cyrilzakka/clinical-trials huggingface dataset:
Dietary Interventions on Glycocalyx Dimensions in South Asian Patients With Diabetic Nephropathy.

Evaluate the effect of a fasting mimicking diet and a food supplement on the microvascular health and urinary heparanase levels in South Asian type 2 diabetic patients with albuminuria.


Eligibility Criteria:
Inclusion Criteria:

1. South Asian patient with diabetes mellitus type 2.
2. Female or male, aged between 18 and 75 years.
3. Body Mass Index ≥18.5.
4. CKD-EPI \>45 ml/min/1.73m² .
5. Proven microalbuminuria defined as albumin/creatinine ratio ≥0.3 and \<30 mg/mmol (single portion) or 3-300 mg albumin per day (24 hours urine collection) in the last twelve months.
6. Systolic blood pressure ≤ 180 mmHg.
7. Treatment with hypoglycemic drugs: metformin, sulphonylureas and/or insulin.
8. Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
9. Patients must be able to adhere to the study visit schedule and protocol requirements.
10. If female and of child-bearing age, patients must be non-pregnant, non-breastfeeding, and use adequate contraception.

4.3 Exclusion

Exclusion Criteria:

1. Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
2. Non-diabetic renal disease e.g. known polycystic kidney disease.
3. Use of LMW heparin and/or immunosuppressive drugs.
4. Significant food allergies for galactose, nuts, soy, tomato, corn, grape, melon and artichoke, which would make the subject unable to consume the food provided.
5. Signs of active infection or autoimmune disease, requiring systemic treatment.
6. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
7. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
8. Use of any other investigational drug.
9. Patient has enrolled another clinical trial within last 4 weeks.
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life

This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.

Caregivers are at high risk for stress, poor quality of life (QOL), and burnout. As a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver QOL. Investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. Upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. The overall aim is to reduce caregiver distress and optimize QOL.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Self-identified caregiver
3. English-speaking

Exclusion Criteria:

1. Unable to provide consent
Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension

The purpose of this study is to evaluate the efficacy and safety of SK3530 in men with ED and hypertension who were taking antihypertensive medication.

SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with hypertension, it is important to determine the efficacy and safety of SK3530 in men with ED taking antihypertensive medication.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension patient taking stable hypertensive medication for at least 4 weeks
* Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period
* Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period

Exclusion Criteria:

* Lab abnormality
* Uncontrolled diabetic mellitus
* High or low blood pressure, orthostatic hypotension
* Hyper- or hypo-thyroidism
Is Virtual Reality a Non-pharmacological Premedication?

Preoperative anxiety of patients who will undergo septorhinoplasty surgery will be measured and their hemodynamic parameters will be recorded afterwards. Then, a video will be shown to the patients through virtual reality glasses and the effect of this application on their anxiety will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II risk group
* Will be operated under general anesthesia under elective conditions
* Going to undergo surgery for septoplasty / rhinoplasty
* Patients whose informed consent was read and approved

Exclusion Criteria:

* Those who do not want to participate in the study
* ASA III - IV-V patients
* Psychiatric-Cognitive dysfunction
* Claustrophobia
* Patients using sedative and narcotic drugs
* Alcohol-drug addicts
* Blind or deaf patients
* Patients who cannot speak Turkish
The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

This study intends to further reveal the effectiveness of intermittent hypoxia in preventing acute hypoxic injury.

Acute exposure to hypoxia can induce acute hypoxic injury (AHI), according to the severity of the injury, it can be divided into acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE). AMS is the most common type, it mostly occurs within 6-12 hours after rapidly entering the altitude above 2500m, sometimes within 1h, and can be manifested as headache, nausea, diarrhea, sleep disorders, etc. The incidence of AMS at the altitude of 2500-3000m is 10-20%, which reaches 50-85% at 4500-5000m above sea level.

Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Therefore, this study aims to conduct a randomized controlled trial to further reveal the effectiveness of IH and explore its potential mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent from the volunteers.
* Healthy volunteers between ages of 18 and 45 years, body mass index (BMI) of 19.0 and 24.9 kg/m2.
* Long-term residence at flatland (altitude of \<100 m), not having been to an altitude ≥1500 m in 30 days.
* Resting peripheral oxygen saturation of more than 90%, cerebral oxygen saturation between 58%-82%, heart rate between 60 bpm and 100 bpm, and blood pressure within the normal range (90-130/60-80 mmHg).

Exclusion Criteria:

* History of cardiovascular, cerebrovascular, pulmonary, hepatic, dermatologic, or hematologic diseases.
* History of substance abuse.
* The use of medications or medical devices.
* Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
Study of Postoperative Cognitive Decline in Aged Patients

postoperative cognitive decline is a common and deleterious complication in aged patients.The link between inflammation and postoperative cognitive decline has also been reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and postoperative cognitive decline is unknown. In this project ,investigators examine the relationship between 5 cytokines measured at there timepoints (preoperative \[PREOP\], postoperative day 1 \[POD1\] , and postoperative day 3\[POD2\]) and postoperative cognitive decline among older adults undergoing orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients who are more than 65 years old
* patients who undergo orthopedic surgery(trauma ,especially fracture of lower limb)
* patients with ASA physical status I-III
* patients who have a consent

Exclusion Criteria:

* patients who are more than 85 years old
* patients with ASA physical status \>III
* patients who have neurological disorders, stroke or other affective central nervous system diseases
* patients who have a history of serious psychiatric illness
* patients with long-term use of psychoactive substances
* patients who undergo multiple trauma and the presence of head injury
Phase I Study of ICP-332 in Healthy Subjects

A multiple ascending dose phase I study of ICP-332 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign the informed consent form
2. Body mass index (BMI) of ≥ 18.5 kg/m2 and \< 30 kg/m2
3. Male or infertile female subjects who are between 18-55 years old (inclusive)

Exclusion Criteria:

1. Significant current or past acute or chronic disease or condition.
2. A history of tuberculosis or current active/latent infection.
3. With a history of drug or food allergy, or allergy to any of the composition components of the study drug, or allergic disease.
4. Subjects with clinically significant abnormalities in the screening examinations.
Oncologic Impact of Splenectomy-omitting Radical Pancreatectomy in Well-selected Left-sided Pancreatic Cancer

When distal pancreatectomy is carried out for left-sided pancreatic cancer, splenectomy is usually performed not only for margin-negative resection but also for effective clearance of the splenic hilar lymph nodes. However, there was no scientific evidence regarding the justifiability for spleen resection. Considering potential immunological function of the spleen, the investigators hypothesized that distal pancreatectomy without pancreatectomy for left-sided pancreatic cancer is superior than Distal pancreatectomy with pancreatectomy in terms of short-term perioperative outcomes and disease-specific overall survival.


Eligibility Criteria:
Inclusion Criteria:

1. Ductal adenocarcinoma
2. Age ≥20 and ≤80
3. General performance status: the Karnofsky score\> 70% or ECOG 0-1
4. Potentially Curative resection
5. Tumor size \< 3cm
6. Pancreatic cancer located on neck or body portion
7. No invasion to spleen or spleen hilum
8. No combined resection except Lt. adrenal gland
9. Distance more than 5cm (≥5cm) between tumor lateral margin and spleen hilum

Exclusion Criteria:

1. Unresectable or locally advanced, metastatic case
2. Patients who do not want surgery
3. ASA (American society of anesthesiologists' physical status classification) score: ≥3
4. Patients with drug or alcohol addiction
5. Patients showing low compliance
6. Patients who not want to involve the clinical trial
7. Patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.)
PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.


Eligibility Criteria:
Inclusion criteria:

The inclusion criteria follow the same criteria which are describe in the newest SPC.

Exclusion criteria:

The exclusion criteria follow the same criteria which are describe in the newest SPC.
Evaluation of Patellar Dimension and Bristol Index in Asian Population

Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. This study aims to evaluate the patellar dimension and Bristol Index of patellar width to thickness (BIPWiT) using magnetic resonance imaging (MRI) in Asian population.


Eligibility Criteria:
Inclusion Criteria:

* knee pain

Exclusion Criteria:

* degenerative joint disease
* patellofemoral pathology
Comparing 18F-FAPI-04 and 18F-FDG PET/CT in Cancer Detection

Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.

In recent years, radionuclide labeled fibroblast activating protein inhibitors (FAPIs) have gradually become a new strategy for targeted diagnosis and therapy. In this study, radionuclide 18F was used to label FAPI, and the imaging value of FAPI was compared with that of common developer 18F-FDG. To evaluate the diagnostic value of 18F-FAPI-04 PET/CT in various malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.

Exclusion Criteria:

The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling to provide written informed consent.
Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation

The purpose of this study is to determine whether left atrium substrate based ablation plus circumferential is effective in the treatment of persistent and long-standing atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.

Exclusion Criteria:

1. Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
2. Patients who have had a previous AF ablation procedure
3. Pregnancy
Video to Promote HPV Vaccination

The purpose of this research study is to determine if video-based education will increase HPV vaccination rates among 11 - 17 year olds.

Human Papillomavirus (HPV) is a common sexually transmitted infection that has the potential to cause cancer. The vaccine is recommended because it prevents the HPV infections that most commonly cause cancer. HPV vaccines offer the best protection to girls and boys who receive the complete, three-vaccine series and have time to develop an immune response before being exposed to HPV. However, vaccination rates are low compared to other vaccines for teens.

Results from this study will help us learn why participants do or do not get the HPV vaccination and whether video-based education can help improve vaccination rates

Eligibility Criteria:
Inclusion Criteria:

* Parent-child dyads in which the child is a male or female age 11 to 17 years who has not received the HPV vaccine

Exclusion Criteria:

* Parent-child dyads in which the child has received the HPV vaccine
* Parent-child dyads in which the child is older than 18 at the time of enrollment
* Non-English speakers
NYCHA Mindfulness-based Smoking Cessation Intervention

The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).

The primary objective of this research is to examine the feasibility, accessibility and impact of a mindfulness-based smoking cessation program for NYCHA residents.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Current smoker (\>= 5 cigarettes per day). Dual tobacco users are eligible as long as their primary tobacco product is cigarettes.
* Ready to quit smoking cigarettes within 30 days
* Able to attend the 8 weekly MBAT sessions at the scheduled days/times
* NYCHA resident
* English language
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Patient Health Questionnaire-2 (PHQ-2) score indicating current risk for depression
* Self-reported diagnosis of schizophrenia, bipolar disorder, schizotypal disorder or other psychotic disorder
Trial on TAP Block After Bariatric Surgery

Patients undergoing bariatric surgery will be divided randomly into two groups: the first will have TAP block upon completion of surgery and the second groups will not have TAP block.

Upon completion of the laparoscopic bariatric procedure to be performed for every patient and just before recovery from general anesthesia, an ultrasound-guided TAP block will be conducted in the operative theater by the anesthetist for group I patients whereas group II will be recovered from anesthesia without having a TAP block.

The ultrasound probe will be placed on the lateral abdominal wall in the mid-axillary line between the lower costal margin and iliac crest. Using ultrasound will allow accurate deposition of the local anesthetic in the correct neurovascular plane. A spinal needle will be advanced using in-plane technique between the aponeurosis of the internal oblique and transversus abdominis muscles. With intermittent aspiration, 20 mL of local anesthetic (0.25% bupivacaine) will be deposited in the TAP on each side and seen as a hypoechoic shadow pushing the two layers apart.

Eligibility Criteria:
Inclusion Criteria:

* All morbidly obese patients of both genders with BMI \>35 kg/m2 who will be admitted to the General Surgery Department within the study period to undergo laparoscopic bariatric procedures will be included in this study. Bariatric procedures to be performed will comprise LSG, roux en-Y- gastric bypass, mini-gastric bypass, gastric plication, and single anastomosis sleeve ileal (SASI) bypass.

Exclusion Criteria:

* Patients unfit for general anesthesia, patients with secondary obesity due to endocrine disorders, patients with psychiatric disorders, patients with drug abuse or history of opioid intake or chronic pain disorder, patients with contraindication to peripheral nerve block such as allergy to local anesthetics and coagulopathy.
Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging

Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region.

This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants.

Exclusion Criteria:

Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases
Assessment of Blood Glucose Monitoring Systems - Evaluation of Oxygen Dependency

Systems for blood glucose monitoring with glucose oxidase enzyme reaction on test strips can be affected by the partial pressure of oxygen of the blood sample. In this study, we investigate the influence of different partial pressure of oxygen in blood samples on measurement results. Systems with labelled oxygen-dependency as well as systems without labelled oxygen-dependency are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* male or female subjects with type 1 or type 2 diabetes or healthy subjects
* signed informed consent form

Exclusion Criteria:

* pregnancy or lactation period
* severe acute illness that, in the opinion of the investigator, might pose additional risk to the subject
* severe chronic illness that, in the opinion of the investigator, might pose additional risk to the subject
Study Comparing the Handling of Two Peripheral IV Catheter Systems

A peripheral intravenous catheter is the most commonly used vascular access device in medicine. Primary objective is to compare insertion and handling of two peripheral intravenous catheters in clinical routine.


Eligibility Criteria:
Inclusion:

* Patients of the center Anesthesiology, Operating-Room Management and Intensive Care Medicine, Gynaecology and Paediatrics in need for peripheral intravenous access
* Male and female patients, adult and paediatric
* Is able to give written informed consent, for children the legal representatives

Exclusion:

* Participation in another intervention trial during the study
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* The potential insertion site shows deformities, phlebitis, infiltration, dermatitis, burns, lesions, nerve injuries with paresthesia or tattoos
* Study PIV catheter site will be placed below an old infusion site
* Patient has a documented or known allergy sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
* Patient requires the application of a topical ointment, or solution under the dressing in addition to the prep required in the protocol
* Patient has or had previous IV catheter-related phlebitis or infiltration during this hospitalization
* Patients with fear of injection
* Preterm infants
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD

This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent implantation in the PDA as initial palliation of cyanotic CHD with duct-dependent PBF.

Study type: Interventional, prospective, single arm, investigator initiated Study population: 10 patients Primary purpose: Treatment Follow up: Review at 1 month and thereafter 3 monthly (clinical examination and echocardiography for stent patency, SaO2 measurement. Serum Iron and Ferritin levels will be measured before procedure and at follow ups. From 6 months onwards the patients will be assessed for the need of repeat catheterization with a view of surgery or for continued observation.

Study endpoints: 9 months post implant or the following: 1)Patients are subjected for surgical repair of CHD; 2)Death before surgical repair; 3)Unplanned re-intervention with additional stenting procedure.

Eligibility Criteria:
Inclusion Criteria:

* Weight \>3.0 kg
* Age \<3 months
* Patients with uncomplicated PDA morphology (the PDA is not tortuous i.e. relatively straight

Exclusion Criteria:

* Weight \<3 kg, age \>3 months
* Angiographic criteria-tortuous PDA
* Family history of diseases related to iron overload or iron disorder e.g. hereditary hemochromatosis
* Other severe congenital anomalies with life expectancy \<12 months