cyrilzakka/clinical-trials huggingface dataset:
Liver Adiposity Effects on Pediatric Statin

Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin


Eligibility Criteria:
Inclusion Criteria:

* 8-21 years
* LDL cholesterol \>130mg/dl (\>95% percentile)
* SLCO1B1 c.521TT genotype
* Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
* Fasting overnight (\~8 hrs.)
* Enrolled in Cardiology Pharmacogenomic Repository

Exclusion Criteria:

* Pregnancy
* Non-fasting
* Non-removable metal in body or MRI unsafe
* Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study.
* Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease.
* History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance)
* Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \*
* Inability to swallow a tablet
* \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin
* Diarrhea in the last 24 hours
* Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)
Continuous Glucose Monitoring in Critically Ill Patients

The purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

Hyperglycemia is is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses.

Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Eligibility Criteria:
Inclusion Criteria:

* Admitted patients expected to stay \>48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.

Exclusion Criteria:

* Admitted patients expected to stay \<48h
QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding

QuikClot Control+ Hemostatic Dressing (QuikClot+) is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV Bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries. QuikClot Control+ is also indicated for temporary control of mild to moderate bleeding in cardiac surgical procedures. QuikClot Control+ is also indicated for use to control bleeding from bone surface following sternotomy.


Eligibility Criteria:
Inclusion Criteria:

* Age range greater than or equal to 18 years old
* Willing and able to give prior written informed consent
* Requiring cardiac surgery

Exclusion Criteria:

* Subject undergoing emergency surgery for any reason
* Subject has active or potential infection at the surgical site or endocarditis
* eGFR less that lo mL per minute
* Subject who is currently participating in an investigational drug or another device trial (excluding registries)
* Leucopenia (WBC \< 3.5x 103/µL), or acute anemia (Hgb \< 10.0 mg/dL or 6 mmol/L), or thrombocytopenia (platelet count \< 50x 103/µL), or history of bleeding diathesis or coagulopathy, or HIT positive
* Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
* Active illicit drug use, verbally confirmed with the patient
* Severe Liver dysfunction confirmed via Child-Pugh of B-C or MELD \> 10
* Female who is pregnant at screening. Confirmation by urine or serum pregnancy test
* Incarcerated or unable to give voluntary informed consent
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing orthotopic liver or split liver allograft transplantation
* Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study

Exclusion Criteria:

* Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
* Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
* Receiving ABO incompatible graft or a graft from a non heart beating donor
* Ongoing dosing with systemic corticosteroids
* Subjects with systemic infection requiring treatment except viral hepatitis
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:

  * \< 3 nodes
  * no node larger than 5 cm
  * no metastases
  * no vascular tumoral invasion
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
* Pregnant woman or breast-feeding mother
* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Unlikely to comply with the Visits scheduled in the protocol
* Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
* Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Ready to Act - Health Education in People With Hyperglycaemia

A pre-randomized study in primary health care was designed to investigate health education in a subpopulation extracted from general practitioners (GPs) in one Danish county in the treatment arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care) study, DK. The overall objective of the 'Ready to Act' health education programme was to support the participants' competences in daily life and act appropriately with respect to their dysglycaemic condition. The achievement of action competence involved four learning objectives: intrinsic motivation, informed decision-making, action experience and social involvement. The programme was delivered in primary care settings (health centre or GP surgeries) by nurses, dieticians, physiotherapists and GPs.


Eligibility Criteria:
Inclusion Criteria:

* age 40-69 years at the time of screening and diagnosed with screen-detected T2D, IGT or IFG (according to WHO criteria).

Exclusion Criteria:

* women who were pregnant or lactating, those with a psychotic illness or an illness with a prognosis of less than one year.
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.

The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
* Patients who have overall good general conditions.
* Patients who have at least one lesion that can be accurately assessed by imaging.
* Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
* Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.

Exclusion Criteria:

* Patients with brain metastases or spinal cord compression.
* Patients with significant abnormal ECG findings.
* Patients with evidence of severe or uncontrolled systemic disease.
* The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
* Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.

Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.

Patients with histologically or cytologically confirmed advanced solid malignancies.
Evaluation of MPM Prepared From Allogenic Bone Graft in Alveolar Cleft Closure: A Prospective Randomized Clinical Trial

The aim of this trial is to figure out the efficiency of Mineralized Plasmatic Matrix prepared from allogenic bone graft on cleft alveolus and oro-nasal fistula closure, adequate bone volume and acceptable density at the site of grafting.MPM might improve the physiological properties of allogenic bone graft and facilitate its handling and application during surgical grafting.This might decrease the need of the second surgical site for harvesting autogenous bone to be grafted with its all complications and hurdles.This trial will help the practitioners in taking the decision of using the MPM prepared from allogenic bone in alveolar cleft closure or not.

Alveolar bone grafting will be performed at 6 to 12 years of age as following :

Group (A):Will undergo grafting with anterior iliac crest bone,(Control group). Group (B):Will undergo grafting with Mineralized Plasmatic Matrix prepared from allogenic bone graft (study group).

In all patients, this will be the first bone graft to be placed in the alveolar cleft. All patients will be monitored clinically and radiographically (by cone beam C.T) for up to 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral alveolar cleft patients

Exclusion Criteria:

* patients with previous failed alveolar cleft grafting procedure.
Refractive Transepithelial Photo-keratectomy (T-PKR) in High Myopia

The aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (T-PRK) without the addition of mitomycin-C for the treatment of high myopia of 6 diopters or more.

In this retrospective study, 69 high myopic eyes of 6 diopters or more were treated in 38 patients by Trans-PRK with the SCHWIND Amaris 500E® excimer laser platform without the use of mitomycin-C. Several outcomes are measured in treated patients, such as postoperative uncorrected visual acuity (UCVA), best spectacle corrected visual acuity (BSCVA), efficacy, safety and predictability of the procedure, as well as corneal haze measurement. The patients are followed-up for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* myopic sphere of -6 diopters or more,
* astigmatism less than 3 diopters,
* stable myopia not progressing for more than one year

Exclusion Criteria:

* age \<18 years,
* myopic sphere less than -6 diopters,
* astigmatism greater than 3 diopters,
* progressive myopia (variation of more than 0.5 diopters over one year),
* abnormal corneal topography or the presence of manifest keratoconus,
* pre-existing eye pathology,
* history of eye surgery,
* active inflammatory or infectious eye disease,
* dermatological disease or systemic connectivitis
Using Generalized Estimating Equation Analysis in a Study of Relaxation Training in Patients With Insomnia.

Background: The purpose of this study was to examine the improvement in insomnia patients using Relaxation Training, and to use the Generalized Estimating Equation model (GEE-I) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration.

Methods: There were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. Of the 24 subjects, 7 accepted the sleep electroencephalogram (EEG). Relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.

Of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.The patients were asked to keep a sleep diary. In the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. Patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.The patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the D Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria.

Exclusion Criteria:

* Patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

This is a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).


Eligibility Criteria:
Inclusion Criteria:

* Signing of the trial specific informed consent
* Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 DXA scan
* Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above

Exclusion Criteria:

* Diabetes mellitus if any of the following are met:

  1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 in trial TCH-306
  2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
* Active malignant disease or history of malignancy. Exceptions are:

  1. Resection of in situ carcinoma of the cervix uteri
  2. Complete eradication of squamous cell or basal cell carcinoma of the skin
* Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
* Female who is pregnant, plans to become pregnant, or is breastfeeding
* Female participant of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/section 10.4 of the protocol
* Male participant not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/ section 10.4 of the protocol
* Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures
Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. The investigators propose a 3D ultrasound device that will provide real-time imaging for the brachytherapy procedure which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

This is an efficacy study to optimize the use of three-dimensional ultrasound imaging for interstitial and intracavitary brachytherapy. In this study, 3DUS images will be acquired during the regular clinical procedure to assess the quality of the images, anatomical detail and location of needles. The acquired images will be analyzed post-treatment and fused with pre-treatment MRI, and post-treatment CT scans to develop a virtual simulated radiation treatment plan, and to verify the applicator positions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas

Exclusion Criteria:

* Above patients who are not offered interstitial or intracavitary brachytherapy as a treatment modality
Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness

Social cognition dysfunction (including emotional perception, theory of mind, and attribution bias) is a common dysfunction in serious mental illness, which may influence their life roles and daily functions. The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness.Thus this study aims to conduct SCIT groups in Taiwan to investigate its feasibility and effectiveness.

This study will include 30 clients. Investigators will randomly allot participants into two group, and conduct a crossover design. The experimental group will receive a 60-minutes manual-guide SCIT session each week for 20 times, which will be leaded by 2 licensed occupational therapists. After the intervention, investigators will analyze demographic data and compare the difference between experimental group and control group on the social cognition performance.

Social cognition dysfunction (including emotional perception, theory of mind, and attribution bias) is a common dysfunction in serious mental illness, which may influence their life roles and daily functions. The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness. There have been evidences showing that the SCIT could improve emotional perception, theory of mind, attribution bias, and social relationship. However, there are no SCIT studies in Taiwan yet. Thus this study aims to conduct SCIT groups in Taiwan to investigate its feasibility and effectiveness.

This study will include 30 clients from a day care ward and community rehabilitation center, excluding clients with acute onset, brain injury, intellectual disability and substance abuse. The investigators will randomly allot participants into two group, and conduct a crossover design. Before and after the intervention protocol, both group receive evaluations of clinical symptoms, emotional perception, theory of mind, and attributional bias. The experimental group will receive a 60-minutes manual-guide SCIT session each week for 20 times, which will be leaded by 2 licensed occupational therapists. There are three main themes of the SCIT: 1) introduction and emotion, 2) figuring out situation and 3) integration: checking it out. After each theme of the intervention, participants will fill out a satisfaction survey. And a senior occupational therapist will observe the group and rate the fidelity of the group. The control group will receive treatment as usual.

After the intervention, the investigators will analyze demographic data and compare the difference between experimental group and control group on the social cognition performance.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mental illness

Exclusion Criteria:

* acute hospitalization within the past two months
* other diseases that may affect cognitive function, such as intellectual disability, substance abuse
Comparative Performance of PureVision, Acuvue Oasys and O2Optix

The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is myopic
* VA correctable to 0.3 LogMAR or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* Wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings