cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency

Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.


Eligibility Criteria:
Inclusion Criteria:

* Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
* age ≥ 18 years,
* Patient´s written informed consent,
* Ability to comply with the protocol procedures

Exclusion criteria

* Diabetes mellitus,
* Infectious disease with fever at time of investigation,
* Known intolerance to the study drug or constituents oft he study drug,
* Oral contraception,
* Known pregnancy or breast feeding,
* Renal failure (creatinine \> 2.5 ULN)
Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis

Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% \~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin \<1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (\<1 cm) hepatectomy on tumor recurrence.


Eligibility Criteria:
Inclusion Criteria:

* HCC with no preoperative RT
* resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function
* compensated cirrhosis or no cirrhosis; Child-Pugh A
* ECOG Performance Status of 0 or 1.
* Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry

Exclusion Criteria:

* unresectable hepatocellular carcinoma patients
* Hepatocellular carcinoma without portal vein tumor thrombus
* Hepatectomy without narrow margin(more than 1cm)
* presence of distant metastasis
* palliative resection with tumor residual
* non-HCC confirmed by postoperative pathology
Niclosamide in COVID-19

This is a two-part, Phase 2, multicentre, randomized, double blind, 2-arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms


Eligibility Criteria:
Inclusion Criteria:

* Part 1 only: Patients hospitalized with a primary diagnosis of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.

Part 2 only: Patients with a primary diagnosis of COVID-19 with or without pneumonia who are not planned to be hospitalized.

* Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least solid-formed 3 stools per week and no more than 3 solid-formed stools per day.
* SARS-CoV-2 RNA presence in rectal swab (or stool test) ≤2 days before randomization by local or central lab.
* Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment

Exclusion Criteria:

* At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.
* Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.
Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.

Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in CVD risk. The mechanism by which this protective effect occurs is not clearly understood but research has focused on its potential to modulate platelet function. This single-blind, randomized, parallel design human intervention trial will recruit 99 participants to consume an orange flavoured beverage containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over a 5-day period. The study aims is to investigate the effects of consuming different doses of the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato pomace extracts was tested prior starting this study by undertaking a single ascending dose study.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men aged between 18 and 26 years
* BMI \>19.5 and \<26.0
* Platelet aggregation response corresponding to ≥ 65%

Exclusion Criteria:

* Known tomato allergy
* Chronic medical conditions requiring active treatment (e.g. cardiovascular disease, diabetes, asthma)
* Gastro-intestinal disease/disorders
* Smokers
* Medically prescribed medication known to affect platelet function
* Self-prescribed medication known to affect platelet function (e.g. aspirin and non-steroidal anti-inflammatory drugs) unless participant is willing to give up.
* Bleeding disorders (e.g. haemophilia)
* Dietary supplements judged to affect study outcome
* Parallel participation in another research project which involves dietary intervention
* Blood donation within 16 weeks prior to the study
* Depressed or elevated blood pressure measurements (\<90/50 or 95/50 if symptomatic or ≥ 160/100 mmHg)
* Any person related to or living with any member of the study team
Live@Home.Path: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families

This study aims at developing, implementing and evaluating a complex intervention involving Learning, Innovation, Volunteers and Empowerment for home dwelling persons with dementia and their caregivers. The investigators hypothesise that a successfully implemented intervention will reduce caregivers burden and be cost-effective.

The provision of economically viable and proper care for the growing group of home-dwelling people with dementia (PWD) is one of the most pressing issues in our society. While a cure for dementia is not yet available, professionals and policy-makers highly prioritize the support of caregivers who experience a vast burden. However, there is a lack of high-quality research investigating clinical, social and economic factors that may add beneficial effects. This project aims to develop, test, and implement a complex intervention for PWD, intended to reduce caregivers' burden, which will aid PWD to stay safely, longer and independently at home with dignity and cost-effectiveness. The term informal caregivers' burden may include different meanings for different people and be related to economic burden, depression and anxiety, quality of life (QoL), or simply the quality of sleep and recreation. In a stepped wedge, cluster randomized controlled trial, involving primary and secondary health care systems in Bergen, Bærum and Kristiansand the 24-month LIVE@Home.Path study will be undertaken in a stepped wedge design. The user-inspired and tailored intervention includes a designated coordinator to the PWD and caregiver for 6 months to introduce a complex intervention involving a) Learning b) Innovation c) Volunteers and d) Empowerment.

Qualitative interviews will determine users' values and wishes, and promotors and barriers for successful implementation of the intervention. Primary and secondary outcomes on cognitive, emotional and social factors, cost-benefit analyses, and QoL of PWD and families will be assessed every 6-month over 2 years.

Update spring 2020: The COVID-19 pandemic severely hampered the implementation of the intervention for the second group. We therefore had to change the design, postponing the intervention in Bærum and Kristiansand, and delivering the intervention in Bergen by phone. In addition, we initiated the PAN.DEM in the LIVE@Home.Path trial, collecting data from phone interviews with caregivers on change in Health services and neuropsychiatric symptoms, risk perception and restrictions. Changes in design approved by Ethical committee (REK: 10861).

Eligibility Criteria:
Inclusion Criteria:

1. Home-dwelling people with dementia (PWD) equal or above 65 years diagnosed according to national guidelines
2. Mini mental state examination score 15-24
3. Functional Assessment Staging Test (FAST score 4-7)
4. Living with a partner, or have regular contact with a caregiver minimum 1 hour/week

Exclusion Criteria:

1. Participate in other trials
2. Expected survival under 4 weeks
Clinical Significance of circMETTL9 Gene in Traumatic Brain Injury

Objective: The relevance of circMETTL9 to the degree of injury, disturbance of consciousness, cognitive function and prognosis in patients with moderate to severe traumatic brain injury (TBI) remains unknown. The purpose of this study was to investigate the effect of circMETTL9 on the degree of injury, disturbance of consciousness, cognitive function and prognosis after TBI.

1. Collect blood samples from patients with moderate to severe TBI and healthy people, and detect the expression of circMETTL9 by Real-time Quantitative PCR Detecting System(qPCR).Receiver operating characteristic curve (ROC) was used to analyze the sensitivity and specificity of circMETTL9 in TBI patients.
2. Using the Glasgow coma scale (GCS) and the coma recovery scale-revised (CRS-R) to assess the patient's disturbance of consciousness at 1, 3, 7, 14, and 21 days after TBI, respectively, The cognitive function of patients was assessed with the revised Rachel los amigos scale-revised (RLAS-R), and the correlation of circMETTL9 with disturbance of consciousness and cognitive function in TBI patients was analyzed.
3. Six months after TBI, the disability rating scale (DRS) and Glasgow outcome scale-extended (GOSE) were used to evaluate the prognosis of patients six months after discharge, and the correlation between circMETTL9 and prognosis was analyzed. sex.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 80 years old, gender is not limited;
2. Have a clear history of TBI and be diagnosed by head CT, and it is the first episode;
3. Glasgow Coma Scale (GCS) score less than or equal to 12;
4. The condition is relatively stable, and there is no serious chronic disease;
5. Obtain informed consent from patients and (or) their families.

Exclusion Criteria:

1 Combined with severe underlying diseases such as respiratory failure, heart failure, liver and kidney insufficiency; previous stroke, intracranial tumor, intracranial infection, dementia, Alzheimer's disease, Parkinson's disease, endocrine disease, immune and blood system diseases.

2. Patients with pelvic fractures, substantial organ damage, etc., which may seriously affect the treatment effect at the time of injury;
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer

The purpose of the study is to determine the value of FLT-PET early after initiated chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the brain should be performed routinely in these patients.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proven small cell lung cancer
* referred for standard chemotherapy
* oral and written informed consent

Exclusion Criteria:

* metal or electronical devices in the body not compatible with MRI of brain or thorax
* pregnancy or lactation
* communication difficulties
Comparative Effectiveness and Prognostic Factors of Surgical and Non-surgical Management of Lumbar Spinal Stenosis

Introduction: Lumbar spinal stenosis is a common cause of low back and leg pain in elderly impacting physical activity and quality of life. Initial treatments are non-surgical options. If unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery when compared to non-surgical treatment, and the optimal time for surgery is not explicit.

Materials and analysis: This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical treatment in patients with lumbar spinal stenosis, and identify prognostic factors for outcome in the context of current clinical practice. Prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. Primary outcome is change in physical function measured by the Zurich Claudication Questionnaire. Secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life, and general self-efficacy. All outcomes are measured at baseline, 6 months and 12 months follow up. Comparisons on these variables will be made between those who undergo surgery for lumbar spinal stenosis and those not receiving surgery at 12 months follow up according to different analysis populations. Prognostic factors include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pre-treatment function, self-rated health, income, general self-efficacy and magnetic resonance imaging graded compression of central stenosis.

Ethics and dissemination: The study has been evaluated by The Regional Committees on Health Research for Southern Denmark (S-20172000-200) and notified to the Danish Data Protection Agency (17/30636). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences following the guidance from the STROBE and PROGRESS statement. Potential sources of bias will be addressed using ROBINS-I.


Eligibility Criteria:
Inclusion Criteria:

1. \>60 years.
2. ICD-10 diagnosis of degenerative lumbar spinal stenosis registered in the nationwide patient registry between January 1st - December 31st 2017.
3. Included in the SpineData registry.
4. Give consent to use patient-reported data for research purposes

Exclusion Criteria:

-
Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet

There is no consensus on the surgical treatment of unremitting, painful flatfeet in children. Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its biomechanical effects. The goal of the investigators was to compare a group treated with subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening. The investigators hypothesis was that the results of arthroereisis would be equivalent to the more established method of calcaneal lengthening.

The purpose of this prospective, non-randomized study was to evaluate two different surgical treatments for symptomatic planovalgus feet: lateral column lengthening osteotomy and subtalar arthroereisis. The goal of the investigators was to compare the outcomes of these two surgeries and determine whether both treatments resulted in clinical improvement. This was accomplished through the use of pre- and post-operative kinematics, pedobarography, radiographic measurements, and validated outcome measures. The investigators were particularly interested in analyzing the kinematic changes to quantify the changes in the foot mobility and alignment during ambulation, as it has not been previously studied to our knowledge. The investigators hypothesis was that both procedures would show significant improvement and be equivalent in their results.

A prospective trial was conducted. The investigators enrolled fifteen patients (mean age 12.8y, 24 feet) with painful, planovalgus feet refractory to conservative treatment. Seven patients (13 feet) were enrolled in the arthroereisis group, and eight patients (11 feet) were enrolled in the calcaneal lengthening group. Though not specifically excluded, none of the enrolled patients had an underlying neuromuscular diagnosis. Kinematic motion analysis was performed on each patient prior to surgery and at one year of follow-up. Pedobarometry studies, radiographs, and validated outcome questionnaires (Oxford Ankle-Foot Questionnaire for Children) were also performed to evaluate the outcomes of both groups.

Eligibility Criteria:
Inclusion Criteria:

* Planovalgus foot deformity
* Patient normally ambulates without use of assistive devices
* Patient is between the ages of 7 and 17 at the initial evaluation

Exclusion Criteria:

* Hip flexion contractures greater than 15 deg.
* Knee flexion contractures greater than 10 deg.
* Ankle dorsiflexion less than 0 deg. (plantarflexion contracture)
* Taking medication which effects motor control
* Inability to follow instructions to perform study
A Study to Compare Two Rehabilitation Protocols for Knee Osteoarthritis

The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).

Participants will be divided as follows:

Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.


Eligibility Criteria:
Inclusion Criteria:

* Age included between 45 and 80 years old
* Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
* Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
* Informed Consent as documented by signature

Exclusion Criteria:

* Younger than 44 years old or older than 81 years old included
* Known drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Participation in another study with an investigational drug within the 30 days preceding and during the present study
* Treatment with an injective approach in the previous 3 month
* Surgical treatment in the previous 12 months.
Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal Cell Carcinoma Receiving A Tyrosine Kinase Inhibitor as First-Line Treatment

The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigue and hand-foot syndrome, with personal inter-variability, and to explore measures that can be taken in terms of both everyday lifestyle and treatment to mitigate or cure such side effects that affect patients.

Prospective, multicentre, observational study in patients with metastatic renal cell carcinoma (mRCC) receiving a tyrosine kinase inhibitor as first-line treatment according to routine clinical practice, designed to evaluate the incidence of fatigue and hand-foot syndrome in order to determine how these affect the baseline characteristics of the patient and his/her disease (age, gender, baseline status, tumour histology, etc.) and the patient's lifestyle as such side effects develop.

An exploratory analysis will be performed of measures that clinicians may adopt to improve patients' quality of life with regards to daytime naps, medication administration time, off-treatment periods, dose reductions and treatment breaks.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old and diagnosed with metastatic RCC who, in the investigator's opinion, are candidates for starting first-line treatment with a tyrosine kinase inhibitor according to routine clinical practice.
* Patients who have no contraindications to the treatment.
* Baseline ECOG ≤ 2.
* Patients who are able to give informed consent on their own without the need for a legal representative.
* Committed patients who are able to complete the quality of life questionnaires and patient diary on their own without the need for a legal representative.

Exclusion Criteria:

* Patients who are not candidates for first-line treatment with a tyrosine kinase inhibitor.
* Patients who are receiving the treatment as second-line or subsequent therapy.
* Untreated hypothyroidism.
* Untreated severe anaemia.
* Pregnancy or breast-feeding.
* Myocardial infarction or cerebrovascular accidents (CVA) within the last 6 months.
* Severe hepatic impairment.
* Concomitant use of potent inhibitors or inducers that interact with hepatic cytochrome CYP3A4.