cyrilzakka/clinical-trials huggingface dataset:
A Study on the Treatment Strategy of NVG Secondary to PDR

With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. For these patients, not only is the effect of drugs in lowering intraocular pressure poor, but the results of surgery are often unsatisfactory. Because of its poor prognosis, clinical research for better strategy is of great significance in the current situation. At present, for such patients, a combination of effective control of intraocular pressure and treatment of the primary disease is often used. The purpose of this study was to investigate the clinical effects of preoperative with/without intraoperative anti-vascular endothelial growth factor (VEGF) drug therapy combined with pars plana vitrectomy (PPV), pan-retinal photocoagulation (PRP), and pressure-reducing valve implantation in patients with NVG secondary to PDR. Furthermore, the changes of neurotrophic factors in the vitreous humor before and after anti-VEGF treatment will be explored.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients aged over 18 years diagnosed with type 1 or 2 diabetic mellitus (DM) confirmed by experienced endocrinologists. Active PDR and NVG was clinically evident across these patients. The indications to perform surgery included vitreous hemorrhage or fibrous proliferation in the macular area, together with uncontrolled intraocular pressure.

Exclusion Criteria:

* (i) coexistent ocular disease that may interfere with visual outcome; (ii) previous history of vitrectomy or anti-VEGF pharmacotherapy in either eye; (iii) a macula-involving retinal detachment for \>6 months in the study eye; (iv) severe external ocular infection; (v) usage of anticoagulant or antiplatelet therapy; (vi) preoperative or postoperative poor diabetes control \[serum hemoglobin A1c (HbA1c) \>11.0%\]; (vii) uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases.
Type 1 Diabetes Autonomic and Vascular Function

The goal of this clinical trial is to investigate the autonomic and vascular function in men and women with Type 1 diabetes. The main questions it aims to answer are:

1. Patients with type 1 diabetes exhibit attenuated vascular function during steady-state exercise
2. Patients with type 1 diabetes have altered autonomic function at rest and during exercise pressor reflex
3. Patients with type 1 diabetes have attenuated muscle sympathetic activity

Elevated blood glucose levels in individuals with type 1 diabetes can result in both microvascular and macrovascular complications. Research conducted by Song et al. revealed that children with type 1 diabetes exhibit abnormal cerebral perfusion. Additionally, autonomic mechanisms are affected in type 1 diabetes, as indicated in an animal study which demonstrated that the exercise pressor reflex is exaggerated in both male and female rats during the early stages of the disease. However, whether this also occurs in human patients with type 1 diabetes remains unknown.

Therefore, in this study we are interested in studying the autonomic control of exercise and vascular function in T1DM humans.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes or a Healthy control

Exclusion Criteria:

* BMI \> 40kg/m2
* Cancer with current treatment
* HIV
* Smoker cigarettes
* Are pregnant or breastfeeding
Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease

Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (\> 1) short (focal; \> 1 and \< 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.


Eligibility Criteria:
Inclusion Criteria:

* PAOD (ABI \<0.90 and/or a decline of \>0.15 after exercise test), Rutherford category 2, 3 or 4
* Multiple (\>1) short (focal; \>1 and \< 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
* Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
* Unilateral occlusive disease
* Age ≥ 18

Exclusion Criteria:

* Patients with PAOD Rutherford category 5 and 6
* Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
* Bilateral lesions with treatment indication
* Contra-indication for anticoagulant therapy
* Renal insufficiency (MDRD \< 50 ml/min)
* Life expectancy \< 6 months
* Known contrast allergy
* Pregnancy
* Unable to complete a questionnaire in the home language
Chest X-ray in Diagnosis of Heart Failure

The objective of this study is to compare the performance of x-chest ray in the diagnosis of acute cardiac insuficiency through the interpretation of a senior and a non-senior.

Acute cardiac insufficiency (ICA) is a leading cause of acute dyspnea in the emergency department (SU) and is associated with a higher risk of morbidity and mortality.

An increasing number of tools for better ICA diagnosis are available in the SUs. However, there is likely room to improve the ICA diagnostic approach using widely available routine tools, including chest x-ray .

Chest x-ray is a rapid and inexpensive method that is routinely performed in an emergency in patients with acute dyspnea. This is the first-line diagnostic imaging modality recommended in the guidelines.

The objective of this study is to compare the performance of x-chest ray in the diagnosis of acute cardiac insuficiency through the interpretation of a senior and a non-senior.

A senior emergency physician or resident and an intern, perform a reading of chest x-ray in any included patient by answering to following questions:

Is there cardiomegaly? Calculation of the cardio-thoracic index Is there a vascular distribution towards the vertices, if so is it uni or bilateral? Is there pleurisy, if so is it uni or bilateral? Is there an interstitial syndrome, if so is it uni or bilateral? Is there an alveolar syndrome, if so if so is it single or bilateral? Is the diagnosis of heart failure very likely, likely or unlikely? Then there will be a comparison of the two answers.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 All dyspnea acute non-traumatic A resident or intern in medicine and a senior are available to read chest x-ray within 24 hours of admission

Exclusion Criteria:

* Age under 18
* Post traumatic dyspnea
* Patient not requiring hospitalization
* Mechanical ventilation from the start
* Cardio-respiratory arrest
* Pregnant woman
* And any patient who cannot achieve reproducibility within 24 hours of admission.
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.

The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
* Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
* Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
* Elevated NT-proBNP
* Pulmonary vascular disease or right ventricular dysfunction

Exclusion Criteria:

* Any prior valid measurement of LVEF \< 40%. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject
* Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
* Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
* Hemoglobin \< 100g/L (\< 10 g/dl) at Screening
* Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
* Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min per 1.73 m2
* Severe hepatic impairment, e.g., Child Pugh Class C

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of the Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program

Depression and anxiety are increasingly common conditions for which primary care providers (PCPs) serve as the initial healthcare contact for most patients. Comorbid depression and anxiety result in higher costs, and treatment as usual, which is referrals to specialty psychiatric care, often contribute to delays in care. Collaborative psychiatric care is an evidence-based strategy to increase mental healthcare access while reducing costs. ADAPT is a novel collaborative care model. By using technology-driven appointments with providers, ADAPT increases access to mental healthcare, and reduces member wait times. This mixed methods study will assess implementation measures of the ADAPT program and the components of ADAPT related to patient mental health improvement compared to specialty mental health care. The hypothesis is that: ADAPT program will have good program reach and efficacy. We will examine program implementation and maintenance. Further, the study looks to uncover member and program characteristics that are associated with depression and anxiety remission and care utilization.


Eligibility Criteria:
Inclusion Criteria:

* Adult Outcomes Questionnaire (AOQ) score between 10-30
* English-Speaking

Exclusion Criteria:

* High risk for suicide defined by answer to question 9 on PHQ-9 of 1 or more
* Diagnosis of bipolar disorder
* Diagnosis of a psychotic disorder
* Dementia diagnosis
* Active substance use disorder diagnosis
* Current hospice
* Current home-based palliative care
* Residing in a skilled nursing facility
* Residing in an assisted living facility
* Non-Kaiser Permanente Member
* Established psychiatric care outside of Kaiser Permanente
Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.

Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Body Mass Index (BMI) \<= 35 kg / m²
* Hemoglobin A1c (HbA1c) \<= 9%

Exclusion Criteria:

* Serum creatinine \>2.0 mg/dL
* Digestive diseases (e.g. malabsorption)
* Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
* Recent cardiovascular event
* Cachexia
* Psychiatric disorder with impairment of understanding
* Participating in other research protocol
Peristomal Mesh for Prophylaxis of Parastomal Hernia

The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Eligibility Criteria:
Inclusion Criteria:

* Condition with indication for establishing a permanent end-colostomy.

Exclusion Criteria:

* Age under 18
* ASA score above 3
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

To compare the pharmacokinetic behavior of azithromycin eye drops in the tear with the original azithromycin eye drops, and evaluate the release behavior of both in the eye.

There are 48 patients will divided into group A and group B randomly . subjects of Group A will given the first test drug, elution after the control drug; Subjects of Group B will given the first control drug, elution given to the test drug.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old, male or female;
* BMI in the range of 19 to 28;
* eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal;
* Good compliance and voluntarily signed consent.

Exclusion Criteria:

* Have eye disease or systemic disease;
* physical examination, laboratory tests, ECG and chest X-ray examination abnormalities and has clinical significance;
* HBsAg, anti-HCV and HIV positive;
* those who used eye drops two weeks before the test and who used any dosage form of azithromycin;
* known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions;
* need to wear contact lenses during the test;
* history of internal surgery or laser surgery history;
* participated in other drug clinical trials in the past three months;
* pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women;
* mental illness or alcohol, history of drug abuse or inability to collaborate;
* Any other circumstances that the investigators consider are unfit to participate in this study.
Evaluation of Visual Performance With Contact Lenses

This study will evaluate the influence of contact lens optical design on visual performance using standard and multifocal soft contact lenses (MFCLs).

The study will examine visual acuity with various contact lenses, with and without glare source, in myopes between the ages of 18-39 years old (inclusive) to determine the effect of different multifocal optical designs on visual performance in the post-fit period.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 39 years of age
* Best corrected visual acuity of at least 20/30
* Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters sphere after vertexing to the corneal plane

Exclusion Criteria:

* Greater than -1.00 diopter of refractive astigmatism at the corneal plane
* Any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Unwilling to have eyes photographed or video recorded
* Pregnant and/or lactating females, by self-report
Molecular Characterisation of Appendiceal Cancer

Patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases, have had cytoreductive surgery, have availability of archival tumour tissue and have consented to our institutional biobank program or have a waiver of consent for deceased patients who have not had the opportunity to provide biobank consent (requested at the time of ethics review). Descriptive analysis of the proportion of genetic mutations identified in appendiceal cancers. This is given by the percentage of pathogenic mutations in the peritoneal metastasis compared to the primary tumour.

Appendiceal cancer is a rare and understudied cancer that frequently leads to metastatic disease with production of copious gelatinous collections in the abdomen, causing severe illness and poor survival. The only definitive treatment available is a complex and aggressive surgical procedure involving removal of organs and the internal lining of the abdomen. There is an urgent need to define clinical predictors of survival, the role of chemotherapy and to develop new treatments.

The genetics of appendiceal cancer has been reported in small cohorts of patients but there has been limited research on how mutations affect treatments or survival. There is no information on how and why primary appendiceal cancers often spread just to the lining of the abdomen. Understanding how genetic mutations evolve in the tumours are important for working out treatments to prevent the spread of cancer. Current high throughput laboratory techniques for analysing the genetic makeup of appendiceal cancer has the power to identify mutation patterns than might predict for treatments and survival outcomes.

This study proposes completing tumour genetic studies on archived cancer tissue removed routinely from patients who previously have had surgery for their appendiceal tumour. The results of genetic tests can then be compared to clinical characteristics of the patients such as survival time and treatments received. Genes in primary appendix tumours can be compared to those in tumours that have spread into the lining of the abdomen to describe what changes if any occur during the spreading process.

This study will help make progress towards better and personalised treatment options, identifying predictors of treatment success and long-term survival. Improved treatments and better selection of patients may ultimately improve quality of life and help patients live longer.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Patients ≥ 18 years old who have been diagnosed with appendiceal cancer with peritoneal metastases,
2. have had cytoreductive surgery
3. have availability of archival tumour tissue

Exclusion Criteria:

* None
The PROAKTIV Study

The overall objective of this study is to identify whether the systematic anticipation of highly structured specialized palliative home care into primary care influences the quality of care and care utilization. Quality of care focusses on the sense of security of patients and family caregivers, satisfaction with care of patients, family caregivers, general practitioners, home care nurses and specialized palliative care nurses, and availability and access to advanced directives. Health care utilization focus on the number of hospitalizations and the length of hospital stays.

The University Center for Palliative Care from the Inselspital Bern conducts this monocentric mixed-methods controlled study and is responsible for informed consent.

Data consists of questionnaires of patients, their family caregivers, general practitioners, home care nurses and if involved specialized palliative home care nurses. Patients and their family caregivers will fill out baseline questionnaires and follow-up questionnaires at 2, 8, 16 and 24 weeks. Patient follow-up will end if the patient dies or the study ends. Family caregivers will be asked to fill out a questionnaire two months after the patient's death.

General practitioners, home care nurses and specialised palliative home care nurses will fill out questionnaires after the patient's death or at the end of the study. Patient survival data will be collected from administrative health data after the end of the study.

Additionally, a nested qualitative study with semi-structured qualitative interviews with patients, family caregivers and care providers will provide an in-depth understanding of preferences, needs, experiences from this phase of life.

Eligibility Criteria:
Patients inclusion criteria:

* 18 years or older
* Able to read and understand German
* Able to fill out questionnaires with only minimal assistance
* Live in the catchment area of SPHC
* Positive screening on the palliative care screening tools
* Expected survival time of approximately six months or less
* Have a GP (or GP medical substitute)
* Registered with Spitex care
* Wish to live at home as long as possible (no plans for long term nursing home uptake)
* Written informed consent

Patients exclusion criteria:

* Planned discharged from hospitals to institutions (e.g. other hospitals, rehabilitations, nursing homes)
* Live permanently in nursing homes
* Cognitive impairments that make it impossible to follow the study (e.g. psychological disorders, dementia, loss of judgement).

Family caregivers inclusion criteria:

* 18 years or older
* Able to read and understand German
* Familiar with the care situation patient
* Written informed consent

Specialized palliative home care team:

* Provide care in German speaking part of canton Bern
* 24/7-availability of specialized palliative care
* Specialized palliative care team including nurses and consulting physician with specialized palliative care certification.
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair

The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.

All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016.

To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register.

Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017).

Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect

The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair.

The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair

Exclusion Criteria:

* If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database