cyrilzakka/clinical-trials huggingface dataset:
Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

* A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
* A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or insulin-dependent diabetic patients
* Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
* Affiliation to the french social security system or equivalent
* People who signed the consent form

Exclusion Criteria:

* Patient who have difficulty to understand the French language
* Patient can not be raised to the use of an insulin pump, or a glucose sensor
* Patient visually impaired
* Patient hard of hearing
* Pregnant woman or woman having a project of pregnancy within 6 months
* Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.
Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial

This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.


Eligibility Criteria:
Inclusion Criteria:

* Primigravida
* \>37 wks

Exclusion Criteria:

* Scarred uterus
* Macrosomia
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria:

* Subjects currently being treated with biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Women who are pregnant or have the intention of becoming pregnant within next 6 months
* Children below 10 years of age
Outcome of Cochlear Implant in Assiut University

Evaluation of the outcome of cochlear implanted children at audiovestibular medicine unit in Assiut university hospital.

Hearing loss is one of the most common health problems affecting people around the world with an average international incidence of 5% .

In Egypt, it affects 16% of the population with an incidence of 14% in children less than 14 years old. 86% of deaf patients had conductive hearing loss (CHL), while sensorineural hearing loss (SNHL) was found in 14%, with a male to female ratio of 3:2 HL .

Cochlear implantation (CI) has become a routine procedure in the United States and worldwide for the management of severe-to-profound SNHL loss. It is a remarkable example of success that was made possible through collaboration between engineers, surgeons, scientists and the medical community .

Early cochlear implantation had a long-term positive impact on auditory and verbal development, if auditory stimulation does not occur within this timeframe, the auditory system degenerates. It has been suggested that in the absence of normal auditory stimulation there is a period of about 3.5 years during which the central auditory system retains its maximum plasticity. This can extend in some children up to the age of approximately 7 years, after which it is significantly reduced. The earlier implantation causes better outcomes, including improved language development, speech perception and speech production skills .

Early research reviews found that the ability to communicate in spoken language was better the earlier the implantation was performed. These reviews also found that cochlear implants provide open set speech understanding for the majority of implanted profoundly hearing-impaired children, and that it was not possible to accurately predict the specific outcome of the given implanted child .

Research since then has reported long-term socio-economic benefits for children as well as audiological outcomes including improved sound localization and speech perception .

The outcome of CI surgery on Quality of Life (QoL) has been greatly investigated via parental questionnaire assessment. This questionnaire was designed with 11 subscales and 58 questions in total. All questions were scaled from 1 to 5: (1 strongly agree; 2 agree; 3 neither agree nor disagree; 4 disagree; and 5 strongly disagree) .

Eligibility Criteria:
Inclusion Criteria:

* Children between (4-14 years) who underwent cochlear implantation surgery between 2015 and 2022.

Both sexes will be included.

Exclusion Criteria:

1. Patients with irregular device use.
2. Implantation less than 6 months.
3. Patients who refused to participate in the study.
EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC

Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce nasopharyngeal cancers. To date, EBV-related head and neck squamous cell carcinoma (HNSCC) is still a major concern in east Asia, especially in China. Concurrent therapies for HNSCC have limited response rate and high chance of relapse. However, EBV-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented EBV antigen become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. One key mechanism of tumor-elicited suppression is the PDL1-PD1 interaction which induces T cell exhaustion. Therefore, TCR-T cells armed with a PD1 antagonist could further enhance the efficacy of TCR-T in solid cancers.


Eligibility Criteria:
Inclusion Criteria:

* Expected to live longer than 12 weeks
* PS 0-2
* Pathology confirmed as EBV positive HNSCC, either metastatic or recurrent disease
* Creatinine \<2.5mg/dl
* ALT/AST is lower than three times ULN.
* No contraindications of leukocyte collection
* Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.
* Understand this trial and have signed an informed consent

Exclusion Criteria:

* Patients with symptomatic brain metastasis
* With other uncontrolled malignant tumors.
* Hepatitis B or Hepatitis C activity period, HIV infected patients
* Any other uncontrolled disease that interferes with the trial
* Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage
* Untreated hypertension or hypertensive patients
* A person with a history of mental illness that is difficult to control
* Researchers do not consider it appropriate to participate in this trial
* Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids
* Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment
* An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements
Evaluation of the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Full-Thickness, Neuropathic Diabetic Foot Ulcers

This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on diabetic foot ulcers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted).
* Diagnosed Type 2 diabetic (i.e. not juvenile onset).
* Have a DFU on the plantar surface of either foot.
* Have a DFU of \>4 wks but \<6 months duration.
* Willing and capable of cooperating to the extent and degree required by the study protocol

Exclusion Criteria:

* Be \< 1cm2 or \>10cm2 in area, by planimetry.
* Demonstrate overt signs of infection.
* Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1).
* Have visible exposed bone or tendon.
* Have an adjacent thermal injury or wound of an etiology other than diabetes.
* Be within 5 cm of any other wound, regardless of etiology.
* Have received enzymatic debriding agents in the past 7 days.
* Have received topical antibiotic therapy in the past 7 days.
* Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement.
* Have exposed bone or tendon, after debridement

The study subject MUST NOT:

* Have received previous treatment for the study ulcer by this Investigator.
* Have more than 3 full thickness ulcers, in total.
* Be pregnant or nursing an infant
* Have a concurrent illness or condition which may interfere with wound healing, such as carcinoma, vasculitis, immune system disorders or connective tissue disorder.
* Be a known alcohol or drug abuser.
* Have received systemic corticosteroids, immunosuppressive or chemotherapeutic agents in the past 30 days.
* Have received radiotherapy, which includes the lower extremity, at any time.
* Have a marked Charcot foot or claw foot deformity which would limit the ability of the subject to wear or be compliant with the wearing of the standardized off-loading device used in this study.
* Have received an investigational drug or device in the past 30 days.
* Have a known hypersensitivity to bovine collagen, oxidized regenerated cellulose (ORC) or silver.
* Be unwilling or unable to be fitted or compliant with the wearing of an ulcer off-loading device.
* Known to be non-compliant or unlikely to complete the study.
* Have ABPI \< 0.7, OR, if ABPI \>1.0 and toe pressure \>0.6.
* Have serum Creatinine \> 3 mg/dL25. have Hgb A1C\>9%
Perioperative Respiratory Support and Postoperative Outcomes

This study aims to evaluate the methodology and parameters of perioperative respiratory support (RS) and the frequency of postoperative pulmonary complications (PPCs) in the Russian Federation. The study will analyze respiratory support strategies, equipment availability, and their correlation with PPC outcomes in surgical patients.

Globally, around 230 million surgical procedures requiring general anesthesia and mechanical ventilation are performed annually. Postoperative pulmonary complications (PPCs) significantly impact clinical outcomes, increasing morbidity and hospitalization duration. Cohort studies have reported a 20-30% risk of PPCs in patients undergoing general anesthesia. Protective ventilation strategies, including low tidal volumes (6-8 mL/kg predicted body weight) and positive end-expiratory pressure (PEEP), have shown to reduce PPCs. However, high tidal volumes (10-15 mL/kg) remain prevalent in routine practice.

The "RuVent-A" study will collect data on respiratory support methodologies, initial ventilation parameters, types of surgical interventions, and associated PPC rates in the Russian Federation. This observational study will analyze patient and equipment data across participating centers without altering routine clinical practices.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years undergoing surgical procedures with general anesthesia and respiratory support.

Exclusion Criteria:

* No
A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.

This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.

This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.

Eligibility Criteria:
Inclusion Criteria:

* Male participants aged 40+
* Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
* Difficulty in getting or maintaining an erection
* Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period

Exclusion Criteria:

* Recent surgeries or invasive treatments
* History of prostate or male reproductive cancers
* Urinary issues caused by neurological conditions
* Previous surgery on the genitals, prostate, bladder, or urethra
* Known allergies to product ingredients
* Diagnosed with chronic health conditions impacting study participation
* Current substance abuse
* Participation in other clinical trials
* Taking medications or supplements targeting LUTS or erectile dysfunction
Clinico-pathologic Correlative Study of 3T Magnetic Resonance Spectroscopy in the Localization of Prostate Cancer

We seek to develop an advanced imaging approach to identifying and localizing prostate cancer. We believe that high field MRI (magnetic resonance imaging) has the potential to do this and we will endeavor to prove this by having patients with prostate cancer pre-operatively undergo a technique called magnetic resonance spectroscopy. After surgery, the microscopic locations of cancer will be compared with the pre-operative images to assess how well the imaging technique succeeds.

The proposed research is enormously relevant to the clinical understanding of early prostate cancer. We propose to test to see whether characteristic patterns of invivo 3T MRSI associated metabolites can be identified in correlation with clinically active tumor reserved on histopathologic analysis of resected specimens. We also plan to demonstrate that 3T MR spectra of prostate cancer will allow for more detailed metabolic assessment with higher sensitivity, specificity and accuracy and publish results established from MR spectra using 1.5T MR units. Functional imaging (eg. molecular imaging such as this) is felt to be the clinical wave of the future for cancer imaging, and if successful, will assume a very major role in the detection, assessment, treatment planning and delivery of drugs, radiation, heat and novel therapeutics in the fight against prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified prostate cancer
* Patient has opted for surgery
* Low risk prostate cancer PSA \<1 0, Gleason \< 7, Stage \< T2b
* No contraindication to MR scanning
* No prior history of malignancy
* Fit for surgery

Exclusion Criteria:

* Nonbiopsied lesion
* Intermediate or high risk prostate cancer
* Unfit for surgery
* Contraindication to MR scanning (i.e. pacemaker, aneurysm clips, claustrophobia)
Effect of Low-Level Laser on Crevicular Interleukin-1β Concentration in Patients with Periodontal Disease: a Relation to Periodontal Inflammaging

This study is done to compare between young age and old age patients with periodontitis (inflammaging) and the effect of diode laser as adjunctive to scaling and debridement


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Aged below 40 or above 60.
3. Provide informed consent and willingness to cooperate with study protocol.
4. Periodontitis stage II patients:

   * CAL from 3-4 mm.
   * Radiographic bone loss (15% to 33%).
   * No tooth loss due to periodontitis.
   * Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

1. Patients with heavy smoking habits
2. History of antibiotics in the previous three months.
3. Pregnant or lactating female.
4. Treatment with any systemic drug.
5. History of systemic disease.
6. Patients who received periodontal treatment in the last 6 months
Randomized Trial of the Impact of Body Scanning and Intensive Behavioral Intervention on Behavioral Change and Health Outcomes

We evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.

We initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). Subjects were randomized either to an intervention group or to usual care. The intervention group received The RENEW™ Program (www.therenewprogram.net) of lifestyle intervention as described below. A whole body CT scan was performed using a multidetector CT scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). This study was carried out in accordance with the recommendations of the Western Institutional Review Board with written informed consent from all subjects. All subjects gavewritten informed consent in accordance with the Declaration of Helsinki. The protocol wasapproved by the Western Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

Men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) -

Exclusion Criteria:

Known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the English language that would preclude successful participation in the program

-
Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion

The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. The study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older
* Known pathological diagnosis of any solid cancer.
* Metastatic spinal lesions 1 cm or greater in diameter.
* Patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions.

Note: The patients must have their treatments at MSKCC.

Exclusion Criteria:

* Patients with renal failure or history of allergic reaction to Gadavist will be excluded.
* Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI.
* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients with inability to cooperate for an MRI exam due to claustrophobia or high levels of anxiety.
* Female patients who are pregnant or nursing.
* Patients with eGFR \< 30 are not eligible to higher risk of NSF.
Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users

Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty.

A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property.

We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to receive total knee replacement arthroplasty from any cause.
* \< 19 years old

Exclusion Criteria:

* patients with cancer
* Patients receiving anticoagulant agents from any cause
* current statin users
* expecting survival from other co-morbidity \< 1year
* Bed ridden patient
* AST, ALT \> 3times of upper normal limit
* CK\> upper normal limit
* pregnancy
* patients who receives hormone replacement therapy