cyrilzakka/clinical-trials huggingface dataset:
A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) pembrolizumab (+) berahyaluronidase alfa in Japanese participants with recurrent or metastatic cutaneous squamous cell carcinoma or locally advanced unresectable cSCC. The primary hypothesis is that pembrolizumab (+) berahyaluronidase alfa will result in greater than 10% objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR).


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically confirmed cSCC by the investigator as the primary site of malignancy
* R/M cSCC cohort only: Has metastatic disease, defined as disseminated disease distant to the initial/primary site of diagnosis, and/or has locally recurrent disease that has been previously treated (with either surgery or radiotherapy) and is not curable by either surgery or radiotherapy
* LA unresectable cSCC cohort only: Is ineligible for surgical resection
* LA unresectable cSCC cohort only: Has received prior radiation therapy (RT) to index site or has been deemed to be not eligible for RT
* LA unresectable cSCC cohort only: Has received prior systemic therapy for curative intent are eligible regardless of regimen
* Has a life expectancy of greater than 3 months
* Must provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated

Exclusion Criteria:

* Has cSCC that can be cured with surgical resection, radiotherapy, or with a combination of surgery and radiotherapy.
* Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study
* Has received prior systemic anticancer therapy including investigation agents within 4 weeks before allocation
* Has not adequately recovered from major surgery or has ongoing surgical complications
* Received prior radiotherapy within 2 weeks of study intervention, or had radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Has an ongoing active infection requiring systemic therapy
* Has a history of human immunodeficiency virus (HIV) infection
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has history of allogenic tissue/organ transplant
Study of the Efficacy of GGRO: a Novel Cognitive Training App

The aim of the present study was to evaluate the efficacy of GGRO reducing OCD related maladaptive beliefs and OCD symptoms. Specifically, a randomized controlled trial with crossover design was carried out in non-clinical population to assess pre-post changes in levels of OCD-related maladaptive beliefs and OCD symptoms, including relationship OCD (ROCD) symptoms, self-esteem, and depressive symptoms following 15 days of using GGRO.

The implementation of Information and Communication Technologies in the treatment or prevention of OCD symptoms has been significantly lower compared to with its application in other anxiety disorders.

Recently, an exploratory study evaluated a brief, game-like, training exercise for challenging OCD-beliefs delivered via a mobile application platform named GGRO. However, more studies are needed to test the efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Being a Spanish at native level, and having a mobile device capable of installing the application GGRO

Exclusion Criteria:

* None
Dietary Assessment and Prevalence of Refeeding Syndrome in High-risk TB Patients in Chhattisgarh, India

Severe tuberculosis (TB) leads to wasting and anorexia, increasing risk of the refeeding syndrome (RFS) as defined by current criteria. TB patients have high metabolic rates and require a high calorie diet, with nutritional supplementation programs improving outcomes. BMI inversely correlates with mortality in these patients. Risk of RFS, a life-threatening syndrome associated with initiation of feeding after a period of low intake, has not been studied in this population and it is not known whether severely malnourished TB patients benefit from lower caloric intake. This study aimed to examine the prevalence of RFS in TB inpatients in rural India and correlate this with baseline and inpatient caloric intake.


Eligibility Criteria:
Inclusion Criteria:

* all adult inpatients admitted to the TB ward
* able to take enteral intake

Exclusion Criteria:

* unable to take enteral intake
Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting

The investigators prospectively studied the effect of aspirin on platelet function in 106 stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6 months).T

Background:

Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery disease. There is controversy regarding the prevalence of aspirin resistance in patients with coronary artery disease and the effect of dose on resistance. Our primary aims were to determine the degree of platelet responsiveness to aspirin, and to study the influence of dose on platelet inhibition and clinical outcomes after coronary stenting.

Eligibility Criteria:
Inclusion Criteria:

* 6 months post stent without complication

Exclusion Criteria:

* subacute stent thrombosis
* unable to discontinue plavix
* dont accept to participate
* contraindication for ASA use
Suspension Syndrome

Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18-50 years
* ASA class 1
* Signed informed consent

Exclusion Criteria:

* Age \<18 or \>50 years
* ASA class \>1
* Informed consent not signed
Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living

To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL) Occupational Therapy programme on the independence of ADL by persons with dementia who are institutionalized. This programme is based on the recovery of the cognitive functions.

This study is a longitudinal and prospective clinical trial approved by the bioethics Commission of the University of Extremadura. 58 senior citizens institutionalized with dementia in residential homes in Extremadura (Spain) received a treatment focusing on activities of daily living with the SADL programme and with conventional occupational therapy during 5 weeks. The studied variables were the cognitive level and the independence level performing ADL. The variables were measured by an occupational therapist independent to the study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment was completed. The standardized tests used were Barthel Index, Lobo's Cognoscitive mini test, Lawton and Brody Scale and Global Deterioration Scale (GDS).

Eligibility Criteria:
Inclusion Criteria:

* Institutionalization in residential homes at least 6 months before the commencement of the study.
* Diagnosis of dementia for at least one year according to the Diagnostic and Statistical Manual of Mental Disorders (DMS IV) criteria.
* Over 60 years old.
* Barthel Index scores greater than or equal to 40%.
* Lobo´s Cognitive Mini Test scores greater than or equal to 15 points.
* To be included in the BADL intervention programme of Occupational therapy in the previous 6 months and to have the informed consent signed by the legal tutor.

Exclusion Criteria:

* To present psychological or behavior symptoms diagnosed by a doctor.
* Barthel Index scores less than 40%
* Not being included in the BADL intervention programme of Occupational therapy in the previous 6 months.
Myocardial Infarction and Periodontitis: Periodontal Health Intervention.

The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* 1)Patients diagnosed with ST-segment elevation myocardial infarction (STEMI). 2)Patients with severe periodontal disease, defined as:

  * 5 teeth with clinical attachment loss (CAL) ≥ 4 mm.

    * Subgingival probing depth (PD) ≥ 6 mm. ③≥ 8 teeth with gingival bleeding on probing (BOP). 3）Age ≥30 years. 4）Written informed consent provided.

Exclusion Criteria:

* 1) under 30 years old; 2) HIV positive, chronic inflammation, tumor disease, drug dependence, use of anticonvulsants, use of immunosuppressive agents, pregnancy, and lactation; 3) significant tooth loss (number of remaining teeth \< 8); 4) long hospital stay (\>10 days), new myocardial infarction before randomization, and stent thrombosis; 5) Refusal to sign informed consent.
Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes

There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of glucose measurement such as consistently measuring on only one side of the body.

The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:

• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (\<70 mg/dL; 70-180 mg/dL; \>180 mg/dL)?

Participants will wear two Freestyle Libre 3 sensors, 1 on the left and 1 on the right arm, continuously for 2 weeks. Participants will need to download the Freestyle Libre 3 app on two separate mobile devices and connect the sensors with Freestyle Libre View accounts provided by the study team. The study team will collect and compare the data between the left and right arm for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* Diagnosed with Type 1 or Type 2 Diabetes
* Willing to wear CGMs for 2 weeks on both arms
* Willing to attend 3 virtual calls meetings over the course of the trial
* Have active health insurance
* Willing to refrain from any heat therapy for the duration of the study
* Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs
* Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs
* Not currently using any Freestyle Libre CGM
* Willing to provide HbA1c readings within 3 months of the trial
* Have a baseline HbA1c equal or above 6.5

Exclusion Criteria:

* Any active dermatologic condition on the upper arms
* Implanted medical devices including another continuous glucose monitoring device (i.e.

pacemaker)

* Critically ill or dialysis patients
* Planned magnetic resonance imaging screening, computed tomography scan, X-ray imaging or high-frequency electrical heat treatment during study period
* Current systemic infections
* Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
* Refusal to sign the informed consent document
* Pregnant, planned pregnancy during study period, or currently breast-feeding
* Fear of needles to the point where patients cannot self-administer the sensors
* History of allergic reactions or hypersensitivity from adhesives
Stapler Hepatectomy for Elective Liver Resection

There is clinical uncertainty and ongoing discussion among liver surgeons regarding the optimal method of parenchymal transection in patients undergoing elective hepatic resection. While the clamp-crushing technique still represents the reference technique for routine liver resections, transection of liver parenchyma using vascular staplers may offer a new and safe technique potentially reducing intraoperative blood loss, operation time as well as peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high, approaches to lower peri-operative complications are urgently required. Due to the lack of evidence it has to be evaluated, if the technique of stapler hepatectomy decreases intraoperative blood loss as a highly relevant predictor of peri-operative complications, patients' hospital stay and finally health care expenditures. These advantages would favor stapler hepatectomy to be applied in routine liver resections. As RCTs are generally considered to generate the most valid scientific evidence on a treatment's effects, the present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Stapler hepatectomy and clamp-crushing feasible based on preoperative imaging
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Expected lack of compliance
* Impaired mental state or language problems
Leveraging Community Health Workers to Combat COVID-19 and Mental Health Misinformation in Haiti, Malawi, and Rwanda

Partners In Health (PIH), in collaboration with Harvard Medical School, aims to develop and evaluate an SMS-based intervention for Community Health Workers (CHWs) to combat COVID-19 and mental health-related misinformation in Haiti, Rwanda, and Malawi. The study involves three aims: identifying locally relevant misinformation through a card-sorting exercise with CHWs, developing targeted messages through cognitive interviewing, and evaluating the effectiveness of SMS-based educational message dissemination via a randomized controlled trial. The evaluation will assess the impact on public health practices, knowledge and attitudes among CHWs, and knowledge and attitudes among community members.

The intervention will involve sending SMS messages to randomized CHWs, addressing either COVID-19 or mental health misinformation. CHWs will have access to a helpline for further support and can provide feedback to refine the messaging. The evaluation will use a time series analysis to measure changes in COVID-19 vaccine administration, mental health service utilization, CHWs' knowledge and attitudes, and community members' knowledge and attitudes. The study aims to empower CHWs with accurate information, improve public health practices, and ultimately contribute to better health outcomes in the communities served by PIH. Rwanda and Haiti CHWs will receive the messages for 12 months, but Malawi CHWs will receive the messages for 6 months due to a CHW transition in country.

Eligibility Criteria:
The intervention will be assigned at the unit of the CHWs. These individuals will also be eligible for the CHW longitudinal cohort.

Inclusion Criteria:

* CHWs affiliated with PIH Rwanda, Malawi, or Haiti
* 18+ years of age.

Exclusion Criteria:

- Less than 18 years old.
Pain Thresholds Under High-dose Topical Capsaicin

Aim of the study is to determine heat pain thresholds (HPT in °C) and cold pain thresholds (CPT in °C) during topical capsaicin 8% application, and mechanical pain thresholds (MPT in g) immediately after to find out the exact skin temperature by which capsaicin initiates the application pain (heat pain threshold, HPT in °C) but also the temperature by which capsaicin does not yet trigger a cold pain (cold pain threshold, CPT in °C). Moreover the investigators want to find out the mechanical pain threshold in g from topical capsaicin and to verify a prolonged effect of capsaicin on the pain thresholds.

Capsaicin is the main pungent ingredient in chili peppers. Topical capsaicin 8% is used for the treatment of peripheral neuropathic pain. Application of capsaicin 8% provokes distinct pain by activating the transient receptor potential vanilloid 1 (TRPV1) receptor. Cooling the skin results in a reliable prevention of the application pain. However, the necessary cooling temperature and if cooling itself produces application pain, is unknown.

Materials and Methods: 10 female and 10 male healthy volunteers will be enrolled in a randomised, double blind, placebo controlled, cross-over study. The left or right forearm of each subject is going to be treated with a capsaicin 8% patch (QUTENZA, Astellas Pharma, Tokyo, Japan) of 9 cm² or a placebo patch (Demo patch, Astellas Pharma, Tokyo, Japan) of the same size for 60 min. Then the other forearm (which has not been tested before) will be treated with the remaining patch. During capsaicin and placebo exposure HPT in °C and CPT in °C are going to be obtained by the thermode of a thermal sensory analyser, TSA-II (Medoc Ltd., Ramat Yishai, Israel). Temperature increase/decrease of the thermode will be stopped, as soon as the subject presses a switch because of a beginning pain sensation. Immediately after exposure a pin prick test will be performed 5 times in a row by pressing a Mini-Spike (B. Braun Melsungen AG, Melsungen, Germany) slowly against the skin of the application areal to determine the pressure necessary to provoke a sharp pain (Mechanical pain threshold in g). 2 weeks later HPT, CPT, and MPT will be determined again in the areas of capsaicin and placebo exhibition.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers 18 ore more years old

Exclusion Criteria:

* dermatologic or neurologic injuries on both thighs, (possible) pregnancy
Hizentra® in Inflammatory Neuropathies - pHeNIx Study

The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes).

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a neurological and rare type of autoimmune disorder. Intravenous immunoglobulin (IVIg) is the first-line treatment for CIDP which has been proven to be effective. For several years, published cases have suggested that the Sub-Cutaneous Ig (SCIg) may be an alternative treatment to IVIg in the treatment of CIDP. Compared to IVIg treatment, the SCIg can achieve more stable plasma IgG concentrations, suggesting a potential reduction in the dose exhaustion effect at the end of the cycle, but also fewer systemic effects. SC administration also enables more straightforward treatment to be given for ambulatory patients.

Based on the PATH study (NCT01545076), a double blind placebo-controlled, randomised, prospective, international multicentre phase III study, Hizentra® obtained an extension of its marketing authorization for the CIDP indication as maintenance treatment after stabilisation with IVIg.

However, in the "real-life" situation, the literature is still based at present on small series of patient or short-term follow-up periods.

However, the methods for switching from the IV to the SC route and the characteristics of patients receiving this treatment are not known. In addition, SCIg administration remote from a specialist centre without assistance from a health professional no longer enables a more regular assessment of the patient in terms of tolerability and efficacy.

The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with the tolerability and efficacy of treatment, which is monitored using a patient application (PRO: Patient-Reported Outcomes). The study duration is estimated to be 36 months in view of: a 24-month inclusion period and a 12-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (aged ≥18 years)
* Patients suffering from CIDP according to EAN/PNS 2021 criteria
* Planned switch from IVIg to Hizentra®
* Patient treated with at least 3 courses of IV immunoglobulin and deemed by the investigator to be dependent on immunoglobulins
* Patient deemed to be stable, with no change in their treatment for the disease during the 3 months prior to inclusion
* Patients who have a smartphone, a tablet or a computer
* Patients who have been informed verbally and in writing of the purposes of the study

Exclusion Criteria:

* Concomitant participation in an interventional clinical study
Lactose, Sucrose & Corn Syrup Tolerance

Lactose, one of the key nutrients in human milk may be critically important to infants for more reasons than being a source of energy. We are interested in understanding how lactose when compared to other sugars influences how nutrients, specifically macronutrients are handled after digestion and absorption. To date, there have been no studies looking at how fat and protein varies when lactose compared to other sugars is ingested. There may be metabolic advantages to considering lactose for nutrition support of premature infants rather than glucose or dextrose as is often used in intravenous feeds, or the corn syrup solids in lactose-free formulas. We hope the information from this study will provide new information on the unique aspects of lactose.

Hypothesis: The hypothesis is that providing carbohydrate as lactose:

1. minimizes the amount of carbohydrate that is converted into fat
2. enables a relatively constant metabolic state throughout feeding interval that avoids swings of high to low insulin, glucose, and fats.


Eligibility Criteria:
Inclusion Criteria:

* male
* at least 19 years of age
* body mass index (BMI) between 18.5 and 25
* fasting blood glucose level \< 6.1 mmol/L (110 mg/dL) measured by glucometer on the day of the study and
* comfortable speaking, reading and understanding English
* comfortable drinking at least one cup (250 ml) of milk
* non-smoking

Exclusion Criteria:

* not willing to provide blood samples, have
* impaired lactose or glucose tolerance,
* pre-diabetes, diabetes mellitus and any other endocrine disorder,
* coronary heart disease, liver function test abnormalities or any chronic disease
* routinely take medications, including aspirin, cyclooxygenase-2 inhibitors, statins and fish oil
* consuming more than 1 alcoholic drink per day