cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.

Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).

Eligibility Criteria:
Inclusion Criteria:

* Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
* Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
* Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.

Exclusion Criteria:

* History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
* Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.

Other protocol-specified inclusion and exclusion criteria may apply.
WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC

Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.

Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response.

PET-CT are preceded before and after treatment is given;

* day 0 before treatment,
* day 2 after treatment and
* day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
* Measurable decease according to RECIST criteria
* Age \> 18 years
* Performance status 0-2 (0-1 for immunotherapy)
* Understands and reads danish

Exclusion Criteria:

* Poor performance status
* Secondary active cancer
* Pregnancy
* Dysregulated diabetes mellitus
Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults

The objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (Lactobacillus plantarum KABP-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass).

Our subjects will be measured 4 times over the course of a 12-week supplementation period - at Baseline, Week 4, Week 8, and Week 12.

We will have 2 groups (N=30 per group):

* Probiotic Lactobacillus plantarum KABP-51
* Placebo (maltodextrin/corn starch) Subjects will be recruited from local fitness/wellness centers and businesses (e.g. Plymouth Fitness; Planet Fitness; Marathon Sports, etc) using a simple flyer.

If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF) before any Baseline measurements are collected.

Participants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. This periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts.

Our expectation is that this fairly simple 12-week design will show that the KABP-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).


Eligibility Criteria:
Inclusion Criteria:

* healthy moderately overweight

Exclusion Criteria:

* Pregnant women
* Inability to complete prescribed supplement regimen
* Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)
Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study

Heart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Thus, one of the cornerstones of managing heart failure includes the use of medications known as diuretics that target the kidneys to reduce fluid accumulation via urination. Deciding on the correct dose of this medication can be quite nuanced as under-dosing can lead to accumulation of fluid, and over-dosing can dehydrate patients and potentially result in lightheadedness/fainting and damage to the kidneys. Currently, options for prescribing diuretics for heart failure include 1) giving patients a regular, fixed dose or 2) having patients monitor their daily weight as a surrogate of their fluid status and then take a dose of diuretic based on a pre-prepared scale. The rationale behind the flexible weight-based diuretic scale is that it can potentially detect early fluid accumulation and thus possibly prevent hospitalization or ED visits, and it also avoids over-dosing and potentially dehydrating patients. Currently, it is not clear whether the flexible diuretic regimen is better than the fixed-dose regimen in preventing ED visits, hospitalizations, kidney damage, or death and as such, this pilot study will directly compare the two commonly used regimens in the management of chronic heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of heart failure, either reduced (Left ventricular ejection fraction \[LVEF\] ≤ 40%) or preserved (LVEF \> 40%) ejection fraction as measured by echocardiography performed within the last 2 months
2. Prescribed and tolerating furosemide with a minimum daily dose of 40mg oral daily
3. New York Heart Association (NYHA) Class II or higher symptoms
4. NT-proBNP cutoff of ≥ 1000 pg/mL performed within 30 days prior to randomization
5. Age \> 18 years
6. English speaking
7. Access to a scale and ability to weigh themselves daily and reliable telephone access

Exclusion Criteria:

1. Myocardial infarction, coronary artery bypass graft surgery, stent insertion and/or angioplasty within 14 days
2. Pregnancy
3. Inability to follow directions and self-monitor as part of a flexible diuretic regimen as discerned by the clinician
4. Allergic reaction to loop diuretics
5. Unable to provide informed consent
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.


Eligibility Criteria:
Inclusion Criteria:

- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.

Part 2:

* Arm A SCCHN:

  * Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
  * PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
* Arm B RCC (clear cell):

  * 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
* Adequate bone marrow, kidney and liver function.
* Performance status of 0 or 1.

Exclusion Criteria:

* Participant disease status is suitable for local therapy administered with curative intent.
* Hypertension that cannot be controlled by medications.
* Active or prior autoimmune disease
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
Chronic Widespread Pain

Cognitive-behavioral treatments have proven effective in helping people with chronic pain. However, due to the limited availability of trained clinicians, many young people with chronic pain problems do not benefit from them. In order to overcome the shortage of clinicians researchers have begun to develop treatment programs that could be self-administered by smartphones. Although this is a step in the right direction, it is equally true that it also encloses a problematic issue. Namely, a large number of experienced clinicians would still be needed to oversee the functioning of these programs, and it does not seem likely that they will be available within a short time, at least in certain countries.

The objectives of this project are (1) to develop a web platform (iPAINs) to assist the clinician in the process of (a) creating and (b) administering cognitive-behavioral treatments for the management of chronic pain in adolescents and young adults, and (2) study the efficacy of a self-administered cognitive-behavioral treatment for young people with fibromyalgia or chronic widespread pain, developed and administered through iPAINs.

iPAINs, will be a computer assisted device made to help create cognitive-behavioral treatment programs (and manage them) that can assist novice or expert professionals in the management of chronic pain in youths (experts who otherwise would not have the resources to develop and manage treatments via Smartphones). Therefore, it will help in the process of knowledge translation in this understudied and undertreated problem (of chronic pain in youths).

This platform (which includes an editor and administrator of treatments) will be evaluated in a sequential phased approach, consisting of 5 independent studies: (1) development of the tool and its contents (ie, digital objects of treatment), and (2) the web environment that allows creating and editing clinical treatments, (3) usability testing of iPAINs by a group of novice clinicians, and (4) experts clinicians to refine the prototype, and (5) a pilot study to determine the feasibility and effectiveness of the tool, that is, implementing a cognitive-behavioral self-administered treatment -through iPAINs- with patients with fibromyalgia or chronic widespread pain (Fibroline).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia or chronic widespread pain
* Capable of understanding, reading and writing in Spanish

Exclusion Criteria:

* Physical disabilities that interfered in the use of a Smartphone
* Severe cognitive impairments
A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms

This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium \[177Lu\] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET).

This study consists of two parts, the exploratory study (Part 1) and the pivotal study (Part 2).

In both parts, participants who signs Informed consent form (ICF) and is eligible for the study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium \[177Lu\] Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 1.1 until disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and have willingness to provide a written informed consent document.
2. Aged 18 years or older.
3. ECOG performance status 0 or 1.
4. Histopathologically confirmed, unresectable locally advanced or metastatic NEN .
5. Disease progression before first dose.
6. Subjects of childbearing potential should voluntarily use an effective method of contraception during treatment and within 4 months (male) or 7 months (female) of the last dose.

Exclusion Criteria:

1. Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks prior to enrollment in the study.
2. Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) \<50%.
3. Uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
4. Any clinically significant active infection.
5. Pregnant or lactating females.
6. Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy or chemotherapy within 4 weeks prior to enrollment.
7. Known other malignancies (except for those without recurrence within 5 years after adequate treatment).
8. Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.
Comparative Efficacy of Dental Flossing Before or After Tooth Brushing on Interproximal Plaque Reduction and Fluoride Retention in That Area

This randomized controlled crossover trial conducted on 25 dental students. in the preliminary session each volunteer was given a toothbrush(Trisa, soft, Switzerland) and toothpaste(Pooneh, Iran) and Dental Floss( Mina, Iran)to use during the study, and they were instructed the proper techniques of brushing and flossing.The study was performed in two treatment sessions and a 48 hour washout period. They passed through the sessions in a randomized sequence. After prophylaxis with rubber cup, they were asked to discontinue all oral hygiene for 24 hour. At the first session , they flossed first followed by brushing (floss-brush group) and at the other session they used dental floss after brushing (brush-floss group) . At each session, before and after brushing and flossing , Dental plaque reduction was assessed using Rustogi Modified Navi Plaque Index. Interdental plaque was collected for measuring fluoride. Differences between the two groups were analyzed with mixed model test.


Eligibility Criteria:
Inclusion Criteria:

* Dental students with 16 teeth in each jaw who had Normal salivary volume No active caries No medicine which could be affect salivary secretion No fluoride consumption in the last two weeks No Antibiotic consumption in the last 4 weeks

Exclusion Criteria:

* Any systemic diseases Periodontal diseases Crowding
Dual-Task Performance in Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system. It is reported that 85% of patients with multiple sclerosis have gait disturbance, 88% balance, and 35-90% fatigue (1, 2, 3). In addition, 65% of patients are reported that their cognitive functions have regressed (4).

It is important to increase the independence of the MS patients in activities of daily living (ADL). Almost all of ADL requires many activities at the same time. For example, toothbrushing involves both the standing balance and the motor activity of the upper limb at the same time. It also requires cognitive tasks such as attention and focusing. Many activities that seem to be the only task are actually multitasking (5).

The aim of this study is to investigate the effects of motor and cognitive additional task on balance, mobility and upper limb performances in MS patients and to determine the factors associated with dual-task performance.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The balance, mobility, upper extremity performance, cognitive function, fatigue, physical activity level, mood, sleep quality, quality of life will be evaluated once.

We will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated measures ANOVA. We will examine the correlations between fatigue severity, physical activity level, mood, sleep quality, quality of life using Pearson bivariate correlations. The significance level is set at p\<0,05.

Eligibility Criteria:
Inclusion Criteria:

* Participants who 18-65 years of age
* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems
A Controlled Trial of Plantain Powder in Infantile Diarrhea

Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea.

The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea.

Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study).

Two hundred patients will be enrolled in 24 months.


Eligibility Criteria:
Inclusion Criteria:

1. Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital.
2. Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject
3. The consistency of the stool is such that it takes the shape of the container into which it is put in.
4. Duration of symptoms should be less than 14 days.

   -

Exclusion Criteria:

1. Children with bloody diarrhea
2. Children with lethargy, fever or other signs of septicemia
3. Children with shock.
4. Children unable to take medications orally.
5. Children with impaired consciousness.
6. Children whose parents refuse permission to be included in the study.
7. Children who are not usual residents of the area and will not be available for follow up.
8. Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc.

   -
Canadian Pulmonary Embolism Diagnosis Study (CANPEDS)

The main objective of the trial is to determine whether D-dimer testing combined with assessment of Pre-Test-Probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for PE.

It may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative D-dimer test

To assess the value of the D-dimer in the diagnosis of PE, we had two sub-groups of patients with suspected PE, low and high pre-test probability. Patients could be randomized either to further or no further testing.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected PE

Exclusion Criteria:

* Treatment with anticoagulants for greater than 24 hours of performance of D-d
* Comorbid condition limiting survival to less than 3 months
* Absence of acute symptoms within 7 days prior to presentation
* Current pregnancy
* Contraindication to contrast (e.g., allergy, renal failure)
* Geographic inaccessibility which precludes follow-up
* Physician believes patient is inappropriate for study
* failure or inability to provide informed consent
Sarcopenic Obesity in the Elderly

Ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as Sarcopenia. Increasingly, obesity has become a compounding factor in ageing-related sarcopenia. The coexistence of obesity and sarcopenia is termed sarcopenic obesity (SO). Older adults with SO are at higher risks of developing diabetes, hypertension, stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer from sarcopenia alone or obesity alone. However, there is insufficient information with regard to the interplay between obesity and sarcopenia. The primary objective of this study is to investigate the impact of SO on insulin resistance in people aged 65-85. Our hypothesis is that SO positively influences insulin resistance in the elderly. We propose to investigate sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years old) population.


Eligibility Criteria:
Inclusion Criteria:

This study will include both male and females aged 65-85 years.

Exclusion Criteria:

1. Lack capacity to consent for the study, or have moderate or severe cognitive impairment;
2. Have difficulty ambulating as evidenced by any one of the following:

   1. Difficulty climbing 10 steps without resting;
   2. Restricted to a wheelchair
3. Have difficulty performing basic activities of daily living;
4. Have had treatment for cancer in the prior 3 years;
5. Have history of cachexia;
6. Have a history of heart failure;
7. Have a permanent pacemaker in situ (due to magnetic resonance scanning);
8. Have an implanted cardioverter-defibrillator (ICD) in situ;
9. Have had myocardial infarction within the last 6 months;
10. Have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma;
11. Are receiving therapy with corticosteroids or immunosuppressants.
12. Are taking direct insulin sensitizers (PPAR-gamma agonists, or thiazolidinediones).
The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care

The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.

This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be diagnosed with diabetes for at least 12 months.
* Patient must be with current physician for at least 12 months.
* Study staff must be able to reach patient by telephone.

Exclusion Criteria:

* Pregnant women are excluded.