cyrilzakka/clinical-trials huggingface dataset:
Making Activity Time for Cognitive Health

Approximately 75% of cancer survivors experience some degree of cognitive deficit throughout their cancer experience, with upwards of one third of breast cancer survivors reporting impairments up to a decade after treatment. Chemotherapy and adjuvant therapy to remove cancerous tissue can result in deficits in attention, speed of processing, memory, and quality of life. Physical activity has been associated with a number of health benefits for breast cancer survivors including improvements in cognitive function. The investigators recently reported on the beneficial effects of acute exercise, or single sessions of physical activity, on processing speed and spatial working memory in breast cancer survivors, suggesting that acute bouts of physical activity may mitigate select domains of CRCI. Specifically, survivors in this study demonstrated faster processing speed, and trended towards faster and more accurate spatial working memory, after thirty minutes of moderate-intensity walking compared to seated rest. But half an hour of walking may be challenging to certain subgroups of survivors, particularly those who are deconditioned or with significant barriers to longer walks. With a renewed focus on un-bouted physical activity and avoiding inactivity during survivorship, it is important to better understand the dose or volume of exercise responsible for providing breast cancer survivors with the greatest cognitive benefits. The investigators examined the effects of varying durations of exercise (e.g., 10, 20 and 30 minutes) on cognitive function in breast cancer survivors to identify the optimal length of acute exercise. Findings from this study will inform new guidelines for acute exercise after cancer.


Eligibility Criteria:
Inclusion Criteria:

* women over the age of 18
* diagnosis of breast cancer
* no longer undergoing treatment
* fluent in English
* no history of dementia or organic brain syndrome
* not currently pregnant
* able to walk unassisted
* no health reasons that would prevent ability to exercise
* not currently enrolled in another exercise research study
* reported trouble with memory/concentration
* physician's consent

Exclusion Criteria:

* male
* no diagnosis of breast cancer
* under 18 years of age
* currently undergoing treatment for breast cancer
* inability to communicate in English
* history of dementia or organic brain syndrome
* pregnant
* unable to walk unassisted
* other health reasons that may prevent ability to exercise
* enrolled in another exercise research study
* no reported trouble with memory or concentration
* non-consent of physician
Study of Colchicine to Prevent the Postpericardiotomy Syndrome

The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.

Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the third day after a cardiac surgery operation
* Age≥ 18 years
* Informed consent

Exclusion Criteria:

All evaluated before the surgical operation:

* Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality
* Serum creatinine \>2.5 mg/dl
* Serum creatine kinase (CK) over the upper limit of normality or known myopathy
* Known gastrointestinal or blood disease
* Pregnant or lactating women or women not protected by a contraception method
* Known hypersensibility to colchicine
* Treatment with colchicine at enrolment
Better Lithotripsy and Ureteroscopy Evaluation of Stenting (BLUES)

This multi-center trial is being completed to compare patient outcomes related to the Imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy.

Eligible participants will be enrolled and randomly assigned to receive the Imajin silicone stent or a non-silicone stent. In addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery).

The trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.


Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, Ultrasound or computerized tomography (CT) scan

  * Renal stone defined as only renal location of stone(s).
  * Ureteral stone defined as ureteral only or ureteral and renal stone(s).
* Planned unilateral ureteroscopy with stent placement without stent string.
* Ability to take oral medication.
* Ability and willingness to complete and adhere to survey questions and responses throughout study duration.

Exclusion Criteria:

* Known planned secondary or staged procedure
* Presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney)
* Presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder)
* Presence of any indwelling ureteral stent prior to ureteroscopy
* Presence of any indwelling nephrostomy tube prior to ureteroscopy
* Ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery
* Renal stone located in calyceal diverticulum
* No indication for stent placement (e.g. spontaneous passage)
* Bladder stone location.
* Pregnancy or lactation
* Known allergic reactions to polyurethane or silicone
The Effects of Kefir on Pediatric Obesity

Kefir, a traditional fermented dairy product in the North Caucasus region, is produced through the fermentation of milk by lactic acid bacteria and yeast. In murine studies, it has been observed that consumption of kefir by obese mice resulted in significantly reduced body weight compared to non-kefir-consuming obese mice. Furthermore, insulin resistance and fatty liver conditions showed improvement in the kefir-fed obese mice. Kefir was found to have its effects on obesity-related conditions through the inhibition of lipid synthesis, stimulation of fatty acid oxidation, elevation of basal metabolic rate, and modulation of oxidative damage.

Obesity has emerged as a global epidemic, and its prevalence in pediatric population is rapidly increasing. Obesity is defined as having a body mass index (BMI) above the 95th percentile for the age. According to statistics from the Health Promotion Administration in Taiwan, the prevalence of obesity among elementary and junior high school students in 2021 was 27.1% and 31.2%, respectively. This implies that approximately one out of every three to four students is obese. Insulin resistance and fatty liver are two common manifestations of childhood obesity. Insulin resistance is found closely linked to type 2 diabetes. Prolonged and chronic fatty liver can progress to cirrhosis and even hepatocellular carcinoma. Effective management of obesity holds the occurrence of these diseases. The objective of this study is to analyze the potential benefits of incorporating kefir into the diet of obese children regarding the improvement of obesity-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* body weight above 50 kilograms, body mass index (BMI)-for-age above the 95th percentile

Exclusion Criteria:

* diabetes mellitus, liver diseases other than non-alcoholic fatty liver disease, cardiovascular diseases other than hypertension and dyslipidemia, renal diseases, neurologic diseases, growth hormone deficiency, thyroid diseases, adrenal disorders, any use of medication for more than 6 months before or during this study, and any adverse responses to dairy products.
Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example

This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention.


Eligibility Criteria:
Inclusion Criteria:

* Obese subjects (BMI\>= \>= 27 kg/m2) with age 18 year-old and less than 65 y/o over will be considered (M/F= 1:1)

Exclusion Criteria:

* Any history of cancer
* Unstable mental status
* Uncooperative subject
* Complex clinical comorbidities, such as heart failure, end-stage renal disease, etc.
* Severe physical disability
Comparison Between the Analgesic Effectiveness of Virtual Reality and Topical Anesthesia: A Clinical Study

A split-mouth, controlled trial aimed to clinically compare and evaluate the effectiveness of virtual reality versus topical anesthesia gel prior to administration of dental anesthesia injection in reducing the perceived pain and anxiety level in adult patients and to find out their preferred procedure.

Heart rate before and after the end of the procedure will be identified, pain intensity of the injection will be identified using a scale, and finally patients' preference will be identified using a questionnaire.

Steps of the Experiment

Step I: before the administration of the local anesthesia injection, heart rate will be measured for the patients using an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.

Step II: at the first appointment, patients will be randomly allocated to receive the injection of the local anesthesia either with topical anesthetic gel or with virtual reality in one side of the jaw.

Step III: immediately after dental anesthesia injection procedure, the patient will be asked to rate the level of perceived pain, using Wong-Baker faces pain rating scale (WBFPS).

Step IV: after the administration of the local anesthesia injection, heart rate will be measured for the patients an FDA Approved pulse oximeter (Santa Medical SM-165 Finger Pulse Oximeter). Findings will be recorded.

Step V: in the next appointment, the other technique (virtual reality or topical anesthetic gel) will be used on the contralateral side for the same patients.

So each patient will receive local anesthesia injection twice, one with topical anesthetic gel and one else with VR in the contralateral side.

Step VI: after completion of both procedures, each patient will be asked to state his/her preference for the delivery system of future injections to be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I, aged between 18 and 65, both male and female, who required bilateral local anesthetic injections in the premolar teeth in the upper jaw.
* Participants are in good general health, take no medications, and have no contraindications to the use of local anesthetic.
* The ability to understand oral and written instructions, and the ability to use the VR controller.

Exclusion Criteria:

* Patients who need intravenous sedation cannot participate in the study.
* If a patient requires only single visit/ treatment or if he/she cannot attend the other visit.
Pharmacokinetic Investigation of UDCA in Bile and Serum

To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state.

see protocol

Eligibility Criteria:
Inclusion Criteria:

* PBC or healthy

Exclusion Criteria:

* pathology which does interfere with safety or PK of UDCA
Rural Interventions for Screening Effectiveness

This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.

PRIMARY OBJECTIVES:

I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.

II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.

OUTLINE: Patients are randomized to 1 of 3 arms.

Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.

Arm II: Patients engage in TIDVD and PN.

Arm III: Patients receive brochures that explain and provide encouragement for cancer screening.

After completion of the study, patients are followed up at 2 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR)
* Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH)
* Provide informed consent
* Able to speak/read English
* Have access to a DVD player or computer that can play DVDs

Exclusion Criteria:

* Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis
* Have a personal history of inflammatory bowel disease (Crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer
* Have a first degree relative with a history of breast or colorectal cancer
* Plan to move outside of the country within the next year
* Reside in a nursing home or other institution
* Are pregnant or intend to become pregnant during the study period
Immunotherapy for Hepatocellular Carcinoma

This study is an observational real-world research conducted on Chinese hepatocellular carcinoma (HCC) patients. Its primary objective is to evaluate the safety and efficacy of immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions.

Hepatocellular carcinoma exhibits a significantly elevated incidence and mortality rate in China. Despite the Chinese population representing a mere 18.4% of the global population, the annual incidence of new liver cancer cases reaches a staggering 466,000 (55.4% of the global total), with 422,000 deaths (53.9% of the global total). Immunotherapy, particularly the implementation of immunotherapy-based combination treatment regimens, holds substantial therapeutic value in the management of hepatocellular carcinoma (HCC), leading to notable breakthroughs and advancements in the comprehensive treatment of liver cancer. The aim of this study is to evaluate the safety and efficacy of immunotherapy-based combination treatment regimens in Chinese hepatocellular carcinoma (HCC) patients under real-world clinical conditions. By collecting and analyzing data on the etiology, clinical characteristics, treatment modalities, and treatment outcomes of HCC patients receiving immunotherapy-based combination treatments in the clinical healthcare setting, the study seeks to provide valuable information regarding treatment patterns and effectiveness for hepatocellular carcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

1. Aged after 18 years (18 is included).
2. Hepatocellular carcinoma diagnosed by pathology or imaging.
3. Patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens.
4. For participants who have previously received treatment according to this protocol, a comprehensive pre-treatment assessment is required, including demographic information, tumor history, medical history, and baseline imaging examinations.
5. Patients voluntarily enroll in this study.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Other conditions regimented at investigators' discretion.
The Effect of Hot Cereal on Digestive Health in Children

The objective of this study is to examine the effects of 2 servings of hot cereal per day over 2 weeks on digestive health in children that typically eat low fiber diets.

Participant eligibility will be screened at visit 1. The study will be a single-arm intervention design. The study procedures will include a pre-study visit, a pre-intervention baseline data collection period, a 14 day intervention period, and an end of study visit.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 7-12 yrs.
* Low fiber eater (\<14 g/d)
* Accustomed to eating breakfast at home
* Demonstrates spoken and written English literacy
* Parent/or legal guardian has experience using a cell phone camera
* Parent/or legal guardian is capable of emailing and texting photos by using cell phone features that enable this such as the select and attach option
* Able to provide assent with parent and/or legal guardian after review of study protocol and procedures
* Parent and/or legal guardian will also be required to provide consent on behalf of the child after reviewing study protocol and procedures

Exclusion Criteria:

* Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
* Use of fiber supplements such as fiber gummies (inulin/chicory root), or Metamucil or Citrucel
* Use of vitamin/mineral supplements, multivitamins, or herbal supplements.
* Participation in any other clinical trial up to 6 months before day 1 of participation in this study
* History of medical or surgical events that may significantly affect the study outcomes including diagnosed gastric or digestive diseases
* Not a regular breakfast eater at home
* High-fiber eater (\>14 g of fiber per day)
* Allergies to any of the ingredients in the test products
* Children taking medication that affects appetite (i.e. certain ADHD medications that depress appetite)
Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis

Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. Many spine surgeons today perform microdecompression for central lumbar spinal stenosis.

Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery (NORspine).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of central lumbar spinal stenosis
* Operation in ≤2 lumbar levels with either open decompressive laminectomy, bilateral microdecompression or unilateral microdecompression for bilateral decompression in the time period between October 2006 and December 2011
* Included in the NORspine registry

Exclusion Criteria:

* History of lumbar fusion
* Previous surgery in the lumbar spine
* Discectomy as part of the decompression
* Associated pathological entities such as disc herniation, spondylolisthesis or scoliosis.
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures

This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications.

Study design:

This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.

The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, patients who will receive 2 internal connection dental implants to replace 3 posterior missing teeth in the mandible with a 3 unit screw-retained FDP with sufficient bone volume and controlled oral hygiene. The intervention group will receive a screw-retained FDP with conical engaging and non engaging abutment configuration, while the comparator group will a screw-retained FDP with both conical non engaging abutment configuration. The primary outcome is changes in marginal bone levels, and the secondary outcomes include technical and mechanical complications, biological complications, and patient satisfaction.

Both groups will receive 2 internal connection implants in the posterior mandible in healed sites of at least 3 months (guided implant surgery). The surgical procedure will follow standardized protocols, with no variations between groups other than the types of implant abutment connections used.

Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: definitive loading, after 6 months of loading, after 2 years loading.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
* Candidates for an implant supported FDP in the posterior mandible.
* Teeth in area of interest extracted at least 3 months prior.
* Bone grafting not needed or only minor GBR needed.
* Controlled oral hygiene.
* Sufficient bone volume.

Exclusion Criteria:

* Patients with edentulous span of less than 3 missing teeth (not eligible to receive a 3 unit 2 implant supported FDP)
* Patients with healing period of extraction sites less than 3 months.
* Extensive bone grafting required prior to or during implant placement.
* Active Bruxism.
* Heavy smoker (\> 10 cigarettes).
* Systemic diseases that might affect bone healing.
* Patients who are not willing or unable to give consent.