cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients

Evaluate the role of Soleus muscle exercise in management diabetic kidney disease

management of diabetic kidney disease. To enhance their glycemic control, diabetic patients are advised to perform 150 minutes per week of moderate-to-vigorous aerobic activity Diabetic patients with regular physical activity have reduced daily insulin dose with more glycemic control. In addition to glycemic control, it has also been postulated that the addition of brief intervals of high intensity, sprint -type exercise to aerobic exercise can decrease the risk of late nocturnal hypoglycemic episodes Marc T. Hamilton et al., 2022, reported that the human soleus muscle could raise local oxidative metabolism to high levels for hours without fatigue, during a type of soleus-dominant activity while sitting (soleus push up exercise), even in unfit volunteers. They reported that soleus push up exercise can improve systemic VLDL-triglyceride and glucose homeostasis by a large magnitude, e.g., 52% less postprandial glucose excursion (∼50 mg/dL less between ∼1 and 2 h) with 60% less hyperinsulinemia. Muscle biopsies revealed there was minimal glycogen use. This can be explained that the soleus doesn't rely completely on intramuscular glycogen, Instead, it uses a mixture of fuels from glucose and lipoproteins.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-60 yrs.,
* patients with Diabetic kidney disease, not on dialysis
* with stabilized diabetic treatment regimen for 3 months before participating in the study

Exclusion Criteria:

* advanced osteoarthritis of lower limb joints
* advanced poly neuropathic patients
* CKD type V on dialysis
* Diabetic Foot
* hemophilia
* bleeding tendency
* AKI
* other causes of chronic kidney disease
* patients refuse to participate in the study
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
* Must have at least one lesion \> 2 cm within the target perfused volume.
* At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
* Total linear length of all lesions must be ≤ 9 cm.
* Must have preservation of \>700cc of normal liver parenchyma outside of treated volume.
* Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
* No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old.

Exclusion Criteria:

* Hemoglobin ≤ 85 mg/L.
* Platelet count \< 50,000/microliter or prothrombin (PT) activity \> 50% normal
* INR \> 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 2.5x upper limit
* AST \> 2.5x upper limit
* For HCC subjects, Bilirubin ≥ 2 mg/dL.
* For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
* eGFR ≤ 60 mL/min/1.73 m2.
* Portal vein thrombosis (PVT).
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
* Estimated lung dose \> 30 Gy as calculated using the lung shunt % and partition model.
Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools

The purpose of this study is to evaluate the effectiveness of a combined parent-student program for smoking prevention in 7th graders in Berlin schools.

The hazardous health effects of smoking and second hand smoke are well known and published. Despite wide spread tobacco prevention campaigns and initiatives, the proportion of children and adolescents who smoke remains high, especially in Germany. Current research indicates that comprehensive strategies, especially with a parental involvement component, appear to be the most effective school-based smoking prevention programs.

A popular smoking prevention program in the city of Berlin is the Karuna interactive show jumping course "Still smoking or already alive?" ("Rauchst du noch oder lebst du schon?" Mitmach - Parcours). This parcours was designed to teach facts about smoking and its health-damaging effects, its negative effects on physical appearance, to promote communication and to enhance participants' awareness of social pressure and their self-efficacy to deal with these situations. No study to date has evaluated its effectiveness in reducing smoking rates among participating students. The study aim is to test the effectiveness of an interactive combined student-parent intervention in 7th graders regarding the reduction of smoking rates among secondary school children aged 12-15 compared to no smoking prevention intervention using self-reported questionnaires. In addition, it will be tested whether the program that involves the combination of a student and a parent intervention is more effective in the reduction of smoking rates in comparison to a program without a parental intervention.

Eligibility Criteria:
School Inclusion Criteria A school is eligible for the study if

* it is located in Berlin
* has 7th grade classes (students between 12-15 years)

School Exclusion Criteria:

* schools offers an extensive smoking prevention program for their students that includes parental involvement.
* schools that do not agree to stop visiting the KARUNA e.V. smoking parcours (if they do) for the next two years in case of being randomized to the control group.
* schools that do not agree to have a parents' night (separate or part of the typical parents' nights) where trained health coaches will introduce and discuss the topic of smoking prevention in youth in case of being randomized to the combined student-parent intervention.

Student Inclusion Criteria A student is eligible for the study if

* Female or male in the 7th grade
* Signed written assent
* Intellectual and physical ability of participant to make an informed decision about study participation
* Attends one of the participating schools
* Has signed approval from parent/caregiver
OCT in Diagnosis of Irregular Corneas

This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions.

The primary goal will be achieved by using optical coherence tomography (OCT) to:

1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
2. Develop OCT metrics for more sensitive detection of keratoconus progression.
3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.


Eligibility Criteria:
Inclusion Criteria:

GROUP A:

* Keratoconus:

  1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
  2. Topography characteristic of keratoconus or pellucid marginal degeneration
* Contact lens-related corneal warpage:

  1. Contact lens use; and
  2. Topography irregularities
* Dry eye:

  1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
  2. Topography irregularities
  3. Presence of punctate epithelial erosion on exam with surface staining
  4. Aqueous deficiency or evaporative dry eye
* Epithelial basement membrane dystrophy (EBMD):

  1. Negative corneal fluorescein staining; and
  2. Corneal opacities; and
  3. Topography irregularities
* Stromal addition or subtraction:

  1. Scars; or
  2. Salzmann's degeneration; or
  3. Stromal dystrophies; or
  4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
* Stromal distortion:

  1. Radial keratectomy (RK); or
  2. Corneal transplants.
* Normal controls:

  1. Healthy eyes with no previous eye procedures/surgeries.

GROUP B:

Participants will be selected from the keratoconus population in Group A based on topography findings.

GROUP C:

Participants will be selected from the stromal addition/subtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK.

Exclusion Criteria (all groups):

* Inability to give informed consent.
* Inability to maintain fixation for OCT imaging.
* Inability to commit to required study visits.
* Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
* Previous corneal surgeries if considered as a keratoconus participant.
* Pregnancy or breastfeeding.
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in India

This study is conducted in Asia. The aim of this observational study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit
* First twenty patients of diabetes visiting the centre during the data collection period
* Patients willing to sign the informed consent form

Exclusion Criteria:

* Repetition of any patient as patients should not be included twice for any reason
* Unwilling to participate or unable to comply with protocol requirements
Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

The goal of this Hybrid Type 2 effectiveness-implementation trial is to test the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) bundle-a multicomponent intervention comprised of a pre-procedure ergonomic timeout checklist and evidence-based implementation strategies-as a strategy to mitigate the risk of Endoscopy-related injuries (ERI) during colonoscopy.

Endoscopy-related injuries (ERI) occur frequently, emphasizing the crucial need to integrate ergonomic principles into endoscopic practice to mitigate risks and prioritize the health and well-being of endoscopists. Checklists are a proven strategy in healthcare behavior modification; however, the efficacy of a pre-procedure ergonomic timeout checklist remains underexplored. To bridge this gap, the aim is to evaluate the effectiveness and implementation of the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) bundle-a multicomponent intervention comprised of a pre-procedure ergonomic timeout checklist and evidence-based implementation strategies-as a strategy to mitigate the risk of ERI during colonoscopy.

Conducted will be a Hybrid Type 2 cluster randomized controlled trial across 10 endoscopy units in North America with 100 participants. Units will be randomized to the SCOPE-E bundle or usual practice. Effectiveness will be measured by comparing Rapid Entire Body Assessment (REBA) scores before and 3 months after implementation between intervention and control groups. Simultaneously, implementation outcomes will be assessed to understand the practicality of this ergonomic intervention and inform widescale adoption. If demonstrated to be effective, the SCOPE-E Bundle is a feasible and cost-effective intervention that holds significant promise for improving ergonomics globally.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopists who perform colonoscopy at least once per week at one of the participating endoscopy units and who are willing to sign an informed consent form before any study procedures are performed

Exclusion Criteria:

* Endoscopists-in-training will be excluded as will endoscopy units that do not have adjustable monitors and patient beds
Fatigue and Sleep in Children and Adolescents With Juvenile Idiopathic Arthritis: A Cross-Sectional Study

The aims of this study is to primarily investigate fatigue and sleep and to secondarily examine possible relationships between disease activity, pain and functional ability in Turkish children and adolescents with Juvenile Idiopathic Arthritis (JIA).

Children with JIA become fatigued easily, experience joint inflammation, pain, limited mobility and report poor sleep quality and daytime sleepiness . It is reported in the literature that children with JIA suffer from poor sleep, parasomnias, daytime sleepiness, sleep fragmentation, cyclic alternating patterns increase, and sleep-disordered breathing compared to healthy children. Sleep was disturbed in almost half of the patients with both JIA and juvenile dermatomyositis, and that sleep disturbance and fatigue were both correlated with disease activity. Increased pain is associated with more sleep disturbance and more fatigue, and these appear to negatively influence quality of life.

So, in this study, fatigue and sleep in Turkish patients with JIA will be investigated by using specific surveys and also secondarily it will be examined possible relationships between disease activity, pain and functional ability in children and adolescents with JIA.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria consisted of a diagnosis of JIA according to the International League of Associations for Rheumatology (ILAR) criteria (13), being aged between 6 - 18 years, and being able to read and write in the Turkish language. All patients were diagnosed as JIA 6 months prior to the study.

Exclusion Criteria:

* Patients were excluded from study if they had a second rheumatic or another chronic disease, a history of mental deficit or psychological problem or no acceptance for participation in the study by their families.
Perioperative Chemotherapy With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Stage I：preoperative therapy

* Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
* Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Eligibility Criteria:
Inclusion Criteria:

* 1.Pathological tissue were gastric cancer by gastric and liver biopsy.

  2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).

  3.gastric cancer with liver metastasis were not able to resectable lesions.

  4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.

  5.ECOG performance status 0-1.

  6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 pper limit of normal range (ULN); ALT / AST≤2.5 upper limit of normal range (ULN) (≤5.0 x ULN if hepatic metastasis); serum creatinine≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.

  8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.

  10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.

  11.The operation can complete the D2 operation(LNM≥15).

  12.LVEF≥50%

Exclusion Criteria:

* 1. Patients with other extrahepatic metastasis Include peritoneal metastasis.

  3. Patients with other malignancy in 5 years.

  4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.

  5.Patients with hypertension failed to control, active bleeding, 3\~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.

  6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.

  7.Patients have history of organ transplantation.

  8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.

  9.Patients combined antitumor drug outside the research program.
Development of Synthetic Medical Data Generation Technology to Predict Postoperative Complications

\<Development of synthetic medical data generation technology to predict postoperative complications\>

In order to develop a model for predicting the occurrence of complications after surgery, it is necessary to establish a cohort along with statistical indicators related to the occurrence of complications. This study aims to combine synthetic medical data based on actual clinical data and develop a predictive model based on synthetic medical data.

This will allow researchers to conduct research only with synthetic data without dealing with actual medical data, allowing them to use and process data without legal constraints, and to create as much data as they want based on various preprocessed, standardized, and labeled raw data.

Patients from three hospitals in Korea (Seoul National University Hospital, Seoul National University Bundang Hospital, Seoul Metropolitan City-Boramae Medical Center) were enrolled for the study.

Medical data (both clinical and laboratory) from 410,000 patients who were conducted surgery between 2005 and 2020 were collected to evaluate the performance of the prediction model using AKI-based prediction model development and external verification.

Based on the collected patient data, synthetic medical data were combined using the machine learning algorithm, and the anonymity and re-identification of the synthesized medical data were evaluated.

Also, the development of AI-based prediction model using synthetic medical data and the actual medical data model were compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years.
* Non-cardiothoracic and non-vascular surgery from five departments (general surgery, obstetrics and gynecology (OBGY), urologic surgery, neurosurgery, and orthopedic surgery)

Exclusion Criteria:

* 1) no information of baseline (≤90 days before surgery) or follow-up (≤7 days after surgery) renal function
* 2) exclusive surgery, including surgeries of deceased patients or surgery that directly affect renal function (partial or total nephrectomy, kidney transplantation)
* 3) preoperative advanced kidney dysfunction, including preoperative serum creatinine (SCr) ≥4.0 mg/dL, baseline eGFR (estimated glomerular filtration rate) \<15 mL/min/1.73 m2, preoperative kidney replacement therapy history, or AKI history within 2 weeks of surgery
* 4) surgery other than general or spinal anesthesia (local anesthesia or monitored anesthesia care)
* 5) missing covariates.
Steady State Bioequivalence Study of Torrent Pharmaceuticals Ltd's Bioequivalence Study of Torrent Pharmaceuticals Ltd's Quetiapine Tablets

Objective:

Primary objective was to study Steady-state bioequivalence of Torrent's Quetiapine Fumarate Tablets 300 mg.

Study Design:

Randomized, Two-Way, Crossover, multiple Dose, and Open-Label


Eligibility Criteria:
Inclusion Criteria:

* Sex: Male of female
* Age: 25-65 years
* Patients who are receiving a stable daily dose of quetiapine 300 mg every 12 hourly for atlist one month
* Patient willing to adhere to the protocol requirements

Exclusion Criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG.
* Significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 30 mm Hg or more and/or a drop in diastolic blood pressure of 20 mm Hg or more on standing)
* Concurrent use of antihypertensive medication or any medication that might pre-dispose to orthostatic hypotension.
* History of allergic reactions to quetiapine or other chemically related psychotropic drugs.
* Concurrent primary psychiatric or neurological diagnosis including organic mental disorder, severe tardive dyskinesia, or idiopathic Parkinson's disease.
* Existence of any surgical or medical condition, which in the judgement of the Principal Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of patients.
* Concurrent use of other drugs known to suppress bone marrow function.
* HIV, HCV, HBsAg positive.
* Expected changes in concomitant medications during the period of study.
* A history of epilepsy or risk for seizures
* positive urine drug of abuse test at enrollment.
* A history of alcohol or drug dependence by Diagnostic and statistical manual of Mental disorders IV(DSM-IV) criteria during the 6 month period immediately prior to study entry.
* A total white blood cell count below 4000/ml, or absolute neutrophil count below 2000/ml
* Female patients with pregnancy or Breast feeding or intend to become pregnant during the study and not able to follow contraception methods.
* History of multiple syncopal episodes.
* Administration any study drugs in last 3 months prior to entry in the study.
* History of significant blood loss due to any reason in the past 3 months.
* Any pre-existing bleeding disorder.