cyrilzakka/clinical-trials huggingface dataset:
Feasibility of the YATAC Programme

Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to increase participation in everyday life and improve health-related quality of life. The development of the intervention is guided by the British Medical Research Council's guidance (MRC) and the framework for the co-production and prototyping of public health interventions by Hawkins et al.

The present study will investigate the acceptability and fidelity of the intervention at the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the results of the study will be used to revise version 1.0 of the programme.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-39 years old at baseline
* Have had any type of cancer
* Have completed primary/active cancer directed treatment (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention, while current hormonal treatments or maintenance therapies are permissible)
* Determined a need for rehabilitation determined by the REHPA scale (a linear analogue scale, where the participants indicate how close they are to living the life they desire after ending cancer treatment). The scale ranges from 0= 'goal reached' to 9= 'infinitely far from'
* Have access to a device with Internet options (i.e., smartphone or tablet)

Exclusion Criteria:

* Dependent in basic personal activities of daily living (personal care, dressing and eating)
* No permanent residence in Denmark
* Not able to speak and understand Danish
Prediction of Preeclampsia (PE) at 11-13 Week

This is an international multicentre prospective cohort study to validate the Bayes theorem based algorithms for the screening of pre-eclampsia (PE) in the first-trimester of pregnancy.

The investigators have previously constructed Bayes model in the first-trimester which combines maternal characteristics and medical history (Mat-CH) together with mean arterial pressure (MAP), uterine artery pulsatility index (PI), and serum placental growth factor (PlGF) with a plan to assess the predictive performance.

The reference standards will be PE defined according to the International Society for the Study of Hypertension in Pregnancy and the American College of Obstetricians and Gynecologists. The systolic blood pressure should be \>140 mm Hg and/or the diastolic blood pressure should be \>90 mmHg on at least two occasions four hours apart developing after 20 weeks' gestation in previously normotensive women and there should be proteinuria (\>300 mg in 24 hours or two readings of at \>2+ on dipstick analysis of midstream or catheter urine specimens if no 24-hour collection is available). In the absence of proteinuria, new onset of any of the following systemic findings: a) thrombocytopaenia (platelet counts \<100,000 µL); b) renal insufficiency (creatinine \>1.1 mg/dL or 2-fold increase in creatinine in the absence of underlying renal disease); c) abnormal liver function (ie, hepatic transaminase levels twice normal); d) pulmonary oedema; or e) cerebral or visual symptoms. Preterm-PE is PE that requires delivery before 37 weeks' gestation. If a participant fulfills the criteria for PE by one definition and not the other she will be considered to have developed PE.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Singleton pregnancy
* Live fetus
* Provide Informed and written consent in the official language of the country

Exclusion Criteria:

* Unable to provide written Informed consent learning difficulties or serious mental illness or an inability to understand spoken and written the official language of the country.
* Multiple Pregnancy
* Non-viable fetus (missed spontaneous abortion or stillbirth)
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy

The aim of the present study is to compare the efficacy of liraglutide vs. naltrexone/bupropion on metabolic and cardiovascular risk markers, weight loss, as well as the postprandial secretion of gastrointestinal hormones involved in hunger and satiety, after a test meal. The study will include 40 patients, who will further be divided into two treatment groups (20 patients on liraglutide vs. 20 patients on naltrexone/bupropion). The patients will be examined at baseline, 3 and 6 months after the treatment initiation.

This is a prospective study of patients aged ≥18 years, who are overweight (BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes) or obese patients (BMI ≥ 30 kg / m2). Patients' data will be collected before starting medication (time 0) and at 3 and 6 months under treatment in the clinical practice of the selected drug, as described in the drug's package leaflet, along with a simultaneous dietary intervention and exercise. Patient groups will be comparable in age, gender and BMI.

The aim of the study is the comparison of the efficacy of liraglutide vs. naltrexone/bupropion in metabolic and cardiovascular markers.

The following parameters will be measured:

* Weight, height, waist and hip circumference
* 24-hour recording of blood pressure and heart rate
* HbA1c, total cholesterol, LDL, HDL, urine albumin/creatinine ratio
* Bioelectric impedance for determination of total and visceral fat and muscle mass Indirect calorimetry for the determination of resting metabolic rate and total energy expenditure
* Determination of baroreflex sensitivity (BRS) and heart rate variability (HRV) to investigate the function of the autonomic nervous system
* Blood sample test meal at 0, 30, 60, 90, 120, 150 and 180 min to determine insulin concentration and gastrointestinal hormones involved in hunger and satiety with modern indirect calorimetry to determine postprandial thermogenic analog scales (VAS)
* Neuropathy tests
* Assessment of quality of life with the SF-36 questionnaire and assessment of the feeling of hunger and satiety
* Echocardiographic determination of the left systolic and telodiastolic diameter of the left ventricle, cardiac fat and the Tei index at times 0 and 6 months with medication
* Pericardial fat

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years with BMI ≥ 30 kg / m2 or BMI ≥ 27 kg / m2 in the presence of dyslipidemia or hypertension or obstructive sleep apnea or fatty infiltration or prediabetes.

Exclusion Criteria:

1. Presence of any clinical contraindications for the administration of liraglutide or bupropion / naltrexone
2. Bariatric surgery
3. Diabetes type 2
4. Active malignancy
5. Medication that affects weight (eg corticosteroids, phenothiazines)
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial

The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for successful cardioversion of atrial fibrillation into sinus rhythm.

Patients with atrial fibrillation may suffer from disabling symptoms such as palpitations, shortness of breath or worsening heart failure. In such patients, it may be beneficial to convert their rhythm to sinus rhythm. Cardioversion can be achieved either pharmacologically or electrically. Pharmacological cardioversion is less successful acutely than electrical cardioversion and may be associated with complications such as prolongation of the QT interval and torsades de pointes (polymorphic ventricular tachycardia). Thus, cardioversion is most often accomplished electrically, using biphasic synchronized shocks of 75-200 Joules. Biphasic electrical cardioversion in atrial fibrillation has shown to be successful (i.e., converting to sinus rhythm) about 88% of the time, on average. The success rate appears to largely depend upon the duration of the arrhythmia and the presence and severity of structural heart disease.

In this study, we will evaluate the effect of intravenous magnesium sulfate on the success rate of electrical cardioversion, and also assess its effect in decreasing the energy levels needed for successful cardioversion. If the study is successful, we will have shown that a simple and inexpensive intervention can increase the success rate of electrical cardioversion, increasing the proportion of patients who can be restored to sinus rhythm. In addition, success with lower energy levels may improve the safety of cardioversion, as high energy levels are more likely to be associated with side effects

Eligibility Criteria:
Inclusion Criteria:

* Patient with new onset Atrial fibrillation less than 48 hours after onset undergoing electrical cardioversion.
* Patients with atrial fibrillation longer than 48 hours on warfarin with documented therapeutic INR levels \>2 for at least 3 weeks prior to the cardioversion, or been on dabigatran for 3 weeks, or a transesophageal echocardiogram on the day of the procedure that excludes intracardiac thrombi, undergoing electrical cardioversion.

Exclusion Criteria:

* Creatinine \>2.0 mg/dl
* Potassium level less than 3.5 mmol/dl
* TSH \< 0.5
* Magnesium levels \>3.0 mg/dl
* Urgent need for cardioversion (e.g., hemodynamic instability, unstable angina, pulmonary edema)
* Patients with recent (less than 6 weeks) acute myocardial infarction
* Patients post-cardiac surgery
* Pregnant women
* Patients who are being treated with antiarrhythmic drugs who have received less than five doses of the drug. For amiodarone, patients who have received less than three weeks prior to cardioversion are excluded.
PFO ACCESS Registry

Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

Eligibility Criteria:
Inclusion Criteria:

Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

Exclusion Criteria:

International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)
Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails

The trial is conducted to investigate the clinical efficacy of a combination product containing calcipotriol and betamethasone formulated as an aerosol foam (Enstilar ©) for the treatment of nail psoriasis in conjunction with physical pre-treatment using a fractionally ablative carbon dioxide laser (AFL). It is hypothesized, based on preclinical data and comparable clinical trials, that laser processing prior to topical administration will lead to increased drug distribution, and thereby increase the efficacy of Enstilar® in treating nail psoriasis.


Eligibility Criteria:
Inclusion criteria

1. Informed consent obtained before any trial-related activities.
2. At least 18 years of age (inclusive)
3. Confirmed diagnosis of psoriatic disease with signs of nail psoriasis on at least 2 digits
4. Minimum nail involvement as assessed by treating physician (N-NAIL score of ≥ 2 for at least two individual nails)

Exclusion criteria

1. Insufficient knowledge of written and spoken Danish.
2. Pregnant and lactating women and women who intend to become pregnant during the trial
3. Pre-existing clinical manifestations of long-term side effects of corticosteroid use including but not limited to skin atrophy or telangiectasias on fingers
4. Presence of any skin condition or coloration (marked suntan, hyperpigmentation, smoking-induced staining, tattoos or body art) that would interfere with the evaluation of the clinical response in the test sites or assessment
5. Any non-psoriatic disease activity within test areas
6. Significant history or current evidence of chronic infectious disease, systemic disorders, or organ dysfunction where the use of Enstilar is contraindicated.
7. Known predisposition for hypertrophic scar formation.
8. Known allergy to any of the components of Enstilar®.
9. Current treatment with systemically or locally acting medications which might counter or influence the trial aim
10. Received any drug as part of a research trial within 30 days prior to initial trial dosing.
11. Artificial nail enhancement or damages associated with it, including (semi-) permanent nail polish e.g. acrylic based gels.
12. Ongoing fungal infections of psoriatic nails
13. Close affiliation with the investigator (e.g. a close relative) or persons working at the respective trial site or the participant is an employee of the sponsor
14. In the opinion of the investigator, the participant is unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state).
Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

This study will be a double-blinded randomized control trial. Patients will be randomized into one of two groups. Patients in Group 1 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL 0.25% bupivacaine on the ipsilateral side as the extraction site. Patients in Group 2 will undergo general anesthesia with a post-induction, post-intubation, pre-procedural subcostal TAP block with 40 mL sterile normal saline on the ipsilateral side as the extraction site. Investigators will be blinded to the randomization of these patients. Following performance of these blocks, patients will receive standard care for the surgery as well as during the postoperative recovery period. Data will be obtained from the EPIC electronic medical record, and from the anesthesia computer record. Patients will be asked postoperatively to assess items such as their nausea and pain scores. Patients will also be contacted by phone within 1-2 days of discharge to obtain analgesic satisfaction scores. This data will be collected on the Redcap server.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-80 years old
* Candidate for general anesthesia
* Undergoing laparoscopic sleeve gastrectomy
* Patients of participating surgeons

Exclusion Criteria:

* Prior bariatric surgery of any kind
* Previous abdominoplasty
* Allergy or intolerance to one of the study medications
* ASA \> 4
* Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of \>5mg/day for one month)
* History of alcohol/drug abuse
* History of hepatic or renal insufficiency
* Patient refusal
Long Term Administration Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients


Eligibility Criteria:
Inclusion Criteria:

1. Out patient;
2. Ocular discomfort severity is moderate to severe;
3. Corneal-conjunctival damage is moderate to severe;
4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
5. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
2. Ocular hypertention patient or glaucoma patient with ophthalmic solution;
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
4. Anticipated use of contact lens during the study;
5. Patient with punctal plug;
6. Any history of ocular surgery within 12 months;
7. Female patients who are pregnant, possibly pregnant or breast feeding;
8. Known hypersensitivity to any component of the study drug or procedual medications;
9. Receipt of any investigational product within 4 months.
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Eligibility Criteria:
Inclusion Criteria:

Include:

* Subjects of either sex aged 18 years or older.
* Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.

Exclusion Criteria:

Include:

* Subjects currently receiving daily morphine or oxycodone (mono-therapy).
* Subjects who are discontinued from BUP3201 due to adverse events.
* Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.

Refer to core study for additional inclusion/exclusion information.
Radiotherapy - Adjuvant Versus Early Salvage

Radical prostatectomy (RP) is the most common curative approach offered to men with newly diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. Having radiotherapy after RP is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising PSA after surgery indicating active cancer. Immediate RT may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. International lack of consensus on the optimal timing of RT has resulted in varied clinical practice. This phase 3 trial will compare the two approaches.

This is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. Patients with positive margins and/or pT3 disease will be randomised to adjuvant RT (Standard Arm) or active surveillance with salvage RT delivered at early relapse (Experimental Arm). 64 Gy in 32 fractions will be delivered to the prostate bed. QoL self-assessment questionnaires, Hospital Anxiety and Depression Score and toxicity will be assessed at baseline, the end of RT and annually for 5 years. Patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. A blood test measuring prostate specific antigen (PSA) is done 3 monthly for the first 5 years for patients randomised to early salvage RT, then 6 monthly from years 5 to 10.

Eligibility Criteria:
Inclusion Criteria:

* Prior Radical Prostatectomy (RP) for adenocarcinoma of the prostate.
* Histological confirmation of adenocarcinoma of the prostate with the Gleason score reported (Radical Prostatectomy specimen).
* Patients must have at least one of the following risk factors: 1) Positive margins, 2) Extraprostatic extension (EPE) with or without seminal vesicle involvement (pT3a or pT3b)
* Capable of starting RT within 4 months of RP (a requirement if randomised to adjuvant RT arm)
* Most recent PSA ≤ 0.10 ng/ml following RP and prior to randomisation
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
* Patient able to adhere to the specified follow-up schedule and complete the Quality of Life and anxiety/depression self-assessments
* Written informed consent obtained prior to randomisation
* Completion of all pre-treatment evaluations
* 18 years and older

Exclusion Criteria:

* Previous pelvic RT
* Androgen deprivation (AD) prior to or following RP
* Evidence of nodal or distant metastases
* Co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up
* Concurrent cytotoxic medication
* Hip prosthesis
Does Acupuncture Activate Endogenous Pain Inhibition in Chronic Whiplash?

This physiological study examines whether acupuncture exerts short-term effects of analgesic mechanisms in patients with chronic whiplash pain. More specifically, it is examined whether acupuncture activates brain-orchestrated pain inhibitory action.

Many patients with chronic pain, including those with chronic whiplash-associated disorders (WAD), show features of central sensitization (CS), a process characterized by generalized hypersensitivity of the somatosensory system. it would be worthwhile identifying treatments able of activating the dysfunctional endogenous pain inhibition in patients with CS and chronic WAD.

Acupuncture is a treatment method widely used for patients with chronic pain, including those with chronic WAD. The effectiveness of acupuncture for the treatment of chronic (neck) pain is supported by several randomized controlled clinical trials, systematic reviews including meta-analyses. However, the effect-sizes are rather small and only short-term effects have been shown consistently.

A randomized cross-over trial comparing acupuncture with relaxation is conducted in order to examine whether acupuncture vs. relaxation for patients with chronic WAD results in:

1. Immediate activation of endogenous pain inhibition (i.e. conditioned pain modulation);
2. Concomitant pain relief;
3. And reduced disability level. Further it is examined whether acupuncture vs. relaxation results in different autonomic nervous system responses.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of chronic WAD grade 1 to 3 according to the criteria as defined by the Quebec Task Force classification
* chronic neck pain and WAD persisting for at least 3 months
* age between 18 and 65 years

Exclusion Criteria:

* classified as WAD grade 4 (neck complaints including fracture or dislocation, or injury to the spinal cord)
* pregnant
* initiated a new conventional therapy during the study period
* taking analgesic drugs 48 hours before testing and/or nicotine, alcohol and caffeine 24 hours before testing