cyrilzakka/clinical-trials huggingface dataset:
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

This trial is conducted in Asia. The aim of this clinical trial is to investigate the bioequivalence of repaglinide and metformin combination tablet versus repaglinide and metformin as coadministered tablets after meal.

The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic trial where the trial participant is randomised to one of six possible treatment periods (Williams design). The trial participant will receive one single dose of each trial product in varying order.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign informed consent before initiating any trial related procedures
* BMI: 19.0-25.0 kg/m2
* Fasting plasma glucose: 3.9-6.1 mmol/L
* Trial participant is judged to be in good health on the basis of their medical history, physical examination, ECG, and routine laboratory data

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease
* Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
* Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens that cannot be stopped at least two weeks prior to start of treatment and for the duration of the trial
* Currently a smoker (more than one cigarette per day or equivalent)
* Use of grapefruit or grapefruit juice within 7 days of trial product dose administration
* Blood donation, surgery or trauma with significant blood loss (400 mL) within the last 2 months prior to trial product dose administration
* Recent history (within the last 2 years) of drug or alcohol abuse
* Known or suspected allergy to trial product or any of the excipients or a history of multiple and/or severe allergies to drugs or foods or of severe anaphylactic reactions
* Subject has taken an investigational drug in another clinical trial within the last 4 weeks.
* Recent history (within the last 3 month) of nausea, diarrhea or gastrointestinal complaints
* History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose additional risk in administering trial product to the trial participant
Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

This study aims to improve the peri- and postoperative care regimen for patients undergoing microvascular reconstruction after head and neck cancer by introducing an enhanced recovery after surgery (ERAS) programme.

Advanced stage head and neck cancers have a poor prognosis and a 5-year survival rate of as low as 35-37%. The treatment is complex and often requires a multidisciplinary approach including surgery. The goal besides removal of the cancer is to restore function and appearance. If possible, both resection as well as immediate reconstruction will be performed during the same surgical procedure. Due to the large bone- and soft tissue loss following the ablative procedure, local solutions are often inadequate for reconstruction. In addition, many patients require post-operative radiotherapy, which may result in tightness of scar tissue and impaired function. In these cases it is necessary to perform the reconstruction using a free flap.

Free flap reconstruction involves tissue taken from other parts of the body, that is transplanted along with the associated blood vessels to the reconstruction site. The vessels of the flap are usually anastomosed to the vessels of the neck (microvascular reconstruction) and the transplanted tissue thereby obtains a blood supply at its new location. Head and neck cancer patients are usually reconstructed using the free fibular flap, the latissimus dorsi flap, the radial forearm flap or the anterolateral thigh flap.

The combination of complicated surgery and often malnourished patients with a low body mass index (BMI), that typically suffer from tobacco and alcohol abuse, commonly lead to postoperative ICU treatment and complications. The most common are infections, re-operations, delayed wound healing and refeeding syndrome, which is reported in up to 35% of patients undergoing major surgery for head and neck cancer.

Even with successful reconstruction, many patients suffer from drooling, lack of adequate clenching, permanent gastric tube feeding, insufficient wound healing and a high recurrence rate. Enhanced recovery after surgery (ERAS) is a peri- and postoperative care concept designed to accelerate recovery and improve convalescence. It has previously been established as superior to conventional care for a wide variety of procedures. As one of the first departments in the world our department has successfully implemented an ERAS program for microsurgical patients that undergo breast reconstruction using autologous tissue. By utilizing our experience with ERAS and combining it with a review of our own patient data we have developed an ERAS protocol for microvascular reconstruction after ablative surgery for head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for ablative surgery for head and neck cancer with primary microvascular reconstruction.

Exclusion Criteria:

* Patients with conditions leading to increased risk of thromboembolic events
* Patients pre-operatively admitted to the ICU
Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden

Evaluation of the effects of the parental support intervention "For our children's sake" on positive parenting outcomes when conducted with incarcerated parents in prisons in Sweden.

Children of incarcerated parents comprise a greatly disadvantaged group in society with elevated risk of ill-health, behavioural problems, and own delinquency and unemployment later in life. Positive parenting comprise an important factor for children's positive and healthy development. Incarcerated parents may have difficulties to engage in positive parenting due to disadvantaged situations affecting parenting negatively such as drug addiction, poverty, or lack of experience of positive parenting in their own childhood. Previous research has suggested that interventions to prevent the intergenerational effect of criminality should be targeting family factors where positive parenting has been emphasised. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes such as positive parent-child interaction, parenting knowledge, empathy, parent stress, increased child contact and active parenting, However, the majority of the programmes evaluated to date have been conducted in the US, with a prison and probation context with limited generalisability to the Swedish system. In Sweden, the parenting programme for incarcerated parents, "For our children's' sake" (FOCS) was developed in 2012-2014 with the aim to support positive parenting for the child's healthy development and is currently delivered in Swedish prisons. The aim of this project is to evaluate the effects of the FOCS parenting programme on parenting outcomes through a controlled trial with a parallel implementation process evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Serving a sentence at any of the included prisons
* Having at least one child in the ages between 0-18 years. Parents of children aged 0-2 and 13-18 years will not be included in the primary outcome measure, as the measure is not developed for these age groups. These parents will be included in the mediator measurements.
* Are in contact with their child/children in any form. If not, these parents are included in the mediator measurements, as the primary outcome: relationship quality, is not applicable.
* Having the legal right to contact the child
* Not committed either a crime against the child or any violent crime against the other parent

Exclusion Criteria:

* Not fulfilling inclusion criteria
Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)

Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order to reduce blood pressure. It is not known if the body compensates over time to the blood pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a faster rate and is higher than it was at the start of the treatment. This study will answer these questions.

This is a phase 2, multicenter, randomized, double-blind placebo-controlled, parallel group study to determine the persistence of the effect of SNP on blood pressure and to assess the potential for rebound hypertension associated with prolonged infusion in pediatric subjects.

The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is less than 17 years of age.
2. An in-dwelling arterial line is clinically indicated.
3. Subject's parent or legal guardian is willing and able to give informed parental permission signing and dating an IRB-approved informed parental permission containing all of the elements of informed consent, and subject provides assent, signing an IRB-approved and -required informed assent, if applicable.
4. Subject is anticipated to require a minimum of 20 mm Hg (15 mm Hg for subjects \< 2 years old) reduction in MAP for at least 12 hours using SNP \[i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects \< 2 years old)\]

Exclusion criteria:

1. Subject weighs \< 3.0 kg.
2. Subject has a known allergy to SNP.
3. Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes.
4. Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or in the intensive care unit.
5. Subject has raised intracranial pressure.
6. Subject is anticipated to need anti-hypertensive drugs other than Sodium Nitroprusside either IV (e.g. dexmedetomidine, esmolol, etc.) or epidural (e.g.local anesthetics, clonidine, etc.) within three terminal half-lives (3X T½ β) of the blinded study drug period. However, patients receiving stable doses of an anti-hypertensive drug(s) prior to the initiation of study drug may be enrolled.
7. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures.
8. Subject is moribund (death likely to occur within 48 hours).
9. Subject has a positive result for the urine or serum HCG test administered at screening.
10. Subject has participated in other clinical trials for investigational drugs within 30 days prior to enrollment
11. Subject has received or will have received Sodium Thiosulfate within 6 hours prior to the start of the open-label period.
12. Subject is either on, or anticipated to be on, ECMO.
Study of Different Gating Techniques for PET Image of Lung and Liver Lesions

Lesions blurred by respiratory motion are common in fluorine-18 PET/CT studies. To avoid these artefacts, several standard gating correction technics are available. the investigator aimed to compare the impact of different gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device on standardized uptake value (SUVmax and SUVpeak) and uptake volume (UV) measurements on different sizes of pulmonary and liver lesions. The feasability of this study will be done using anthropomorphic coupled with a motion phantom and on a series of patients.

PET-CT images will be acquired on a Biograph Vision600 PET/CT, fitted with 26cm axial field of view and time of flight.

Phantom study will use an anthropomorphic TORSO phantom with a programmable motion phantom, mimicking respiratory motion (QUASAR). Spheres with various internal diameters will be introduce into the lungs (air density) adding an axial mechanical device simulating breathing movement of +/-20mm. Concentration in the spheres will be the same for all diameters. The background and liver activities will be approximatively respectively 38 and 14 MBq. This phantom will be a simulating patient only for lung lesions.

The investigator will compare 6 different PET acquisitions: standard 3min acquisition without movement as our reference of "trues SUVmax and UV", 3min acquisition with simulated breathing movement without any gating and 3min with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.

Patient study will be on 50 consecutive patients with lung or liver nodules. 18F-FDG injection will be around 2.5 MBq/kg.

The investigator will compare 5 different PET acquisitions: standard acquisition with free respiratory movement as our reference of "trues SUVmax and UV", acquisitions with respectively gating techniques based on phase, amplitude, elastic-motion monitored with and without pressurre sensor device.

Eligibility Criteria:
Inclusion Criteria:

* presence at least of one hepatic or lung nodule

Exclusion Criteria:

* none
TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC

According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Child-Pugh score≤ 7
* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
* the primary HCC being in BCLC C stage according to NCCN guideline
* No previous systemic therapy for HCC

Exclusion Criteria:

* Diffuse HCC
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy
Video-Interpreting in Prehospital Emergency Medicine - Feasibility Study

50 responsive patients with language barriers will be included in this study. The prehospital emergency physician will start video-interpreting via a tablet. Feasibility, quality of communication, usability as well as changes in diagnosis and treatment will be gathered and analysed.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, at least 18 years old
* awake, responsive patients
* language barrier (Albanian, Dari, Romanian, Turkish, Modern Standard Arabic, Arabic, Farsi, Russian, Hungarian, Bosnian-Croatian-Serbian, Kurdish (Kurmanci), Slovakian, Bulgarian, Polish, and Czech)

Exclusion Criteria:

* unconscious patients
* out-of-hospital cardiac arrest patients
* delay of treatment or transportation due to e-interpreting
* refusal of video-interpreting by the patient
A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours

This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will be assessed when administered alone and in combination with repeated doses of capivasertib.

This is 2 part study: Part A and Part B. Part A of the study consists of a screening period and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam + capivasertib). During Part A, the PK profile of midazolam will be determined with and without capivasertib.All participants will receive capivasertib treatment (4 days on/3 days off); however, at the Investigator's discretion, ER positive breast cancer patients may also receive fulvestrant in addition to capivasertib and midazolam. Participants completing Part A without disease progression or unacceptable toxicity, who are considered likely to continue to benefit from further capivasertib treatment (with or without certain standard of care treatment) in the opinion of the Investigator will enter Part B. Part B of the study consists of an extended treatment period with capivasertib, with or without certain standard of care treatment, followed by a 30-day safety follow-up.

Part A of the study may be extended to allow the administration of midazolam on a rescheduled Cycle 1 Day 8(C1D8) and Cycle 1 Day 12(C1D12 ) visit.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with documented evidence of locally advanced inoperable or metastatic solid tumours who may be suitable to receive capivasertib treatment.
2. Eastern Cooperative Oncology Group/World Health Organization performance status 0 to 1 and with minimum life expectancy for 12 weeks.
3. Participant should have at least one lesion that can be assessed by computed tomography/magnetic resonance imaging or plain X-ray at baseline.
4. Body mass index within the range 18 to 32 kg/m\^2

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Radiotherapy with a wide field of radiation within 4 weeks of the first dose of capivasertib and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study intervention initiation.
2. Participants with diabetes mellitus type I or participants with diabetes mellitus type II requiring insulin treatment.
3. Undergone a major surgery within 4 weeks of the first dose of capivasertib.
4. Any unresolved toxicities from prior therapies higher than CTCAE grade 2 or any unresolved toxicity that may interfere with PK assessment at the time of study intervention initiation.
5. Participants with spinal cord compression or brain metastases.
6. Participants with severe or uncontrolled systemic diseases, active bleeding diatheses, or active infection.
7. Previous allogeneic bone marrow transplant or solid organ transplant.
8. Known immunodeficiency syndrome.
Early Mobilization in Older Adults With Acute Cardiovascular Disease

The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.

The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic EM program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. Nested cohort studies will explore (1) the relationship between EM, sedentary time, and posthospitalization outcomes and (2) the impact of EM on muscle mass loss and inflammation in older adults with acute CV disease.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* no planned cardiac surgery during admission

Exclusion Criteria:

* projected cardiac ICU stays less than 24 hours
* patients unable to complete follow-up
Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study

The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty without any of the disorders under study (controls) will be evaluated. All subjects will be comprehensively assessed with structured diagnostic interviews and neuropsychological testing. All EEG analyses will be conducted under blind conditions. Conditional probability and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of the EEG scan, using the clinical diagnosis of ASD as the gold standard.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 6 and 17 years of age.
* Right handedness.
* Fulfills DSM-IV-TR diagnostic criteria for ADHD, bipolar disorder (BPD I, II, or NOS), or ASD (autistic disorder, Asperger's disorder, or PDD-NOS) as established by clinical diagnostic interview and supported by K-SADS-E module for respective diagnoses.
* Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
* Subjects and their legal representative must be considered reliable.
* Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.

Exclusion Criteria:

* Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
* I.Q. \< 85
* History of active seizure disorder (as suggested by EEG suggestive of seizure activity and/or history of seizure in last 1 month)
* Pregnant or nursing females.
* Subjects with a medical condition that will either jeopardize subject safety or affect the scientific merit of the study, including:
* Organic brain disorders
* Uncorrected hypothyroidism or hyperthyroidism
* Renal or hepatic impairment.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
* Current diagnosis of schizophrenia
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
* Significant sensory deficits such as deafness or blindness.
Kidney Disease After COVID-19

To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.


Eligibility Criteria:
Criteria:

Inclusion Criteria:

* Adults, age ≥18 years
* Confirmed diagnosis of COVID-19

Exclusion Criteria:

• No confirmed diagnosis of COVID-19