cyrilzakka/clinical-trials huggingface dataset:
Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.

Objectives

Primary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

Secondary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between

* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection)

To assess differences in side effects e.g. periinterventional bleeding

Explorative Objective:

To explore tumor mutational burden with regard to

* solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* cytologic material by (EBUS-guided) TBNA
* liquid biopsy

Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent to the study and the study specific procedures prior to any study intervention
2. Male or female patients aged ≥18 years
3. Patients with primary diagnosis of suspected lung cancer OR Patients with known NSCLC and suspected relapse after therapy
4. Bronchoscopically visible tumor

Exclusion Criteria:

1. Preexisting malignancy other than NSCLC
2. Contraindication for bronchoscopy according to the international guidelines, daily clinical practice and the local regulations with

   * Patients with existing or at risk of pulmonary and cardiovascular decompensation
   * Patients at increased risk of bleeding with antiplatelet agents except of aspirin (clopidogrel, ticlopidine, ...) , anticoagulant therapy (prolonged PTT), thrombocytopenia (\< 50.000/ul) or coagulopathy (prolonged in vitro bleeding time).
   * Intolerance to sedation
   * Unstable or immobile cervical spine
   * Limited motion of the temporomandibular joint
3. Previous enrolment in the present study
Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.

Background The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.

Methods The investigators conducted a data-based observational study that included 4776 patients. Post-induction hypotension (pIOH) is defined as a decrease during the first 20 min after anesthesia induction and maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Underwent elective surgery
* Received general anesthesia
* Planned overnight stay in the hospital after surgery

Exclusion Criteria:

* Under 18 years of age
* Cardiac surgery
* Transplant surgery
* Preoperatively receiving vasoactive drugs
* Patients with mechanical circulatory support
* Pediatric surgery
* Patients from ICU
* Patients with scheduled postoperative ICU admissions
Cervical Stabilization Exercises in Patients With Rheumatoid Arthritis

The aim of this study is to investigate the effectiveness of cervical stabilization exercises on cervical positioning error in rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic, recurrent polyarthritis of the synovial joints. Although the prevalence of the disease shows ethnic differences, the average prevelance of the disease is 1%, and the female/male ratio is 2.5-3/1. The average age of onset is between 30-50 years. Common cervical involvement in RA patients was first described by Garrod in 1890. The most common inflammatory arthritis involving the cervical vertebra is RA. Thoracic and lumbar spine involvement is less common compared to cervical spine involvement in the disease.

Proprioceptive sense is defined as a type of specialized sensory model that includes joint movement (kinesthesia) and position sense. Mechanoreceptors located in different structures such as muscle, tendon, joint capsule and skin in both axial joints and peripheral joints provide the perception of joint position and movement. The sense of proprioception provides dynamic joint stability and various movement skills without the need for conscious planning. It also prevents premature joint degeneration by preventing uncontrolled load on the joints. The cervical proprioceptive system consists of mechanoreceptors of the cervical intervertebral joints, neck muscles and vertebral ligaments, muscle spindles localized in the deep muscles of the cervical spine, and sensitive fibers connecting the neurons in posterior horn of the spinal cord to the neck proprioceptors. Cervical vertebrae, unlike the thoracic and lumbar regions, has an additional importance due to the abundance of mechanoreceptors that provide reflex connections and proprioceptive input with the vestibular central and central nervous systems. In previous studies, it has been shown that the sense of cervical proprioception is impaired in patients with chronic neck pain due to traumatic and degenerative causes. It has been shown that cervical proprioceptive sensory dysfunction in RA causes, vestibular symptoms, changes in contol of eye movements and postural disorders in cervical paravertebral muscles.

No study investigating the effect of exercise on cervical proprioception in RA patients was found in the literature. The aim of this study was to determine the effects of cervical stabilization exercises on cervical proprioception in RA patients. The secondary aim of the present study is to evaluate the effects of cervical stabilization exercises on the functional status and quality of life in patients with RA.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with RA according to the ACR 2010 Criteria
* Being between 18 and 65 years old
* To be able to understand the given commands

Exclusion Criteria:

* Refusing to participate in the study
* History of trauma involving the neck
* Having an orthopedic disorder concerning the neck
* History of spine surgery
* Having a disease that affects vestibular system
* Upper extremity involvement due to a disorder other than RA
* Being pregnant
Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)

The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.

The remaining target is:

- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination
* Presence of lower urinary tract symptoms (LUTS)-IPSS \>0
* Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice.
* Until inclusion into PMOS the patient has not been treated with GnRH analogue.
* The patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy).

Exclusion Criteria:

* Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient.
* Physician or patient can stop treatment at any moment, if any indications or reasons exist.
Study of Atenolol Influence on Blood Pressure During Resistance Exercise

The study was designed to investigate if atenolol is able to blunt blood pressure increase during resistance exercise in hypertensive subjects.

The study compared intra-arterial blood pressure responses during leg-extension resistance exercise performed to fatigue at 40, 80 and 100% of 1 RM in hypertensive patients receiving placebo (first) and atenolol (second) on a single blind manner.

Eligibility Criteria:
Inclusion Criteria:

* hypertension with blood pressure levels below 160/105 mmHg under placebo.
* age between 30 and 60 years
* nonobese

Exclusion Criteria:

* target organ lesion
* cardiovascular risk factor
* cardiovascular disease
* physically active
Investigation of the Effects of Clinical Pilates Exercises on Primary Caregivers of Special Needs Children

The aim of this research is to investigate the effectiveness of clinical Pilates exercises applied to primary caregivers of children with special needs, flexibility, muscle strength, endurance, cardiovascular endurance, fatigue, coping attitudes and quality of life, depression and anxiety.

Individuals participating in the study will be randomly divided into two groups through the randomized allocation software program. The first group will be given Clinical Pilates exercise training, while the second group will be considered as the control group. The exercises will be applied to the group attending the Clinical Pilates exercise training for 45-60 minutes, twice a week for a total of 8 weeks. Each movement will consist of one set and 10 repetitions. In the Clinical Pilates program, equipment and exercises will be gradually increased. Equipment to be used throughout the Clinical Pilates program; Pilates cushion, Elastic resistant band (red, green, blue), Exercise ball (65 cm) In the Clinical Pilates group, the training session will start with the warm-up program, core stabilization training, clinical Pilates exercises will be applied to increase the postural smoothness and strength, and the exercise session will be terminated with the cooling period. The clinical Pilates group will be given 5 key elements of clinical Pilates (Respiratory-Centre focus- Chest placement - Shoulder placement - Head-neck placement) will be explained. No exercise program will be applied to the control group for 8 weeks. A sufficient number of trials will be conducted to enable participants to adapt to the evaluation and treatment. The evaluations will be done as pre-test and post-test for both groups and then the groups will be compared. Individuals who have agreed to participate in the study and have signed the information consent form will be included.

Eligibility Criteria:
Inclusion Criteria:

* Caring for children over 3 years of age≥1 with special needs,
* Caring for the child for at least 6 months, with or without blood connection (mother, father, nan, aunt, sibling, carer, etc.)
* Being between the ages of 18-55,
* Has not had regular exercise in the last 6 months (3 days a week, more than 20 minutes)

Exclusion Criteria:

* Have serious orthopaedic, neurological, rheumatologic and psychiatric problems that may prevent clinical Pilates exercises.
* Pregnancy
* Has had a traumatic injury or surgery in the last 6 months
IgA-positive Versus IgA-negative Immune Complex Vasculitis

Cutaneous vasculitis due to vascular deposition of large circulating immune complexes is a disease frequently seen by general practitioners and dermatologists. The clinical symptom is palpable purpura with predilection for the lower legs.

In some cases vasculitis also affects systemic organs, such as the kidneys and the intestine.

When the immune complexes contain immunoglobulin class A (IgA) and when there is systemic involvement, the disease has been referred to as Henoch Schönlein purpura.

When there are no signs of systemic involvement, the disease has been referred to as cutaneous leukocytoclastic angiitis.

The investigators hypothesize that palpable purpura with predilection for lower legs is a pathognomonic clinical sign for immune complex vasculitis in both IgA vasculitis and IgA-negative vasculitis, but that only the presence of IgA in immune complexes is likely to be associated with systemic involvement and therefore warrants more extensive diagnostic procedures Vice versa the investigators postulate that the presence of IgG or IgM without IgA in immune complexes excludes systemic involvement The investigators also want to investigate to which of the 2 groups patients with palpable purpura and negative immunofluorescence should be assigned.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven leukocytoclastic vasculitis
* clinically palpable purpura

Exclusion Criteria:

* no histological confirmation
* relevant data missing in file
Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light (non-ultraviolet spectrum) at 405nm has been shown to be germicidal. We hypothesize that use of this light in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Visible light is safe for routine, continual exposure, and is less harmful than sunlight. We plan to install ambient, germicidal lighting in 4 operating rooms. This ambient light is not directly applied to patients (does not involve the surgical procedure lights). Patients will undergo surgery according to usual practice. We will conduct a case-control study where operating rooms with surgeries with the lights are matched to operating rooms with surgeries without lights.

In Aim 1, 4 OR-pairs will be observed each day over an anticipated 103 working days for the primary outcome of S. aureus transmission events over a total minimum study period of 5.2 months (103 working days).


Eligibility Criteria:
Inclusion Criteria:

* Operating Rooms with and without the bactericidal lights where adult patients undergoing orthopedic, cardiothoracic, gynecology/oncology, and neurological surgery.

Exclusion Criteria:

* Operating Rooms with and without the bactericidal lights where pediatric, incarcerated, and/or pregnant patients undergoing surgery outside of the classifications above.
DXR Stent for Vascular Healing and Thrombus Formation: OCT Study

The purpose of this study is to evaluate the efficacy of a novel dual drug-eluting stent (DXR stent), which slowly releases both cilostazol and paclitaxel, for strut coverage, malapposition, and thrombus formation, assessed by an optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

1. Patient

   * Age \>=19 years
   * Clinically indicated to invasive coronary angiography
   * Patient capable and willing of giving written informed consent
2. Angiographic

   * coronary artery disease confined to native coronary artery
   * \>50% diameter stenosis by invasive coronary angiography
   * reference diameter 2.5-4.0mm, lesion length ≤30 mm

Exclusion Criteria:

1. Patient

   * Inability to provide written informed consent
   * Serious comorbidity which may affect the trial by decision of investigators
   * Prior CABG to target vessel
   * Congestive heart failure with NYHA Class III or IV or left ventricular ejection fraction less than 30%
   * Prior ST elevation myocardial infarction within 72 hours from the procedure
   * Hemodynamic or electrical instability including shock
   * Serious coronary artery spasm, unrelated to catheter
   * Pregnancy or possible pregnant status
   * Allergy to iodinated contrast agent
   * Serum creatinine \>=1.7 mg/dL or creatinine clearance \<= 30 ml/min
   * ST elevation myocardial infarction
2. Angiographic (OCT)

   * Left main disease
   * Severely calcified lesion
   * Severely tortuous, or TIMI flow grade 0 or 1 by angiography, or inappropriate for OCT procedure by investigators' decision
Diastolic Hyperemia-Free Ratio in Patients With CAD

The investigators aimed to identify the value of concordance between the diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR) during pre-interventional and post-interventional period using a 0.014" COMET II Pressure Guidewire

The physiologic assessment of coronary artery disease and ischemia-guided percutaneous coronary intervention (PCI) has become a standard practice for patients with coronary artery disease. Fractional flow reserve (FFR) represents hyperemic flow limitation caused by an epicardial coronary stenosis and its clinical usefulness has been proven by many clinical studies. However, the FFR is limited to clinical use despite the fact that it is recommended by the guideline due to the inconvenience of patients using medications used to induce maximum hyperemia, and the need for additional procedure time. Recently, a physiologic index which does not require hyperemia, instantaneous wave free ratio (iFR), was introduced and recent trials showed non-inferiority of iFR-guided strategy for 1-year clinical outcome, compared with FFR-guided strategy. Recently, not only iFR but also various intravascular pressure measurement techniques have been developed, one of which is diastolic hyperemia-free ratio (DFR). DFR uses the mean Pd/Pa calculated over the period in diastole defined as that during which arterial pressure is negatively sloped and below the mean arterial pressure. DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization in patients with NSTEMI. In the case of DFR, there is no issue in terms of safety because it is conducted in the same way as iFR, but there are not many studies on the validation between DFR and FFR. Therefore, the present study aimed to identify the quality of concordance between DFR and FFR, determine the features associated with discrepancies in DFR and FFR.

Eligibility Criteria:
Inclusion Criteria:

* Patients, ≥ 19 years of age, who are diagnosed with stable angina pectoris including silent ischemic heart disease and 50\~90% stenosis of the coronary artery.
* Acute coronary syndrome patients with multivessel disease who have 50\~90% stenosis of a non-culprit vessel on coronary angiography.

Exclusion Criteria:

* Patients with acute coronary syndrome and single vessel disease.
* Patients with hypersensitivity or contraindication to antiplatelet treatment.
* Female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
* Patients with a life expectancy shorter than 1 year.
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction

A preliminary study to determine the possibility of using far infrared (FIR) radiation to treat impotency.

Erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. Erection depends on a complex interaction of psychological, neural, vascular and endocrine factors.

We are proposing a non-drug and a non-invasive radiation treatment for the enhancement of erection.

Eligibility Criteria:
Inclusion Criteria:

* Persons with erection challenges

Exclusion Criteria:

* None
An Observational Study on Treatment Compliance by Children Treated With Growth Hormone

This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.


Eligibility Criteria:
Inclusion Criteria:

* Child treated for at least one year with growth hormone any growth hormone product
* Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

* Refusal to participate
* Child and/or parent unable to give consent or fill out the questionnaires
* Child participating in a therapeutic trial
Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants

The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.

This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born by caesarean section

Exclusion Criteria:

* Gestational weeks \<37 Birth weight \<2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases
Breakfast, Exercise and Metabolic Health in Healthy Men

This project aims to investigate the impact of acute bout of submaximal exercise under different pre-exercise dietary conditions (fasted state versus high carbohydrate breakfast versus high protein breakfast) on postprandial glycaemic, appetite regulation and energy balance.

Participants will be asked to arrive to the laboratory between 08:00 and 9:00 am after not eating for between 12-14 hours i.e. in a fasted state (water intake is permitted and encouraged). Participants will then be given one of three test drinks (i.e., breakfast): 1) water only; 2) high carbohydrate drink; or 3) high protein (whey protein) drink. Each of these drinks will also contain 500 mL of water and artificial sweetener. 2 h after breakfast, participants will then exercise on a treadmill for 45 min followed by a 2-h oral glucose tolerance test (OGTT) and 30 min ad libitum lunch intake. Blood samples, blood pressures and questionnaire (e.g., appetite and mood) will be collected in a regular pattern throughout the trials. Cognitive functions will be tested at baseline, pre-exercise and 2 h post-exercise. Energy balance will be assessed using food diary and an accelerometer for the rest of the day after leaving the laboratory until midnight.

Eligibility Criteria:
Inclusion Criteria:

* Healthy physical active men (self-reported regular exercise at least 30 min moderate-intensity 3 times per week)
* Aged between 30 to 55 years
* Weight stable for more than 3 months (no change in weight +/- 3%)
* Non-smoker

Exclusion Criteria:

* Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
* Taking medications that may influence lipid or carbohydrate metabolism or immune system function
* Women
* Physically inactive