cyrilzakka/clinical-trials huggingface dataset:
Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial

Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, and pressure ulcers.

Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.

Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.

Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.

We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can \& should be done. The main aims of this study are:

1. How easy it is to recruit ILD patients to see a dietitian
2. Whether patients will attend dietetic appointments
3. Whether food/nutrient intake is increased following dietetic intervention
4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI \& quality of life.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 20kg/m2, or if aged \>75, BMI ≤ 21 (Righini et al., 2013)
* Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of baseline BMI or weight loss \>2 kg if BMI is normal.

Exclusion Criteria:

* Co-morbidities currently requiring a specialised diet (including enteral feeding)
* End of life care (estimated less than 6 weeks left to live)
* Expected introduction of anti-fibrotic or immunosuppressive treatment or introduction/increase corticosteroid dose during trial period
* Pregnancy
* Unable to give consent
Revaccination With Influenza Vaccine GSK1247446A

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
* Planned administration of an influenza vaccine other than the study vaccines during the entire study period
* Previous vaccination against influenza since January 2007.
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of confirmed influenza infection within the last 12 months.
* Pregnancy.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
* Acute disease at the time of enrolment.
Detection of the Most Common Microorganism of Infective Endocarditis in Assiut University Hospital

Indocarditis is an endogenous infection acquired when organisms entering the blood

stream establish on the heart valves, therefore, any bacteremia can potentially result in endocarditis.

Infective endocarditis is an uncommon disease that often presents as pyrexia of unknown origin.

The mortality rate in endocarditis was very high before the antibiotic era, even now a day, the

mortality rate is around 20%(1).A variety of microorganisms can cause IE; staphylococci and streptococci account for the majority of cases. Staphylococcal IE is a common cause of healthcare-associated IE ; streptococcal IE is a common cause of community-acquired IE. Common bacterial pathogens include Staphylococcus aureus , Viridans group streptococci , Enterococcus, Coagulase-negative staphylococci , Streptococcus bovis , other streptococci , gram-negative bacteria, HACEK organisms in this category include a number of fastidious gram-negative bacilli: Haemophilus aphrophilus(subsequently called Aggregatibacter aphrophilus and Aggregatibacter paraphrophilus); Actinobacillus actinomycetemcomitans (subsequently called Aggregatibacter actinomycetemcomitans); Cardiobacterium hominis; Eikenella corrodens; and Kingella kingae , and fungi (1,2). A variable proportion of IE remain blood culture- negative (1-4). Most clinically significant bacteremias are detected within 48 hours; common and fastidious pathogens (such as members of the HACEK group) may be detected within five days of incubation with modern automated blood culture detection systems. The optimal volume of blood for each blood culture in adults is 20 ml.

Zoonotic agents, such as Coxiella burnetii, Brucella spp., and Bartonella spp. were frequently detected in North Africa and identified as causes of infective endocarditis (IE) in Egypt (3,4).Blood culture is the most important investigation for diagnosing infective endocarditis

andto know the prevalence rate of different bacteria and their antibiotic sensitivity pattern.Positive blood culture is the cornerstone of microbiological diagnosis of IE; three sets of blood cultures detect 96 to 98 percent of bacteremia. At least three sets of blood cultures should be obtained from separate venipuncture sites prior to initiation of antibiotic therapy. Patients with IE typically have continuous bacteremia; therefore, blood cultures may be collected at any time and need not necessarily be obtained at the time of fever or chills.

MATERIAL and METHOD A total of 150 blood cultures were received from 50 clinically diagnosed cases of bacterial endocarditis .

Blood sample was collected under all aseptic precautions.


Eligibility Criteria:
Inclusion Criteria:patients that are clinically diagnosed as infective endocarditis before starting antibiotics

Exclusion Criteria:patients that receive antibiotics before taking the blood sample
Porous Baseplate in Total Knee Replacement

This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.

All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
* Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
* Aged 21 years or older
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery
* Known medical condition limiting patient life expectancy to \< 2 years
* Expected to receive contralateral TKA within 1 year
* Inflammatory arthropathy
* Prior patellectomy
* PCL deficiency
* Major (\>25 degree) coronal plane deformity
* Bilateral coronal plane deformity requiring simultaneous bilateral TKA
* Bone defects requiring augments, cones and/or stemmed implants
* Body Mass Index greater than 40
Writing Down Goals

The women's health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.

People's stated preferences are often inconsistent with what matters most to them (their values). And they are often based on misconceptions, distress, and less effective cognitive coping strategies. For instance, a person might say "My goal is to have no pain" when that is not possible. Or they might say "My goal is to get the shot that fixes this" when there is no such shot. It may go without saying that people want: "To be able to live a normal lifestyle" and "To be able to accomplish most of their goals." In other words, people want to be able to be themselves. They are seeking care because they are not able to be themselves or they are concerned that they may not be able to be themselves. The word health comes from an old German word meaning "whole."

One part of good health is correcting or alleviating pathophysiology (e.g. reading glasses). Another part of good health is evolving one's inner narrative (e.g. "I'm older now and need glasses to read").

The women's health IPU at UT Health Austin is happy with having patients write down their goals at their first visit and then tracking those. It would be interesting to study people seeking musculoskeletal specialty care to determine whether asking patients what result of their care would be rated a success helps direct the clinician-patient interaction in a more fruitful direction compared to the usual clinical interaction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18+)
* Orthopedic visit

Exclusion Criteria:

* Patients who are illiterate.
* Patients who do not speak English.
The Effects of Nateglinide and Acarbose on the Post-Prandial Glucose Control in Type 2 Diabetic Patients

In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Korean
* Type 2 diabetes mellitus
* No prior history of diabetic ketoacidosis
* HbA1c between 7.5-10.0%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Gestational diabetes mellitus
* Secondary diabetes mellitus
* Severe hyperglycemia with symptoms
* Severe chronic diabetic complications (PDR,s-Cr\>1.3mg/dL)
Effects of Conditioning Exercises and Resistance Interval Training on Post CABG Patients.

Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease. Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment. Invasive interventions like PCI and CABG aim to enhance coronary flow, restoring blood flow to ischemic myocardium. Post-CABG challenges include depression, anxiety, and factors affecting quality of life. Physiotherapy impacts heart rate variability, with virtual reality physiotherapy reducing both heart rate variability and hospital stay. Cardiac rehabilitation involves lifestyle changes, enhancing functional capacity, and supporting early recovery. Pre-operative respiratory muscle training improves outcomes. Acute high-intensity interval exercise and mild continuous exercise benefit exercise recovery. This research compares conditioning exercises and resistance interval training effects on post-CABG patients' well-being.

The randomized clinical trial will be conducted in physical therapy department at the District Headquarters (DHQ) in Gujranwala, employing a non-probability convenience sampling technique. The study aims to include individuals aged 40-55 years. Participants in phase IV cardiac rehabilitation. Both female and male will be included.Exclusion criteria involve individuals with another clinical trial involving physical protocols. Regular practice of physical exercise of more than 150min per week in last 3 months. Decompensated heart failure. Further exclusions encompass individuals who have had an acute myocardial infarction or cardiac surgery within the last 6 months, severe valvular heart diseases, uncontrolled cardiac arrhythmias, asymmetric septal hypertrophic cardiomyopathy with dynamic obstruction in the outflow pathway, musculoskeletal disorders limiting completion of the exercise program, and impaired cognitive status affecting understanding and adherence to the study protocol. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training. The difference in improvement before and after 6 weeks will be documented and compared.

Eligibility Criteria:
Inclusion Criteria:

* age 40-55 years
* post-coronary artery bypass graft (CABG) patients both females and males were included
* New York Heart Association criteria IV
* Hemodynamically stable patient

Exclusion Criteria:

* Fall in New York Heart Association criteria II III;
* Hemoglobin \< 9 g/dL;
* Patients with peripheral or vascular problems of the lower limb,
* Cognitive and/or mental disorders;
* Exercise limiting comorbidities (primarily orthopedic, neurological condition)
* Enrollment in another clinical trial involving physical training protocols.
* Not willing to participate
Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).

In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.


Eligibility Criteria:
Inclusion Criteria:

1. Age from over 20 to under 60 years;
2. Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
3. Mid-low rectal cancer (distance from anal edge≤12cm);
4. cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
5. Expected curative resection through L-PANP;
6. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
7. ASA (American Society of Anesthesiology) score class I, II, or III;
8. Written informed consent;
9. Urinary and sexual function normal preoperatively

Exclusion Criteria:

1. Severe mental disorder;
2. History of previous pelvic surgery;
3. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
4. History of other malignant disease within past five years;
5. History of unstable angina or myocardial infarction within past six months;
6. History of cerebrovascular accident within past six months;
7. History of continuous systematic administration of corticosteroids within one month;
8. Contraindication of heart, brain, lung, etc dysfunction;
9. Requirement of simultaneous surgery for other disease;
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
11. Rectal cancer invades surrounding tissues;
12. Existence of genuine incontinence or severe stress incontinence preoperatively
Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Eligibility Criteria:
Inclusion Criteria:

* progressive keratoconus stage 1-2

Exclusion Criteria:

* any concomitant ocular disease
Retrospective Descriptive Study of Platelet Transfusion in Patients With Palliative Hematologic Malignancies at the University Hospital of Besançon

Development of palliative care is less effective for patients with hematologic malignancies. Limited data is available for end of life care in this population, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting.

The purpose of this study was to describe retrospectively platelet transfusion in the six last few month of life of patients with hematologic malignancies at the CHU of Besançon (France) between 01/07/15 and 31/12/16.


Eligibility Criteria:
Inclusion Criteria:

* patient with hematological malignancies
* transfused in platelet at least once in the last 6 months of life
* hospitalised or follow up at the CHU of Besancon at least once
* dead during the period of the study

Exclusion Criteria:

* patient with other oncologic malignancies
* not transfused in platelet in the last 6 months of life
* never hospitalised or follow up at the CHU of Besancon
* alive
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection

The purpose of this study is to determine whether patients who have asymptomatic HIV infection can discontinue antiretroviral therapy (ART) without adverse clinical, virologic, or immunologic consequences. This study will also assess the virologic, immunologic, and clinical outcomes in any patients who restart ART.

Patients who can discontinue ART without a significant loss of virologic or immunologic control and without an increase in clinical events may be spared the expense and adverse effects of treatment. However, the consequences of treatment discontinuation in patients with asymptomatic HIV infections are not well understood. This study will follow the clinical and immunologic progression of HIV infection in patients who have low HIV viral load and preserved CD4+ cell counts at the time ART is stopped.

Patients will fast for at least 8 hours prior to the first study visit. At this visit, blood will be drawn and body measurements will be taken. Patients will then discontinue their ART. Patients taking nonnucleoside reverse transcriptase inhibitors (NNRTIs) will stop taking NNRTIs 48 hours before withdrawing their other ART drugs. Study visits will occur every 4 to 8 weeks for the first year, then every 12 weeks for the second year. Blood will be taken at most visits, and patients will be asked to fast for at least 8 hours prior to Week 12 and 24 visits and again every 6 months. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* ART with 2 or more drugs for 6 or more months
* CD4+ cell count(s) \> 350 cells/mm3 immediately prior to initiation of first ART
* CD4+ cell count \> 350 cells/mm3 within 45 days prior to study entry
* Plasma viral load \< 55,000 copies/ml within 45 days prior to study entry
* Willingness to discontinue ART at study entry
* Negative serum or urine pregnancy test within 14 days prior to study entry

Exclusion Criteria:

* Pregnancy or breast-feeding
* Systemic cancer chemotherapy, systemic investigational agents, or immunomodulators within 30 days prior to study entry
* Drug or alcohol use or dependence that would interfere with adherence to study requirements
* Illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or has been clinically stable on therapy for at least 30 days prior to study entry
* Chronic medical condition that would have a negative impact on the participation of the patient or would be expected to result in significant use of the medical care system
* History of an HIV-related illness or complication in CDC categories B and C
* Nonadherence to ART
* Active infection with hepatitis B and currently taking adefovir at doses \> 10 mg or 3TC and/or TDF