cyrilzakka/clinical-trials huggingface dataset:
Gene Expression in Cumulus Cells to Predict Pregnancy

The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21-39 years
* IVF cycle 1 or 2
* BMI \<35
* Fertilization method: ICSI and/or IVF
* Day 3 or day 5 embryo transfer
* Treatment cycle intended for single or double embryo transfer
* Use own oocytes, not oocyte donor
* ≥ 3 embryos at final assessment
* Donor sperm acceptable
* Willing to comply with protocol and study procedures

Exclusion Criteria:

* Polycystic Ovarian Syndrome
* Presence of fibroid(s): \>4 cm intramural or submucosal fibroids
* History of chemotherapy or radiation to the abdomen or pelvis
* Use of donor oocytes
* Use of reinseminated oocytes
* Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
* Concurrent participation in another clinical study
* (Male): Surgically removed sperm
* (Male): \<5 million sperm count
The Study on Nutritional Status of Patients With Mild Cognitive Impairment

The global aging population is rising year by year. According to the result of Taiwan epidemiological survey, dementia has become the health issue in aging population. Mild cognitive function impairment may present years before dementia is diagnosed. Therefore early diagnosis of dementia at its Mild cognitive function impairment stage is beneficial for disease prevention and potentially delaying the deterioration of cognitive function impairment. Nutritional status includes a healthy diet, favor body composition and activity habits, which not only reduces the risk of nutritional metabolic diseases, but also has a direct relationship with delaying cognitive function impairment. The dietary quality index of Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay diet (MIND diet) may prevent aging and positively associated with delaying dementia in elderly. However, the result in dietary quality index and delaying cognitive function impairment from current studies were still unclear. In additions, based on the differences in dietary patterns between Taiwan and Western countries, no current calorie and dietary nutrition recommendations. This cross-sectional study is to investigate the association between dietary quality index and nutritional status risk factors in cognitive function impairment patients and expected to develop an assessment tool for Taiwanese clinical nutrition strategies and applications.

Aging populations is rising by years in Taiwan. Mild cognitive function impairment (MCI) has become the important health issue. Current knowledge of the etiology of cognitive decline is incomplete, the potential modifiable factors, such as diet may delay the deterioration of disease. This study is aimed to comprise the differences nutritional status,include dietary nutrients intake, MIND diet scores,body composition analysisin with mild cognitive impairment. Design and methods: this cross-sectional study from July, 2019. According to clinical dementia rating (CDR) and mini-mental state examination (MMSE), subjects are divided into healthy group (CDR = 0 and MMSE ≧ 26) and MCI group (CDR ≧ 0.5 and MMSE ≧ 26). Dietary data were obtained by 3-day dietary records and nutrients intake were calculated by trained dietitian. We expected to understand the nutritional status of patients with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥40 years old (regardless of gender)
2. Complete 3-day dietary record, Mini-mental state examination and Clinical dementia rating assessment
3. Independent physical activity

Exclusion Criteria:

1. No amputation, edema, cancer, terminal case, thyroid disease and stroke include stroke history
2. No family support
3. Psychological problem
4. Extremely data of dietary record(\< 500 kcal or \> 3500 kcal)
The Efficacy of High Density Formula 1.5 kcal/ml or 1 kcal/ml On Catch Up Growth In Growth Faltering Children

High density calorie is an Oral Nutrition Supplement (ONS) which is a high calorie formula (High Density Formula) and suggested as nutritional therapy to assist children who are undernourished or undergoing growth faltering. The World Health Organization (WHO) and the Indonesian Ministry of Health have established regulations governing the use of ONS for children suffering from undernutrition, whether or not an infection is present. ONS available on the Indonesian market provides an energy density of between 1-1.5 kcal/ml.

This study has the potential to clarify the advantages of ONS administration and evaluate its efficacy in comparison to nutritional therapy (1 kcal/ml or 1.5 kcal/ml) to facilitate rapid catch-up growth by examining the rate of increase in body weight, body lenght and undernourished children, particularly when infection is present.

Purposes:

1. Analyze the effect of the 1.5 kcal/ml high dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
2. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections
3. Analyze the effect of the 1 kcal/ml calorie dense formula (ONS) on the average weight gain in undernourished children accompanied by infections
4. Analyze the effect of 1 kcal/ml calorie dense formula (ONS) on the average increase in PB in undernourished children accompanied by infections
5. Analyze the effect of the 1.5 kcal/ml calorie dense formula (ONS) on changes in nutritional status in undernourished children accompanied by infections

This research is a retrospective observational study using medical record data from the EMR Husada Utama Hospital. Based on the EMR, data will be taken on patients who are able to consume 300-400 kcal of solid food, given 400 cc ONS 1.5 kkal/ml (Nutrini drink) equivalent to 600 kcal as group 1. Patients who are able to consume 500-600 kcal solid food are given 1 kkal/ml 400 cc ONS (SGM optigrow) equivalent 400 kcal as group 2. The rate of increase body weight and body height will be measured at day 0, 30 , 60 and 90 after consumed high dense formula, then it will be plotted in WHO Growth Chart to show the enhancement of nutrition status.

The statistical analysis including test of normality and homogeneity test, followed by paired sample T-test or Wilcoxon, depend on the normality and homogeneity test.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 years - 5 years, are diagnosed tuberculosis (TB) and urinary tract infection (UTI)
* Children who have feeding difficulties
* Children who malnourished or have undergoing weight malnutrition

Exclusion Criteria:

* Children with fluid retention
* Children with organomegaly
* Children with tumor masses.
* Children with congenital abnormalities
* Children wither cerebral palsy, hormonal disorders, and syndromes.
Local Consolidative Radiation Therapy Plus TKI Versus TKI Alone in Driver Mutated OM-NSCLC

A Phase II randomized controlled trial of TKI Alone versus TKI and Local Consolidative Radiation Therapy in oncogene driver mutated oligo metastatic Non-small cell lung cancer patients.

Randomization Arms: Eligible patients will be randomized in 1:1 ratio to TKI alone or TKI + LCRT. This will be an intention to treat randomized study.

Arm 1: Continuation of TKI therapy alone Arm 2: Continuation of TKI therapy + Local Consolidative Radiation therapy to loc0-regional disease and 1-5 oligometastatic sites

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pathologically proven diagnosis of NSCLC
2. Patients with positive oncogene driver mutation (EGFR or ALK/ROS)
3. Patients who have received at least 2-4 months of TKI therapy without progression
4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)
5. Patients suitable for local consolidative therapy
6. Adequate end-organ function CBC/differential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:

   * Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
   * Platelets ≥ 50,000 cells/mm3;
   * Hemoglobin ≥ 8.0 g/dl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable);
7. Patients with ECOG performance status of 0-2
8. Age \> 18 years
9. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration

Exclusion Criteria:

1. Patients with progressive disease after 2-3 months of initial TKI therapy
2. Patients with negative oncogene driver mutations (EGFR/ALK/ROS)
3. Patients not suitable for local consolidative radiation therapy
4. Patients who are not suitable for further continuation of TKI therapy due to toxicity
5. Severe, active co-morbidity defined as follows:

   * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
   * Transmural myocardial infarction within the last 6 months;
   * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
6. Patients with prior history of radiation therapy to thorax
7. Patients with second malignancy (Synchronous or Metachronous)
8. Pregnancy
Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery

This prospective randomized study evaluates the nephroprotective effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit during cardiac surgery with cardiopulmonary bypass.

The aim of this work is to study nephroprotective effects of nitric oxide (NO) supplementation to the cardiopulmonary bypass (CPB) circuit during cardiac surgery with normothermic CPB in adult patients. The prospective randomized study is performed in the settings of Federal Cardiology Center. A total of 96 adult patients who underwent cardiac surgery with CPB are enrolled in the study. Patients are randomized to two groups: main group receive NO treatment; control group undergoes sham procedure. In the main group, NO is supplied to the CPB line in a dose of 40 ppm throughout the entire CPB period. The primary endpoint is the frequency of acute kidney injury (AKI). The secondary endpoints are urine output during CPB; uNGAL level 4 h after surgery; plasma concentration of free hemoglobin (Hb); concentrations of NO metabolites (nitrite (NO2-) and nitrate (NO3-)) and the total concentration of metabolites of NO (NOx, μM/mL) in blood plasma in the intraoperative period; concentration of proinflammatory (TNF-α, IL-1β, -6, and -8) and anti-inflammatory mediators (IL-1ra, IL-4) in blood plasma in the intraoperative period. Cumulative fluid balance, diuresis, and Lasix doses are assessed within the first 48 h of the postoperative period. The dynamics of serum creatinine is assessed during the first week following the intervention.

Eligibility Criteria:
Inclusion Criteria:

Age above 18 years; planned primary cardiac intervention with cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, and surgical reconstructions of the left ventricle.

Exclusion Criteria:

Preoperative anemia; the intake of nephrotoxic drugs or the use of X-ray contrast within 72 h before surgery; active phase of endocarditis; emergency surgery; chronic kidney disease; hematologic diseases accompanied by hemolysis; complications of the surgery and the early postoperative period.
Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock

Amikacin dose optimization is challenging in critically ill patients. The use of BestDose software algorithm-based drug optimization could help to achieve the recommended target concentrations (60-80 mg/L) after administration of the second dose of amikacin, associated with improved outcome. The study investigators hypothesize that 80% of patients undergoing drug dosing optimization using the BestDose software in the interventional group will reach the predefined PK/PD targets.


Eligibility Criteria:
Inclusion Criteria:

* The patient or their legal representative must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient has septic shock according to the SEPSIS-3 definition in the 24 hours preceding inclusion, regardless of the source of infection
* Patient having already received a first dose of amikacin in the 22 preceding hours
* Patient with an expectation of receiving at least 2 doses of amikacin
* Patient with available amikacin therapeutic drug monitoring

Exclusion Criteria:

* The subject is participating in an interventional study that could influence the primary outcome, or is in a period of exclusion determined by a previous study
* The patient is pregnant, parturient or breastfeeding
* Patient has a contra-indication or an allergy to treatment by amikacin
* Patient is not expected to survive beyond 48 hours
Comparison of ARISCAT Score and Post-operative Pulmonary Complication Rate in Percutaneous Nephrolithotomy

Postoperative pulmonary complications are relatively common in all age groups and are closely related to increased costs, morbidity and mortality in the postoperative period. In recent years, various risk indices have been developed for preoperative evaluation to predict postoperative pulmonary complications, such as the American Society of Anaesthesiologists Physical Status Classification (ASA), the Assessment of Respiratory Risk in Surgical Patients in Catalonia (ARISCAT). The ARISCAT score has demonstrated promising results in identifying patients at higher risk for pulmonary complications. The ARISCAT risk index is derived from multiple variables, including age, oxygen saturation, previous respiratory tract infections, anaemia, abdominal or thoracic surgery, operative time, and emergency surgery. The ARISCAT risk index is used to predict respiratory failure, bronchospasm, respiratory tract infections, atelectasis, pneumothorax, pleural effusion, and aspiration pneumonia.

Percutaneous nephrolithotomy (PNL) is a type of operation performed endoscopically in a prone position in cases of kidney stones that cannot be broken by extracorporeal shockwave lithotripsy (ESWL) and/or cannot be removed by ureterocystoscopy. The prone position is one of the positions that limits lung capacity and respiratory function. The objective of this study was to assess the relationship between the ARISCAT score in patients undergoing PNL and the occurrence of pulmonary complications in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III patients
* Patients who undergone of Percutaneous Nephrolithotomy procedure

Exclusion Criteria:

* Patients with any liver and/or kidney failure
* Obese patients (body mass index (BMI) 30 and above)
* Trauma patients
* Cancer patients
* American Society of Anesthesiologists (ASA) IV patients
* Cardiac arrhythmia, implanted pacemakers
* A history of chronic pain
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
* If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening.
* If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening.
* Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening.
* Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening.
* Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken these medications within 28 days prior to screening.
* Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test.
* Men who are sexually active with women of childbearing potential agree to use male barrier contraception.

Exclusion Criteria

* Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening.
* History of stroke or transient ischemic attack within 3 months prior to screening.
* Participants who exhibit symptoms of heart failure at rest.
* Participants who have a current malignancy or a previous malignancy in the past 5 years prior to screening, except for those who have a documented history of cured nonmetastatic squamous cell skin carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
* Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Cetrotide Treatment Optimization

Rationale:

In daily practice fertility treatment is increasingly patient focused and innovative medication and standardized treatment guidelines are being developed to improve patient convenience.

GnRH antagonist cotreatment to prevent premature luteinization during ovarian stimulation for IVF and ICSI greatly reduces the burden of treatment, partly by reducing the number of injections by around 21 compared with the optimal GnRH agonist 'long' protocol. However, the optimal GnRH antagonist protocol is still not known. There are a number of reasons to suggest that both the simplicity of treatment and clinical outcomes could be further improved by commencing GnRH antagonist treatment on the same day on which ovarian stimulation is started. These include more synchronized follicle development and reduced rates of premature luteinization. This study will investigate whether a novel early fixed start protocol improves outcomes in comparison to the widely employed late fixed start protocol.

Objective:

To demonstrate whether an early fixed start antagonist protocol improves the live birth rate compared with a late fixed start antagonist protocol by 5%.

Study design:

Prospective, multicenter, investigator sponsored, randomized controlled trial

Study population:

* Normo-ovulatory women \< 39 years with an indication for IVF or ICSI
* No more than 2 previous unsuccessful IVF/ICSI cycles
* BMI ≤ 32 kg/m2

Intervention:

Two different GnRH antagonist treatment protocols used in daily practice will be compared. Patients will be randomized to receive one of the following two treatments:

* Early fixed start: start GnRH antagonist treatment with Cetrotide 0.25 mg on the same day as FSH, cycle day 2.
* Late fixed start: FSH will be administered from cycle day 2. GnRH antagonist treatment with Cetrotide 0.25 mg will commence on cycle day 6.

Main study parameters/endpoints:

The primary endpoint is the live birth rate per started cycle. A secondary endpoint is the number of embryos available for transfer.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

In addition to recording clinical outcomes, endocrine studies will be carried out at the UMC Utrecht in a sample of 200 participants who will be subjected to blood sampling at three points during the treatment cycle: prior to commencing treatment on cycle day 2, cycle day 6 and the day of hCG administration.The aim of this substudy was therefore to prospectively compare the effect of a cycle day 2 versus cycle day 6 fixed start GnRH antagonist protocol on LH, estradiol and progesterone levels in the mid and late follicular phase. In order to investigate whether the early fixed protocol exerts a significant extra burden on patients compared to the late start protocol, another group of 200 participants at the UMCU will be requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale).


Eligibility Criteria:
Inclusion Criteria:

* Normo-ovulatory women \< 39 years with an indication for IVF or ICSI

Exclusion Criteria:

* More than 2 previous unsuccessful IVF/ICSI cycles
* BMI \> 32 kg/m2