rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
"Colorectal Leakage App" for Early Detection of Anastomotic Leakage After Colorectal Surgeries
Status: Recruiting

The aim of this prospective observational study is to evaluate the effectiveness of the mobile application "Colorectal Leakage App" in the early diagnosis of anastomotic leakage after colorectal surgeries at the National Research Oncology Center in Astana, Kazakhstan.

Main Questions:

Development, validation, and implementation of the mobile application "Colorectal Leakage App," based on the Dutch Leakage Score.
Evaluate the diagnostic effectiveness of the application in detecting anastomotic leakage after colorectal surgeries.
Determine the frequency of anastomotic leakage after colorectal surgeries performed in the colorectal surgery sector of the National Research Oncology Center in the Astana city.

Participants in the study, individuals aged 18 and above undergoing colorectal surgeries, will be monitored by the mobile application "Colorectal Leakage App" in the postoperative period for early identification of anastomotic leakage.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Scheduled patients with benign and malignant colorectal diseases undergoing surgical treatment, including the creation of anastomoses (ileocolic, colocolic, colorectal anastomoses), with or without a preventive stoma. Male and female patients aged 18 years and older. ECOG = 0-2; 6. Satisfactory hematological indicators and parameters of liver and kidney function.  Exclusion Criteria:  Participants under 18 years old. Pregnant, lactating, or planning pregnancy participants. ECOG>2; Unresctable tumors. Patient's refusal to continue participating in the study.. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Scheduled patients with benign and malignant colorectal diseases undergoing surgical treatment, including the creation of anastomoses (ileocolic, colocolic, colorectal anastomoses), with or without a preventive stoma. - SamplingMethod: Probability Sample
Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients
Status: Not yet recruiting

This study is a prospective, multicenter study in which a serum sample will be collected at the day of starting neo adjuvant treatment in breast cancer patients

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Women with a new diagnosis of triple negative breast cancer who have not yet started systemic treatment. Patients with stage I-III disease, patient with locoregional recurrence who have not been treated with chemotherapy before. , Aged < 60 years Women having a (regular) physiological menstrual cycle Patients who are assigned to receive neoadjuvant chemotherapy with or without immunotherapy, targeted therapy and endocrine therapy Patients must be systemic treatment naïve for current malignancy (e.g. no chemotherapy, hormonal therapy or targeted therapy) Signed written informed consent  Exclusion Criteria:  current use of hormonal contraception or in the six weeks prior to start of neoadjuvant systemic treatment for breast cancer, such as: Oral contraception (OAC) Hormonal intra-uterine device (IUD, Mirena) No ovarian function suppression to preserve fertility Other forms of hormonal contraception, including but not limited to: nuva-ring, Implanon, prikpil  Currently pregnant and / or breast feeding. In case of use of hormonal contraception or breast feeding in de last year: patients should have had at least 2 menstrual cycles since stopping hormonal contraception.  - active other malignancy  IVF-trajectory for egg cell preservation prior to start of neoadjuvant systemic treatment - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult
Effect of Diaphragmatic Release in Sleep Quality During Pregnancy
Status: Recruiting

Sleep disordered breathing (SDB) is very common during pregnancy, and is most likely explained by hormonal, physiological and physical changes. Maternal obesity, one of the major risk factors for SDB, together with physiological changes in pregnancy may predispose women to develop SDB. SDB has been associated with poor maternal and fetal outcomes. Thus, early identification, diagnosis and treatment of SDB are important in pregnancy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Pregnant women (at third trimester), diagnosed with sleep disordered breathing by the gynaecologist. Their ages will range from 30- 40 years old . Their BMI will be 25 to 30kg/m2. All are multipara.  Exclusion criteria:  Women will be excluded from the study if they have:  Previous pulmonary surgery. any pulmonary diseases. Asthma. Neurological disorders Musculoskeletal disorders (severe osteoarthritis, osteoporosis) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: pregnant female - MinimumAge: 30 Years - MaximumAge: 40 Years - StdAgeList: Adult
A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)
Status: Not yet recruiting

The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The main inclusion criteria include but are not limited to the following:  Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness. History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder. Body mass index is 18 and 40 kg/m^2, inclusive. If currently taking an antipsychotic, is able to discontinue it's use at least 5 days prior to study start and the duration of the study.  Exclusion Criteria:  The main exclusion criteria include but are not limited to the following:  Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases. Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion. History of cancer (malignancy). Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome. History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia. Substance-induced psychotic disorder or behavioral disturbance. DSM-5 TR defined substance use disorder within 3 months of screening. History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures. Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus. Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening. Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Evaluation of Medication Management Service
Status: Recruiting

Medication management services (MMS) is a pharmacist-led service of optimizing the medication use and health outcomes, by promoting medication safety and enhancing the ability in self-management of health and diseases of patients and their caregivers. Yet, only limited evidence on the implementation of MMS service in Hong Kong is available. The goal of this clinical trial is to evaluate the cost effectiveness and effects of implementing MMS in community pharmacies owned by 8 non-government organizations (NGOs) in Hong Kong on humanistic and clinical outcomes in patients with hypertension and/or type II diabetes mellitus. The clinical trial aims to look into the following aspects:

To evaluate the perception and satisfaction of patients on MMS service
To investigate whether MMS could improve patients' adherence to their medication regimen, health-related quality of life, health outcomes and health service utilization, as well as their ability to understand and cope with their illness and drug-related problems
To identify and categorize the types of drug-related problems identified during MMS
To evaluate the cost-effectiveness of implementing MMS in community pharmacies

MMS services will be rolled out in a total of 8 NGO community pharmacies progressively (2 pharmacies per phase) in 4 successive phases. Participants will complete the questionnaires at the following time points throughout the trial, namely 1) during recruitment, 2) baseline (1 month before MMS), 3) 3 months after MMS begins, 4) 12 months after MMS begins, and 5) 24 months after MMS begins. Researchers will compare the results of questionnaires conducted at different time points to identify the potential changes in the effects of MMS. Furthermore, researchers will link up the electronic health records of the participants and identify the potential changes in the health outcomes and health service utilizations after receiving MMS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  aged 18 years or above diagnosed with Type 2 diabetes mellitus and/or hypertension having regular follow-up on Type 2 diabetes mellitus and/or hypertension at Hospital Authority no A&E admission/hospitalization in the past 3 months no recent changes in medication regimen in the past 3 months polypharmacy (taking 5 or more chronic medications) using at least 1 high-risk medication (Anticoagulants, Oral hypoglycaemics, Insulins, psychotropic medications or immunosuppressants) able to communicate in Cantonese and/or English  Exclusion Criteria:  aged below 18 unable to give informed consent unable to communicate in Cantonese and/or English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
Status: Recruiting

Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  diagnosis of non-infectious chronic uveitis before the age of 16; signed informed consent form.  Exclusion Criteria:  Patients with a diagnosis of infectious uveitis history of malignant pathology, history of demyelinating pathology, history of cerebral vasculitis - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 16 Years - StdAgeList: Child - StudyPopulation: The data of patients who have been under the care of the hospital since 2010 will be included, and new patients diagnosed from the date of Ethical Committee approval onwards for the next 10 years will also be included - SamplingMethod: Non-Probability Sample
Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy
Status: Recruiting

The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consent form signed Patients with a biopsy-proven prostate carcinoma planned ORP or RARP  Exclusion Criteria:  No exclusion of patients who fulfil the above inclusion criteria - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with biopsy-proven prostate cancer who undergo open or robotic-assisted radical prostatectomy at the Martini Clinic are included (N=1000). - SamplingMethod: Probability Sample
D-OCT for Detection and Subtyping of BCC: a Diagnostic Cohort Study
Status: Not yet recruiting

The current gold standard for diagnosing basal cell carcinoma (BCC) is the histopathological examination of biopsy specimen. However, non-invasive imaging modalities such as optical coherence tomography (OCT) may replace biopsy if BCC presence and its subtype can be established with high confidence. Subtype differentiation is crucial; while superficial BCCs (sBCC) can be treated topically, nodular (nBCC) and infiltrative BCCs (iBCC) require excision. Dynamic OCT (D-OCT) is a functionality integrated within the OCT device, enabling the visualization of vascular structures through speckle variance.

Descriptive studies have unveiled vascular shapes and patterns associated with BCC and its respective subtypes. These findings suggest that D-OCT could contribute to the accuracy of BCC detection and subtyping. Yet comparative clinical studies between OCT and D-OCT are lacking. In the proposed diagnostic cohort study, we aim to assess whether D-OCT assessment is superior to OCT in terms of accuracy for BCC detection and subtyping.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18+ years Lesions suspect for non-melanoma skin cancer or premalignancy Patient underwent D-OCT scan and biopsy conform regular care  Exclusion Criteria:  Patient unable to sign informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This diagnostic cohort study will include patients (18+ years) who underwent a biopsy and D-OCT scan for lesions suspect for BCC skin cancer. Patient data was retrieved from a pre-existing registry (METC: 2022-3555). All D-OCT scans were obtained at the outpatient dermatology clinic of Maastricht University Medical Center+ (MUMC+) using a Vivosight Multi-beam Swept-Source Frequency Domain OCT scanner (Michelson Diagnostics Maidstone, Kent, UK; resolution <7.5 µm lateral, <5 µm axial; depth of focus 1.0 mm; scan area 6 × 6 mm). All scanned lesions were histopathologically examined by a dermatopathologist blinded to D-OCT scans and D-OCT assessment. - SamplingMethod: Non-Probability Sample
Remote Assessment of OCT Scans for BCC Detection
Status: Not yet recruiting

Basal cell carcinoma (BCC) is the most common form of cancer and entails approximately 80% of all cutaneous malignancies. This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful, causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures. Moreover, awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient. The drawbacks of biopsy could be overcome by optical coherence tomography (OCT), a non-invasive diagnostic modality that may replace biopsy in up to 66% of patients. However, OCT assessors are scarce which hinders the implementation of OCT. This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics. Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion. But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment. In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs (CDP-OCT).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18+ years of age Underwent OCT scan and punch biopsy for lesions suspect for BCC  Exclusion Criteria:  Unable to sign informed consent - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Included cases contain OCT scans of patients with lesions suspect for BCC. Three OCT assessors will be included in this study to assess the OCT scans with and without clinical and dermoscopic photographs. - SamplingMethod: Non-Probability Sample
Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery
Status: Not yet recruiting

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.

A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  request for permanent sterilization at the time of cesarean delivery 24 weeks' gestation or beyond 21 years old or older Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).  Exclusion Criteria:  vaginal delivery history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy) placenta accreta spectrum placenta previa history of bleeding diathesis. - Gender: Female - GenderBased: Yes - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients aged 21 years or older undergoing permanent sterilization at the time of cesarean delivery at 24 weeks' gestation or beyond, 21 years old and older - SamplingMethod: Non-Probability Sample
Postpartum Initiation of Long-acting Reversible Contraceptives: Knowledge Attitude and Practice Study (KAP)
Status: Recruiting

Comparing Knowledge, attitude and Practice of clients and service providers about the regular (6 weeks) versus earlier initiation of LARC, through a structured questionnaire prepared in English and translated to local language i.e. Arabic.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Client's group All clients who were attending family planning centers in public health facilities at the study period if they have had a postpartum LARC method (Copper IUD, Progestin-releasing IUS, Subdermal implant) or willing to use it in the first year after delivery.  Service provider group:  All service providers who are working in primary health care units & hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers.  Exclusion Criteria:  Clients and service providers who refused to participate in the study Clients who are currently using or willing to use a method other than LARC - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: Client's group:  All females visiting family planning centers in public health facilities who delivered within a year and receiving a LARC method or willing are asked to volunteer.  Service provider group:  All service providers who are working in primary health care units & hospitals, including general practitioners, ob/gyn. specialists, nurses, and social workers are asked to volunteer. - SamplingMethod: Non-Probability Sample
Effects of Medisinstart for Type 2 Diabetes
Status: Recruiting

Medisinstart is a counseling service in pharmacies where patients who start taking a new medicine receive two follow-up appointments with a pharmacist. The aim of the service is to promote correct medication use and increase patient adherence. The effect of Medisinstart has previously been studied among patients starting a new cardiovascular drug. The aim of the project is to map the effects of Medisinstart among patients starting a new medication for type 2 diabetes. Knowledge about the effects of Medisinstart is important in order to maximize the benefits of the service for patients and society. The project is being conducted as a randomized controlled trial among adult patients starting a new medication for type 2 diabetes. The intervention group receives Medisinstart, while the control group only receives prescription dispensing as normal. Data collection includes HbA1c analysis in blood samples and responses to questionnaires. HbA1c is an established measure of glycemic control.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Extracted a new drug/active substance (A10A/A10B) for type 2 diabetes Age ≥ 18 years The drugs are administered by the patient/relatives Good command of Norwegian, both written and spoken  Exclusion Criteria:  Inability to understand and/or complete consent forms, questionnaires and/or other patient-oriented materials Not able to attend physical appointments in the pharmacy Not given written consent to participate in the study Diabetes medication is administered by a healthcare professional Known pregnancy HbA1c is unsuitable as an average measure of blood glucose at baseline Received initiation of medication for type 2 diabetes within the last year Ongoing participation in other studies involving similar interventions to increase adherence and ensure correct medication use - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Clinical Research on Acute Intermittent Porphyria and the Use of Carbohydrate-Rich Diet as a Treatment
Status: Recruiting

The main aim of this clinical trial is to learn about the effect of carbohydrate-rich diet as a treatment for AIP (acute intermittent porphyria).

Aim: Investigate the diet's impact on tissue and serum glucose, plasma insulin, cytokine levels, amino acids, and gut microbiota in AIP, and their correlation with PBG (Porphobilinogen).

Aim: Assess the diet's effect on AIP symptoms and health status in AIP. Aim: Measure the effect of a high-carbohydrate diet on mitochondrial activity in AIP Aim: Map and detect potential mutations in mitochondrial genomic DNA in AIP Aim: Discover new markers in AIP through RNA sequencing and machine learning.

Participants will follow two diet plans, a 4-week intervention with 60-65 E% carbohydrates and a 4 week intervention with 40-45 E% carbohydrates.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosis of AIP  Exclusion Criteria:  Not having diagnosis of AIP Undergoing treatment as part of other clinical research on AIP Pregnancy Diabetes Below 18 years of age - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult