cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Renal Effects of APX-115 in Subjects With Type 2 Diabetes and Nephropathy

This is a proof of concept (PoC) trial to evaluate the safety, tolerability and renal effect of APX-115 in subjects with Type 2 diabetes and nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of type 2 diabetes and nephropathy
* First morning void (FMV) UACR between 200 and 3000 mg/g, inclusive
* 30 mL/min/1.73m2 ≤ eGFR ≤ 90 mL/min/1.73m2 using CKD-EPI formula at screening
* HbA1c ≤ 10% at screening visit
* Subject who has been taking unchanged dosage of ACE inhibitor or ARB medication for at least 3 months prior to screening and is not anticipated to change its dosage during the course of the study
* Willing to be under dietary management for diabetes

Exclusion Criteria:

* History of type 1 diabetes mellitus or gestational diabetes
* Subject's renal impairment and/or albuminuria is considered to be of origin other than Diabetic Kidney Disease
* Subject with uncontrolled blood pressure
* Clinically significant abnormal laboratory findings
* History of any cardiovascular event within 6 months prior to screening or cardiovascular procedure planned during the clinical trial
* Diagnostic or interventional procedure requiring a contrast agent within 4 weeks before the screening visit or planned during the course of the study
* Clinically significant ECG abnormalities on a 12-lead ECG at the screening visit or before randomization
* Current or history of NYHA class IV heart failure
Pet Ownership and Glucose Control in Early Adolescents With Type 1 Diabetes

This study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.

Efficacy of treatment for Type 1 diabetes mellitus (T1DM) is dependent on adherence to self-care behaviors and collaborative parental involvement. Adolescence is a vulnerable time for the deterioration of glycemic control in patients with T1DM. In particular, parental monitoring declines during early adolescence. This often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. Consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.

Eligibility Criteria:
Inclusion Criteria:

* age 10-13 years
* diagnosis of T1DM
* duration of T1DM for at least one year
* fluency in English
* two recent consecutive HbA1c values 8.0 - 13%

Exclusion Criteria:

* clinical or laboratory characteristics suggestive of type 2 diabetes mellitus
* involvement in foster care
* dual-home living situation
* severe psychiatric disorders
* developmental delay or cognitive impairment
* current participation in another study that may impact glycemic control
* regular usage of a continuous glucose monitor
* HbA1c \> 13% (because these individuals may need a more intensive intervention than this is intended to provide).
Measuring Uterine Electrical Activity Throughout Pregnancy and Labor Measuring Uterine Electrical Activity Throughout Pregnancy and Labor

The EUM100pro (Electrical Uterine Monitor)is a uterine contraction monitor which measures uterine contractions based on the electrical activity of the uterine muscle.The study will compare the EUM100pro measurements to the already existing uterine contractions monitors (tocodynamometer and Intra Uterine Pressure Catheter) in pregnant women with complaints of uterine contractions.

The main objective of the study is to demonstrate that the EUM100pro is as good as the current methods for monitoring pregnancy in labor (tocodynamometer, IUPC) in measuring uterine contractions. This will be performed by measuring the expectancy of time differences between the tocodynamometer/IUPC and the EUM in the beginning, end, peak and duration of each contraction. A good correlation will be 0.9 and significance of 95%.

100 women will be recruited to the study. The measurement with the EUM100pro will not interfere with the usual clinical care, meaning- the EUM100pro will be used in addition to the standard care and monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Women at term with complaint of uterine contractions at Meir Medical Center
* Women at preterm with complaint of uterine contractions at Meir Medical Center.
* Women at gestational age \>24 weeks
* Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

* Subjects who refused to sign the informed consent form
* Abnormal fetal heart rate recording at admittance
* Subjects with indications for immediate delivery
* Subjects younger than 18 years of age
* Subjects at gestational age \<24 weeks
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-D )

To compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (arriving at the emergency department between 4.5-6 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility Criteria:
1. Age ≥ 18 years;
2. Patients who arrive at the emergency department between 4.5-6 hours of symptom onset\* (\*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for endovascular thrombectomy;
7. Informed consent signed.

Exclusion Criteria:

1. Baseline NIHSS score \< 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for endovascular thrombectomy;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Vestibular Socket Therapy in Immediate Implants With Grafting Materials

The current research aims at evaluating the outcomes of the vestibular socket therapy in immediate implants using collagen plug, demineralized freeze-dried bone allograft, and deproteinized bovine bone minerals at both radiographic and clinical levels


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they have one or more hopeless teeth without signs of acute infection in the maxillary anterior region.
* Remaining roots or non-restorable teeth with sufficient bone apically and palatably to allow proper implant positioning with sufficient primary stability.
* Optimal compliance as evidenced by no missed treatment appointments and a positive attitude towards oral hygiene.
* Medically free

Exclusion Criteria:

* Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
* Smokers, diabetics, pregnant or lactating women.
* History of chemotherapy, radiotherapy in head and/or neck region.
* Bisphosphonate therapy
Individual Placement and Support and/or Cognitive Remediation Therapy Added to TAU in Patients With Early Schizophrenia

This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.

This is an assessor blind, randomised controlled trial, employing a factorial design. This trial aims to assess the feasibility of IPS, CRT or their combination as an add on to treatment as usual. Patients with early schizophrenia spectrum disorder will be recruited from major psychiatric units in Pakistan. Treatment as usual (TAU) will comprise of patient's current antipsychotic medication as prescribed by their responsible clinician. Patients will be randomised into IPS, CRT, their combination or TAU, according to the 2x2 factorial schedule in the table. A total of 30 participants will be recruited in each cell, giving a total of 120 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female patients aged between 18-35 years.
2. Diagnosis of schizophrenia confirmed by SCID meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
3. Stable on medication for the past four weeks.
4. In contact with mental health services
5. Within 5 years of diagnosis.
6. Able to demonstrate the capacity to provide informed consent to take part in this feasibility trial, as assessed by their own clinician.

Exclusion Criteria:

1. Active DSM-V substance abuse (except nicotine or caffeine) or dependence within the last three months
2. Relevant CNS or other medical disorders
3. Diagnosis of Learning Disability.
Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression

The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.


Eligibility Criteria:
Inclusion Criteria:

* On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).
* Absence of evidence or suspected virologic failure on antiretroviral therapy
* Absence of known primary mutations in the protease gene
* Only 1 highly active antiretroviral therapy (HAART) prior to current one
* HIV RNA \< 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)
* On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir \[TDF\]) for at least 8 weeks before study entry, without treatment-limiting adverse effects

Exclusion Criteria:

* Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
* Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)
* Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).
* CD4 \< 100 cells/mm3
* Grade IV laboratory values: Hemoglobin \< 6.5 g/dL or white blood cells (WBC) \<800/mmm3 or absolute neutrophil count \< 500/mm3, or platelets \< 20,000/mm3 or diffuse petechiae.
Relation Between Serum IGF-1 & BMI In Acne Vulgaris

cross-sectional study in which participants will be recruited at dermatology \& Andrology out-patient clinics in Assuit university hospital, Egypt after patients examination by dermatologists \& obtaining an informed consent


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged from 15 to 45 years old suffering from acne vulgaris.
2. Both sexes.

Exclusion Criteria:

1. Insulin resistance and diabetic patients
2. Females with polycystic ovarian syndrome
3. Treatment with drugs that can influence IGF-1level such as corticosteroid, insulin, hypoglycemic agents, and isotretinoin within one year before the date of study.
4. Other causes of acne or acneform eruption as steroid-induced
Efficacy of Hypnosis During Embryo Transfer Procedure on Clinical Pregnancy Rate for Patients Undergoing Assisted Reproductive Technology IVF or ICSI

The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure


Eligibility Criteria:
Inclusion Criteria:

Consent to participate in study Age ≥ 18 years and \< 41 years IVF or IVF/ICSI attempt GnRH antagonist or agonist stimulation protocol Scheduled transfer of 1 or 2 embryos

Exclusion Criteria:

Refusal to provide consent refusal hypnosis FSH \> 13 mUImL CFA \< 8 follicles AMH \< 0.5 ngml Patient not covered by the social security system (NHS)
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>18 years of age, with active RA;
* receiving treatment for RA on an outpatient basis;
* females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

Exclusion Criteria:

* major surgery within 8 weeks prior to screening;
* rheumatic autoimmune disease or inflammatory joint disease other than RA;
* treatment with methotrexate within 8 weeks of baseline;
* concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.
Supplementation With Cholecalciferol in Dialysis Patients

Hypovitaminosis D is highly prevalent among patients with chronic kidney disease, especially in those undergoing dialysis. The loss of protein to the dialysis solution seems to contribute significantly to the reduced serum levels of vitamin D in these patients. As a result of the disease and the dialysis procedure, there is high prevalence of chronic inflammation and high risk of infections. There is evidence in other populations, that vitamin D has immunomodulatory effects by stimulating the production of cathelicidin, an antimicrobial peptide and suppressing the production of proinflammatory cytokines. Thus, this study aims to investigate the effects of cholecalciferol supplementation on immunological markers in patients in hemodialysis and peritoneal dialysis with hypovitaminosis D . This is a randomized, double-blind, placebo-controlled trial in which patients who have vitamin D deficiency \[25 (OH) D \<20 ng / mL\] will be allocated to the intervention group (cholecalciferol) or control (placebo). Patients will receive supplemented 100,000 IU / week cholecalciferol a period of 12 weeks. Before and after the intervention will be determined 25(OH)D, cathelicidin, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and C-reactive protein serum. In monocytes, we will evaluate cathelicidin, IL-6 and TNF-α, 25(OH)D receptor and α 1-hydroxylase enzyme expression.


Eligibility Criteria:
Inclusion Criteria:

* 25 (OH) \< 20 ng/ml
* Peritoneal dialysis or hemodialysis \> 3 months

Exclusion Criteria:

* Use of vitamin D or its analogues, corticosteroids and immunosuppressive
* Peritonitis in the previous month at baseline
* Liver, neoplastic, infectious or autoimmune diseases and positive HIV
* Hypercalcemia
Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate

Urinary stones are a common disease affecting one in 11 people . Their clinical presentation varies from being silent to severe loin pain owing to urinary obstruction. Currently, ESWL is the treatment of choice for most renal calculi ⩽30 mm, with success rates of 60-99%. Although many treatment options exist, ESWL has the advantages of simplicity and non-invasiveness. In contrast, failure of a first ESWL attempt requires a follow-up ESWL procedure, or an alternative procedure, both of which increase medical costs.

Advancements in imaging have significantly contributed to this process. In the mid- 1990s, computed tomography (CT) began to replace intravenous urography (IVU), abdominal films (KUB), and ultrasound (US) in stone diagnosis. Studies demonstrated that CT had superior sensitivity and specificity for stone diagnosis compared to the aforementioned modalities. Now non-contrast multidetector CT (NC-MDCT) is the gold standard for the detection of urinary system calculi. CT is also clinically useful as it can show alternate renal and non-renal pathology if present.

Many factors have been reported to predict ESWL outcome, such as skin-to-stone distance (SSD), stone size, stone location, multiplicity, the energy used, and Hounsfield Unit (HU) values measured by non-contrast computed tomography (NCCT).

Excellent fragmentation results are produced using ESWL. However, the retention of post-ESWL fragments in the kidney continues to be a significant medical issue. Only 32% of calcium stone patients in research were found to remain stone-free for 12 months following ESWL, according to the results. As a result, it appears that fragment growth and persistence are frequent after ESWL \[10\].

The first ESWL residual that is accessible must undergo a thorough stone analysis to properly carry out the subsequent treatments to prevent relapse or recurrent stone because stone-free rates after ESWL are directly connected to stone placement, size, number, and composition

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years.
* stone size up to 25 mm for renal pelvic stones and up to 15 mm for upper ureteric stones.
* SSD \< 11 cm.

Exclusion Criteria:

* any patient with contraindications to ESWL as
* uncontrolled urinary infection.
* clotting alterations.
* aortic or renal artery aneurysm.
* pregnancy.
* serious skeletal malformations.
* serious obesity and or contraindications to CT as pregnancy.
Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection

The aim of work to assess the effectiveness of preoperative vaginal cleansing with povidone iodine on reduction of post caesarean section wound infection

Research questions:

Does vaginal cleaning using povidone iodine before cesarean section has effect on reduction of postoperative wound infection??


Eligibility Criteria:
Inclusion Criteria:

* 1. Pregnant women who are 37 weeks gestation or more scheduled for elective cesarean section or those in labor with a limited number of vaginal examinations less than 5 times preoperatively.

  2. Pregnant women who are 37 weeks gestation or more with rupture of membranes but duration less than 24 hours

  3. Women consenting to be included in the study.

Exclusion criteria:

1. Abnormally invasive placenta and placenta previa.
2. Intra-partum fever.
3. Prolonged rupture of membranes more than 24 hours
4. History of exposure to radiation treatment for cancer.
5. History of Gynecological infections (PID).
6. History of abdominal infections, e.g., peritonitis.
7. Debilitating diseases like Diabetes mellitus, Thyroid disorders, Cushing disease, abdominal malignancy.
8. Obesity is defined as pregnant BMI \>30 kg/m2.
9. History of wound infection or burst abdomen.
10. History suggestive of massive bleeding during previous cesarean section.
11. allergy to iodine-containing solutions
12. Pregnant women with severe anemia defined as Hb \<7 g/dl.
13. Cases with intra-abdominal drain deployment are discarded.
14. Obstructed labor with numerous vaginal examinations.
Machine Learning-assisted Analysis of Microcirculation Patterns and Parameters

Machine learning has been widely used in clinical medicine in recent years. It can be used for disease classification, disease severity grading, genetic testing, image analysis, adjuvant treatment recommendations, and predicting patient prognosis. Because sublingual microcirculation can be used for guiding shock resuscitation, a real time automated analysis is required for rapid changes of clinical condition. This study aims to use machine learning to analyze the parameters and patterns of sublingual microcirculation.

The sublingual microcirculation videos are extracted from the 11 clinical trials conducting in the National Taiwan University Hospital.

In the first stage, the microcirculation videos and the related information are included in a de-identified manner. Each microcirculation video in the database will have a unique code. The video-related data will include the patient's height, weight, blood pressure, heartbeats, health status, major diseases, laboratory examination values, video quality description, automated vascular analysis (AVA) 3 software analysis results including total vessel density (TVD), perfused vessel density (PVD), proportion of perfused vessels (PPV), microvascular flow index (MFI), and heterogeneity index (HI). The length of each micro-cycle video is 4-6 seconds, and there are 25 frames per second. Take a picture as a representative image, each video can correspond to 4 images, and each micro-circulation image will also be marked with its image quality. Machine learning model will be trained for distinguishing the quality of videos and images. Only good-quality videos and images will be used for further analysis.

In the second stage, 80% of the microcirculation videos and images will be used for training and validation to find the best model, and then the remaining 20% of microcirculation videos and images will be used to test the model performance. The first training purpose is to automatically distinguish the size of blood vessels, calculate TVD, and draw a histogram of the number of microvessels of different diameters. The second training purpose is to measure the blood flow velocity in each small vessel and calculate PVD, MFI, and HI values.

Eligibility Criteria:
Inclusion Criteria:

* Microcirculation videos and images from previous clinical trials in the National Taiwan University Hospital with signed informed consent and agreement of further analysis

Exclusion Criteria:

* Microcirculation videos and images from previous clinical trials in the National Taiwan University Hospital with signed informed consent but disagreement of further analysis.