cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
* Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

* diabetic ketoacidosis.
* evidence of retinopathy at baseline.
* Body Mass Index \>30.
* Severe or acute organ damage.
* Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
* Severe psychiatric disorder.
* Presence of malignancy.
Risk of Chronic Post-surgical Pain After TKA

Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures.


Eligibility Criteria:
Inclusion Criteria:

* From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.

Exclusion Criteria:

* Patients whose post-operative pain information cannot be confirmed through outpatient visit records 1 year after surgery
* Those who have undergone surgery other than knee arthritis surgery within 1 year after surgery
Perioperative Measurements of Diastolic Function in Cardiac Surgery

This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:

1. The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
2. The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
3. The influence of drugs such as enoximone on these outcome measures.

Over the past two decades, perioperative TOE has become routine part of monitoring in the setting of cardiac surgery. In many centres around the world nearly 100% of pateints undergoing cardiac surgery are monitored using this modality. There are several studies and observational reviews suggesting intraoperative TOE can change management and thus indirectly influence outcome in patients undergoing valve, aortic or bypass graft surgery. Certainly in our centre at The Heart Hospital, it is routine practce to perform an intraoperative TOE in all patients undergoing cardiac surgery in order to guide surgical and anaesthetic management of the patient. Despite this use of TOE there is very little evidence of how TOE influences patient related outcomes, both morbidity and mortality.

Several advances have occurred over the years involving both better technology to image the heart with TOE along with the development of novel measurements of heart function. As technology has evolved, many modalities and measurement have not been validated in the setting of cardiac surgery. In our observational clincal trial we aim to investigate the following:

1. The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
2. The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
3. The influence of drugs such as enoximone on these outcome measures.

While many of these measurements have been validated in the care of medical patients, they have not been examined in the surgical setting. In addition, its ability to predict outcome has never been tested. We believe this study will help us answer these important questions.

Eligibility Criteria:
Inclusion Criteria:

* Systolic dysfunction (EF \<50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
* Able to give informed consent

Exclusion Criteria:

* Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)
Registry of Anesthesia and Perioperative Medicine

To assess mortality and morbidity associated to anesthesia interventions

Currently evidence-based medicine is one of the most important tools guiding our medical practice. Part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others.

A clear example, especially useful daily in anesthesia work, is the NSQIP score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. NSQIP score is considered to make decisions in both the American and the European guidelines for preoperative evaluation for surgery.

Latin-American or Chilean databases are not available at the present time. Chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry.

The investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the Chilean population, observe its evolution, and detect risk factors. Moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.

Eligibility Criteria:
Inclusion Criteria:

* All individuals
* Individuals agreeing to participate in the study by signing a consent

Exclusion Criteria:

* The subjects who had insufficient data in their files
Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.

Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix.

However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.

Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its changes during the three trimesters of pregnancy, the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of cervical softness, was also proposed.

Reduced CCI values correspond to greater compressibility and cervical softness. Studies conducted to study cervical remodeling on animal models suggest an early increase in cervical softness that begins immediately after conception followed by shortening and dilation in the terminal stages of pregnancy so that minimal changes in cervicometry correspond to a significant increase in cervical softness . Therefore the study of the early stages of cervical remodeling, such as cervical softness through the ICC, could allow to identify in a timely manner women with an increased risk of preterm birth.

The purpose of this study is to define and standardize the transvaginal technique to determine the CCI, its reference range and establish its potential predictive use in the threat of preterm birth before 32, 34 and 37 weeks.

The purpose of this study is to verify the hypothesis that the introduction of a universal screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may be associated with a predictive ability to deliver preterm higher than current protocols.

Eligibility Criteria:
Inclusion Criteria:

Singleton gestations 18-50 years of age

Exclusion Criteria:

Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Labor or cerclage in situ at the time of randomization Women with altered state of consciousness, seriously ill, with mental handicaps;
A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial

The purpose of this study is to assess the safety, tolerability, and potential efficacy of IMB-1018972 in patients with non-obstructive HCM.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hypertrophic Cardiomyopathy consistent with current US and European guidelines
* Ability to perform an upright treadmill cardiopulmonary exercise test
* Agreement to abide by contraceptive requirements

Exclusion Criteria:

* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability
* Women who are pregnant, planning to become pregnant or lactating
* Participation in another clinical study involving a test product or invasive medical device within 28 days (or within 5 elimination half-lives of the respective test product, whichever is longer), prior to first dosing
The Infected Bone Nonunion and Soft Tissue Defect of Long Bone Treated Simultaneously With Ilizarov Technique

In this retrospective study, the investigators evaluated the clinical and functional results of infected nonunion of the long bone with soft-tissue defects treated simultaneously with Ilizarov technique combining open dressing change in 22 patients. The investigators wanted to find out whether that the internal bone transport with external fixator combining open dressing change is a valuable method to treatment for those patients with infected bone nonunion and poor condition of the soft tissue such as sinus, skin defect.

From January 2002 to now, totally 22 patients (18 males, 4 females) were underwent internal bone transport for infected nonunion in the long bone with soft-tissue defects. The mean age of the patients was 36.5 years (range, 19 to 57). The infected nonunion occurred on the femur in 1 patients, the tibia in 21 patients. The hybrid mono-lateral limb reconstruction external fixator was used, combined with bone transport. The results were evaluated by the classification of the Association for the Study and Application of the Method of Ilizarov (ASAMI) which divided into bone and functional categories

Eligibility Criteria:
Inclusion Criteria:

* Patients with infected nonunion of long bone with soft tissue defects or sinus, without systemic illness that could affect their immunologic status (e.g., AIDS, diabetes mellitus, liver cirrhosis).

Exclusion Criteria:

* Patient noncooperation and an age of less than 18 years
Pentoxifylline in the Treatment of NEC in Premature Neonates

Pentoxifylline improves microcirculation and decreases TNF alpha levels associated with sepsis, rendering it of potential therapeutic value in necrotizing enterocolitis in premature neonates.

Preterm neonates with a clinical suspicion of necrotizing enterocolitis (NEC) will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1. Treatment group: to receive IV pentoxifylline (5 mg/kg/hour to run over 6 hour x 6 days) and 2. Placebo group: to receive an equal volume of ½ normal saline to run over 6 hours x 6 days.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<1750 gm. birth weight
* Abdominal x-ray consistent with NEC (dilated loops, bowel wall edema, fixed or persistent dilated loop with (or without pneumatosis)

Exclusion Criteria:

* Abdominal perforation
Evaluation of Salivary Flow and Buffer Capacity Associated to Aged People's Oral Health

The purpose of this study is to identify the relation of the salivary flow and the buffer capacity of the saliva with medicine, buccal discomfort and auto-related illnesses in aged people.

Study clinical of prevalence. 68 aged, average 70.4 years, SD ± 7.27 represented institution's residents of long permanence. Questionnaire was applied, organizing the data for Software SPSS version 15. The test qui-square of Pearson was used, level of significance 5% and reliable interval 95%. 80% presented pH normal. The salivary Flow: 32.3% very low, 41.2% reduced and 25.5% normal. 30.9% mentioned dry mouth, 22.1% tasting's problems, 17.6% dysphagia and 14.7% burning mouth. Main systemic illnesses: 48.5% declared cardiovascular problems, 17.6% diabetes and 16.2% osteoporosis. 76.5% used medicine. There was a significance statistic between medicine taking and dry mouth (p=0.013), buffer capacity and burning mouth (p=0.019), salivary flow and medicine taking (p=0.048). The low salivary flow and the buffer capacity of the saliva influence in the aged people's health condition, as the drugs influence the results.

Eligibility Criteria:
Inclusion Criteria:

* aged people with 60 years old or more,
* ills or not,
* able to realize tests
* people who want to participate of research

Exclusion Criteria:

* people less 60 years old
Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

Partial pressure of carbon dioxide(PCO2) is mainly evaluated by partial pressure of arterial carbon dioxide (PaCO2), and is used as an index for prognosis and NPPV introduction in chronic respiratory failure. Arterial blood gas analysis for PaCO2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. The transcutaneous PCO2 (PtcCO2) is a non-invasive measurement and its measured value is close to PaCO2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. However, PtcCo2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). The end-tidal pressure of expired CO2 (PetCO2) can be measured non-invasively, easily and continuously. PetCO2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. The investigators decided to investigate whether PetCO2 is useful for monitoring respiratory status in patients with respiratory disorder.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with respiratory disorder.
* Subjects who are clinically stable for the last 2 weeks

Exclusion Criteria:

* Subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks.
* Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Eligibility Criteria:
Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder.
* Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Symptomatic or untreated urinary tract infection at time of enrollment
Examination of the Postprandial Bone Remodeling in Persons With Reduced GIP-Receptor Activity

The bone tissue of the human adult body is in a constant process of break-down (resorption) and rebuilding (formation), a process called bone remodeling. The extent to which bone remodeling happens varies during the day, especially a decrease in the bone resorption is observed after eating.

The overall purpose of this study is to examine the possible role of the hormone Glucose-dependent Insulinotropic Polypeptide (GIP) in Bone Remodeling. GIP is released from cells in the gut after eating, and previous studies have shown an effect of GIP on bone tissue. In addition, it has been observed that the risk of bone fracture is 60% higher in women with a mutation in the GIP receptor, when compared to women with a normal functioning GIP receptor.

In the present study humans with a mutation in their GIP receptor is compared to humans with a normal functioning GIP receptor. The study population will be examined during a meal stimulation test, where blood will be sampled regularly. The blood samples will be examined for markers of bone resorption among other markers of bone remodeling, GIP and other gut hormones.

The hypothesis for the present study is that GIP secreted after meal ingestion inhibits bone resorption. Thus it is expected that the decrease in resorption is less pronounced in the humans carrying the GIP-receptor mutation, compared to humans with a normal functioning GIP receptor.


Eligibility Criteria:
Inclusion Criteria:

* Verified mutation (Glu354Gln) of the GIP-receptor

Exclusion Criteria:

* Type 2 diabetes
* Pregnancy
* Previous long-lasting treatment with steroids
* On-going steroid treatment (with the exception of inhalation-steroids)
* Osteoporosis
Birth Control Patch Study

400 healthy women needed contraception will be asked to participate in this study. Half will be given EVRA, half will be given FC Patch low. They will be expected to apply the patches for 21 days of their cycle, for 7 cycles in total. The study will compare the patterns of menstrual bleeding on these two treatments, plus how effective they are at preventing pregnancy, general safety, and their acceptability to the participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women requesting contraception aged 18-35 years old
* Smokers must not be older than 30 at time of informed consent
* History of regular cyclic menstrual periods, normal cervical smear

Exclusion Criteria:

* Pregnancy or lactation
* Obesity (BMI\>30), hypersensitivity to any ingredients of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/accumulation/ metabolism/excretion of the study drug), any diseases / conditions that may worsen under hormonal treatment
Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.

To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.

The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.

Eligibility Criteria:
Inclusion Criteria:

* Children age starting from 5 to 12 years.
* Genders eligible for study: both sexes.
* American Society Of Anesthesia (ASA) I-III.
* Scheduled to undergo laparoscopy.

Exclusion Criteria:

* Refusal of regional block or patients requiring emergency procedures.

  * Known Local Anesthetics drug sensitivity
  * Bleeding disorders with International Normalised Ratio (INR) \> 1.5 and/or platelets \< 100 000.
  * Skin lesions or wounds at site of proposed needle insertion.
  * Evidence of peritonitis or septicemia.
  * Hepatic disease or enlargement.
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.

This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

Eligibility Criteria:
Inclusion Criteria:

* Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery

Exclusion Criteria:

* Unstable Class IV heart failure