cyrilzakka/clinical-trials huggingface dataset:
Functional Gastrointestinal Disorders in Pediatric IBD

Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.

Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.

Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* IBD (Crohns disease, Ulcerative colitis or IBD-U)
* in remission (defined as: Physician's global assessment = remission, no nocturnal stools, no blood in stools, \< or = 3 stools/day, C reactive protein \< 10 mg/L, erythrocyte sedimentation rate \< 20 mm, no flare of disease or change of treatment in the last 3 months, no ongoing corticosteroid therapy
* followed for IBD for at least 1 year

Exclusion Criteria:

* presence of an ileostomy or colostomy
* past history of total colectomy
* unable to understand written French or to answer the questionnaires
Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.

The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.

This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.

Eligibility Criteria:
Inclusion Criteria:

* Parturients who gave consent
* has low bishop score (≤5)
* term singleton cephalic presenting fetus
* intact membranes
* no contraindication to vaginal delivery

Exclusion Criteria:

* those who refused consent
* preterm delivery
* vaginal infection
* non-cephalic presentation
* multiple gestation
* low lying placenta/previa,
* vaginal bleeding,
* previous cesarean section
* rupture of membranes
Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction

As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively

PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients
2. Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
3. Patients with 3rd molar impactions
4. Absence of systemic diseases
5. age ⩾18 years and the ability to cooperate with the requirements of the study protocol.

Exclusion Criteria:

1. Medically compromised patients.
2. Immunocompromised patients.
3. Patients that do not consent.
4. Patients that are below the age of 17.
5. Patients that are pregnant.
6. Fully erupted molars will be excluded. smokers (\&amp;gt; 5 a day) will be excluded as well.
Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors

A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase inhibitors as adjuvant treatment.

Aromatase inhibitors (AIs) are the adjuvant treatment of choice in postmenopausal women with early, hormone receptor-positive breast cancer (BC), because they produce improved survival rates compared with tamoxifen. Progressive bone loss and subsequent fractures are associated with adjuvant AIs, administered either alone or sequentially after tamoxifen in postmenopausal women with early BC. Recent findings of National Surgical Adjuvant Breast and Bowel Project (NSABP) B-34 also suggest that bisphosphonates might have anticancer benefits for older postmenopausal women. "BONADIUV" trial is a single-blind, randomized, placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone mineral density (BMD) in women taking AIs.

Patients undergo a baseline BMD and if they result osteopenic (lumbar spine and/or trochanter -1\< T-score \<2.5), they are randomized in a 1:1 ratio to receive either placebo or oral ibandronate. All patients receive oral supplementation of calcium and Vitamin D3, once daily for two years. Study duration is 2 year, with planned six-months evaluation.

A total of 72 patients per arm of treatment are needed to obtain a 85% statistical power in order to detect a 2% BMD mean difference between the two arms. Considering a 15% dropout, around 82 patients per arm are planned to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hormone-receptor positive early breast cancer
* Menopausal status
* Age \< 75 years
* Written informed consent

Exclusion Criteria:

* Premenopausal status at time of randomization
* Comorbidities with increased risk of osteoporosis (primary hyperparathyroidism, hyperthyroidism, rheumatoid arthritis)
* BMI \< 18
* Chronic use of steroids
* Use of bisphosphonates at time of randomization
* Psychiatric disorders
Identification of Benign and Malignant Breast Nodules Using Ultrasound-modulated Optical Tomography: A Multicenter Study

Ultrasonic light scattering imaging is a new functional imaging technology that combines traditional B-mode ultrasound imaging and light scattering tomography (DOT). It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption of lesions. This study aims to evaluate the value of ultrasonic light scattering imaging in the differential diagnosis of benign and malignant breast nodules, and to evaluate the consistency between ultrasonic light scattering imaging and examiners in the differential diagnosis of benign and malignant breast nodules.

Breast cancer is the most common malignant tumor in women and the second leading cause of cancer death worldwide. Therefore, early detection and timely treatment of breast cancer are of great significance to controlling and reducing breast cancer mortality. Breast ultrasound has been widely used in the detection of breast cancer, but ultrasound is highly dependent on the examiner in terms of technology, and the examination results are greatly affected by the examiner's subjectivity, which increases unnecessary surgery and punctures, causing great trouble to clinicians and patients. Moreover, the value of conventional ultrasound in the differential diagnosis of breast masses is still limited, while the emergence of new technologies such as artificial intelligence and elastic imaging has improved the accuracy of ultrasound diagnosis to varying degrees.

The recently developed ultrasound light scattering imaging technology is used in breast ultrasound imaging systems to assist in morphological analysis based on the description and final evaluation of the Breast Imaging Reporting and Data System (BI-RADS), providing a new way to distinguish benign and malignant breast nodules.

Ultrasonic light scattering imaging technology is a new functional imaging technology that integrates traditional B-type ultrasound imaging and light scattering tomography (DOT). It uses B-type ultrasound to locate lesions and uses DOT to measure the concentrations of total hemoglobin, oxygenated hemoglobin and deoxygenated hemoglobin in diseased tissues based on the differences in the absorption rates of light of specific wavelengths in different tissues. It also measures the neovascularization at the tumor site and its potential local hypoxia stimulation. It introduces additional physiological information to current breast screening methods, often before morphological abnormalities. It can improve the accuracy of early diagnosis of breast cancer based on the characteristics of abnormal blood supply and oxygen consumption in lesions.

Eligibility Criteria:
Inclusion Criteria:

Had breast lesions detected by ultrasound Age 18 or older Upcoming FNAB or surgery Signing informed consent

Exclusion Criteria:

Patients who had received a biopsy of breast lesion before the ultrasound examination Can not cooperate with the test operation Patients who were pregnant or lactating Patients who were undergoing neoadjuvant treatment.
Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.

This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh class A or B
* Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
* Patient not a candidate for surgical resection or percutaneous ablation
* age \> 18 years old and able to consent

Exclusion Criteria:

* Child-Pugh class C
* Model for End-Stage Liver Disease (MELD) score \>16
* Extrahepatic disease
* Bilateral or main portal vein thrombus
* Total bilirubin \> 2.2
* Serum albumin \< 2.6
* Life expectancy \< 2 months
* Uncorrected INR \> 2
* Eastern Cooperative Oncology Group (ECOG) status \> 2
* Tumor burden \> 50% liver volume
* Hepatofugal portal venous flow
the Effect of Probiotic on Sleep Quality Management

The goal of this clinical trial is to learn about the improvement of sleep quality of probiotic BLa 80 in 110 healthy college students. The main question it aims to answer is whether probiotic BLa80 can effectively improve the sleep quality of college students. The experiment commenced with participants continuously consuming the recommended amount of the probiotic powder for approximately 8 weeks. Simultaneously, they were required to fill out an "Effect Evaluation Form" every week and submit it to relevant department. At the end of the first and eighth weeks, participants underwent tests for five liver functions, four lipid profiles, blood sugar, and uric acid levels, as well as stool sample collection. They then completed the "Mid-Term Effect Evaluation Form".

Over the past few decades, the health benefits of probiotics have garnered extensive scientific attention. Particularly in the treatment of gastrointestinal and metabolic disorders, probiotics have shown potential therapeutic effects. The benefits of probiotics to the intestinal environment include improving intestinal barrier function, producing antimicrobial substances, competing with pathogenic bacteria, and regulating cavity acidity. However, research results on the benefits of probiotics for healthy adults are inconsistent. This may be due to variations in consumer sensitivity to the effects of probiotics and differences between probiotic products. The relationship between gut microbiota and human health has been widely recognized, especially in relation to diseases like obesity and diabetes. To verify the effects of the Bifidobacterium BLa80 product, a consumer test experiment was conducted, aiming to test and collect data on the changes in the gut microbiota of participants before and after using the product. The test plan lasted for 10 weeks, including a washout period at the beginning and end. During the experiment, participants consumed Bifidobacterium BLa80 and underwent multiple health checks and evaluations.

Eligibility Criteria:
Inclusion Criteria:

* PSQI Pittsburgh Sleep Quality Index score \> 6 and \< 18;
* ISI insomnia Severity Index score \> 8 and \< 23.

Exclusion Criteria:

* Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
* Mental or nervous system diseases, celiac disease, lactose intolerance, allergy;
* Have the following diseases: irritable bowel syndrome, diabetes, ulcerative colitis, etc.;
* Recent antibiotic treatment (i.e. \< 3 months before study start);
* Participants who smoked more than 10 cigarettes per day were excluded;
* Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products;
* Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested.
Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia

For correct of presbyopia, in this study, the investigators have recruited subjects who aged 45\~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent ophthalmic examination including manifest refraction, uncorrected distance visual acuity (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA), corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on dominant eye of participants. The investigators recommend use of pinhole contact lens at least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic examination same above 2 weeks after first apply of pinhole contact lens. The investigators will compare ophthalmic parameters mentioned above before and after wearing pinhole contact lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting presbyopia.


Eligibility Criteria:
Inclusion Criteria:

* Age, 45\~65 years with presbyopia

Exclusion Criteria:

* Patients with anterior segment pathology,
* Patients with previous intraocular or corneal surgery,
* Patients with severe cataracts,
* Patients with corneal abnormalities( including endothelial dystrophy, recurrent corneal erosion, etc.),
* Patients with history of chronic dry eye, macular degeneration,
* Patients with retinal detachment, or any other fundus pathology
Efficacy and Safety of Perioperative Use of Breztri Aerosphere to Relieve Cough After Lobectomy

Cough after lobectomy is common. The prevention and treatment of cough after lobectomy is not standardized. Breztri Aerosphere is often used to relieve cough. Therefore, we conduct a single center placebo-controlled study to evaluate the efficacy and safety of perioperative use of Breztri Aerosphere in relieving cough after lobectomy.

This study is a single-center, prospective, randomized, controlled clinical trial to understand the efficacy and safety of perioperative use of Breztri in relieving cough after lobectomy. This study plans to include 128 subjects from the Department of Thoracic Surgery of the First Affiliated Hospital of Guangzhou Medical University. Participants will be randomly divided into according Breztri group and placebo group to the ratio of 1:1. Participants in Placebo group will receive 0.9% normal saline for 3 days before operation and 14 days after operation (n=64). Participants in Breztri group will receive Breztri for 3 days before operation and 14 days after operation (n=64). All patients will undergo screening and baseline visits. After sugery, they will be followed up for 2 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in this research and abide by the research regulations, understand and comply with and cooperate with the corresponding inspections, comply with the follow-up plan, and voluntarily sign the written informed consent.
2. Outpatients, 18 years old ≤ age ≤ 70 years old, preoperative examination of cardiopulmonary function can tolerate surgery.
3. Patients planning to undergo lobectomy.
4. No obvious cough before surgery.

Exclusion Criteria:

1. Participated in other interventional clinical trials 90 days before enrollment
2. Pregnant and lactating women (budigrafo is not recommended during pregnancy and lactation)
3. Patients with obvious cough before surgery (which affects the evaluation of drug effect)
4. History of alcohol or narcotic drug abuse, or a history of mental illness, confrontational personality, bad motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in this study
5. Preoperative respiratory infection, allergic rhinitis, bronchial asthma, chronic obstructive pulmonary disease, postnasal drip syndrome, oral ACEI drugs, CVA, EB, obvious acid reflux, heartburn, etc.
6. Patients with severe cardiac insufficiency or heart-related diseases before surgery
7. Diabetes before surgery
8. Severe liver and kidney damage before surgery

8) ACEI/ARB used within 1 month 9) Use of drugs that may cause cough or suppress cough within 1 month 9) Preoperative narrow-angle glaucoma, benign prostatic hyperplasia, or bladder neck obstruction 10) Patients who are using beta2 agonists or acetylcholine receptor antagonists or inhaled glucocorticoids 11) Tumor recurrence 13) Patients with severe infection or obvious pleural effusion found on postoperative chest X-ray
Effect of Nurse-led Supportive Care on Quality of Life

Breast cancer is the most common type of cancer in women with a high mortality rate in the world. The several methods are used in the treatment of breast cancer. One or more of these methods can be preferred according to the characteristics of women with breast cancer. Women may experience many different physiological and psychological symptoms during each treatment process.This situation negatively affects the quality of life of women with breast cancer. For this reason, there is a need for an intervention that could improve quality of life in women with breast cancer. In the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.

This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer. This trial was conducted in the general surgery clinic of training and research hospital located in Turkey. All patients were women who had breast surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer
* Having breast cancer surgery
* Planned to receive chemotherapy
* Able to use a phone
* Who agreed to participate in the study

Exclusion Criteria:

* Having communication problems
* Having psychological diseases
* Receiving any supportive care