rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
RemI for Post-Bariatric Surgery Weight Regain
Status: Not yet recruiting

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).

The main research aims are:

To compare changes in body weight over 12 months in 200 bariatric patients who have regained > 5% of their weight and are randomly assigned to ABTi or Control.
To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women Ages 18-70 years old Weight regain of at least 5% from lowest postoperative weight Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment Ability to give consent Ability to speak, write, and understand English  Exclusion Criteria:  Long-term treatment with oral steroids Current use of weight loss medication (OTC or prescription) Current pregnancy or plan to become pregnant within 12 months Psychiatric hospitalization in the past 6 months Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality Self-report of alcohol or substance abuse within the past 12 months Current, self-reported use of tobacco products Weight loss > 10 lbs in the past 3 month History of more than one bariatric procedure Inability to walk at least one city block without assistance - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression
Status: Recruiting

Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI > 27.5) and non-severely overweight/normoweight (BMI < 27.5) patients affected by prostate carcinoma.

ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.

iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  affected by prostate cancer  Exclusion Criteria:  - - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients affected bt prostate cancer both obese or not obese - SamplingMethod: Non-Probability Sample
The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus
Status: Not yet recruiting

To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,

i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.

ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.

iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.

iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with GDM as confirmed by the Oral Glucose Tolerance Test during pregnancy Age ≥ 21 and ≤ 45 years Attended first (baseline) session of GDM diet counselling session Able to read and comprehend English Have a digital device accessible to social media platform Have SingPass access Able to provide informed consent  Exclusion Criteria:  With known Type 1 or Type 2 diabetes Have multiple pregnancy - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 21 Years - MaximumAge: 45 Years - StdAgeList: Adult
Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents
Status: Not yet recruiting

This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with a biopsy-proven solid tumor, scheduled for surgery at the Erasmus Medical Center. Signed and dated informed consent obtained before any study-related procedure is performed.  Exclusion Criteria:  Terminated surgical procedure. No fresh specimen available. Participation in a clinical trial for which the patient receives another fluorophore perioperatively. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control
Status: Not yet recruiting

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ASA I-II women scheduled for elective CS under intrathecal anesthesia.  Exclusion Criteria:  had local infection, bleeding disorder or known allergy to any of the study medications - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 45 Years - StdAgeList: Adult
Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
Status: Not yet recruiting

The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pittsburgh Sleep Quality Index score is 8 or above. Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.  Exclusion Criteria:  Movement disorder, inability to move independently. Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid). Eye diseases such as glaucoma, diabetic retinopathy, and cataracts. Bipolar disorder. Light-induced epilepsy. Sleep disorders such as sleep apnea and involuntary leg twitching. Currently taking sedative-hypnotic drugs or receiving other non-drug treatments. Beck depression inventory-II score is greater than 13 points. Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers. Acute illness. Abnormal blood pressure or fever. Pregnancy and pregnant women. Special physical abnormalities and sensory nerve abnormalities. Infectious diseases. Coagulation disorder. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Inhibin B/AFC Ratio for Ovarian Response
Status: Not yet recruiting

Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.

A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  first IVF; without severe male factor involved.  Exclusion Criteria:  Patients with endometrioma; ovarian cyst; AMH < 0.5 ng/ml; increased serum TSH (thyroid-stimulating hormone) or prolactin levels; endocrinopathies; previous oophorectomy; failure to visualize one of the ovaries on ultrasound. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult - StudyPopulation: Follicle counting (AFC) will be performed prior to the administration of gonadotropins. For ovarian stimulation, a flexible protocol will be used with a GnRH antagonist (gonadotropin-releasing hormone) and doses of 150-300 IU of recombinant FSH administered daily. Follicular growth will be monitored by ultrasound and hCG (human chorionic gonadotropin) will be administered when two or more follicles reach 17 mm in diameter; In this last ultrasound, the pre-ovulatory follicle count (PFC) will be performed to calculate the FORT. Ovarian puncture will be performed 36 hours after hCG administration. On the fifth day of induction, a blood sample will be collected from the patient for subsequent inhibin B measurement by enzyme-linked immunosorbent assay (ELISA). These samples will be stored at the Insemine Human Reproduction Center - SamplingMethod: Probability Sample
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
Status: Not yet recruiting

This study is researching an experimental drug called linvoseltamab ("study drug").

This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.

The study consists of 2 phases (Phase 1 and Phase 2):

In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.
In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.

The study is looking at several other research questions, including:

How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long
How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long
What the right dosing regimen is for linvoseltamab
What side effects may happen from taking linvoseltamab
How much linvoseltamab is in your blood at different times
Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Confirmed diagnosis of AL amyloidosis, as described in the protocol Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol Previously treated after at least 1 prior therapy and no more than 4 lines of therapy (including autologous stem cell transplant) and requiring further treatment as assessed by the Investigator N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening  Key Exclusion Criteria:  History of other non-AL amyloidosis Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening Myocardial infarction within the past 6 months prior to the first screening visit Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug  NOTE: Other protocol defined inclusion/exclusion criteria apply - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications
Status: Not yet recruiting

During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications.

Eligibility:
- EligibilityCriteria: İnclusion criteria:  Patients who will undergo elective cardiopulmonary bypass surgery and agree to participate in the study Patients who will undergo coronary or valve surgery Surgeries performed on a stopped heart Patients over 18 years  Exclusion criteria:  Patients undergoing emergency cardiac surgery Patients who will undergo redo surgery Patients who will undergo total circulatory arrest surgery Patients in a state of preoperative shock Patients with acute and chronic hypoxemia (PaO2 <65mmHg, SpO2 <95 in room air) Patients followed with mechanical ventilation for 7 days before surgery Patients with BMI>35 Patients with obstructive sleep apnea syndrome Patients with pulmonary artery pressure >50 mmHg Patients with glomerular filtration rate <30 ml/min - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who are over 18 years and agree to participate in the study. - SamplingMethod: Non-Probability Sample
Autonomic Involvement in Patient With Cognitive Decline
Status: Recruiting

Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  male and females between 50 and 85 years cognitive decline (dementia, lewy's body dementia, Parkinson dementia, Alzheimer dementia) mild cognitive decline ( lewy's body MCI, Parkinson MCI and Alzheimer MCI) Ability to assume the upright position  Exclusion Criteria:  diabetes mellitus eye problems severe cognitive decline heart disease peripheral neuropathy language barrier oncological disease medical pathologies associated with cognitive deficits - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult
ENDOPLY System in Humans: a Pilot Study
Status: Not yet recruiting

Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI 30-40, i.e. class I and II obese patients Age above 18 and below 60 years Having failed multiples diet attempts  Exclusion Criteria:  Achalasia and other oesophageal motility disorders Severe esophagitis Gastroduodenal ulcer Heart disease and hypertension without treatment Pulmonary, renal or hepatic failure, cancer Pregnancy ongoing, scheduled or in the past months Previous bariatric surgery or endoscopic bariatric technique Participation to another study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism
Status: Recruiting

This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. written informed consent signed prior to enrolment 2. age > 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells <3×109/L, and/or platelet <50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism  Exclusion Criteria:  Patients with any of the following are not eligible for enrollment in this study  Coagulopathy or other blood disorders Recent use of anticoagulant drugs Severe hypertension and cardiac insufficiency Bone marrow aspiration results showed bone marrow suppression Combined with other spleen malignant diseases Severe skin infection at the puncture site Participated in other clinical studies within 2 months prior to the start of the study Patient or his/her authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning
Status: Recruiting

Mannequin training for emergency home delivery on medical doctors and nurses

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  medical doctors and nurses  Exclusion Criteria:  none - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: volunteers - SamplingMethod: Non-Probability Sample
Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety?
Status: Recruiting

The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:

Can preoperative information through a VR headset lower the patients preoperative anxiety?
Can VR information make the patients more ready for surgery. Painscore will also be collected.

Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.

If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Scheduled for total knee arthroplasty Scheduled for spinal anesthesia Age of 18 or above Ability to understand the trial protocol, risks, and benefits and provide signed informed consent  Exclusion Criteria:  Inability to read and understand Danish Uncooperativeness (as judged by investigators) Claustrophobia or fear of small spaces Disorders that prevent the person from wearing a VR device Highly visually or auditive impaired - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult