cyrilzakka/clinical-trials huggingface dataset:
The Effect of Using High-flow Nasal Oxygen-delivery System in Patients Under Intravenous General Anesthesia

In general anesthesia, gas exchange was altered by shunt and uneven ventilation perfusion ratios. Lung atelectasis was a cause of impaired oxygenation. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It has physiological effects: reduction of anatomical dead space, positive end expiratory pressure (PEEP) effect, constant fraction of inspired oxygen, and good humidification. The hypothesis of this study is using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis.

After general anesthesia, almost 90% patients have lung atelectasis. The lung atelectasis persisted even after the surgery, and caused post operative complication, for example: fever, pleural effusion, hypoxemia, pneumonia, and respiratory failure. So, how to improve lung function after the surgery is a important issue. High-flow nasal cannula oxygen therapy delivers adequately heated and humidified medical gas at up to 60 L/min of flow. It provides respiratory support: 1. Reduction of dead Space by clearance of expired air in the upper airways. 2. Delivering positive airway pressure. 3. delivering optimal humidity, which helps maintain function of the mucociliary transport system, clearing secretions and reducing the risk of infections. Many reports suggest that high-flow nasal cannula decreases breathing frequency and work of breathing and reduces intubation rate in critical ill patients. Although high-flow nasal cannula was used widely in intensive care unit (ICU) , there are no enough evidence in patients under general anesthesia. The hypothesis of this study is that using high-flow nasal oxygen in intravenous general anesthesia could improve lung function and prevent lung atelectasis. Liver tumor radiofrequency ablation was performed sometimes in patients under general anesthesia. Intravenous general anesthesia is one of the anesthesia choice. Oxygen mask is the traditional oxygen delivery system. Apnea, hypoxemia, and CO2 retention are common situation in intravenous general anesthesia. So high-flow nasal oxygen is an ideal oxygen delivery system in intravenous general anesthesia. This randomized control study will enroll patients receiving CT guided liver tumor radiofrequency ablation under general anesthesia. One group will receive high-flow nasal oxygen, the other group will receive traditional oxygen mask. The primary outcome is lung atelectasis area in CT scan. The secondary outcome is respiratory function (for example: arterial blood gas, lung injury biomarkers, saturation, postoperative pulmonary complication)

Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatic tumor undergoing CT guided radiofrequency ablation
* Age \> 20 years old

Exclusion Criteria:

* Cardiac dysfunction, such as heart failure \> NYHA class II, coronary arterial disease
* Impaired renal function, cGFR\< 60 ml/min/1.73 m2
* Pulmonary disease
Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping

Increased blood loss after vaginal or cesarean delivery is one of the top causes of maternal complications. Oxytocin is a common medication given to mothers by IV or an injection to limit the amount of blood loss after delivery. The investigators do not know the best time after delivery that oxytocin should be given. This research is being done to find out if starting the medication oxytocin right after the baby is born or after the placenta comes out decreases the amount of blood lost after birth when we delay cord clamping after birth.

The optimal timing of prophylactic oxytocin administration on both maternal and neonatal outcomes has not been definitively established with delayed cord clamping. Maternal considerations include the risk of postpartum hemorrhage, need for additional uterotonic medications, need for maternal transfusion, retained placenta, and postpartum drop in hemoglobin. Neonatal considerations include markers of neonatal well-being such as arterial pH and 5-minute Apgar score, as well as hemoglobin and bilirubin levels. There is currently no protocol on the timing of third stage prophylactic oxytocin and its administration is based on physician/ delivery provider's preference. The investigators propose a quality assessment initiative, through a randomized controlled trial designed to compare the blood loss between administrations of prophylactic oxytocin immediately after delivery of the neonate versus after delivery of the placenta with delayed cord clamping.

Eligibility Criteria:
Inclusion Criteria:

* All laboring women (induced, augmented, or spontaneous) at term admitted to Labor and Delivery while comfortable
* Scheduled cesareans
* Women aged 18 years or older
* Admitted at NewYork-Presbyterian Morgan Stanley Children's Hospital (CHONY) or Allen Pavilion Labor and Delivery units

Exclusion Criteria:

* Multifetal gestation
* Placental abruption or antepartum hemorrhage
* Maternal bleeding disorder
* Known fetal anomaly or anemia
* Fetal growth restriction with abnormal Doppler
* Significant maternal anemia (pre-operative hemoglobin ≤ 7g/dL
* Intrapartum stillbirth
* Placenta accreta spectrum
* Abnormal placentation (previa or abruption)
* Planned cord blood banking
* Refusal of blood products
* Any contraindication for delayed cord clamping
* Maternal history of aortic stenosis or pulmonary hypertension or other severe cardiac structural disease
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Inclusion Criteria:

Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR \> 150mL

Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 50 years
* Signs and symptoms of BPH
* IPSS of ≥ 10
* Prostate volume of ≥ 20 mL
* PVR \> 150 mL

Exclusion Criteria:

* History of allergy to a AR antagonists
* Treatment with antiandrogen drugs
* Drugs with anticholinergic activity
* Significant history of orthostatic hypotension
* Concomitant neurological diseases
* Known or suspected neurogenic bladder dysfunction
* Carcinoma of the prostate or bladder
* Previous surgery for BPH or bladder neck obstruction
* History of recurrent UTI
* Concomitant active UTI
The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study

The effect of infusion pressure on the outcomes of phacoemulsification surgery.

The Centurion phacoemulsification system with active sentry allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other surgical systems. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during phacoemulsification will lead to improved outcomes. This is of particular interest in patients with vascular retinopathies such as diabetic retinopathy where the retinal vasculature is compromised, as well as glaucoma and other optic neuropathies where there is established nerve fibre layer loss.

The investigator will carry out a feasibility study with a two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low (30mmHg) versus the higher pressure (\~70mmHg) as currently used) using the active sentry system with assessment of a range of exploratory endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree

Exclusion Criteria:

* Dense cataract precluding adequate retinal imaging
* posterior polar cataract
* subluxated cataract,
* other vision affecting pathology,
* severe glaucoma
Bilateral Ultrasound Guided Intramuscular Quadratus Lumborum Plane Block Versus Bilateral Lateral Quadratus Lumborum Plane Block in Controlling Postoperative Pain in Cancer Patients Undergoing Open Nephrectomy

This study aims to evaluate the efficacy of bilateral ultrasound-guided intramuscular quadratus lumborum plane block (QL4) versus bilateral lateral quadratus lumborum plane block (QL1) in controlling postoperative pain in cancer patients undergoing open nephrectomy.

Post-surgical somatic pain is very distressing to patients, which may lead to significant complications.

Practitioners initially used these as ilioinguinal, iliohypogastric, rectus sheath blocks, and in the early 21st century, transversus abdominis plane (TAP) blocks. A recent variation of the TAP block is known as the quadratus lumborum block (QLB).

The QL block effectiveness is believed to result from the spread of Local Anesthetic cranially from the lumbar deposition into the thoracic paravertebral space (TPVS). So, the QLB seems to relieve somatic and visceral pains.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II-III.
* Body mass index (BMI): (20- 40) kg/m2.
* Type of surgery: midline incision for unilateral open nephrectomy.

Exclusion Criteria:

* Patient refusal.
* Age \<18 years or \>65 years
* BMI \<20 kg/m2 and \> 40 kg/m2
* Known sensitivity or contraindication to drugs used in the study
* Contraindication to regional anesthesia, e.g. local infection at the introduction site, pre-existing peripheral neuropathies and coagulopathy.
* Physical status ASA IV
* Patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
* Patients with a history of drug abuse
* Patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
* All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.
Relaxation Training to Decrease Pain and Improve Function in Adolescents With Cerebral Palsy

This study will examine the effectiveness of relaxation training for providing pain relief and improving physical and psychological functioning in youth with physical disabilities due to cerebral palsy.

Chronic pain is a serious problem in many youths with disabilities. There is a growing body of research supporting the efficacy of relaxation training for reducing chronic pain in adults. Given this evidence, there has been a growing interest in determining whether these findings also generalize to youths with chronic pain. This study will address a significant gap in the medical literature by examining the efficacy of relaxation training for providing pain relief and improving function in youths with physical disabilities. The study will evaluate the effects of relaxation training on global physiological arousal, pain-site specific muscle tension, and perceived control over pain. Physiological arousal will be assessed via hand temperature and galvanic skin response. Muscle tension will be assessed via surface EMG biofeedback recordings before, during, and after each treatment session. Self-efficacy concerning pain control will be assessed via a modified Survey of Pain Attitudes and modified Coping Strategies Questionnaire.

Sixty youth (age range 10 to 20 years old) with spastic type cerebral palsy (CP) will be randomly assigned to either the relaxation training group or a distraction control group. Youths in the relaxation training group will be given eight sessions of autogenic relaxation training and will be asked to practice relaxation at home using audio tapes. Youths in the distraction control group will receive eight sessions of distracting story-telling and will be asked to listen to age-appropriate audio tapes of stories at home. Study visits are scheduled weekly for eight weeks. Average pain intensity will be assessed with a numerical rating scale. Secondary outcome measures include psychological functioning and pain interference with personal activities. Medical services utilization will be assessed by asking the parent or guardian about any medications taken by the participant, any illnesses or medical complications, any medical treatments received, and the frequency of health care visits. Participants will be assessed at 1, 3, 6, 9, and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* Referred by the study physician
* Chronic cerebral palsy-related pain for at least 3 months prior to study entry. The pain needs to have an average daily occurrence of 3 on a 0 to 10 scale, where 0 is no pain and 10 is extreme pain.
* Primary language is English

Exclusion Criteria

* Acute painful conditions
* Cognitive impairment as determined by a score \< 12 on the modified Mini-Mental Status Exam
Stretta In Reflux Uncontrolled by IPP

The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.

The study is over a period of 1 year. After checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. Control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.

In case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. The procedure will be scheduled between week 24 and week 27. The patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP

Exclusion Criteria:

* Recent oeso-gastro-duodenal endoscopy(\< 3 months)
* Oesophagitis \> grade A
* Endobrachyoesophagus \> C0M1
* Hiatal Hernia \> 2 cm
* Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP according to needs
* Predominant symptom of Gastrooesophageal reflux disease other than heartburn
* Patients contra-indicated for radiofrequency technique
* Pregnant women
Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).

Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.

In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.

Eligibility Criteria:
Inclusion Criteria:

* able and willing to perform the test

Exclusion Criteria:

* under 4 years of age
* unable or unwilling
Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.

The primary objective of this trial is to evaluate the efficacy of delamanid administered orally as 100 milligrams (mg) twice daily (BID) for 2 months followed by 200 mg once daily (QD) for 4 months in combination with an optimized background treatment regimen (OBR) versus placebo with OBR during the 6-month Intensive Period of MDR TB treatment. Following the 6-month Intensive Period, OBR was administered alone during the Continuation Period for 12 to 18 months (from Month 7 up to Month 24). The trial also included a post-treatment follow-up period of 6 to 12 months (Month 19 to Month 24 to the end of Month 30). OBR given throughout the study was administered as per World Health Organization (WHO) guidelines and national treatment norms.

This trial is a multicenter, randomized, double-blind, stratified, placebo-controlled trial that was conducted globally in 2 parallel groups at 17 sites in 7 countries qualified to treat MDR TB.

Eligibility Criteria:
Inclusion Criteria:

* Provide written, informed consent
* Current diagnosis of MDR TB
* Chest radiograph consistent with TB
* Able to produce sputum
* Negative urine pregnancy test and agree to use a highly effective method of birth control and/or adequate method of contraception

Exclusion Criteria:

* Allergy to any nitro-imidazoles or nitro-imidazole derivates
* Diseases or conditions in which the use of nitro-imidazoles or nitro-imidazole derivates is contra-indicated
* Use of disallowed medications
* Renal impairment
* Abnormal electrocardiogram (ECG) results
* Cardiovascular disorders
* Body mass index (BMI) \< 16 kg/m\^2
* Karnofsky score \< 50%
* Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy
* Alcohol abuse
* Pregnant, breast-feeding, or planning to conceive or father a child
* Recent use of methadone, benzodiazepines, cocaine, amphetamine/methamphetamine, tetrahydrocannabinol, barbiturates, and opiates
* Previous exposure to delamanid
* Administered an investigational medicinal product (IMP) within 1 month prior to Screening (Days -21 to -2).
* Evidence of extensively drug-resistant TB based on the definition from WHO
* Human immunodeficiency virus (HIV) co-infection for participants screened at sites not participating in the HIV subtrial (data from the HIV subtrial will be reported separately from the Clinical Study Report for Study 242-09-213).
Bone Microarchitecture in Women Practicing Golf

After the age of 50, one in three women and one in eight men will experience at least one fragility fracture during the rest of their lives. It is currently recognized that physical activity has an osteogenic actions, especially when it includes the impact transmitted to the skeleton. In this context, the investigators propose a study to determine whether the regular practice of golf could be particularly beneficial for the skeleton, not only in the lower limbs, due to repeated impacts to the ground when it requires sustained walking, but also the upper limbs due to the impacts transmitted by the club at the time of striking the ball, as has been amply demonstrated with racquet sports.

Each patient will have 1 blood samples and 1 measure of bone by 3D micro-tomography (3D CT Scan).These examinations and sampling will take place on 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Golfers: Regular playing golf for over 2 years at 8 to 12 hours per week recruited into golf clubs.
* Walkers: regular practice of walking for over 2 years at 8 to 12 hours per week recruited into the walking clubs.
* Sedentary: no intensive physical activity (\<2 hours / week), recruited in clubs seniors.

Exclusion Criteria:

* concomitant bone disease ,
* Hip prosthesis the dominant side
* Endocrinopathy
* hypercalcemia, vitamin D deficiency, hypo- or hyper calciuria
* Active smoking (more than 5 cigarettes / day), chronic alcoholism,
* Treatments received in the previous six months and resounding on bone metabolism such growth promoters, all osteoporosis, corticosteroids.
Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early.

Exclusion criteria: allergy to sevoflurane, inability to understand the questionnaire

Parameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect

A prospective single-blinded randomized study will be conducted in patients of the Dermatovenereology Clinic of the 3rd Medical Faculty of Charles University (3LF UK) and the University Hospital Kralovske Vinohrady (FNKV) with painful non-healing tibial ulcers. Pain intensity on a numerical rating scale (NRS 0-10) must be NRS\>4. The envelope method will be used for randomization. To blind patients, therapy will be performed by separating patients with a drape from the treatment area of the body. As sevoflurane has a typical odor, it will only be used in the control group to soak up absorbent material held under the distal pole of the wound without skin contact. In the active treatment group, sevoflurane will be applied at the beginning of the wound treatment at approximately 1 ml/cm2 of the ulcer surface. The standard therapy used in the control group will use only Cyteal TM lavage solution, which contains hexamidine diisetione 100 mg in 100 ml, chlorhexidine digluconate 20% solution 100 mg and chlorocresol 300 mg.

The primary aim of the study will be pain relief after sevoflurane therapy. Pain intensity will be measured by NRS at 1-hour intervals (excluding sleep); decrease of 2 point for at least 4 hours will be considered significant. Secondary aim will be healing of ulcers. The effect will be controlled by elimination of pathologic microbial colonization, cleaning of the base of the wound and decreasing the size of the ulcer. Microbial colonization will be measured by microbial swab culture before application, after the 1st application before dressing and on the 5th day after application), the appearance of the defect base will be assessed by the appearance of the surface, the size of the defect will be measured in cm2.

Eligibility Criteria:
Inclusion Criteria:

* Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS\>4) non- healing tibial venous ulcers

Exclusion Criteria:

* Allergy to sevoflurane
* Inability to understand the pain-intensity questionnaire