rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study of KK2269 in Adult Participants With Solid Tumors
Status: Recruiting

This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.

In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.

In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.

Eligibility:
- EligibilityCriteria: Key Common Inclusion Criteria for Parts 1 and 2:  Patients who are ≥ 18 years old at the time of informed consent Patients who have disease measurable by RECIST v1.1 Patients with an ECOG PS of 0 or 1 Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator The specified periods have passed respectively after the completion of previous cancer treatments as of the date of enrollment Patients who agree to use a medically effective method of contraception  Key Additional Inclusion Criterion for Part 1:  •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor  Key Additional Inclusion Criteria for Part 2:  Patients with histological or cytological evidence of any of the following disease: Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma NSCLC Patients who are suitable for docetaxel treatment  Key Common Exclusion Criteria for Parts 1 and 2:  Patients with an uncontrolled or serious intercurrent illness Patients with known active central nervous system metastasis Patients with a history of ≥ Grade 3 allergic reaction to any antibody drug Patients with a history of autoimmune disease Patients with a history of HIV, HBV, or HCV at screening Patients who have a history of primary immunodeficiency  Key Additional Exclusion Criterion For Part 2:  Patients with a history of treatment with docetaxel - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
EXOPULSE Mollii Suit & Cerebral Palsy
Status: Recruiting

Spasticity is a frequent and debilitating symptom in patients with cerebral palsy. It can alter the patients' balance, mobility, as well as their quality of life (QoL). The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous electric nerve stimulation using EXOPULSE Mollii suit, might be of help in this context.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age between 5 and 12 years. Having a clinical diagnosis of unilateral or bilateral spastic cerebral palsy since at least one month. Being able to walk freely, with slight limitation or using ancillary equipment's (Gross Motor Function Classification System (GMFCS) score ≤3). Having a PBS score < 45. Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale). Having spasticity with a score of at least 1+ on the MAS  Exclusion Criteria:  Being included in another research protocol during the study period Being unable to undergo medical monitor for the study purposes due to geographical or social reasons Having contraindications to wearing EXOPULSE Mollii suit (i.e., implanted electronic medical devices or equipments which can be disrupted by magnets including ventriculoperitoneal shunts and intrathecal baclofen pumps, electronic life support equipment or high-frequency operation equipment, as well as well electrocardiography equipment or cardiac stimulator) Having a change in the pharmacological therapy over the last three months Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain, skin diseases). Suffering from a cutaneous disease Using another medical device Being part of other protected populations as defined in articles L. 1121-5, L. 1121 6,1121-8 and L. 1122-1-2 of the Public Health Code - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 12 Years - StdAgeList: Child
Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale
Status: Recruiting

"Investigating the Development, Validity, and Reliability of the Avoidance of Sports Activities Photo Scale" is crucial in determining the specific functional status of the shoulder joint, especially for overhead athletes experiencing shoulder pain, to identify which sporting activities restrict them the most and to fill the gap in the literature. Additionally, visually indicating activities through photographs will provide visual feedback, making it easier to assess functional status. Our study aims to develop a specific functional survey for the shoulder joint in overhead athletes, examine the validity and reliability of this scale, and contribute to the literature.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male and female athletes aged between 18-35, Engaged professionally in sports involving overhead activities for at least 3 years (volleyball, basketball, swimming, badminton, water polo, tennis, American football, handball, etc.), Actively participating in competitions for at least 1 year, Experiencing current traumatic or non-traumatic pain, or having a history of shoulder pain, or having chronic shoulder pain, Native Turkish speakers.  Exclusion Criteria:  Neurological and/or rheumatological disease, Active local or systemic infection, History of cancer, Severe visual impairment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult
Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Status: Recruiting

A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests (porto- systemic collaterals at imaging, platelet count <150.000 x mm3, spleen size >13 cm in the largest axis, alteration of elastography parameters of the liver or spleen) naïve to treatment with NSBBs,  Exclusion Criteria:  Child Pugh >A6 Hepatocellular carcinoma Portal vein thrombosis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Consecutive outpatients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests, naïve to treatment with NSBBs, will be evaluated over a two-years period. - SamplingMethod: Non-Probability Sample
Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte
Status: Not yet recruiting

This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.

Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.

The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.

Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinical and radiological diagnosis of claw nail in at least one toe. Pain associated with claw nail for at least 1 month.  Exclusion Criteria:  Pregnancy or breastfeeding Previous trauma or surgery on the affected toe Systemic diseases such as diabetes mellitus, renal insufficiency, rheumatoid arthritis Current or previous treatment for ingrown toenail within the last year Severe digital deformities (e.g. Hallux Valgus, hammer toe, claw toe) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The target population will be adult men and women diagnosed with painful claw nails. It is estimated to recruit 115 patients who meet the selection criteria from the podiatric consultation. The expected mean age is 45-55 years, a range consistent with the typical prevalence of this deformity. There will probably be a higher proportion of women given the greater predisposition of this sex. Participants should have nail curvatures and toenail pain of more than 1 month of evolution. Other concomitant pathologies and factors that could confound the association between osteophyte and nail curvature will be excluded. - SamplingMethod: Non-Probability Sample
Spectroscopic Profiling of Extracellular Vesicles By Resonant Gold Nanostructures in the Infrared
Status: Recruiting

Extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. Nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. The main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.

Eligibility:
- EligibilityCriteria: Inclusion  18 years old with a diagnosis of liver cirrhosis of different etiology 18 years old with a diagnosis of hepatocellular carcinoma  Exclusion  Have not signed the informed consent Pregnant women - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The target population of this study is divided into two groups: a) control group, 32 cirrhotic patients and b) oncology group, 32 patients diagnosed with hepatocellular carcinoma - SamplingMethod: Probability Sample
The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation
Status: Not yet recruiting

This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at each post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Qualification for the first autologous or allogeneic HCT due to hematologic malignancies or solid tumors Age ≥ 18 years Signed written informed consent Ability to read and write in Polish Daily access to the Internet by computer and/or mobile device  Exclusion Criteria:  Major psychiatric or cognitive disorder that would impede providing informed consent and study participation Inability to cooperate and give informed consent Hearing, seeing, or movement impairment that precludes participation Current participation in any form of psychotherapy No access to the Internet No access to a computer and/or mobile device Inability to use a computer and/or mobile device and the Internet - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities
Status: Recruiting

Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Embryos: embryos that have reached the blastocyst stage Sperm: samples used for IVF during infertility treatment Endometrium: endometrial spectra in cases where an embryo transfer was performed into the uterus  Exclusion Criteria:  For all groups: ectopic pregnancy Embryos: presence of only one blastocyst, and that embryo prognosed by the model as negative Sperm: a cycle where less than 3 oocytes suitable for fertilization were obtained; total pathological fertilization; 60% or more immature oocytes at the time of fertilization registration - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 44 Years - StdAgeList: Adult
Digital Bonding vs. Direct Bonding Study
Status: Not yet recruiting

This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subject is 12 years of age or older. Subject is able and willing to provide their own informed Assent AND Subject or Legal Authorized Representative (LAR) is able and willing to sign the Informed Consent Form Subject is able and willing to be available for all scheduled study visits. The Subject is treatment-planned for required comprehensive orthodontic treatment for both arches using brackets. Subject's current orthodontic treatment plan does not include extractions, orthognathic surgery, post-orthodontic restorative treatment (with the exception of minor spaces for tooth shaping post-orthodontic treatment), or temporary anchorage devices. Subject has all permanent teeth erupted (dentition including second molars). Subject has an Angle Class I or Class II (up to 3mm) molar and canine relationships. The Subject has mild to moderate crowding (crowding less than 5 mm in each arch) Subject has an overbite measuring between -1 mm (open bite) and 5 mm (deep bite). The Subject's intra-oral scan must have been taken within 90 days of bracket placement. The Subject is anticipated to complete treatment within 18 to 24 months.  Exclusion Criteria:  Subject has a history of adverse reaction to any materials used in this study. Subject is pregnant or breast feeding. Subject has advanced periodontal disease. Subject has non-movable teeth (e.g., implants, bridges, ankylosed teeth). Subject has more than 1 tooth excluded from the initial bonding (not including 2nd molars), e.g., no bracket placed on tooth due to position of the tooth at that point in time (tooth turned 90 degrees) Subject will have more than 25% of the total number of brackets bonded to a non-enamel surface (e.g., restoration). Subject has developmental abnormalities of the enamel (e.g., hypoplasia, moderate to severe fluorosis). Subject has erupted 3rd molars. Subject is, in the opinion of the investigator, unsuitable for enrollment in the study for reasons other than those specified in the above exclusion criteria. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult
Pain, Anxiety, and Comfort Levels in Coronary Angiography
Status: Not yet recruiting

The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  over 18 years Conscious patients  Exclusion Criteria:  Patients undergoing intubation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing coronary angiography in the coronary intensive care unit - SamplingMethod: Probability Sample
Image Enhanced Endoscopy IBD
Status: Not yet recruiting

Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.  Exclusion Criteria:  Any active disease Inadequate bowel preparation Previous surgical resection involving the colon History of bowel cancer - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
Status: Recruiting

The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).

The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter < 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization Signed informed consent  Exclusion Criteria:  Severely reduced systolic ejection fraction of the left ventricle (EF < 35 %) Severe renal impairment (eGFR < 30ml/min/1.73m2) Severe chronic obstructive pulmonary disease (GOLD D) Contraindication for application of papaverine or regadenoson - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult