cyrilzakka/clinical-trials huggingface dataset:
Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope

The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years
2. American society of Anesthesiology (ASA) score 1 and 2
3. Renal or upper ureteral stone of diameter ≤ 2.0 cm

Exclusion Criteria:

1. Ureteral stricture, renal or ureteral deformity
2. Pregnancy
3. Patients with chronic kidney disease, CKD (serum creatine\> 177 umol/L)
Predictability of Gestational Diabetes Mellitus in First and Second Trimester

The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels.

The primary outcome will be development of gestational diabetes mellitus in the second or third trimester.

The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton pregnancies
* Women at least 18 years old and not under guardianship

Exclusion Criteria:

* Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus
* Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment
* Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities
POINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain

The investigators do research on chronic pain treatment to minimize the risks associated with opioids.

The investigators know that patients suffering from chronic pain need good treatment. The use of opioids for chronic, non-cancer related pain may seem appropriate in the short term, but can often have negative consequences for both the individual and society in the long term.

Several factors-the escalating use of opioids to chronic pain patients, the increasing use of strong opioids in particular, and the increasing number of overdoses caused by prescription opioids-point to the start of an opioid epidemic in Norway.

Objectives The overall goal of the POINT project is to provide knowledge to optimize treatment of patients with chronic pain in order to avoid unnecessary escalation of opioid treatment, improve their quality of life and reduce the burden of disease.

In the long run our objective is to prevent the unwanted consequences of opioid treatment and improve patients' quality of life.

Ultimately, through this project the investigators hope to prevent an opioid epidemic in Norway.

To achieve the main goal, the investigators will focus on pain patients and their doctors, as increasing opioid use may occur through the patient-doctor interaction.

Methods

The project will develop and test a non-drug interventions that consist of an interdisciplinary group treatment .

Financing The Research Council of Norway

Cooperation St. Olavs Hospital

Stavanger Hospital Trust

City of Stavanger

National Institute of Public Health (FHI)

Alcohol and Drug Research Western Norway (KoRFor)

Foreningen for kroniske smertepasienter (FKS) Norwegian Forum of Disabled Peoples' Organizations (SAFO)

Cooperation with other projects Injury Prevention and Outcomes following Trauma

Eligibility Criteria:
Inclusion Criteria:

* non-malignant, chronic pain
* Registered in Stavanger municipality
* Consent to participation.
* Age 18 - 67 years
* Pain duration \<10 years

Exclusion Criteria:

* malignant pain condition
Human Irisin Concentration in Sarcopenia

Irisin has been identified as a novel myokine that drives brown-fat-like conversion of white adipose tissue. In this cross-sectional study, the researches investigated whether serum irisin levels are decreased in patients with sarcopenia compared with control subjects with normal muscle mass, and assessed the association between serum irisin levels and various metabolic parameters.


Eligibility Criteria:
Inclusion Criteria:

* 20\<age\<80
* apparently healthy subjects

Exclusion Criteria:

* a history of cardiovascular disease
* diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease
Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.

A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,

Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.

Eligibility Criteria:
Inclusion criteria:

1. Age 18-75 years.
2. Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon.
3. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37)
4. Duration of symptoms must be at least 12 months.
5. An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion.
6. Conventional Physical Therapy must have been tried at least three months without positive effects on symptoms from affected foot.

Exclusion criteria:

1. Previously undergone surgery for plantar fasciitis.
2. Patients with severe talocrural pathology or serious malalignment of foot and ankle
3. Severely reduced peripheral circulation or chronic ulcerations of the foot
4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
5. Patients with a contraindication/non-compliance for MRI examination.
6. Unable to walk without aid.
7. Not able to read and/or speak a Scandinavian language or English adequately.
Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease

The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.


Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* clinical diagnosis of CKD
* signed informed consent

Exclusion Criteria:

* End-stage renal disease(ESRD) or dialysis
* Acute kidney injure(AKI)
* history of solid organ or bone marrow transplantation
* active malignancy within 24 months prior to screening or metastatic cancer
* HIV infection or AIDS
* acute inflammation
Inspiratory Muscle Training in Wheelchair Basketball Players

Investigate the effects of Inspiratory Muscle Training on the physical performance and cardiorespiratory variables of wheelchair basketball players.

The respiratory system has been touted as a limiting factor of physical performance during high intense physical exercises. This limitation is related, among other things, with the fatigue of respiratory muscles. The fatigue of these muscles during physical exercise generates many physiological reflex activation culminating in reduced blood flow to the limb muscles, resulting in decrease in muscle performance. Researchers showed that the inspiratory muscle training (IMT) is able to generate improved of athlete's physical performance. However, when it comes to wheelchair athletes there are still divergent views on the effects of IMT on the physical performance. Thus, this study aims to evaluate the effects of IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players. For this purpose, the investigators will select 40 wheelchair basketball players of both genders. The participants will be allocated blindly and randomly into two groups that differ by the proposed interventions. In IMT Group, the participants will be submitted to a IMT program with inicial load of 50% of maximal inspiratory pressure (MIP); the SHAM Group will be submitted to a simulated IMT with load of 15% of MIP. All participants will pass through the same evaluation procedures before and after the interventions, so that the investagators can evaluate the benefits generated by the IMT on the physical performance and cardiorespiratory variables of wheelchair basketball players.

Eligibility Criteria:
Inclusion Criteria:

* training wheelchair basketball for more than one year.

Exclusion Criteria:

* cardiovascular or respiratory disease.
* motor or cognitive impairments that influencing the results of evaluations.
* smoking.
Impact of Pandemic of Presentation to Emergency Department and Admissions

Observational study assessing the impact of the COVID-19 pandemic on presentations and admission to hospital in children and young adults.

The COVID-19 pandemic has had a major impact on healthcare utilisation and delivery for children and young adults. This is despite these groups experiencing minimal morbidity and almost no mortality as a direct result of the pandemic. The immediate impact of the first lockdown in April 2020 has been well documented. A number of studies show a marked reduction in presentations of children and young adults to the emergency department.

The question is now, are these trends continuing and are they particularly impacting on specific groups and on specific presentations? With these data, services can be modified to minimise any potential for deleterious effects. It may also be possible to target groups who are not utilising health services as the investigators would expect.

The investigators will use fully anonymised routine data on presentations and admission of 0 to 24 years olds to University Hospital Southampton NHS Foundation Trust. Data will be graphed to show trends in activity before and after the start of the pandemic. An interrupted time series regression analysis will be used to assess the significance of any changes in trends.

Eligibility Criteria:
Inclusion Criteria:

* Children and young adults aged 0 to 24 years
* Presented +/- admitted to the emergency department at University Hospital Southampton NHS Foundation Trust between the 1st of April 2016 and 31st of March 2021

Exclusion Criteria: None
Relational Agents in Cervical Cancer Education (RACE)

The goal of this clinical trial is to assess the feasibility of using interactive teaching to educate cervical cancer patients about Human papillomavirus (HPV) and HPV vaccinations.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and older
* Patients with an ICD9 diagnosis of cervical/vaginal/vulvar cancer or dysplasia receiving care at Karmanos Cancer Institute or OU Health Stephenson Cancer Center

Exclusion Criteria:

* Patients who are recorded in the EHR as requesting to be removed from research
* Non-English speakers
* Any cognitive disability that prevents informed consent
* Any individual recruited in previous phases of the Study will be excluded.
Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis

The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:

• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.

A crossover design is used to compare treatments with or without the BioLogic Fusion function activated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥18 years of age
* Chronic bicarbonate standard high-flux haemodialysis or hemodiafiltration for at least 3 months
* Dialysis frequency 3 x per week
* Dialysis duration per session ≥ 4h
* Patient on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes
* No residual renal function (definition: ≤100 ml urine/day)
* Stable dry body weight for at least 4 weeks
* Subjects who are willing to give a voluntary consent to participate in the study

Exclusion Criteria:

* Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
* Vascular access insufficiency (mean blood flow \<200ml/min)
* Patients treated with dialysis profiles: sodium profile, Ultrafiltration (UF) profile, and temperature profile
* Use of the BioLogic fusion function during the last 9 dialysis sessions recorded at the site (retrospective screening period)
* Pregnant or nursing women. Women of childbearing potential must agree to avoid pregnancy during the study period
* Factors which may interfere with full participation in the trial
* Any contra-indication to haemodialysis treatment per se, as described in the Instructions for Use (IFU)
* Any serious medical condition or disability, which in the opinion of the investigator limits the life expectancy and would preclude completion of the study
C-peptide Concentrations in Type 2 Diabetes Treated With Insulin; is it Time to Revise the Treatment of Type 2 Diabetes

C-peptide is used to evaluate beta cell reserves. Patients with type 2 diabetes are treated with insulin for different indications. Other than beta-cell insufficiency and organ failures, insulin treatment is needed for a specified period. The investigators want to evaluate beta cell reserves in patients with type 2 diabetes treated with insulin for at least six months to see if that is the case. The investigators also want to compare the characteristics of these patients according to their beta cell reserves.

In patients with type 2 diabetes, initiation of insulin therapy is indicated in several conditions such as severe insulin resistance, acute metabolic decompensations, surgery, pregnancy, and progression of diabetic complications, and also when glycemic control cannot be achieved with effective lifestyle regulation and non-insulin antidiabetic medications. Some of these indications are transient, and patients should be reassessed to choose the appropriate treatment options. Clinical inertia is one of the new topics expressed in the recent diabetes guidelines. The investigators aimed to investigate the beta cell reserves of the patients with type 2 diabetes who are treated with insulin, to see if they have insufficient insulin secretion and if not, to compare their characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes who had been treated with insulin as a monotherapy or as a component of combination therapy for at least 6 months.

Exclusion Criteria:

* Diagnosis of other types of diabetes,
* end-stage renal failure,
* history of renal transplantation,
* diabetic acute metabolic decompensation,
* decompensated heart failure,
* advanced liver disease,
* pregnancy,
* acute or chronic pancreatitis,
* pancreatic carcinoma,
* acute infections,
* use of medications that might affect glucose regulation (e.g. corticosteroids)
Effectiveness of the Supportive and Palliative Care Review Kit (SPARK) for Cancer Patients in the Acute Hospital

Introduction

There is a rising need for palliative care services in Singapore due to a rapidly ageing population and an increasing incidence of cancer. Current existing resources are inadequate - novel models of care are needed to expand access to palliative care without requiring significantly more specialist palliative care manpower.

Oncologist-driven referrals to a palliative care consultation service is the norm worldwide, including Singapore. This results in variable access to palliative care due to differences in referral practices. Palliative care involvement is also often delayed. In this study, the investigators propose to test Supportive and Palliative care Review Kit (SPARK) - a novel integrated model of care in which the palliative care team co-rounds with the medical oncology team.

Specific Aims and Hypothesis

This study aims to evaluate the impact of SPARK compared to usual care. The study investigators hypothesize that SPARK will result in more advanced cancer patients having access to palliative care, and at the same time operate at lower net cost. The study investigators also hypothesize that the improved efficiency of SPARK will result in shorter hospital length of stay for stage 4 cancer patients.

Methods

A cluster randomized trial with step wedged design will be used to compare SPARK to usual care. Data will be collected on health services utilization and access to palliative care services. Net costs will also be compared between SPARK and usual care. Semi-structured interviews with patients and healthcare professionals will be used to explore differences in experiences of healthcare provision between both models of care.

Importance

Singapore has a rising prevalence of cancer patients who require palliative care input, but only a minority are able to access it at present. If the SPARK model of care proves to be a scalable and cost-effective way of expanding access to palliative care, more cancer patients can benefit from palliative care.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted under the care of the medical oncology team in Singapore General Hospital will be included.

Exclusion Criteria:

* Patients below 21 years old.
Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)

The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Peritoneal metastases is the main cause of relapse and death after surgery in patients with serosa positive or locally-invaded-gastric cancer (LIGC). Recent researches showed that PIPAC and Olaparib are effective to control peritoneal metastases in different malignant diseases but it has not been tested for gastric cancer patients. The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
* Clinical stage: cTNM: T4b and or N0-3 M0
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Prior chemo or radiotherapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease

The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Clincial diagnosis of chronic venous insufficiency
* Age: 18-80 years
* Patient's information and willingness to participate

Exclusion Criteria:

* Age under 18 years
* Lower limp edema not caused by venous insufficiency
* Acute deep venous thrombosis
* Arterial occlusive disease
* Diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion
* immobile Patients
* Pregnancy
Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)

To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
* logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.

Exclusion Criteria:

* history of vitrectomy in the study eye;
* history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
* major surgery within the prior 6 months or planned within the next 28 days;
* uncontrolled hypertension;
* known coagulation abnormalities or current use of anticoagulative medication other than aspirin.