rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study
Status: Not yet recruiting

Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.

The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with soft tissue sarcoma Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.  Exclusion Criteria:  Refusal of consent Women of childbearing potential without a negative pregnancy test; or women who are lactating. Any serious and/or unstable pre-existing medical disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Soft tissue sarcoma patients who are actively deliberating on joining a clinical trial for their condition but have yet to complete the enrollment and randomization stages. - SamplingMethod: Probability Sample
Delving Into Participation Trends of Scleroderma Clinical Trials
Status: Not yet recruiting

Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.

The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient has been diagnosed with scleroderma Patient has self-identified as planning to enroll in an observational clinical trial Patient is a minimum of 18 years or older  Exclusion Criteria:  Patient is pregnant Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with scleroderma who are actively considering participation in a clinical trial for this ailment, but have not yet concluded the enrollment and randomization phases. - SamplingMethod: Probability Sample
Prospective Evaluation of AI R&D Tool for Patient Stratification: a Trial for Renal Immuno-oncology Model Experimental Evaluation 2
Status: Not yet recruiting

Pear Bio has developed a predictive biomarker technology that combines 3D cell culture, microscopy and computer vision to measure the response of an individual patient's tumor sample to different systemic therapy regimens that are tested simultaneously ex vivo.

This study will recruit patients with advanced or metastatic kidney cancer who are due to start a clinically-indicated new line of therapy.

The oncologist will be blinded to the response on the Pear Bio test (the test will be run in parallel with the patient's treatment). The primary objective of this study is to establish the sensitivity and specificity of Pear Bio's test results against patient outcomes (objective response, progression-free survival, depth and duration of response, overall survival).

Eligibility:
- EligibilityCriteria: Inclusion:  Able to give written informed consent prior to admission to this study. Female or male aged ≥18 years.  Evidence of advanced RCC with intention to receive systemic therapy, defined as:  Clinical suspicion of advanced RCC with intention to undergo a clinically-mandated biopsy and subsequent systemic therapy OR Histological evidence of advanced RCC with intention to undergo subsequent systemic therapy and willing to undergo additional research biopsy At least one lesion evaluable under RECIST 1.1 criteria Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy. Willing to undergo venous sampling for 40mL of blood  Exclusion:  Early stage kidney cancer Patients who do not have kidney cancer Patients with RCC that do not intend to receive systemic therapy Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Previous diagnosis of other cancer. Previously treated cancer may be acceptable in some circumstances (e.g. surgery for an unrelated cancer > 5 years ago) after discussion with the Sponsor. No lesions are amenable to biopsy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with advanced or metastatic kidney cancer, due to start a new line of therapy - SamplingMethod: Non-Probability Sample
Safety and Efficacy of a Novel Flexible Bipolar in POEM
Status: Recruiting

Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM.

To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure.

This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with 18 years of age or older. Patients referred to the participating center (IECED) with a clinical diagnosis of achalasia with an indication for POEM, including previously failed Heller myotomy, balloon dilation or POEM Patients who provide informed consent.  Exclusion Criteria:  Patients who have contraindications for esophagogastroduodenoscopy (EGD). Patients with an Eckardt score < 3 before POEM. Positive diagnosis of Chagas disease. Patients unable to withstand general anesthesia. Pregnancy and lactation. Barret's esophagus. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity
Status: Not yet recruiting

The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Is at least 19 years old by the time of the screening visit Be in good general health as determined by the investigator Have at least 2 non-adjacent teeth and is diagnosed with hypersensitive  Exclusion Criteria:  Is allergic to the active drug substance or other excipients used in the investigational product Has any history of alcohol or drug abuse Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit Has active dental caries or history of dental caries - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult
A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants
Status: Not yet recruiting

The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  1. Body mass index between 18 and 30 kilograms per square meter (kg/^m2), inclusive.  3. Negative polymerase chain reaction test result for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at Check-in.  4. For participants ≥ 55 years of age, ongoing conditions must be considered by the Investigator to be stable and adequately controlled by allowed concomitant medications.  Key Exclusion Criteria:  Plans to undergo elective procedures or surgeries at any time after signing the Informed Consent Form (ICF) through the follow-up visit. Any condition affecting study treatment absorption. History of gastrointestinal surgery, gastroesophageal reflux disease, or other clinically significant and active gastrointestinal condition per the Investigator's discretion. Clinically significant acute gastrointestinal symptoms within 30 days prior to study Check-in (Day -1). Chronic, recurrent, or serious infection, as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1. For participants < 55 years of age: Use of any prescription medication (excluding oral contraceptives and hormone replacement therapy), OTC oral medications including proton pump inhibitors (PPI), histamine H2-receptor antagonists (H2 blockers), and antacids (excluding acetaminophen and aspirin ≤ 100 mg daily), or nutraceuticals including vitamins/mineral supplements/herbal medicines within 28 days prior to Day -1 and throughout the study. For participants ≥ 55 years of age: Up to 5 medications are allowed if they are taken at a stable dose level and regimen.  NOTE: Other protocol defined Inclusion/Exclusion criteria may apply - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 30 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
Status: Recruiting

The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.

The main questions it aims to answer are:

Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?
Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?
What is the prevalence of sleep apnea among high-risk individuals in Greenland?
Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?

Participants will:

Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation
Blood samples for full genome sequencing

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Type 2 diabetes and/or morbid obesity (BMI >40) Over 18 years old  Exclusion Criteria:  Does not speak either English, Danish or Greenlandic - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis
Status: Not yet recruiting

osteoporosis is a common disease that affect most of postmenopausal women. various treatment procedures are used to avoid future complain among postmenopausal population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Their ages were ranged from 50-60 years. Their BMI not exceeded 30 kg/m2. All postmenopausal women past of at least one year after menopause. Had no regular physical activities during the past 6 months.  Exclusion Criteria:  Patients didn't take any drug before the study (e.g. calcium tablets, multivitamins containing calcium and vitamin D) that affects bone metabolism. Patients that were smoking or having alcohol consumption. Histories of fracture and surgery, or severe injuries - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 50 Years - MaximumAge: 60 Years - StdAgeList: Adult
Effect of a Specific and General Physical Exercise Intervention on Gaming and E-Sport Performance
Status: Recruiting

The goal of this randomized control intervention study is to test the effect of i) a specific physical training for e-sport and ii) a general physical training on e-sport performance, compared to iii) not training physically at all.

Participants are gamers and e-athletes who play at least >2hours peer week. The main questions it aims to answer are:

Does physical training have an effect on e-sport related abilities (hand grip strength, reaction, anticipation)
Does the training of specific elements, which aim at these abilities "out-game", transfer on the actual skills needed using a keyboard and mouse

Participants will be randomly - but mediated by hours of playing per week - distributed in 1 of 3 groups.

Group 1 will 3 times per week for 30 minutes perform a specific physical training with focus on abilities needed in e-sport (grip strength, reaction, anticipation) over a timespan of 8 weeks.
Group 2 will perform a similar physical training (load, intensity) to Group 1, but without specific elements.
Group 3 will serve as control group without any training.

Researchers will compare Group 1, Group 2 and Groups 3 to see if the different trainings (Group 1 and Group 2) have different effect on e-sport performance and if no training (Group 3) differs in e-sport performance development.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  playing video games on a regular basis (>2h per week) willing to take part in an 8 weeks intervention period containing physical training  Exclusion Criteria:  any reasons which would make participation in physical activity impossible, such as acute injuries, chronic health problems or medical advices - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 10 Years - MaximumAge: 50 Years - StdAgeList: Child, Adult
Women and Maternity: Development of a Nutritional Education Project
Status: Not yet recruiting

The "first 1000 days of life", from conception to 2 years of life, are crucial for promoting the health of both mother and baby. During this period, a woman's diet and lifestyle play a significant role in determining the future health of the child. The perinatal period is an ideal time for regular contact with healthcare providers who can institute an intervention to encourage pregnant women to make nutritional changes to improve their health and that of their babies.

Therefore, an educational program on an appropriate lifestyle during the "first 1000 days" can represent a crucial primary prevention strategy in reducing the risk of developing obesity and non-communicable diseases (NCDs) during childhood and later adulthood.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age ≥ 18 years; first trimester; parents' ability to speak and understand the Italian language; parents' ability to sign the informed consent and to fill in the questionnaires  Exclusion criteria:  age < 18 years; diagnosis of chronic and/or eating disorders - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women (first trimester) - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis
Status: Recruiting

Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥21 years Multiple sclerosis diagnosis Stable disease-modifying therapy (DMT) over the past 6 months Walking dysfunction (i.e., abnormal gait pattern, Expanded Disability Status Scale (EDSS) score of 4-6.5, and/or Patient-determined disease steps (PDDS) score of 3-6) Able to walk for 6 minutes at self-paced speed. Handheld assistive device is acceptable. Symptomatic fatigue (Fatigue Severity Score ≥ 4)  Exclusion Criteria:  Adults unable to consent Pregnant women Prisoners Multiple sclerosis relapse within the last 30 days Other neurological disorders besides multiple sclerosis Cardiorespiratory or metabolic diseases (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task. Severe osteoporosis Failure to pass the graded exercise stress test Implanted cardiac pacemaker Metal implants in the head or face Unexplained, recurring headaches History of seizures or epilepsy Currently under medication that could increase motor excitability and lower seizure threshold Skull abnormalities or fractures Concussion within the last 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult
High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial
Status: Recruiting

The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients over 18 years of age. Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes. Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI). Radicular syndrome of three months or more of evolution. Normal or pathological electromyogram (EMG). Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire. Patients with a previous positive block diagnosis. Patients who have signed the informed consent document.  Exclusion Criteria:  Patients under 18 years of age. Patients with non-radicular low back pain. MRI not consistent with the patient&#39;s symptoms. Patients with peripheral neuropathy of the lower extremities. Patients with a history or current diagnosis of serious mental disorder. Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome. Infection at the puncture site. Coagulation disorders. Pregnant patients. Patients who refuse to sign the informed consent document. Patients allergic to radiological contrast. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Game-based Pediatric Diabetes Education
Status: Recruiting

The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).

The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.

Eligibility:
- EligibilityCriteria: For youth:  Be between the age of 6 to 12 years. Have been diagnosed with type 1 diabetes for at least 1 year. Be currently taking insulin through multiple daily injections or an insulin pump. Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor. Be willing to comply with all study visits and procedures.  For Parent:  Biological or adopted parent with custody and medical decision making of the patients Living with identified patients Over 18 years old Resident of Allegheny County  Exclusion Criteria:  -Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child