rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
Status: Not yet recruiting

This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Male or female. Aged 18-65 years (both inclusive) at the time of signing informed consent. Body Mass Index (BMI) between 27.0 and 39.9 kilograms per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.  Exclusion Criteria:  Previous dosing in a study with an amylin analogue. Presence or history of pathological bleeding tendencies, recent serious bleeding, recent myopathy or rhabdomyolysis, malignant hypertension and any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions including type 1 or type 2 diabetes mellitus. Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator. Glycated haemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening. Activated partial thromboplastin time (APTT) less than (<) 22.1 seconds (lower normal limit [LNL]-0%) or APTT greater than (>) 28.1 seconds (upper limit of normal [UNL) +0%) at screening. Prothrombin time < 70% (LNL-0%) or prothrombin time > 130% (UNL-0%) at screening. Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic cytochrome P450 (CYP) pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol and highly effective contraceptives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Randomized Trial of Hydrus Microstent Versus Goniotomy
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:

How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
How do the safety profiles of these three microinvasive glaucoma surgeries compare?

Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Visually significant cataract planned for surgery Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees <15 dB Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points <15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point <15 dB Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery Willing and able to understand and provide informed consent Willing and able to attend postoperative examinations per protocol schedule  Exclusion Criteria:  Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation Selective laser trabeculoplasty within 90 days of study enrollment Iridotrabecular contact for 180 degrees or greater Peripheral anterior synechiae in nasal or inferior angle Best corrected visual acuity worse than 20/200 Phacodonesis on pre-operative examination Vitreous in anterior chamber on pre-operative examination Nanophthalmos Anti-platelet and anticoagulant medications other than aspirin 81mg daily Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant) Abnormality in study eye that could affect tonometry Glaucoma diagnosis other than the above Normal tension glaucoma Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor) History of uveitis in either eye Inability to complete gonioscopy examination Use of oral steroids within 90 days or anticipated use of oral steroids Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide History of steroid-associated IOP elevation Medically unfit for attending planned study visits Involvement in another interventional research study - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial
Status: Not yet recruiting

The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:

The efficacy in reducing blood transfusion for topical tranexamic acid administration
The safety of tranexemic acid, topically used

As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.

Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Elderly patients (age &gt; 60 years) Femoral neck fractures from low energy mechanism Household ambulator Undergoing cementless bipolar hemiarthroplasty at KCMH Informed consent  Exclusion Criteria:  Allergy to TXA History of VTE History of hip surgery, pathological fracture, hip infection Congenital or acquired coagulopathy Hb &lt; 10 g/dL or Platelet &lt; 140,000 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Examination of Pain, Posture, Physical and Mental Status in Seasonal Hazelnut Workers
Status: Not yet recruiting

The collection of hazelnuts grown in our country provides a great source of employment for local people and seasonal workers. However, geographical conditions in hazelnut growing areas, challenging variable weather conditions in August and insufficient number of workers create a disadvantageous environment for seasonal workers.

In this study, it was aimed to investigate the effects of working conditions on mental status, fatigue, pain severity and postures (posture disorders, developmental delays, etc.) of young adults working in Giresun during the hazelnut picking season in comparison with the group living in the same sociodemographic and cultural environment but not working as seasonal workers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria (For seasonal workers):  Volunteering to participate in the study. To be between the ages of 18-34. Having worked as a seasonal worker in Giresun for at least 1 month during the hazelnut harvest period.  Inclusion Criteria (For controls):  Volunteering to participate in the study. To be between the ages of 18-34. Not having worked in any agricultural work during the summer period. Living in the same socioeconomic environment as the group working as seasonal workers  Exclusion Criteria:  Having visual, auditory, etc. communication problems that will prevent participation in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 34 Years - StdAgeList: Adult - StudyPopulation: Seasonal agricultural workers and not working control group in the same age and socioeconomic environment - SamplingMethod: Probability Sample
Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis
Status: Not yet recruiting

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Must be willing and able to provide written, signed informed consent. Male individual at least 8 years of age with clinical diagnosis of XLRS caused by mutations in RS1. Best corrected visual acuity (BCVA) in the study eye of less than or equal to 63 (corresponding to a Snellen acuity of 20/63). Must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer.  Exclusion Criteria:  Lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina. Pre-existing eye conditions that would contribute significantly to visual loss or increase the risk of an intravitreal injection (e.g. DR、RVO or large retinal detachment). Any intraocular surgery in the study eye within 6 months prior to screening. Use of topical carbonic anhydrase inhibitors within 3 months prior to screening. Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration. Prior receipt of any AAV gene therapy product. Use of any investigational agent within 3 months prior to screening. - HealthyVolunteers: No - Gender: Male - MinimumAge: 8 Years - StdAgeList: Child, Adult, Older Adult
Online Yoga for Improving the Well-being of Desk-based Workers
Status: Recruiting

The goal of this clinical trial is to evaluate the effectiveness of an 8-week online yoga intervention in improving the well-being and productivity of desk-based workers. The main questions it aims to answer are:

How effective is an 8-week online yoga intervention in improving the well-being (mental and physical) and productivity (work engagement and job performance) of the yoga group compared with passive controls?
Are there any differences in well-being and work-related measures between the yoga and control groups?

Participants in the yoga group will practice yoga three days a week for 8 weeks and will be compared with a wait-listed control group, which will continue with the usual routine for 8 weeks. Researchers will evaluate the impact of yoga on the well-being and productivity of desk-based workers.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants working remotely/hybrid aged 18 years and above. living and working in the UK. speak and understand English. Fulfil the health criteria (e.g., No current injuries ). Are willing to commit to an 8-week online streamed yoga course, three times a week, 60 min each session  Exclusion Criteria:  Current yoga practice or related activities. Medical or psychiatric conditions limiting the practice of yoga in general Not suffering from any serious medical or psychiatric illness. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Status: Recruiting

Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Between the age of 18 - 85 years Can provide consent Negative urine B-hCG Continued follow-up with the bariatric surgery team. BS includes one of the following: gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch. Phase I: Underwent BS within the last 3 years Phase II: Will undergo BS within the next 3 months or underwent BS in the last 30 days  Exclusion Criteria:  Unable to provide consent Pregnant or breastfeeding BMI < 35 Revision surgery of one of the following BS from above Prior history of autonomic dysfunction prior to BS Developed AD 72 months post-procedure No evidence of AD/OI - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Phase I: who have undergone bariatric surgery in the last 3 years. Phase II: who will undergo bariatric surgery within the next 3 months. - SamplingMethod: Non-Probability Sample
Magnetic Field Application in Patellofemoral Pain Syndrome
Status: Recruiting

The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Having been diagnosed with patellofemoral pain syndrome by an orthopedic physician Volunteering to participate in the study Having pain for more than eight weeks Patients who did not undergo surgery  Exclusion Criteria:  Patients diagnosed with rheumatological disease Patients who have previously had steroid injections in the knee area Patients with entrapment neuropathy and deformity in the lower extremity Patients who are pregnant Patients suffering from scoliosis, Patients who use non-steroidal anti-inflammatory and antidepressant regularly for any reason - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes
Status: Recruiting

Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD.

MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India.

The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals with or without T2DM between ages 30 to 70 years  Exclusion Criteria:  Age below 30 years Patients with hepatitis B, hepatitis C or HIV disease Patients with significant alcohol intake (>14 drinks/week in men and >10 drinks/week in women).  Patients on corticosteroids and chemotherapeutic agents. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Individuals with or without diabetes will be enrolled - SamplingMethod: Non-Probability Sample
Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery
Status: Recruiting

Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Aged 18-90 years at the time of initial recruitment Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1  Exclusion Criteria:  Oesophageal squamous cell carcinoma Previous oesophageal and gastric resection History of another cancer within five years. If a new other cancer type is diagnosed within the sampling time frame, no further samples will be taken. Participants with co-morbidities preventing breath collection Unable or unwilling to provide informed written consent Pregnant women - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients seen in a hospital (secondary or tertiary level care) setting - SamplingMethod: Probability Sample
Cohort IMEA 070 -Lenacapavir Compassional
Status: Not yet recruiting

Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202  Exclusion Criteria:  Absence of visits with virological assessment subsequent to inclusion visit Participant opposition to use of follow-up data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022 - SamplingMethod: Non-Probability Sample
Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience.
Status: Not yet recruiting

The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Parent or doctor of a child screened for PKU, born during the inclusion phase of the study Family's first exposure to PKU: the PKU child must be either the eldest or the first sibling to be diagnosed with PKU following neonatal screening  Exclusion Criteria:  Failure to master the French language. Child screened is neither the eldest nor the first sibling to be screened. Refusal by the parents. Any other reason which, in the investigator's judgement, would impair the participants' ability to follow the study protocol, or the interpretation of interview data (e.g. the participating parent has a history of serious psychiatric pathology, one of the parents died at the child's birth, Couples in which one of the members suffers from a known decompensated psychiatric pathology at the time of recruitment. Couples where one of the members is under legal protection or a security measure, etc …). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Parent(s) of children screened for PKU, doctors in charge of the announcement and midwives in charge of the NBS. - SamplingMethod: Non-Probability Sample
AI4HOPE Dementia Pain Assessment Pilot Study 1
Status: Not yet recruiting

The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Mild or moderate dementia of any type Able to provide informed consent, or consent from surrogate decision maker Able to self-assess patient-related outcome (PROM) or experience (PREM) measures  Exclusion Criteria:  Ongoing delir Severe cognitive impairment (MMSE < 10 [22]) Unable to provide informed consent Life expectancy estimated less than 3 months - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult
NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery
Status: Recruiting

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.

The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.

A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).

The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  planned, first-time, bilateral thyroid surgery  Exclusion Criteria:  planned unilateral thyroid surgery, previous thyroid surgery, pregnancy lactation age < 18 years age > 75 years ASA 4-5 grade (American Society of Anesthesiology) inability to comply with the follow-up protocol - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult