cyrilzakka/clinical-trials huggingface dataset:
Atrial Fibrillation and Neuropathic Pain After Thoracotomy and Continuous Application of Magnesium Sulphate.

Atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. The continuous application of magnesium sulphate may have a prophylactic effect. The investigators record the incidence of atrial fibrillation during a seven day period after thoracotomy as well as the incidence of chronic neuropathic pain during a three months period, comparing one group with a continuous application of magnesium sulphate against one group without magnesium sulphate.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* posterolateral thoracotomy for lung parenchyma resection
* informed consent

Exclusion Criteria:

* hypersensitivity for magnesium sulphate
* pre-existing atrial fibrillation
* participation in another trial
* pregnancy or breastfeeding
Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy

Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may reverse erectile dysfunction in affected patients. The present study aims to investigate in a larger cohort if severe sleep apnea is independently associated with erectile dysfunction and if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* apnea-hypopnea-index \> 30/h
* no CPAP therapy
* male gender
* 18-80 years of age
* having or attempting to have regular sexual intercourse

Exclusion Criteria:

* apnea-hypopnea-index \< 30/h
* already treated by CPAP
* female gender
* age \< 18 or \> 80 years
* not having or not attempting to have regular sexual intercourse
The Effect of Use of Kahoot in Pediatric Emergency Nursing Course on Students' Course Success and Motivation Levels

With the characteristics of the new generation and the innovations brought by the age, it has become inevitable to use new educational, instructive and entertaining methods in nursing education. Considering the problems experienced by nursing students with traditional education, the use of Kahoot will be a remarkable result in the literature. The gamification process with Kahoot encourages thinking skills in situations where the subject is sensitive and challenging, ensuring better retention of information and improving internal motivation. Therefore, in order to make learning efficient and to ensure the active participation of students, it should be processed using different interactive methods in nursing education. Pediatric emergency nursing course is a content-intensive and rich course that blends emergency and pediatric nursing, containing information on child health and development in addition to the learning outcomes of the emergency nursing course. This study was carried out within the scope of the pediatric emergency nursing course; It is thought that it will enable students to repeat the basic concepts of the course, master the terminology, and provide a supportive learning environment for pediatric emergency nursing, which is a difficult field for students, and will contribute to nursing education and nursing literature.

This study was planned as a randomized controlled study to determine the effect of using Kahoot in the pediatric emergency nursing course on students' course success and motivation levels.

Eligibility Criteria:
Inclusion Criteria:

* Those over 18 years of age,
* Third year nursing students,
* Taking the pediatric emergency nursing course for the first time,
* Those who have not experienced Kahoot before,
* Nursing students who volunteer to participate in the research will be included in the research.

Exclusion Criteria:

* Those who do not volunteer to participate in the research
Online Brain Training Intervention for Over 50s

This study is an open trial investigating the long-term use of an online brain training programme for adults over 50. It will determine whether there is sustained benefit to cognition, and whether this group can be engaged in this form of intervention over a period of 12 months.

This study will evaluate an optimised brain training programme to determine whether it is engaging for older adults and whether it results in improvement or maintenance of cognition over a 12 month period.

The Brain Training intervention

The programme is an updated version of the original 'Brain Test Britain' intervention, which was successfully evaluated in a large previous trial. It consists of a series of games or tests, completed on a computer. Each test is designed to target the participants' reasoning and problem-solving ability, for example by asking them to balance weights on a see-saw or select the 'odd-one-out' from a series of shapes. As the participants progress over the course of the study they will receive increasingly more challenging versions of each test, depending on their performance. The intervention has been updated from the original to improve engagement through improved visuals, more intelligent difficulty setting and a more engaging delivery platform.

The research delivery platform: PROTECT

A novel infrastructure resource has been developed at King's College London within the Maudsley Biomedical Research Unit for Dementia (BRU-D), which provides the opportunity to deliver the intervention to large numbers of older adults. The Platform for Research Online to investigate Cognition and Genetics in Ageing (PROTECT) is an online research tool. PROTECT is currently recruiting a cohort of over 10,000 adults over 50 who are cognitively healthy or have early cognitive impairment. Participants provide demographic and lifestyle information and will complete a battery of validated cognitive assessments annually. The focus of all research conducted through PROTECT is on the prevention of dementia and risk reduction. The optimised brain training intervention will be delivered through this platform. PROTECT has ethical approval from the NHS Research Ethics Service Committee for London Bridge (Ref: 13/LO/1578).

Study Design

Design: 12-month open online clinical trial Participants: 5000 adults over 50 Setting: Intervention delivered at home, online through the PROTECT website

Recruitment

Recruitment will be achieved through the PROTECT site through a national advertisement strategy. This will be accomplished through partnerships with the media and third sector. All participants registered on PROTECT will be invited to take part and provided with the information sheet. Participants will consent through the secure online procedure on the PROTECT site.

Eligibility Criteria:
Inclusion Criteria:

* Over 50,
* Have access to a computer and the internet
* Registered as a participant on the PROTECT website

Exclusion Criteria:

* Established diagnosis of dementia
Intravesical Bupivacaine on Post-Operative Ureteroscopy Pain

Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy.

This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged ≥ 18 years old.
* Diagnosis of nephrolithiasis planned for flexible or semi-rigid ureteroscopy in the treatment of stone disease with ureteral stenting.

Exclusion Criteria:

* Foley catheterization
* History of allergy to bupivacaine
* Antegrade ureteroscopy
* Transplant or ectopic kidney
* Ureteral or bladder reconstruction
* Pregnancy (which is a contraindication to elective ureteroscopy)
* Dialysis
* Surgical complication (significant bleeding, ureteral perforation, significant urothelial damage)
* Suspicion of untreated urinary tract infection
* History of pelvic radiation
* Neurologic disease with a diagnosis of neurogenic bladder dysfunction
* History of chronic pain (fibromyalgia, interstitial cystitis, opioid abuse)
Evaluation of the Long-term Persistence of Hepatitis A Antibodies in Healthy Adults Who Were Vaccinated 21-25 Years Earlier With GlaxoSmithKline (GSK) Biologicals' Hepatitis A Vaccine, Havrix®

The purpose of this study is to assess the long-term persistence of immunity to hepatitis A in adults who were vaccinated 21-25 years earlier with hepatitis A vaccine, Havrix®.

This is a long-term persistence study in which subjects who participated in the primary studies HAV-112 (208109/108) or HAV-123 (208109/114) and did not receive an additional dose of hepatitis A vaccine since then, will be invited to provide a blood sample at Years 21 to 25 after their second vaccine dose. No vaccine will be administered during the study period.

Eligibility Criteria:
Inclusion Criteria:

* A male or female who received two doses of Havrix in study HAV-112 (208109/108) or HAV-123 (208109/114), and received no further booster dose since then.
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
* Written informed consent obtained from the subject.

Exclusion Criteria:

* History of hepatitis A disease since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114).
* Administration of a hepatitis A vaccine at any time since completion of the primary vaccination series in studies HAV-112 (208109/108) or HAV-123 (208109/114) including a challenge dose of the study vaccine, as a part of the study procedures, during the long-term persistence phase.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
* Administration of hepatitis A immunoglobulins and/or any blood products and/or long-acting immune-modifying drugs within six months prior to study entry.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
* Administration of long-acting immune-modifying drugs within six months prior to study entry (e.g. infliximab).
* Concurrently participating in another clinical study during the period starting 30 days before and ending 30 days after each study visit, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers

To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, clinical laboratory tests
* Age ≥21 and ≤45 years
* Haemoglobin within the normal ranges.
* Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation

Exclusion Criteria:

* Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Relevant surgery of gastrointestinal tract
* History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
* History of gastric ulcera and cholecystectomy
* Occult blood in faeces
* Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Relevant chronic or acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Alcohol abuse (more than 40 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to understand and comply with protocol requirements, instructions and protocol stated restrictions, the nature, scope and possible consequences of the study
* Subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis

A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.


Eligibility Criteria:
Inclusion Criteria:

* Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
* Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
* Treatment-naive to any approved or investigational anti-HCV medication.
* Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.

Exclusion Criteria:

* Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
* Any current or historical clinical evidence of decompensated cirrhosis.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid \> lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
* History of suspected or confirmed hepatocellular carcinoma.
Health Coaching to Effect Lifestyle Behaviour Change

A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes) but without pre-existing cardiovascular disease will effectively help participants change their lifestyle behaviour and prevent or delay onset of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-60 years
* Last recorded fasting blood glucose between 6.0 abd 6.9 mmol/L
* Last recorded blood pressure between 130-139 mmHG systolic and/or85-89 mmHG diastolic

Exclusion Criteria:

* Diagnosis of diabetes on the chart
* Diagnosis of hypertension on the chart
* taking an anti-diabetic medication
* taking an antihypertensive medication
An Evaluation of Brief Online Hypnosis for Migraine and Tension-type Headaches

This study aims to conduct an initial evaluation of whether a single, online, group-based session of hypnosis followed by self-hypnosis can decrease symptoms of migraine and tension-type headaches as well as improve quality of life and perceived self-efficacy over the condition.

This study is a pilot randomised controlled trial (RCT) comparing a single, online, group-based session of hypnosis followed by self-hypnosis for people with migraines or tension-type headaches with a wait-list control. A battery of self-report measures and a 2-week headache diary will be administered online at baseline (weeks 0 and 1), post-intervention (weeks 7 and 8) and at follow-up (weeks 11 and 12).

Eligibility Criteria:
Inclusion Criteria:

* Self-reported diagnosis of migraine or tension-type headaches from a General Practitioner (i.e. family physician) and/or specialist physician.
* Score above the cut-off for either migraine or tension-type headache on the Headache Screening Questionnaire.
* Have experienced at least one headache every two weeks over the last 3 months.
* Otherwise healthy physically and mentally.
* Able to understand written and spoken English.
* Have the IT equipment necessary to access Zoom videoconferencing and the Qualtrics survey system.

Exclusion Criteria:

* Substantial medical or psychiatric co-morbidities including diagnoses of epilepsy, psychosis or personality disorder, and/or taking psychiatric medication.
* A diagnosis of medication overuse headache.
Defining the Optimal Hormonal Replacement Therapy in Turner Syndrome

The purpose of this study is to examine whether a larger dosage of estrogen than the one used today will secure the development of a normal sized uterus and increase the strength of the bones in girls and young women with Turner syndrome.

The purpose is also to evaluate whether aortic dilatation is present in this group of patients, and if the estrogen dosage will influence the emotional well-being and self-esteem of the patients.

Turner syndrome is a common chromosomal disorder with only one X-chromosome or partial deletions in one X-chromosome in all or some of the cell-lines in the body. Appr. 18 girls/year are being born with the syndrome in Denmark. The syndrome is mostly known for reduced final height and the lack of pubertal development with infertility, but it is also known for diseases influencing other parts of the body like the heart with the risk of development of aortic dilatation and subsequently dissection with the risk of rupture, profuse bleeding and sudden death. Reduced bone strength and increased risk of bone fracture are also features of the syndrome. Treatment with growth hormone and female sex-hormones are well-established treatments.

Girls and young women with Turner syndrome ages 10 to 21 years will participate. The girls ages 15 to 21 years will randomly and double blindly receive treatment with either 2 mg or 4 mg estrogen for 5 years. Yearly examinations with blood tests, physical examinations, questionnaires, ultrasound and MR-scan of the internal female genitalia, DEXA-scan of the bones and MR-scan of the heart will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Verified Turner syndrome
* Ages 10-25 years

Exclusion Criteria:

* Contraindications to the MR-scan
* Contraindications to the trial medication
* Severe or chronic sickness with impact on the parameters of the study or incompatibility with the trial medication
* Intake of medications with interactions with trial medication
Endometrial Biopsy Protocol for In Vitro Fertilization (IVF)

Endometrial biopsy has been shown to improve IVF pregnancy and live birth rates. The optimal time of performing the biopsy is yet to be established.

In this study, the investigators will compare different temporal timing of the biopsies with regards to the menstrual cycle and their affect on the success rates of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* normal menstrual cycle
* between 1-6 previous failed IVF cycles
* normal hormonal profile

Exclusion Criteria:

* intrauterine procedure in last 3 months
* hydrosalpinx
* intrauterine lesion /malformation
Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis

This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* documented history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
* have a qualifying best-corrected visual acuity

Exclusion Criteria:

* abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
* IOP \> 21 mmHg at Screening or Baseline/Day 1 Visits
* use of steroids in the past 30 days or retinoids in the past 12 months
* uncontrolled systemic disease
Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases

The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.


Eligibility Criteria:
Inclusion Criteria:

* Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years
* Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment.
* Patients will have 1 to 3 separate spinal sites that require treatment.
* Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels
* ECOG 0-2
* Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal
* people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control
* Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approved informed consent document

Exclusion Criteria:

* Prior or planned radiation off study within or overlapping with study treatment site
* Inability to have either an MRI or a CT scan. Patients with pacemaker will be allowed to undergo CT instead of MRI
* Pediatric patients (age \<18 years old), pregnant women, and nursing patients will be excluded
* Histology's of myeloma or lymphoma
* Patients with strength 1-3 (of 5), bladder incontinence, bowel incontinence, and/or bladder retention that is associated with spinal site to be treated
* Prior surgery to spinal site intended to be treated with protocol SRS
* Excluded those with SINS 13-18