will test the hypothesis that breathing through an inspiratory resistance device will improve orthostatic tolerance and reduce orthostatic hypotension in patients with neurogenic orthostatic hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with neurogenic orthostatic hypotension by the Vanderbilt Autonomic Dysfunction Center
* Decrease in systolic blood pressure ≥ 20 mmHg with position change from supine to standing (10 minutes)
* Evidence of reproducibility suggestive of non-reversible nervous system origin for the orthostatic hypotension
* Age between 18-80 years
* Male and female subjects are eligible
* Able and willing to provide informed consent

Exclusion Criteria:

* Overt cause for orthostatic hypotension (such as acute dehydration)
* Inability to give, or withdrawal of, informed consent
* Pregnant
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy

The present study revealed that the TL position is supposed to be more efficient not only for lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in this position may be easier for doctors than in the lithotomy position.

VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of the study was to enlighten the gap in the literature regarding the pain score and procedural time during VOH for diagnostic purposes in TL position. In order to gain scientific evidence, a randomized controlled trial was conducted to compare pain score and duration of procedure between the standard lithotomy position and TL position. Also, the convenience for the physician performing the procedure was assessed. To the best of our knowledge, this is the first study in the literature investigating the effect of the position of the patient during the procedure on both time, pain, and the convenience for the physician simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* uterine disorders
* abnormal uterine bleeding
* infertility

Exclusion Criteria:

* pregnancy
* cervical disorders
* pelvic infections
Learning Diagnostic Skills Online (German: Diagnostik Skills Online Lernen)

Clinical psychologists give diagnoses to their patients everyday and these diagnoses determine if and how these patients will be treated. Misdiagnoses can have severely adverse effects. Therefore, teaching diagnostic skills to clinical psychologists is very important during their undergraduate, graduate and postgraduate training.

One major problem in teaching diagnostics is that there are too few opportunities to practice with real patients due to legal and ethical restrictions. The aim of the DiSkO-project is, therefore, the development and evaluation of a blended learning course to teach diagnostic skills to (future) clinical psychologists.

In order to make the diagnostic training more practical a series of video files of simulated diagnostic interviews will be presented in an online course. These video files will be divided in different segments and presented with questions and automatic feedback. In a second step, learners will make a transfer to a real face-to-face diagnostic situation with an actor simulating a patient.

The DiSkO- course will be evaluated in a randomized-controlled trial at three universities in Germany (Ruhr-University of Bochum, Philipps University of Marburg, University of Cologne). To test whether students are equally good in administering a diagnostic interview after taking the DiSkO-course compared to students who took part in a traditional face-to-face university course a noninferiority-analysis will be conducted. Furthermore, diagnostic knowledge and attitudes toward evidence-based assessment after taking part in DiSkO vs. the face-to-face course will be compared.

The investigators aim at disseminating the open source DiSkO-course to other universities or institutions of tertiary education in Germany with the aim of improving the diagnostic training for students, better prepare them for their clinical practice and thus improve patients' health care in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Psychology bachelor students of a cooperating university (Ruhr-University of Bochum, University of Cologne, Philipps-University of Marburg)

Exclusion Criteria:

* previous participation in a diagnostic seminar
Biomechanics of Lumbar Region in Low Back Pain

The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.

The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded.

Eligibility Criteria:
Inclusion Criteria:

* The age range of 18-65
* Having non-specific LBP
* Volunteering to participate in the study

Exclusion Criteria:

* Having any psychiatric and mental problems
* The presence of any disc, bone, and muscular pathology in the lumbar region
* Having any previous operation on the lumbar region
Respiratory Muscle Training in Adults With Spinal Cord Injury

The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.

The design of the study is a randomised, triple-blind clinical trial with a control group.

The size of the sample will be 56 participants with cervical spinal cord injury and 56 with dorsal spinal cord injury. They will be randomized in two groups: experimental or control. The experimental group will perform combined inspiratory and expiratory muscle training as part of their rehabilitation programme during 6 weeks. The control group will continue their usual treatment.

Measurements will be taken at baseline, and post-intervention.

The statistical analysis will be an intention-to-treat analysis, and the data processing and analysis will be carried out with the Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows (Armonk, NY: IBM Corp.).

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with spinal cord injury.
* Over 18 years of age.
* Time of evolution less than 6 months and at least 4 weeks after the date of injury.
* Level of lesion between C5 and D5 and degree of involvement A or B. In case of involvement A with partial preservation zone this should not include abdominal musculature according to the international standardised classification of the American Spinal Injury Association.

Exclusion Criteria:

* People with chest trauma.
* Mechanically ventilated.
* Pregnant women.
* Any medical or psychiatric condition that could affect the ability to complete the study.
* Carrying a tracheostomy tube that does not tolerate occlusion.
* People who can not sit upright.
TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam

This study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study.

The purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy adult males.
* Subjects with a BMI of at least 18.0 and less than 30.0 at the screening examination and the examination at admission.

Exclusion Criteria:

* Subjects with significant concomitant or historical disease of the metabolism, liver, kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or psychiatric diseases, accompanied by clinical symptoms or with other clinically significant disease, who are unsuitable for participation in this study, in the opinion of the investigators.
* Subjects who are found by the investigators to have significant clinical abnormality at the screening examination, the examination at admission, or the examination at the day of first administration of Digoxin or Midazolam.
EMERALD - AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

The study will focus on the number of patients moving to persistent Atrial Fibrillation as a function of cumulative %Vp (\< or \>40%), in a general dual-chamber pacemaker population through a 2 year follow-up (n=2188).

The same endpoint will be analyzed in sub populations (Sinus Node Disease and AVB) at 4 years follow up (n=4290).

Eligibility Criteria:
Inclusion Criteria:

- Patient implanted (primo-implant, replacement, upgrade) with dual chamber pacemaker from less than two months or implanted at inclusion.

Exclusion Criteria:

* Contraindicated for cardiac pacing, according to the ESC and ACC/AHA/HRS guidelines
* Permanent or persistent atrial tachyarrhythmia
Second Primary Cancers in Patients With Castration Resistant Prostate Cancer

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride.

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among mPC and mCRPC patients not treated with radium-223-dichloride. The source of data for this study will be the German Pharmacoepidemiological Research Database (GePaRD). A retrospective cohort study covering the time period from 2004 to 2013 will be conducted. The study population will comprise CRPC patients developing bone metastases. These patients will be followed up for the occurrence of second primary malignancies, end of study, or death due to any cause. As this study serves as a historical control group for a single-arm observational study, incidence rates of second primary malignancies obtained from these studies will be compared by the standardized incidence ratio using results from this study as a reference.

Eligibility Criteria:
Inclusion Criteria:

* Members of the mPC cohort will have to fulfill all of the following criteria:

  * Valid information on sex, age and the region of residence
  * A period of at least 12 months of continuous insurance preceding cohort entry
  * Diagnosis of PC (ICD-10 Code C61) in the study period (01-Jan-2004 to 31-Dec-2011)
  * Diagnosis of bone metastases (ICD-10 Code C79.5) in the enrolment period (01-Jan-2005 to 31-Dec-2011)
  * In addition to the criteria of the mPC cohort, members of the mCRPC will additionally have to fulfill:
  * One of the following in the enrolment period and before or at the same time with bone metastases

    * Discontinuation of the initial chemical castration, change of the agent or modality of the Androgen deprivation therapy (ADT), or start of treatment for advanced Prostate cancer (PC) after the primary ADT.
    * Surgical castration and initiation of ADT treatment
    * Treatment with medication specific to mCRPC.

Exclusion Criteria:

* Patients will be excluded from the mPC and from the mCRPC populations if they meet one of the following criteria:

  * First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
  * Use of any radiopharmaceuticals for bone metastases (e.g., samarium, strontium, rhenium, radium)
Mix Vaccine for Metastatic Kidney Cancer

The aim of this study is the safety and efficacy of mix vaccine to small metastases of kidney cancer.

By enrolling patients with small metastases of kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction