cyrilzakka/clinical-trials huggingface dataset:
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids

The objective of this study is to provide critical information regarding both common and distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.

This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The study will characterize the effects of EPA alone and DHA alone, relative to each other and to placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene expression, and plasma lipid and lipoprotein levels.

Eligibility Criteria:
Inclusion criteria:

* fasting plasma TG levels between 150 and 500 mg/dL
* C-reactive protein (CRP) levels ≥2 µg/mL
* at least one of the following criteria for the definition of metabolic syndrome:

  * abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women),
  * hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and
  * fasting glucose ≥110 mg/dL.

Exclusion criteria:

* high-fish diets (\>2 fish meals/week)
* taking fish oil supplements or supplements containing EPA or DHA
* allergy to sardines
* allergy to sunflower oil
* regular use of anti-inflammatory medications (NSAID, COX inhibitors, corticosteroids)
* anticoagulant therapy
* alcohol consumption \>7 drinks/week
* uncontrolled thyroid dysfunction
* insulin-dependent type 2 diabetes mellitus
* kidney or liver disease
* smoking
* alterations in coagulation
* use of lipid altering medications
Autobiographical Memory Flexibility Training (MemFlex) for Posttraumatic Stress Disorder

The experience of trauma not only impacts the way an individual thinks and feels, but can also produce changes in the way someone remembers their personal past. It is not only memories of the trauma that are affected- avoidance of trauma memories can also lead to memories of other events becoming vague, and in particular, memories of positive experiences can seem out of reach. This memory difficulty promotes posttraumatic stress disorder (PTSD). This study will explore an intervention that aims to improve memory difficulties, which should then flow on to improve PTSD. The study will be completed with individuals who have experienced a single incident trauma. Twenty five participants will complete MemFlex straight away, and 25 will go on a waiting list. Once this first group has finished MemFlex, the researchers will compare the two groups to see if the programme produced a larger reduction in PTSD symptoms. MemFlex is workbook-based, and as such, if it is successful it may offer an easy, cheap, and accessible way to offer psychological treatment to PTSD sufferers around the world.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Posttraumatic Stress Disorder (as indexed by the Farsi version of the Structured Clinical Interview for DSM disorders \[SCID\])
* Aged over 18 years

Exclusion Criteria:

* Lack of oral and/or written fluency in Farsi
* Traumatic brain injury or cognitive impairment, indexed via self-report
* Current experience of psychosis, indexed by SCID
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule

The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:

A. vaginal flora and Nugent score.

B. vaginal pH.

C. functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement).

D. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 8 weeks of follow-up
* The patient is menopausal (amenorrhea) for over 2 years and less than 10 years
* The patient has a body mass index \<35
* The patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant or breastfeeding
* The patient is not menopausal (both clinically and biologically)
* The patient has a body mass index \> 35
* The patient has a genital prolapse higher than stage 2 with a surgical indication
* The patient has stress incontinence with a surgical indication
* The patient suffers from vaginismus
* Presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection
* Hemorrhagic or neoplastic genital pathologies
* Existence of a hormone-dependent tumor, genital bleeding of unknown origin
* Current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin
* Known hypersensitivity to hyaluronic acid or mannitol
* Known hypersensitivity to Betadine
* Known hypersensitivity to Lidocaine
* Hypersensitivity to EMLA®
* Previous urogynaecological vulvovaginal surgery
High-Power Short-Duration Radiofrequency Ablation in Patients With Typical Atrial Flutter

The aim of cavotricuspid isthmus (CTI) dependent flutter ablation is the bidirectional conduction block of CTI. The probability of achieving a permanent bidirectional block at the CTI depends, mainly, on the ablation energy applied and the quality of the obtained lesion. Among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.This is a multicenter 1:1 randomized, blinded (open for the operator) study. Two CTI ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 W applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (Ablation Index \>500 at the anterior half of the CTI and \>400 at the posterior half with de CARTO 3 system; 2) experimental treatment branch consistent of CTI block using individual high power (90W) short duration (4 seconds) point-by-point applications. The main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. Secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cavotricuspid isthmus dependent flutter referred to ablation
* Patients clinically and hemodynamically stable.
* Patients who give informed consent.

Exclusion Criteria:

* Refusal to participate in the register or inability to understand the informed consent.
* Age under 18.
* Patients who have already undergone previous flutter ablation procedures.
Self-adherent Wrap Techniques for Orbital Surgery

The purpose of this study is to evaluate the interface pressure measurements of applying self-adherent wraps on eyes after orbital tumour extirpation.

The purpose of this study is to evaluate the interface pressure measurements of the folded and classic techniques of applying self-adherent wraps on eyes after orbital tumour extirpation.

Eligibility Criteria:
Inclusion Criteria:

* over 16 years old
* diagnosed as orbital disease or ocular tumor
* surgery under general anesthesia

Exclusion Criteria:

* any uncontrolled clinical problems
Nursing Interventions for Glycemic Control

Introduction: Diabetes mellitus (DM) is a very frequent pathology, which can lead to renal failure and the need for renal replacement therapy. In people with chronic kidney disease (CKD) and diabetes mellitus (DM), glycemic control is very important for the prevention of microvascular injury. In this context, the Nursing Process (NP) is the instrument to guide care, contributing to the attention of individuals' needs. Objective: To evaluate the results of Nursing Outcomes Classification (NOC), obtained through interventions of the Nursing Interventions Classification (NIC) for the glycemic control, in patients with diabetes in renal replacement therapy, with a diagnosis of Unstable Glycemia, of the North American Nursing Diagnosis - International (NANDA-I). Method: Randomized clinical trial in three dialysis services in southern Brazil. Population: Type I and II diabetes patients on hemodialysis. Sample: Over 18 years old, literate, who accept to participate in the study by signing a Term of Consent Free and Clarified. Exclusion criteria: severe uncorrected deficiency in hearing, speech, total amaurosis, degenerative neurological diseases, or score less than 20 in the Mini Mental State Examination. Randomization occurred by clusters, considering dialysis shifts. The CG followed routine treatment and guidelines, while the IG received nursing interventions on a monthly basis for 6 months. Variables related to NOC scores and the knowledge, attitude and self-care tests for DM were applied before and after the intervention period. After the intervention period, a washout period of 06 months will occur, after which the variables will be collected.

After randomization, the intervention group was assesses by a nurse determining the nursing outcomes (NOC)for the specific nursing diagnosis Unstable glycemia. One educational intervention per month was done:

1. Teaching: individual and Teaching: disease process.
2. Control of hyperglycemia and Control of hypoglycemia.
3. Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)
4. Teaching: psychomotor skills ( was performed with a view to the management and application of insulin). In case of use oral antiglycemic agent the Teaching: prescription drugs and control of hyperglycaemia and hypoglycemia was repeated
5. Teaching: Foot care.
6. Teaching: activity / prescribed exercises. After the completion of the six intervention patients were assessed for outcome classification the study will contemplate a 6 months washout between the NOC assessment ( end of interventions and final assessment)

Eligibility Criteria:
Inclusion Criteria:

* diabetic with chronic kidney disease on hemodialysis
* over 18 years old
* literate,
* who accept to participate in the study by signing a Term of Consent Free and Clarified

Exclusion Criteria:

* severe uncorrected deficiency in hearing, speech,
* total amaurosis,
* degenerative neurological diseases,
* score less than 20 in the Mini Mental State Examination
To Compare the Efficacy of Surgery Followed by Sunitinib With Surgery Followed by Imatinib in GIST Patients With Progression on Imatinib.

To compare the efficacy of surgery followed by sunitinib with surgery followed by imatinib in GIST patients with progression on imatinib;To investigate the optimal therapy after surgery in GIST patients with focal or multifocal progression in imatinib

Primary Endpoint: To evaluate the progression free survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib Secondary Endpoint：To evaluate the overall survival of the patients with progression receiving surgery followed by sunitinib therapy comparing with surgery followed by imatinib the relationship of c-kit secondary mutation and progression free survival of surgery followed by TKI therapy the safety and tolerability of the two therapy.

Statistics:All the statistical analysis is performed using SPSS version 20.0 (IBM corporation, United States). Pearson's chi-squared test was used to compare categorical variables. PFS and OS analyses were estimated with Kaplan-Meier method and log-rank test and multivariable analyses were performed to assess survival difference. A two sided p-value of \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. .Histopathological diagnosis of metastatic GIST.
2. . After the treatment of imatinib, imatinib 400mg/day after treatment, the tumor generalized.
3. . Patients with generalized progress were satisfied with tumor reduction after imatinib resistance for various reasons.
4. at least 1 month after surgery for imatinib treatment or sunitinib treatment.
5. at least one imaging assessment was received after surgery.
6. . Complete clinical data and follow-up data.

Exclusion Criteria:

1. . Before operation, he was treated with sunitinib
2. . Patients receiving tumor reduction were not satisfied with the standard of the reduction of tumor.
3. . The treatment of imatinib or sunitinib after surgery was less than 1 month.
4. . Incomplete clinical data or follow-up data.
Puppet Show and Storytelling Effect Among Children With Cancer

Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer.

Methods A non-equivalent control group pre-test and post-test, between subjects design was conducted in the Maternity \& Children Hospital Bisha, Al-Namas General Hospital, Kingdom of Saudi Arabia and Suez Canal University Hospital at Egypt. A total of 100 children (ages 3-12) admitted for treatments in this hospital were invited to participate in the study. Of the 100 paediatric patients; 50 received puppet show and storytelling interventions and 50 received usual care.

Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children with cancer. Pediatric nurses play interventions such as puppet show and storytelling have been used to promote oral medication adherence for children with cancer also to help them to overcome their negative emotions during hospitalization

.

Eligibility Criteria:
Inclusion Criteria:

* children with cancer who were diagnosed with the disease
* stay in the hospital for a minimum of three days in a row.
* The children were aged between three and twelve.

Exclusion Criteria:

* Children who were getting palliative care
* weren't enrolled in a comparable program
* those with recognized cognitive
* learning disabilities were not included in our sample
A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.


Eligibility Criteria:
Inclusion Criteria:

* 19\~75 years old, healthy volunteers and renal impairments
* eGFR \>= 60mL/min/1.73m2
* 60 mL/min/1.73m2 \> eGFR \>= 30mL/min/1.73m2
* written informed consent

Exclusion Criteria:

* AST or ALT \> 1.5 \* Upper normal range
* Total bilirubin \> 1.5 \* Upper normal range
* Blood CPK \> 1.5 \* Upper normal range
* Total Cholesterol \>1.5 \* Upper normal range
* Woman who is pregnant or lactating
* Patients who are difficult to participate in cinical trials judged by Investigators
* have participated in other clinical trials within 180 days before IP intake
Oxis 9mcg Turbuhaler Clinical Experience Investigation

The purpose of the investigation is to confirm the ADR development and the contributing factors possibly having an impact on the safety under the post-marketing actual use of Oxis 9 mcg Turbuhaler.

Oxis 9mcg Turbuhaler Clinical Experience Investigation

Eligibility Criteria:
Inclusion Criteria:

- Patients treated with Oxis for the first time due to 'relief of various symptoms associated with airway obstructive disorders of chronic obstructive pulmonary disease (Chronic bronchitis, Pulmonary emphysema), which is the indication of this drug.
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation

Tacrolimus is a standard and widely used maintenance immunosuppressive agent after solid organ transplantation.The purpose of this trial is to determine if dosing of tacrolimus through genetics will help in early attainment and maintenance of the correct dosage level in the early post-transplant period. This pilot dose-finding trial will help to determine a dosing strategy guided by genotypes and age for solid organ transplant recipients that will be further validated through a multi-centre trial as an immediate next step. The study hypothesizes that dosage levels determined through age and genotype will be attained faster and more accurately than the standard dosing procedures in the 14-days after the transplant. Further, this study hypothesizes that a genotype and age dosing strategy will cause a faster recovery (tested through the kidneys' ability to clear creatine from the blood) and result in lower frequencies of adverse effects and rejection of the transplant.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years old
* Assessed and/or listed for heart, kidney, liver transplantation
* Planned oral or enteral maintenance immunosuppression with tacrolimus post transplant
* Informed consent of legal guardian

Exclusion Criteria:

* Contra-indications to oral or enteral tacrolimus
* Co-morbidities that preclude standard dosing e.g. significant renal or hepatic insufficiency
* Participation in other investigational drug trials within 30 days of study initiation
The Effect of Ganglion Sphenopalatine Block Versus Placebo on Persistent Headache Following COVID-19 Infection

The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (SPG block) on persistent headache following acute COVID-19 infection.

Adult patients with persistent headache following COVID-19 infection will be enrolled in the study. The patients will be randomised into three groups; bilateral SPG-block withto receive local anesthetic (lidocaine + ropivacaine), bilateral SPG-block with placebo (isotone NaCl) or bilateral "sham"-block with placebo (isotone NaCl).

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the headache in standing position 30 minutes after block in the group Ropicavain-Lidocain and "sham".

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Moderate to severe headache (NRS \>= 3) with self reported duration of minimum 6 hours during the past week as well as moderate to severe headache (NRS \>= 3) on the day of intervention.
* Onset of headache during or maximum 4 weeks after PCR-verified COVID-19 infection.
* Headache must have persisted for at least 4 weeks following COVID-19 diagnosis.

Exclusion Criteria:

* Patients who cannot cooperate to the study
* Patients who does not understand or speak Danish
* Allergy to the drugs used in the study
* Has taken opioids within 12 hours prior to intervention
* History of migraine or persistent headache before COVID-19 infection.
* Active COVID-19 infection (defined by the Danish Goverment regulations, i.e. 48 hours after last symptoms (omitting long term effects) or 7 days after positive COVID-19 test if no symptoms.
Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis

The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to two different methods of putting needles in their arteriovenous fistula and, 2) if we can adequately coordinate all of the sites to get useful multicentre trial data

To determine the feasibility of 1) randomizing patients to step-ladder versus buttonhole cannulation techniques, and 2) coordinating the multiple Canadian sites that are required for the definitive study.

Secondary Objectives: To determine 1) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced training time for high dose home hemodialysis patients, 2) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced overall cost, 3) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced complications (infection - local and systemic, radiologic/surgical interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm formation, missed insertions), and 4) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced patient discomfort with needling for intensive home hemodialysis patients

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients \> 18 years old,
2. Training for home hemodialysis
3. Able to give informed consent,
4. Arteriovenous fistula 5. Life expectancy of greater than 12 months.

Exclusion Criteria:

1. Potential to be lost from the program within 12 months of training (planned living donor transplant, transfer to peritoneal dialysis (PD) or move from training centre catchment area),
2. Allergy to mupirocin,
3. Short segments or aneurysms within the arteriovenous fistula (AVF) that the attending nephrologist believes require buttonhole cannulation.,
4. Mechanical heart valves,
5. Patients who require intradermal lidocaine for needle insertion -