cyrilzakka/clinical-trials huggingface dataset:
Evaluation of BD Glucan in Peritoneal Fluid for the Diagnosis of Fungal Peritonitis

Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to the time of treatment administration. Routine microbiological techniques give results too lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to develop diagnostic tools to initiate antifungal therapy as early as possible.

The B D glucan detection, one of the major components of the candida cell wall, can be useful for a early diagnosis.

There are several techniques on the market for the detection of glucan. In Europe and America, the most used is Fungitell (Associated of Cape Cod, Inc).

There is several studies about the use of such kits for fungemia. A number of studies are reporting evidences of a early diagnosis.

But, in medical literature, there isn't study focused on the detection of B D glucan in peritoneal fluid for Candida peritonitis diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* written informed consent for inclusion in the study
* stay in intensive care unit
* diagnosed with a peritonitis
* peritoneal fluid collected by a surgery or radiology procedure, analysed at bacteriology laboratory of l'institut des agents infectieux, l'hôpital de la Croix Rousse

Exclusion Criteria:

* Pregnant woman
* Moribund patient
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility Criteria:
General Inclusion Criteria:

* Patient has type 2 diabetes mellitus (T2DM)
* Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
* Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
Effect of kcal and PACE Labelling on Self-served Portion Size

Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).

See attached protocol documents.

Eligibility Criteria:
Inclusion Criteria:

* United Kingdom residents
* Age ≥ 18
* Fluent in English
* Have access to a computer and Internet

Exclusion Criteria:

* Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)
The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training

This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in the relationship between physical fitness/activity and executive functions in typically developing children and children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder.

Nowadays children are getting more inactive and participate less in sports or daily physical activity. Previous studies have shown that a good physical fitness is associated with improved cognitive functions. While being physical active, physiological changes take places in the brain. Brain-derived neurotropic factor is one of the neurotropins that plays a crucial role in this process. Executive functions are cognitive processes that are responsible for organizing and controlling goal-directed actions. These functions are developing during childhood and play an important role in daily- and school functioning.

This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in the relationship between physical fitness/activity and executive functions in children.

In a first trail the effect of physical fitness and physical training on executive functioning and levels of Brain-derived neurotropic factor will be studied.

In a second trail the research question is expanded by investigating the same relations in children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder.

Protocol trail 1: The included (typically developing) children will be randomized and stratified for level of physical fitness into 2 groups: the intervention group and the control group. The intervention group will receive physical activity training 2 times a week during 8 weeks. The control group will receive no additional training. At the beginning and the end of the training period both the intervention and control group will be tested for physical fitness and level of executive functioning.

Protocol trail 2: Identical protocol to trail 1 except the participants will be children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder in stead of typically developing children.

Eligibility Criteria:
Trail 1

Inclusion Criteria:

* typically developing children

Exclusion Criteria:

* children with: executive function-, neurological- or cognitive disorders

Trail 2

Inclusion criteria:

* typically developing children (control)
* children with Developmental Coordination disorder, Attention deficit disorder or Autism Spectrum disorder

Exclusion criteria:

* Children with neurological- or cognitive disorders
Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.

Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride in the relief os dyspepsia symptoms on research participants diagnosed with functional dyspepsia.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent;
* Participants aged 18- 70 years;
* Clinical diagnosis of functional dyspepsia according to Rome III criteria;
* Minimum score of 22 points in PADYQ questionnaire

Exclusion Criteria:

* Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological;
* Positive diagnosis for Helicobacter pylori;
* Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization;
* History of esophageal surgery, gastrointestinal or other intra-abdominal surgery;
* Hypersensitivity to the components of the formulations;
* Allergy tartrazine yellow dye;
* Allergy to aspirin;
* Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit;
* Use of NSAIDs or aspirin more than two days a week (except AAS \<325mg / day), other drugs that induce gastrointestinal symptoms;
* Pregnant women or women without adequate contraception;
* Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it;
* Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase;
* Diagnosis of neurological or psychiatric diseases or decompensated diabetes;
* Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers;
* Alcoholism or sporadic use of alcohol and illicit drug use.
Postoperative Cognitive Dysfunction in Heart Surgery

To determine the rate of Postoperative Cognitive Dysfunction (POCD) in the early and late postoperative periods by comparing the preop and postop period mini mental status tests in participants undergoing open heart surgery, and to compare the results of the investgators clinic with the world literature.

Postoperative delirium (POD) and Cognitive Dysfunction (POCD) are changes in mental status, especially in the geriatric surgery population.Unlike other forms of delirium, POD results in early full recovery.Postoperative Cognitive Dysfunction (POCD) is more difficult to define and implies temporal consciousness impairment associated with surgery.

While the diagnosis of delirium requires the detection of symptoms, the diagnosis of POCD requires preoperative neuropsychological testing and determining how much reduction will mean cognitive dysfunction. Postoperative delirium management is complex and requires multiple strategies. Methods of treating and preventing POCD are still uncertain.It is known that POCD is most commonly seen in patients undergoing open heart surgery.In this study, the investigators aim is to evaluate whether there is any change in cognitive status in the postoperative period compared to the preoperative period of participants who will undergo open heart surgery due to valve pathology or coronary stenosis.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 age
* American Society of Anesthesiologists (ASA) II-III

Exclusion Criteria:

* \>75 age
* \<18 age
* Patients who died within 48 hours after the operation
Association Between HER2 Status and pCR Rate in ER-positive Breast Cancer Receiving Neoadjuvant Endocrine or Chemotherapy

In estrogen receptor (ER)-positive breast cancer (BC), human epidermal growth factor receptor-2 (HER2)-low ones are reported to have distinct clinical and molecular features from those with HER2-zero or HER2-positive status. However, the association between HER2-low status with response to endocrine therapy is largely unknown. In this study, we included 518 ER-positive BC patients who received either neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NCT). The pathologic complete response rate (pCR) of HER2-low and HER2-zero tumors re-sponding to neoadjuvant therapies were compared. The difference in disease-free survival (DFS) and overall survival (OS) between the two groups was also analyzed. The pCR (defined as ypT0/isNx) in HER2-low BCs and in HER2-zero BCs for NET cohort and NCT cohort were compared.


Eligibility Criteria:
Inclusion Criteria:

patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021

Exclusion Criteria:

none
Excimer Light for Alopecia Areata

Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.

Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease.

Excimer laser has been shown to be effective in the treatment of AA in controlled studies. The main disadvantage of the previous studies evaluating excimer laser is choosing separate patches as a control which does not account for interlesional treatment response variability. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. However, there are only a few studies that evaluated the efficacy and safety of UVB excimer light in AA. Those studies have shown that UVB excimer light is effective in the treatment of AA but none of them was conducted in a controlled fashion.

There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.

Study Objectives

1. To evaluate the potential for UVB excimer light to induce hair regrowth within AA patches.
2. To assess the side effect profile of UVB excimer light when used in the treatment of AA.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Subject has a patch of at least 12 cm2 on the scalp with no evidence of hair regrowth.
* Subject is willing and capable of cooperating to the extent and degree required by the protocol.

Exclusion Criteria:

* Patients who received treatment for alopecia areata within the past 4 weeks.
* Patients with alopecia totalis or alopecia universalis.
* Patients with known photosensitivity like having polymorphous light eruption, connective tissue diseases, porphyria or Xeroderma pigmentosum.
* Pregnancy or breast-feeding.
* History of previous skin cancer.
* Patients that have participated in another investigational drug or device study within 30 days of enrollment.
Effects of Inspiratory Muscle Training in Patients With Parkinson's Disease

In this study investigators will examine the effects of inspiratory muscle training and balance training in patients with Parkinson's Disease

Parkinson's Disease (PD) is the most common type of Parkinsonism and mainly due to degeneration of basal ganglions and substantia nigra occurs. Balance disorders are one of the common problems in patients with Parkinson's disease. These balance disorders; loss of postural reflexes, insufficiency in postural adjustments, rigidity in the trunk and extremities, and many disorders such as akinesia. Because of balance disorders in patients with PD, increase in addiction to daily life activities, causes physical disability. In the case of PD pulmonary problems may be the leading cause of mortality and mortality. Respiratory symptoms in these patients cause problems in weakness, swallowing, coughing, voice and speech functions. When the investigators look at the current literature, the effect of balance and respiration on Parkinson's patients is found to be seperately but their effect on each other is not sufficiently emphasized. For this reason, the researchers' aim to investigate balance and postural control in patients with Parkinson's disease and to increase the strength of respiratory muscles and to improve balance and postural control.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson'S Disease
* Ages between 60 and 85 years
* Grades 1 to 3 according to Modified Hoehn-Yahr Scale

Exclusion Criteria:

* Lung surgery or diagnosed lung disease history
* Dementia
* Having a orthopedic disorder which may affect balance and/or mobility
* Severe dyskinesia and cognition problems
Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)

To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx) 2. With at least one risk factors after radical surgery ①positive margin; ②close margin（\<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.

  3. Have at least one contraindication to cisplatin as defined:

  ① Age\>65 years old; ②Creatinine clearance (CC) \> 30 and \< 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)\* ((140-Age) / (Serum Creatinine)) \* (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.

  4. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following:
  1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
  2. Platelets count \>= 80 \* 10\^9/l
  3. Hemoglobin \>= 80 g/dl
  4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
  5. Total bilirubin \<= 1.5 times institutional ULN
  6. Creatinine clearance \>30 ml/min 8. Signed written informed consent

Exclusion Criteria:

1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
5. Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
The Effectiveness of a Positive Psychology App in the General Population

The corona crisis has a negative impact on the mental wellbeing of the Dutch population. Positive psychology exercises (PPOs) can potentially improve mental well-being and reduce mild and moderate psychological complaints. Previous research has shown moderate to large effects of PPOs on well-being in people with reduced wellbeing and psychological symptoms at baseline. The University of Twente developed an app (Training in Positivity; TiP) based on an effective intervention. The goal of this study is to investigate the effectiveness of TiP in the general population in people experiencing reduced mental wellbeing as a result of the corona crisis. People using the app will be compared to a waiting list control group.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is at least 18 years old
2. The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
3. The participant is willing to do a positive psychology exercise 6 days a week for 3 weeks
4. The participant has sufficient command of the Dutch language to be able to complete questionnaires and exercises.
5. The participant gives consent to participate in the study using the online informed consent procedure.

Exclusion Criteria:

1. The presence of severe anxiety symptoms: a score of 15 or higher on the Generalized Anxiety Disorder 7 items (GAD-7)
2. The presence of severe depressive symptoms: a score of 20 or higher on the Patient Health Questionnaire (PHQ-9).
Pain Relief Strategies for Dressing Change in Chronic Wounds

A small-scale study using interviews to explore patients', carers' and health care professionals' experience of pain relief strategies currently used in UK practice for dressing change in chronic wounds.

In 2012/2013, the National Health Service (NHS) managed an estimated 2.2 million adults \>18 years of age with a wound, of which 48% were estimated as being chronic. A chronic wound is an open sore in the skin that does not heal, or takes a long time to heal, and frequently comes back. Chronic wounds include pressure ulcers (bed sores), venous (vein-related) leg ulcers, and foot ulcers in people who have diabetes. Pain is a common experience for people living with chronic wounds and can result from the wound itself, treatments for chronic wounds, including dressing changes; or be anticipatory. Pain during dressing change has been reported as the worst part of living with chronic wounds, followed closely by wound cleansing. Furthermore, dried out dressings and adherent products are most likely to cause pain and trauma at dressing changes as is gauze, while products such as hydrogels and soft silicone dressings are least likely. Evidence suggests that supporting the surrounding skin during dressing removal is not considered a priority, despite evidence that many adhesive products may lead to skin stripping and potential skin trauma and pain.

There is at present little recent evidence of pain relief strategies that are currently being used in the UK for dressing change in chronic wounds that includes patients', carers' and healthcare professionals' (people who work in the NHS) use and experience of these. This qualitative research will explore providers' and recipients' self-reported experiences of chronic wound care, and explore strategies used to reduce pain at dressing change. It will ask about the perceived success of these strategies from different participant perspectives, along with how pain is assessed. Perceptions of what factors might contribute to pain at dressing change (e.g., dressing and wound type, skill levels) will be captured along with perceptions of what could improve the management of pain at dressing change.

Eligibility Criteria:
Inclusion Criteria:

* Living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound
* Ability to give informed consent
* Aged aged 18 years or above

Exclusion Criteria:

* Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents)
* Inability to provide informed consent
* Inability to communicate in English
* Not living with a chronic wound, informally or privately caring for someone with a chronic wound or providing medical care (e.g. dressing change) for someone with a chronic wound
* Under 18 years of age
Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects

This is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* 1. Advanced/Metastatic non-small cell lung cancer NSCLC patients.
* 2. The patient himself/herself must be 18 years of age on day of signing informed consent.
* 3. The subject has signed the informed consent form.
* 4. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors.
* 5. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration

Exclusion Criteria:

* 1. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.