cyrilzakka/clinical-trials huggingface dataset:
Preoperative Anaemia prevaLence In surgiCal patiEnts

Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality.

Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery.

Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. Due to the potential risk of additional blood loss, anaemia represents a serious disease condition within the surgical field. Especially patients undergoing major elective surgery are at risk of substantial blood loss. Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery. Results will facilitate design of supplementation strategies to improve haemoglobin level before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Written informed consent prior to study participating according to the national law requirements
* Patients undergoing major surgery
* Expected hospital stay with a minimum of 24 hours

Exclusion Criteria:

* Preoperative autologous blood donation
* Patients with expected re-surgery within the planned 7-day recruitment period
Evaluation of Psychotherapeutic Intervention Model in Nursing

This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis ineffective coping. For this purpose, validity and reliability studies of the assessment tools will be carried out initially, and then a randomized controlled study will be conducted.

This study aims to evaluate the efficacy of the psychotherapeutic intervention model in nursing on patients with nursing diagnosis of ineffective coping (International Classification of Nursing Practices (ICNP)/North American Nursing Diagnostic Association (NANDA)). For this purpose, first of all, validity and reliability studies of "Coping" and "Self-Esteem", which are the results of NOC (Nursing Outcomes Classification), will be conducted, and then a randomized controlled study will be conducted (Turkish version). 200 patients will be included in the validity and reliability phase of the study, which was conducted in a hospital outpatient psychiatric setting in Turkey. The randomized controlled second phase will be carried out, single-blind, nurse-led, with approximately 26 patients with anxiety randomized to intervention (n=13) or control groups (n=13). The usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old,
* Literacy,
* Having applied to the psychiatry outpatient clinic,
* Being regularly treated in a psychiatry outpatient clinic,
* Having a medical diagnosis of generalized anxiety disorder,
* Having at least one of the defining characteristics of the nursing diagnosis of ineffective coping according to the nursing process.

Exclusion Criteria:

* Medical diagnosis of dementia or psychotic spectrum disorder,
* Cognitive disorder,
* Confused state of consciousness
* Psychomotor agitation,
* Moderate or severe intellectual disability
* Expressing suicidal thoughts
* Suicide attempt in the last month
* Continuing psychological counseling at the moment.
Pathophysiology of Hypoventilation in Obesity and Effects of Bariatric Intervention

Breathing is impacted by obesity. Early changes are characterised by significant breathing abnormalities during sleep (a condition called sleep disordered breathing, the most common of which is obstructive sleep apnoea). As the breathing changes worsen in severity, it may result in a rise in carbon dioxide levels during daytime causing a condition called obesity hypoventilation syndrome (OHS). The current treatment for obesity related breathing changes include supportive breathing therapy at night, optimisation of associated medical conditions and weight loss.

Weight management is an important part of obesity treatment. Weight loss strategies such as life-style modification do not always work. Weight loss surgery (bariatric surgery) has been shown to be an effective weight management intervention with long-term results. This study aims to understand breathing changes that occurs due to obesity and their resolution after weight loss surgery. The investigators are aiming to recruit participants with sleep disordered breathing who are currently awaiting bariatric surgery. In particular, the investigators are interested in comparing breathing changes in participants with OHS, who have abnormal regulation of their carbon dioxide levels, and participants with sleep disordered breathing with normal CO2 regulation.

Participants will be recruited through outpatient clinics for sleep disordered breathing. The participants will undergo comprehensive breathing assessments on enrolment including an overnight sleep study. Participants will undergo further daytime breathing assessments before and after their bariatric surgery. End of study will be 6 months after surgery - participants will have a final comprehensive breathing assessment including an overnight sleep study to review resolution of their breathing changes. Depending on the wait list time for the bariatric surgery, it is anticipated that participants will be enrolled in the study for 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. BMI \> 40
3. Patients with significant sleep disordered breathing requiring treatment
4. Patient is being assessed for bariatric surgery for either gastric sleeve or gastric bypass surgery

Exclusion Criteria:

1. Patients with decompensated hypercapnic respiratory failure (pH\< 7.3)
2. Chronic hypercapnic respiratory failure due to a cause other than obesity such as neuromuscular, chest wall or airway disease
3. Unstable cardiac disease including coronary artery disease and heart failure
4. Significant co-morbid psychiatric disease requiring anti-psychotic medications
5. Chronic pain syndrome on high dose opioid medications
6. Treatment for drug or alcohol addiction
7. Cognitive impairment that would prevent informed consent
8. Pregnancy
9. Need for long-term renal replacement therapy
10. Patients who undergo bariatric intervention with gastric balloon or gastric band.
An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.


Eligibility Criteria:
Inclusion Criteria:

* RA for at least 1 year
* Clear clinical signs of active RA in 1 knee joint
* Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
* Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
* Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

Exclusion Criteria:

* Serious bacterial infection in last 3 months
* History of TB
* History of cancer within 5 years
* Evidence of latent or active bacterial or viral infection
* Intra-articular corticosteroids within 3 months
* Exposure to live vaccines
* Exposure to CTLA4Ig or BMS-188667
* Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
Online Nutrition Advice in the UK (EatWellUK)

The EatWellUK study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet quality.

Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).


Eligibility Criteria:
Inclusion Criteria:

* aged \> 18 years old

Exclusion Criteria:

* aged \< 18 years old
* not living in the UK
* pregnant/lactating
* no or limited access to internet
* following a prescribed diet for any reason
* intolerance or food allergy
* subject with diabetes, or any other metabolic disorder or illness that alters nutritional requirements
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer

Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).


Eligibility Criteria:
Inclusion Criteria:

1. Female Patients aged 18 to 75 years.
2. International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
3. Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
4. ECOG performance status: 0 or 1.
5. Resectable disease by laparoscopic assessment after 3 cycles of NACT.
6. Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
7. Estimated life expectancy of \> 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.

Exclusion Criteria:

1. Metastatic ovarian carcinoma.
2. Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
3. Presence of pregnancy or breast-feeding.
4. History of other invasive malignancies in the previous 5 years.
5. History of a recent \< 6 month cerebrovascular accident.
6. Uncontrolled systemic disease or contraindication to chemotherapy.
7. Progressive disease on NACT.
8. Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
9. Severe comorbidities (ACCI \>= 4)
Vasculitis Pregnancy Registry

The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess

1. each woman's vasculitis severity and pregnancy-related experiences, and
2. pregnancy outcomes.

The study will consist of several on-line surveys to assess each woman's vasculitis severity, pregnancy-related experiences, and pregnancy outcomes. Participants will be asked to complete questionnaires at study entry, during the second trimester, during the third trimester, and postpartum. Investigators estimate that it will take approximately 20 minutes to complete each survey. The survey is available in Spanish, Portuguese, Italian, and Turkish.

All women enrolled in the Vasculitis Patient-Powered Research Network (VPPRN) (with specified disease, sex, and age inclusion criteria described below) will be invited via email to participate in this on-line study. The survey data will be stored by the Data Management and Coordinating Center (DMCC) at the University of South Florida. Upon conclusion of the study period, the data will be sent to the Study Chairs.

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years of age or older with one of the following diseases may take part in the study:

   * Behçet's disease;
   * Central nervous system (CNS) vasculitis;
   * Cryoglobulinemic vasculitis (Cryoglobulinemia);
   * Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);
   * Giant Cell (Temporal) Arteritis (GCA);
   * Granulomatosis with polyangiitis (also called Wegener's);
   * IgA vasculitis (Henoch-Schoenlein purpura);
   * Microscopic polyangiitis (MPA);
   * Polyarteritis nodosa (PAN);
   * Takayasu's arteritis (TAK);
   * Urticarial vasculitis;
   * Other/Suspected Diagnosis.
2. Women must be pregnant (self-report) at the time of enrollment into the registry.

Exclusion Criteria:

1. Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.
2. Unable to provide consent.
Effects of Transcranial Direct Current Stimulation (tDCS) on Language

This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).

This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.

Study design:

Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).
* Patients must be adults and have English-language fluency.
* Patients must be eligible to undergo MRI.

Exclusion Criteria:

* Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
* Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
* No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
* Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials
CoQ10 and Prednisone in Non-Ambulatory DMD

This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of DMD. Participants who are enrolled in this study should not have taken any corticosteroids within the last six months. This is a 13-month, prospective, randomized study comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5 ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in wheelchair confined males age 10 to 18 years with an established DMD diagnosis.

Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy affecting 1:3500 male births worldwide. Despite an increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains largely supportive. Improvement in the treatment of DMD will depend upon the development of better therapies. Affected boys become symptomatic at 3 to 5 years of age with proximal leg weakness that impairs mobility, ability to get up from a squat, and precludes a normal ability to run. By 8 years of age, some affected boys begin to lose the ability to walk and resort to a wheelchair for mobility. This shift from the ambulant to non-ambulant phase occurs in all boys with a diagnosis of DMD by age 12 years. In this study, participants will be randomized into groups after being screened to determine eligibility. Participants will then be followed for a 12-month investigation period.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-18 years
* Non-ambulatory (primary mode of transportation is via wheelchair for 3 years or less)
* Confirmed DMD diagnosis
* Steroid-naive for the 6 months prior to screening
* Stable dose of b-blocker or ACE inhibitor medication for the 6 months prior to screening, if taking either of these medications
* Ability to provide reproducible repeat QMT grip score within 15% of first assessment score
* Has not participated in other therapeutic research protocol within the last 6 months prior to screening
* Ability to swallow tablets

Exclusion Criteria:

* Failure to achieve one or more of the diagnostic inclusion criteria cited above
* Symptomatic DMD carrier
* Use of carnitine, other amino acids, creatine, glutamine, CoQ10 or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) within the last 3 months
* History of significant concomitant illness or significant impairment of renal or hepatic function, or other contraindication to steroid therapy
* Positive PPD
* No prior exposure to chickenpox and no immunization against chicken pox
* Baseline serum CoQ10 level of 5.0mg/ml or greater
Assessment of Peripheral Perfusion in the Critically Ill Patient

The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral perfusion in patients in septic shock and after cardiac surgery.

The aim of this study is to validate PPI as a continuous, objective measurement of peripheral perfusion indicated by clinical sings of tissue perfusion in patients with septic shock. Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound of liver, kidney and gut. In a group of healthy volunteers the investigators will determine normal values in ambient temperature and after cooling of an extremity. Another group of patients after cardiac surgery, where usually a poor tissue perfusion without metabolic failure is present will serve as another "control" population in their post-surgery stabilization period. The values from healthy volunteers and cardiac surgery patients will be compared to those of patients in septic shock.

Eligibility Criteria:
Septic patient:

Inclusion criteria:

* ICU admission with septic shock defined as:
* documented infection (suspected or confirmed) AND
* systemic mean blood pressure \<65mmHg requiring any dose of vasopressor despite adequate fluid resuscitation (min. 20ml/kg crystalloids) AND
* lactate \>2mmol/l
* Deferred consent by a relative with following informed consent by patient as documented by signatures (Appendix Informed Consent Form)

Exclusion criteria:

* Age \<18 or \>80 years
* present or suspected myocardial ischemia
* acute pulmonary embolism
* known liver disease - Child-Pugh -Class B or C
* known chronic renal failure
* known peripheral artery disease

Patient after cardiac surgery:

Inclusion criteria:

* ICU admission after coronary artery bypass grafting or valve surgery with cardiopulmonary bypass
* General consent with admission at the University hospital

Exclusion criteria:

* Age \<18 or \>80 years
* known peripheral artery disease
* no or only low dose of vasopressors (\<300µg/h) at ICU admission
* present or suspected myocardial ischemia
* acute pulmonary embolism
* known liver disease - Child-Pugh -Class B or C
* known chronic renal failure

Healthy volunteers:

Inclusion criteria:

- Informed consent as documented by signature (Appendix Informed Consent Form)

Exclusion criteria:

* Age \<18 or \>80 years
* known peripheral artery disease
A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure

A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, 18-80 years of age.
* Prevalent PD patients with CHF with cardio-renal syndrome type II, on stable ultrafiltration, for more than two months, treated with PD based UF according to German national guidelines.

  * Therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema
  * Recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months
  * Isolated failure of the right heart chamber
* Treatment based on night time APD therapy combined with a day time long dwell.
* Obtained written consent to participate in the study.

Exclusion Criteria:

* End stage renal disease requiring dialysis.
* Malignant disease.
* On-going infection.
* Diabetes mellitus.
* HIV and/or hepatitis positive.
* Pregnancy.
* Breastfeeding women.
* Participation in other clinical trials within one month before inclusion.
* Abdominal hernia.
* Cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload.
* Any immune deficiency.