cyrilzakka/clinical-trials huggingface dataset:
Effect of Fiber Composite-enriched Breads on Glycemic Responses

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at intervals over 2 hours. They also rated their feelings of satiety fasting and at intervals over 2 hours.

Health organizations recommend fiber-rich and whole-grain foods for healthy diets due to their physiological beneficial effects on human health. But, little information is available between these 2 food categories, i.e. fiber added to foods versus fiber naturally present in foods. The present study investigated the effect of enriching white wheat flour with wheat bran at 2 levels (15 and 30%) to produce 15% fiber-rich bread (15FRB) and 30% fiber-rich bread (30FRB) and compared them with white bread (WB) and whole-grain bread (WGB) in terms of bread quality, palatability, satiety, and glycemic response. Ten healthy subjects were studied on 4 separate days with each subject testing all 4 types of bread. On each test day subjects came to the test center after an overnight fast. After 2 fasting finger-prick blood samples 5 minutes apart, they ate a portion of one of the breads containing 50g available carbohydrate and had further blood samples at 15, 30, 45, 60,90 and 120 min after starting to eat. After each blood sample also rated their feelings of satiety on a 7-point scale from extremely hungry to extremely full.

Eligibility Criteria:
Inclusion Criteria:

* Good health

Exclusion Criteria:

* Known history of AIDS, hepatitis, diabetes or a heart condition
* Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director
* Any condition which would increase risk to the subject or affect the results in the opinion of the medical director
* Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines.
In Vivo Depiction Of Bone Vascularization With UHR-CT CT And Deep Learning Algorithm Reconstruction: A Preliminary Study

To evaluate the image quality and ability to depict in vivo bone vascularization with an ultra-high-resolution computed tomography (UHR-CT) scanner using a deep learning reconstruction (DLR) and hybrid iterative reconstruction (HIR) algorithms, compared to simulated conventional CT, using osteoid osteoma (OO) as a model.


Eligibility Criteria:
Inclusion Criteria:

* Proven osteoid osteoma
* Ultra High Resolution CT

Exclusion Criteria:

* None
Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)

The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.

Accurate diagnosis of food allergy depends on food challenge outcome. The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing.

With a view towards improved in vitro diagnostic methods, the investigators intend to evaluate the diagnostic potential of basophile activation testing in patients with hazelnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to hazelnut in the past, patients with pollinosis but no symptoms of hazelnut allergy and non-atopic control subjects.

Eligibility Criteria:
Inclusion Criteria:

Primary Inclusion criteria:

* Male and female subjects, age ≥ 14 years
* Informed Consent as documented by signature

Secondary inclusion criterion

* Group A: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation
* Group B:positive skin test (SPT) with birch pollen and hazelnut and negative food provocation with hazelnut.
* Group C: negative case history of hazelnut and birch allergy and negative skin test (SPT) with hazelnut and birch pollen and negative food provocation with hazelnut

Exclusion Criteria:

* Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ACE) inhibitors (2 days), omalizumab (2 months)
* Women who are pregnant
* Lack of safe contraception
* Uncontrolled asthma, forced expiratory volume (1 second) \<70% predicted value
* Acute allergic disease
* Chronic urticaria
* Mastocytosis
* Other clinically significant concomitant disease states
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study
Single Dosing Clinical Trial of HL151

The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after single oral administration of TALION tab, a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age of 19-45
2. Body weight≥50kg and BMI 18\~29 kg/m2
3. Subject who sign on an informed consent form willingly

Exclusion Criteria:

1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
2. Subject with acute disease within 28 days prior to study medication dosing
3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
4. Subject with clinically significant chronic disease
5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
6. Use of any prescription medication within 14 days prior to study medication dosing
7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
8. Subject with clinically significant allergic disease
9. Subject with known for hypersensitivity reaction to bepotastine
10. Subject with any of the following conditions in laboratory test

    * AST/ALT \> UNL (upper normal limit) x 2
    * Total bilirubin \> UNL x 2
    * Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\]
    * SBP\<100mmHg or ≥160mmHg, DBP\<60mmHg or ≥100mmHg
    * QTc\>440msec on ECG
    * Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L
11. Immunological incompetence, immune deficiency or taking immunosuppressants
12. Subject who cannot take standard meal
13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
14. Subject with blood transfusion within 30days prior to study medication dosing
15. Participation in any clinical investigation within 90days prior to study medication dosing
16. Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day)
17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
19. Subject who are not using adequate means of contraception
20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
21. Subject with history of drug abuse or drug addiction
Triage Survey for Infectious Disease Eligibility

SWIFT-ID-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials for diagnosis, treatment, or prevention of infectious diseases such as in the areas of HIV, vaccines, and other infectious-diseases areas. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical/surgical history, physical examination, comorbidities, and any current symptoms. Informed consent will be done electronically (preferable) or on paper. Informed consent may be done in-person or remotely, depending on patient preference. Information related to HIV, hepatitis B and C, other infectious diseases, or substance use disorder will also be obtained if applicable. Site staff may collect vital signs, fingerpick testing, urine drug screens, blood draws, EKG, and pregnancy tests. Some testing may be recommended in a fasting condition. A doctor will review medical history and results of the above evaluations with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians, other providers, and pharmacies to determine eligibility for clinical trials. A follow-up phone call may be needed to discuss testing results and/or trial eligibility. If a participant is deemed eligible for future trials and if the participant remains interested, counseling on contraception requirements for trials will be discussed.


Eligibility Criteria:
Inclusion Criteria:

- 1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.

2. Participant is at least 18 years old.

Exclusion Criteria:

1. Participants are pregnant, breast-feeding, or planning to become pregnant.
2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results or makes them unsuitable for the study for another reason.
3. Current or recent moderate or severe substance use disorder impacting their ability to follow study related procedures.
4. Reported history of coagulopathy or bleeding disorder considered a contraindication to phlebotomy.
5. Any condition that in the investigator's opinion makes a participant unsuitable for the clinical trial study.
6. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.
Effects of Menthol Gum Chewıng on Postoperatıve Nausea, Vomiting, and Length Of Hospital Stay in Children Undergoing Appendectomy: A Randomızed Controlled Trıal

The study was conducted as an experimental study to determine the effect of menthol chewing gum application on postoperative nausea, vomiting and hospital stay in children with appendectomy. The population of the study consisted of children aged 7-18 who underwent appendectomy in Bursa Yüksek İhtisas Training and Research Hospital Pediatric Surgery clinic between April and June 2022. In the sample of the study, a total of 60 children (menthol gum group- intervention group=30, control=30) who had postoperative nausea-vomiting, accepted to participate in the study and met the sample selection criteria were included. Starting from the second hour after the child was brought to the clinic after appendectomy, the children in the chewing gum group with nausea and vomiting were chewed gum for an average of 15 minutes. The patients in the study group were not intervened except for routine nursing care. During the chewing gum (between 5-10. minutes), up to 30., 60. and 120. Minutes after the chewing gum.The patient was re-evaluated in terms of nausea with the BARF nausea scale. Episodes of vomiting were recorded in patients with vomiting. After the quantitative stages of the study were completed, the patient's level of relief was evaluated using a verbal descriptive scale. Nausea and vomiting were also evaluated before the patient was discharged.


Eligibility Criteria:
Inclusion Criteria:

* Child and parent's willingness to participate in the research
* The child has no intellectual disability or perception problems.
* Patients who underwent general anesthesia
* Patients who do not develop postoperative complications
* Patients in the 7-18 age group
* Patients who can tolerate chewing gum in the postoperative period
* Patients who like to chew gum
* Patients with nausea and vomiting

Exclusion Criteria:

* Patients with a diagnosis of diabetes
* Patients with teeth and jaw problems
* Patients with menthol allergy
* Patients with irritable bowel syndrome
* Patients with a history of reflux
* Patients whose cognitive level is not suitable
* Patients with a nasogastric tube
Cardiac Autonomic Dysfunction in Childhood Cancer Survivors

This study is being done to evaluate heart rate activity and sleep patterns, among participants in the Long-Term Follow-Up (LTFU) study.

Primary Objective

Using mobile health (mHealth) technologies in a large and well-characterized cohort of childhood cancer survivors, our primary objective is to understand the magnitude of increased risk of cardiac autonomic dysfunction by (a) comparing prevalence rates among survivors and siblings, and (b) determining the prevalence within specific subgroups of childhood cancer survivors defined by race, sex, cancer type and treatment exposures, and type and severity of chronic health conditions.

Secondary Objectives

Among long-term (≥5 years) survivors of childhood cancer (a) identify demographic, disease, treatment and cognitive-behavioral factors associated with an increased risk of cardiac autonomic dysfunction, (b) develop and validate risk prediction models for future clinical use in identifying individuals who may benefit from targeted interventions, and (c) investigate associations between dysfunction and perceived well-being.

Potential participants will be recruited by email and phone. Survivors who wish to participate will complete an online consent form and then a series of short questionnaires to determine study eligibility. This data collection will take place in DatStat Connect, which is the online consenting and data collection tool utilized for the CCSS. Consented/enrolled SJLIFE participants will receive a link via email to complete surveys related to autonomic functioning and current medical concerns and asked to schedule delivery of a WHOOP® strap prior kit prior to scheduling a device setup session with a team member. The kit will include the WHOOP® strap, brief instructions for setup, and prepaid return mailing materials. The WHOOP® strap will be shipped to the participant and each participant will complete a training session and app installation, if needed, and instructions regarding during of wear (two weeks)

Eligibility Criteria:
Inclusion Criteria:

* Enrollment on the CCSS protocol.
* 18 years or older.
* Has a smartphone and is willing to download the WHOOP® app for the duration of study participation.
* Reports no history of allergic reaction (e.g., rash) to fitness monitoring wearables.

Exclusion Criteria:

* Unable to independently provide informed consent.
* Visual impairment that prevents participant from engaging with study materials.
* Unable to read or understand study materials in English.
* Mailing address outside the United States.
Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review

Patient previously healthy found to have spontaneous gastric intramural hematoma

28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous.

Eligibility Criteria:
Inclusion Criteria:

* any patient presenting with gastric bleeding tumors

Exclusion Criteria:

* patients on anticoagulants and patient with gastric medical history
Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS

The aim of this study is to investigate the possibilities of early and precise management to decrease portal vein pressure in cirrhotic patients, guided by a non-invasive 3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to determine the normal range of pressure density in different sites of HPS. Cirrhotic patients without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG groups are followed-up and treated according to Baveno V consensus in portal hypertension. Patients in vPVPG-monitored groups are followed-up by anatomic computed tomographic angiography (CTA) and Doppler ultrasound every six months. Once vPVPG is above 12mm of mercury (Hg), participants will receive carvedilol treatment. All cirrhotic patients are followed-up with the incidence of portal hypertension-related complications, mortality rate and life quality assessment.

The non-invasive 3D-HPS is a newly-developed test to determine vPVPG based on anatomic computed tomographic angiography (CTA) and Doppler ultrasound. In this study, vPVPG is determined by the 3D-HPS.

Eligibility Criteria:
Inclusion Criteria:

* Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
* Child-Pugh score \< 9
* No visible gastro-esophageal varies by endoscopy

Exclusion Criteria:

* Patients with malignant diseases
* Treatment with vasoactive drugs
* Prior transjugular intrahepatic portosystemic stent-shunt surgery
* Patients with known allergy to iodinated contrast
* Treatment with immunosuppressants
* Renal sufficiency
* Patients with coronary artery diseases, or treated with anticoagulants
* Pregnancy
* Inability to adhere the follow-up
* Any life-threatening disease
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise

Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control. In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group). The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.


Eligibility Criteria:
Inclusion Criteria:

* non specific low back pain for at least four weeks
* at least moderate disability (as indicated by an Oswestry disability index (ODI) \> 8% (Mannion et al., 2006))
* low levels of biopsychosocial risk factors (STarT Back Screening tool \> 4 points) (Hill et al., 2011)
* at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)

Exclusion Criteria:

* specific low back pain
* pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
* vertigo or equilibrium disturbances
* systemic diseases (e.g. tumours and diabetes)
* injuries
* surgeries of the legs within the last six months
* medication affecting postural control
* pregnancy
The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy

Injection of intraperitoneal bupivacaine revealed an analgesic effect whether injected alone or in combination with other adjuvants, which increase duration of analgesia and decrease the dose of administered bupivacaine thus minimizing its side effects e.g. Opioids, Corticosteroids and Magnesium sulphate.

Neostigmine, a cholinesterase inhibitor that produces muscarinic receptor-mediated analgesia, increased postoperative analgesia when combined with local anaesthetics. Peripheral afferent nerve fibres contain muscarinic receptors, these could be a good target for pain suppression.

The use of neostigmine as adjuvant to intraperitoneal bupivacaine was not previously investigated. In this study the investigators will compare the analgesic effect of bupivacaine alone and bupivacaine in combination with neostigmine when injected intraperitoneal in patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* • American Society of Anaesthesiologist (ASA) I-II.

  * Age 18 - 60 years.
  * Elective laparoscopic cholecystectomy.
  * Body Mass Index (BMI) \<35 (kg/m2).

Exclusion Criteria:

* • Anaphylaxis to local anaesthetics.

  * Anaphylaxis to Neostigmine.
  * American Society of Anaesthesiologist (ASA) III-IV.
  * Chronic pain diseases.
  * Acute cholecystitis.
  * Psychological or nervous system diseases
Preparing Children for Anesthesia With an Educational Pop-Up Book

The study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. The study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. The study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.


Eligibility Criteria:
Inclusion criteria:

* Ages 5-12 (inclusive)
* Undergoing outpatient medical procedures under general anesthesia with inhalation induction
* English-speaking
* Able to provide electronic consent/assent (legal guardian)

Exclusion criteria:

* Patients with severe developmental disabilities
* Unable to obtain electronic consent/assent from a legal guardian