cyrilzakka/clinical-trials huggingface dataset:
The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis

The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.

The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.

Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.

Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.

In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.

Eligibility Criteria:
Inclusion Criteria:

* a history of shrimp allergy

Exclusion Criteria:

* severe anaphylactic reaction from seafood
* pregnancy
* underlying diseases such as cardiovascular, hepatobiliary, and renal diseases
* on systemic corticosteroid or β-blocking agents
A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)

This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation. This study will also describe Real-World Progression-Free Survival (rwPFS) and Overall Survival (OS) for treatments prescribed in routine practice for mNSCLC with BRAF V600E mutation. Adverse events (AEs) related to treatment management will also be described.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the time of first-line treatment initiation for mNSCLC,
* Patients who initiated a first systemic treatment for mNSCLC in the metastatic setting from 01 December 2017 and before their study entry date (retrospectively enrolled patients), or Patients who initiated a first systemic treatment for mNSCLC (metastatic setting) at or after their study entry date (prospectively enrolled patients),
* Confirmed diagnosis of Stage IV mNSCLCat any time before study inclusion Stage IV M1a, M1borM1c, as per the American Joint Committee on Cancer (AJCC cancer) staging manual,
* Confirmed presence of BRAF V600E mutation - via tumor biopsy, metastasectomy, or liquid biopsy - at anytime before study inclusion,
* Signed ICF or non-opposition to study participation,according to local regulations.

Patients eligible for prospective QoL data collection must, in addition to the above mentioned criteria, meet ALL of the following criteria to be eligible for the study:

* Patients who initiate a first or second systemic treatment line for mNSCLC (metastatic setting) with a BRAF V600E mutation at or after their study entry date

Exclusion Criteria:

* Concurrent or another previous malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, in-situcarcinoma of the cervix, Bowen's disease or Gleason ≤ 6 prostate cancer,
* Previous, ongoing, or planned participation in a clinical trial involving an interventional drug as a first-or second-line systemic treatment for mNSCLC.
Decolonization Efficacy of Polyhexanide Vs. Mupirocin

This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Scheduled for elective spinal surgery
* Colonized with Staphylococcus aureus
* Informed consent provided

Exclusion Criteria:

* Emergency spine surgery
* Methicillin-resistant Staphylococcus aureus (MRSA) or mupirocin-resistant S. aureus
* Known allergies to products used in the trial
* Pregnant or breastfeeding women
* Recent antibiotic therapy (within 14 days)
* Known non-compliance, substance abuse, or psychological disorders
* Participation in another antimicrobial trial within the last 30 days
Calcium-Phosphorus Regulation Therapy on Heart Valve Disease

The goal of this clinical trial is to learn if calcium-phosphorus regulation therapy can slow the progression of heart valve calcification in patients with degenerative heart valve disease and chronic kidney disease (CKD). The main questions it aims to answer are:

* Does Sevelamer lower the progression of heart valve calcification compared to calcium carbonate over 12 months?
* What are the impacts of calcium-phosphorus regulation therapy on major cardiovascular events such as heart failure, cardiovascular death, and the need for valve surgery? Researchers will compare Sevelamer to calcium carbonate to see if Sevelamer is more effective in reducing heart valve calcification.

Participants will:

* Take Sevelamer or calcium carbonate daily for 12 months.
* Undergo echocardiography and CT scans at baseline and after 12 months to assess heart valve calcification.
* Attend follow-up visits at 3, 6, 9, and 12 months to monitor blood tests and adjust treatment as needed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years old.

  * Degenerative valvular heart disease clearly diagnosed by ultrasound or clinical history with calcification manifestation (including no stenosis or insufficiency due to calcification, mild, moderate and severe stenosis and insufficiency caused by calcification).

    * Glomerular filtration rate \< 60 mL/min (CKD-EPI formula).

      * Serum phosphorus \> 1.45 mmol/L (4.5 mg/dl).

Exclusion Criteria:

* Patients refuse to sign the informed consent form for the study.

  * Non-degenerative valvular heart disease even if there is valvular calcification, such as rheumatic valvular heart disease, congenital valvular heart disease, etc.

    * Valve lesions are evaluated by cardiac surgeons and have indications for surgical thoracotomy or interventional medical treatment and there are no surgical contraindications.

      * Life expectancy less than 1 year. ⑤ Abnormal parathyroid function.

        * Those with renal insufficiency who are planned to undergo dialysis treatment within half a year.

          * Malignant tumor.
Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations

The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic risk modifier testing, and to examine how they make decisions about their healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Female patient, age 25 years or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
* Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified
* No personal history of breast cancer
* English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.

Exclusion Criteria:

* Previous receipt of any prophylactic mastectomy.
* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation.
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates.

After being informed about the study and potential risks, all participants (patients and caregivers) giving written informed consent will be invited to participate in one of three research activities: interviews (n=10), nominal group technique meetings (n=64), or card-sorting and rating survey (n=40).

Eligibility Criteria:
Inclusion Criteria:

Liver transplant (LT) candidates are:

* Adult ESLD patients (age=19-74 years) who are assigned to the LT waitlist
* English-speaking
* No contraindication to moderate intensity physical activities
* Physician clearance for participation in moderate intensity physical activities
* No history of dementia or organic brain syndrome

Caregivers:

* Adult (age≥ 19 years)
* English-speaking
* Provide direct care to LT candidates

Exclusion Criteria:

* Inability to communicate verbally in English
* Documentation of cognitive deficits
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* Nonsmoking Male or Female (of non-child bearing potential)
* Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
* Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

Exclusion Criteria:

* Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
* Subject is on 3 or more oral anti-diabetes medications
* Subject has a history of type 1 diabetes
* Subject has a diagnosis of glaucoma or is blind
* Subject has had trauma to one or both eyes
Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients

This study is a prospective, multicenter clinical trial. The study is planned to be conducted at a qualified clinical trial center, and 30 subjects are planned to be enrolled to evaluate the feasibility and safety of magnetically controlled capsule endoscopy (MCE) system in the examination of gastric disorders in patients with moderate to severe obesity (BMI ≥ 35 kg/m2).

Metabolic surgery, as one of the most important treatments for obesity, has been widely used worldwide. Esophagogastroduodenoscopy (EGD) is mostly used in the perioperative preoperative application of metabolic surgery to improve or exclude preoperative diagnosis, including gastrointestinal tumors, various types of upper GI mucosal lesions, esophagitis, esophageal hiatal hernia, gastrointestinal interstitial tumors, etc. However, EGD is an invasive examination and can cause discomfort without anesthesia, resulting in low patient compliance. In 2013, ANKON took the lead in developing the world's first capsule endoscope system that utilizes precise multi-dimensional rotational movement of a robotic arm and adaptive matching to achieve precise magnetic control, which is convenient for observing specific lesions from an appropriate angle and has been shown to have high diagnostic accuracy for gastric diseases (highly consistent with EGD, with sensitivity and specificity of 90.4% and 95.7%, respectively, and accuracy of 93.4%). It has been clinically proven that MCE is safe and effective in the upper gastrointestinal tract, but there is a lack of clinical systematic studies on its application to moderately and severely obese people.In summary, this exploratory study is designed to preliminarily verify the clinical feasibility and safety of MCE for upper gastrointestinal examination in moderately obese people (BMI ≥ 35 kg/m2).

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of obesity: BMI ≥ 35kg/m2;
2. Be scheduled to undergo gastric examination;
3. Be able to provide informed consent.

Exclusion Criteria:

1. With swallowing obstruction or disorders; 2. With known or suspected gastrointestinal obstruction, stenosis and fistula; 3. Have no conditions for surgery or refuse to undergo any abdominal surgery; 4. Be allergic to or have other known contraindication or intolerance to the drug used in the study; 5. With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; 6. Women during pregnancy; 7. Currently enrolled in another clinical trial of a drug or device; 8. Other conditions determined by the investigator to be inappropriate for enrollment.

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Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment

The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.

Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cystic fibrosis aged over 18
* Patients treated for 1 year by elexacaftortezacaftor-ivacaftor
* Normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin
* Patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor

Exclusion Criteria:

* Patient not eligible for triple CFTR modulator
* Patient intolerant to triple corrector
* Pregnant woman
A Study of LY3375880 in Healthy Participants

The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.

This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
* Are women who are of childbearing potential or who are lactating
Chronic Effects of Fats on Satiety & Energy Needs

The purpose of this study is to evaluate the effect of dietary fat on satiety (the experience of fullness between one meal and the next) and energy metabolism over an extended period of time (chronic effects). How dietary fat sources affect satiety, appetite and energy use is unclear. The investigators will use a controlled setting for the studies. They want to know if the source of dietary fat alters satiety, satiety hormones, and energy expenditure responses after consuming different diets.

This work will address the interaction of obesity and dietary fatty acids in regulating satiety and energy metabolism. The primary objective is to determine the effects of chronic intake of dietary fatty acids of varied saturation and chain length on satiety, thermogenesis and energy utilization in healthy individuals. The investigators hypothesize that unsaturated fatty acids will 1) increase satiety and 2) increase energy metabolism and that 3) the fatty acid binding protein polymorphisms are associated with reduced energy expenditure in response to dietary fat intake.

Eligibility Criteria:
Inclusion Criteria:

* body mass index between 25.0-34.9 kg/m2
* free of major diagnosed, untreated medical conditions
* non-smoking or use of other tobacco products, including e-cigarettes
* not taking steroid-based medications
* not planning to or currently attempting to gain or lose weight
* willing to comply with study demands
* low intake of long chain omega-3 fatty acids (\<0.10 g/d) or willing to reduce intake for 6 weeks prior to starting the study

Exclusion Criteria:

* diagnosed eating disorders
* diabetes (blood sugar ≥ 126 mg/dl)
* hypertension (systolic \> 160 mmHg or diastolic \> 100 mmHg)
* diagnosed cardiovascular, pulmonary, skeletal and metabolic diseases
* currently pregnant or planning to become pregnant, or lactating
* taking medications known to affect appetite, blood lipids, body composition, body weight, or food intake (appetite control drugs, steroids, antidepressants)
Post-Exercise Hypotension After Water Exercise

Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60 years of age and older. Hypertension can be prevented and modified with lifestyle interventions that include regular exercise. Water exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (BP) response to water exercise, a response termed postexercise hypotension (PEH). We will assess PEH after a session of water aerobics in physically active, older women with hypertension. Twenty-four women will be randomly assign to participate in a 45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.


Eligibility Criteria:
Inclusion Criteria:

* resting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg documented by a physician;
* 65 to 80 years of age;
* physically active on land but not water (exercising 3 or more days per week as determined by the International Physical Activity Questionnaire long-form).

Exclusion Criteria:

* any febrile condition and/or infectious diseases;
* no other chronic diseases or conditions other than hypertension;
* body mass index (BMI) \> 35 kg/m2;
* active smoker;
* physical or mental limitations that prevent exercising.
Towards Precision Medicine for Diabetes in Pregnancy

Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion.

Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin.

Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* having a confirmed single, viable pregnancy past 20 weeks gestation.
* assigned to pharmacological (ie metformin) treatment for GDM.

Exclusion Criteria:

* pre-existing diabetes, hypertension (SBP \>160 mmHg \& DBP \>110 mmHg)
* using medication related to study outcomes prior to GDM diagnosis (insulin, metformin, glyburide, systemic steroids, mood stabilizers, ADHD medication)
* smoking or using recreational drugs that may affect pregnancy outcomes
The Effect of Nocturnal Haemodialysis on Arterial Stiffness

Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium which reduce blood vessel compliance. Although there is growing evidence that increased arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical and biochemical parameters.


Eligibility Criteria:
Inclusion Criteria:

* adult dialysis patients
* able to perform home nocturnal haemodialysis

Exclusion Criteria:

* age \< 18 and \> 80 years
* any patient who is anticipating a live renal transplantation in forthcoming 12 months