cyrilzakka/clinical-trials huggingface dataset:
Sentinel Lymph Node Mapping Post-Injection Site Pain

This is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both FDA-approved agents used for sentinel lymph node biopsy (SLNB). Breast cancer patients who are already scheduled for SLNB as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. After injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. There will be no change to the patient's treatment plan other than the addition of pain questionnaires. The investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (DCIS) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan.
* The patient has provided written informed consent before participating in the study, as has his/her responsible caregiver, if applicable.
* The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.
* The patient is greater than 18 years of age at the time of consent.
* The patient has an performance status of Grade 0 - 2.
* The patient has a clinical negative node status at the time of study entry.
* If the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year.

Exclusion Criteria:

* The patient is pregnant or lactating.
* The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
Utilizing Topical Sodium Hypochlorite to Ameliorate Radiation Dermatitis

The objective of the pilot study is to determine compliance, acceptability, and feasibility of using topical sodium hypochlorite to ameliorate or reduce radiation dermatitis, and to collect preliminary data and estimates for planning a larger efficacy study.

This 3-week single-arm pilot study will collect information on subject treatment compliance and feedback from subjects (and nurses/subject's treating oncologist) on the acceptability of the use of the treatment. We will also collect data on Common Terminology Criteria for Adverse Events and patient reported outcomes measured using the pain and pruritus PROMIS short-form tools and patient reported outcomes, measured using the Dermatology Life Quality Index (DLQI) tool.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Been diagnosed with head and neck cancer requiring radiation therapy or skin cancer requiring radiation treatment to the neck
* Are scheduled for a radiation therapy planning session (CT simulation)
* Have a scheduled radiation therapy start date within 1 to 2 weeks from the CT simulation
* Are able to comply with the study protocol

Exclusion Criteria:

* Patients who are pregnant, which may lead to discontinuation of radiation therapy
* Patients currently on immunotherapy
* Active or past history of inflammatory lesions in the radiation field that could interfere with assessment
* Patients who are undergoing re-irradiation to the head and neck
* Patients must not have any other condition or situation beyond those listed above which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study.
* Patients who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible.
* Participation in other clinical trials that would alter the radiation dose typically utilized for definitive chemo and radiation therapy treatment of head and neck cancer.
* Use of other topical treatments on the skin in the treatment field. No other products are allowed except Aquaphor® ointment.
Women's Health Food Frequency Questionnaire

The aim of this study is to develop a tool that can measure the iron, folate, and vitamin B12 content of a diet through a literature review, database search, and a pilot study using a food consumption record. This tool will be used to accurately evaluate the iron, folate, and vitamin B12 content of the diet in non-pregnant women of reproductive age who are not currently pregnant. The research will be conducted on 350 women between the ages of 18 and 50 who are of reproductive age (menstruating). A questionnaire will be administered to the volunteer participants, which will consist of sections on general information, dietary habits, frequency of food consumption, and a 24-hour dietary recall.

The study is planned in three stages. In the first stage, a three-day food consumption record will be taken from 50 non-pregnant (menstruating) women of reproductive age in order to determine the foods to be included in the food consumption frequency section, and the questionnaire sections and questions (nutrition habits and food consumption frequency questionnaire) will be designed. In the second stage of the study, the questionnaire developed in the first stage will be applied to 350 non-pregnant (menstruating) volunteer women of reproductive age through face-to-face interviews. In this stage, the blood parameters of at least 100 individuals whose blood counts have already been taken for routine tests and treatments and who meet the inclusion criteria of the study will also be recorded from their patient files. In the third stage, the questionnaire will be applied again to 75 individuals who have completed the second stage at least 2 weeks later in order to evaluate the reliability of the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Between the ages of 19-50
* Of reproductive age
* Not pregnant
* Menstruating
* Not having a disease that affects nutrition
* Not following a special diet (weight loss diet, etc.)

Exclusion Criteria:

* Male sex
* Under 19 or over 50 years of age
* Having a disease that affects nutrition
* Following a special diet (gluten-free diet, etc.)
* Making changes in diet for the purpose of weight loss
* Of reproductive age but not menstruating
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck \& Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, 18-45 years of age (inclusive).
* Body mass index should be less than or equal to 30
* Screening procedures completed within 28 days prior to dosing.
* If female and:

  * of child bearing potential, is practicing an acceptable barrier method of birth control for the duration of the study
  * is postmenopausal for at least 1 year
  * is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

* Subjects with a recent history of drug or alcohol abuse or addiction.
* Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
* Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
* Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.
* Subjects demonstrating a positive drug abuse screen when screened for the study.
* Female subjects demonstrating a positive pregnancy screen.
* Female subjects who are currently breastfeeding.
* Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or hormonal contraceptives within 14 days of dosing will not be allowed to participate.
* Subjects with a history of allergic response(s) to losartan, hydrochlorothiazide or related drugs.
* Subjects with a history of clinically significant allergies including drug allergies.
* Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).
* Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to dosing.
* Subjects who have used tobacco products within 90 days of Period 1 dose administration.
* Subjects who report donating greater than 150 mL of blood within 14 days prior to dosing.
* Subjects who report receiving any investigational drug within 28 days prior to dosing.
* Subjects who report taking any systemic prescription medication in the 14 days prior to dosing.
* Subjects who report an intolerance of direct venipuncture.
* Subjects who report consuming an abnormal diet within the 28 days prior to dosing.
Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients

The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, and to assess the relationships between sonographic structural changes and hemiplegic shoulder pain.

Painful shoulder is a common complication following hemiplegic stroke. This pain may interfere with functional improvement, the patient's quality of life, and it may impede the process of rehabilitation. Further understanding of rotator cuff tendon impairment and other shoulder soft tissue structural abnormalities in stroke patients may help clinicians in assigning more complete therapeutic plans to hemiplegic patients. The radial extracorporeal shock wave therapy has promising results in patients with musculoskeletal problems and in those with various causes of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex regional pain syndrome .The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, as well as to explore the relationships between sonographic structural changes and hemiplegic shoulder pain. This study will be a benefit in the physical therapy field and may guide rehabilitation programs of physical therapy towards better results through decreasing time needed to perform activity of daily living, decreasing dependency and making patient an active member in society.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient's age ranges from 40 to 60 years. 2. Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).

  3. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24).

  4. Patient who understand the study process and signed the informed consent form.

  5. Patient with stroke more than 3 months ago. 8. Patient with shoulder pain and limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic side.

Exclusion Criteria:

* The following patients will be excluded from the study:

  1. Patients who cannot express their own pain intensity.
  2. Patients with a history of trauma or surgery to the shoulder on the affected side.
  3. Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0.
  4. Patients with a history of shoulder pain before the stroke.

  6. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.

  7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.
Changing Population Salt Consumption in Lithgow, Australia

The objective of this study is to determine whether a community-based salt reduction program can reduce average salt consumption levels. Baseline levels of salt consumption were measured in 2011, the salt reduction program was then implemented, and now in 2014 investigators are remeasuring salt consumption levels in the community. The hypothesis investigators are testing is that the salt reduction program will have led to a change in salt consumption levels between 2011 and 2014. The study is being done in Lithgow, a regional town in New South Wales , Australia.

The primary objective of this project is to determine whether there have been changes in average salt consumption levels in the Lithgow population from 2011 to 2014. The primary null hypothesis to be tested is that there will be no difference between the mean 24-hour urinary sodium excretion levels between 2011 and 2014.

The sample of 419 individuals with 24-hour urine samples in the baseline survey and 600 individuals in the follow-up survey will provide 80% power to detect a difference of 0.7 g/day salt between the mean levels of excretion before and after the intervention. There will be more than 95% power to detect a difference of 1.0 g/day salt or greater.

Eligibility Criteria:
Inclusion Criteria:

* All adults over the age of 20 years residing in the Lithgow area are eligible
* No exclusion based on inter-current illness, use of medications or any other aspect of demography or personal history.
Clinical Study for Treatment-naïve IOPD Babies to Evaluate Efficacy and Safety of ERT With Avalglucosidase Alfa

This is a single group, treatment, Phase 3, open-label study to assess efficacy, safety, pharmacokinetic (PK), pharmacodynamics (PD) of avalglucosidase alfa in treatment-naïve male and female participants with IOPD.

Study details include:

* Study duration: Screening - up to 4 weeks;
* Primary Analysis Period (PAP) - 52 weeks;
* Extended Treatment Period (ETP) - 52 weeks;
* Extended Long term Treatment Period (ELTP) - 104 weeks; 4-week follow-up period for a total study duration - up to 4.08 years.
* Treatment duration: Up to 4 years
* Visit frequency: every other week and potentially every week

Study duration may be variable by country, including at least completion of the PAP and ETP, and up to 4.08 years.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have confirmed diagnosis of infantile-onset Pompe disease defined as: the presence of 2 lysosomal acid α-glucosidase (GAA) pathogenic variants and a documented GAA deficiency from blood, skin, or muscle tissue; or the presence of 1 GAA pathogenic variant and a documented GAA deficiency from blood, skin and muscle tissue in 2 separate samples (from either 2 different tissues or from the same tissue but at 2 different sampling dates).
* Participants must have established cross-reactive immunological material (CRIM) status available prior to enrollment.
* Participants must have cardiomyopathy at the time of diagnosis: ie, left ventricular mass index (LVMI) equivalent to mean age specific LVMI

  * +1 standard deviation for participants diagnosed by newborn screening or sibling screening;
  * +2 standard deviation for participants diagnosed by clinical evaluation.
* Parents or legally authorized representative(s) must be capable of giving signed informed consent.

Exclusion Criteria:

* Participants with symptoms of respiratory insufficiency, including any ventilation use (invasive or noninvasive) at the time of enrollment.
* Participants with major congenital abnormality.
* Participants with clinically significant organic disease (with the exception of symptoms relating to Pompe disease).
* Participant received any Pompe disease specific treatment, eg enzyme-replacement gene therapy (ERT).
* Participant who has previously been treated in any clinical trial of avalglucosidase alfa.
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III

Evaluation of personalized oral hygiene education on plaque accumulation and gingival inflammation in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on clinical attachment level in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on the psychological determinants described by the Health Action Process Approach (HAPA) and the mediating role of these psychological determinants in oral hygiene habits and clinical parameters in periodontal patients stage I/II/III.


Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years old
* Subject having signed an informed consent
* Subjects with periodontal disease Stage I/II/III :
* ≥ 15 teeth/implants
* Bleeding index at ≥ 25%
* Plaque index ≥ 20%
* Not requiring antibiotic prophylaxis prior to periodontal treatment.
* Not having received surgical periodontal treatment in the last 12 months.
* Smokers of ≤10 cigarettes/day

Exclusion criteria:

* \<15 teeth/implants
* Physical or mental disability that does not allow for the performance of oral hygiene procedures.
* Chronic progressive pathology (diabetes...) / immunodeficiencies (HIV...)/ systemic infections.
* Ongoing drug treatment leading to a significant change in the periodontal condition (anti-epileptics, calcium antagonists, immunosuppressants, hormonal treatments, etc.).
* Ongoing drug treatment that can influence the periodontal condition (anti-inflammatory drugs, antibiotics)
* Patients with severe xerostomia or with Gougerot-Sjögren's syndrome.
* Subjects undergoing treatment for cancer
* Pregnant or breastfeeding women
* Smokers of \> 10 cigarettes/day
* Impossibility to give information about the subject (subject in an emergency situation, difficulties in understanding the French language, etc.).
* Subject under safeguard of justice
* Subject under guardianship or curatorship
Renal Function Prediction in Living Donor Transplant Using Baseline Data

This study aims to predict early post-transplant kidney function in living donor kidney transplant recipients using baseline characteristics of donors and recipients. The study involves analyzing pre-transplant data to develop a machine learning model that predicts serum creatinine levels one year post-transplant. This research may improve decision-making and outcomes for transplant patients


Eligibility Criteria:
Inclusion Criteria:

- Recipients and donors of living-donor kidney transplantation.

Exclusion Criteria:

* Donors or recipients with follow-up durations of less than 1 year.
* Recipients who received simultaneous organ transplantation in addition to kidney transplantation.
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers

The sutdy aims to to demonstrate the non-inferiority of JP-1366 10 mg compared to Lanston Capsule 15 mg in preventing NSAIDs-induced peptic ulcers and to compare/evaluate the efficacy and safety of JP-1366 10 mg.


Eligibility Criteria:
Inclusion Criteria:

1. Adult male/female aged 19 years or older as of the date of obtaining consent
2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous administration of NSAIDs for 24 weeks or more
3. Those with one or more of the following risk factors for ulcer development at the time of screening
4. Subjects who fully understand this study and voluntarily signed the informed consent form.

Exclusion Criteria:

1. Those who cannot undergo upper gastrointestinal endoscopy
2. At the time of screening, those who were confirmed to have active stage ulcers (A1, A2) or healing stage ulcers (H1, H2) in the stomach or duodenum according to the Sakita-Miwa Classification\*
3. Those with a confirmed history of malignant tumor within 5 years
4. Those with a confirmed history of signal symptoms suggestive of malignant disease of the gastrointestinal tract
5. Those who need to continuously take corticosteroids, antiplatelet agents, and anticoagulants during this study (however, the following cases are permitted):
6. Pregnant and lactating women or those with a positive pregnancy test result at screening
7. Those who participated in another study and were administered investigational products or had medical devices applied at least once within 4 weeks from the screening visit(Visit 0)
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk

The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein.

We aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. In addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* age : 19 \~ 70 yrs
* Type 2 diabetes : HbA1c \<10%
* Prediabetic state : HbA1c 5.7\~6.4%

Exclusion Criteria:

* Type 1 diabetes, secondary diabetes
* dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users
* Thyroid disease with abnormal thyroid function test
* Liver disease with abnormal liver function test
* severe kidney disease
* pregnant or lactating women
* current smoker
* severe obesity
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017).
* Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients).
* Patients in whom data collection is possible from the medical records (applicable for Group A and B patients)
* Further inclusion criteria apply

Exclusion Criteria:

* Patients who were previously treated with nintedanib.
* Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone..
* Patients who are participating in a clinical trial.
* Further exclusion criteria apply.