cyrilzakka/clinical-trials huggingface dataset:
Sustained Cord Circulation at Emergency Cesarean Section

The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care?

Researchers will compare resuscitation with sustained cord circulation to standard resuscitation practices to see if it provides better outcomes.

Participants (term neonates born by emergency Cesarean section) will:

Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes

Study Title

Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial

Primary Objectives:

To compare sustained cord circulation during resuscitation with standard care for term neonates born by emergency Cesarean section, and evaluate:

A composite outcome of admission to neonatal care for predefined criteria (asphyxia at birth, respiratory distress, hypoxic-ischemic encephalopathy, hypoglycemia) and death before admission.

Secondary Objectives: Secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences.

Study Design: A multicenter, stepped-wedge cluster randomized trial.

Study Population: Singleton term neonates born alive, gestational age ≥37 weeks, by emergency Cesarean section with epidural/spinal anesthesia, where the pediatric/neonatal team has been called to attend.

Intervention: Neonates will be kept close to the mother with the cord intact. When in need of ventilatory support, the neonatal team will give respiratory support with sustained cord circulation, following neonatal cardiopulmonary resuscitation (CPR) guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes.

Control: Management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. In cases where ventilatory assistance is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management.

Power analysis: With significance level 0.05, the power to detect the anticipated risk reduction (50%) would be \>0.85.

Study Duration 2025-2028

Eligibility Criteria:
Inclusion Criteria:

* Singleton neonate
* Born alive
* Gestational age ≥37 weeks
* Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.

Exclusion Criteria:

* Major congenital malformation that may affect resuscitation or outcome measures.
* Major genetic disorder that may affect resuscitation or outcome measures.
MARIS Study; Mediterranean Approach to Reduce Insulin-Resistance Study

Background: During the 1990s, the prevalence of the metabolic syndrome in the Netherlands ranged from 3% in women of 20-39 yrs to at least 33% in men 55 yrs and older and it is expected to increasing. Prevention is therefore warranted. In this respect the amount and type of fat in the diet deserves attention. Recently, an intervention study reported that a diet high in mono-unsaturated fatty acids (MUFA) such as from olive oil, increased insulin sensitivity in healthy subjects. However, additional beneficial effects can be expected from the Mediterranean diet as a whole. Hypothesis: Replacing saturated fatty acids (SFA) by mono-unsaturated fatty acids (MUFA) will improve hyperinsulinemia and dyslipidemia, and a typical Mediterranean diet will even have more pronounced effects. Study objectives: To investigate the impact of the Mediterranean diet, and especially the intake of MUFA, on markers of the metabolic syndrome in high-risk subjects. Methods: The controlled dietary intervention will include 60 subjects aged 40-65 years with moderate abdominal obesity. After a run-in diet for 2 weeks they will be assigned randomly to receive one of the three diets for a period of 8 weeks. Measurements of serum insulin concentration and other parameters will be carried out at weeks 2 and 10. Expected results: Our study will provide information on the role of MUFA and the expected beneficial impact of other factors of the Mediterranean type of diet on the metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥ 94 cm for men or ≥ 80 cm for women
* Age from 40 to 65 years at the time of randomisation
* Written informed consent obtained

Exclusion Criteria:

* Unable or unwilling to comply with study procedures.
* The use of drugs for lowering serum cholesterol, serum triglycerides, blood pressure, or diabetes.
* Unusual dietary patterns, including high alcohol intakes
* Recent (\< 4 weeks) or current participation in a study with any investigational drug or dietary intervention.
* High concentrations of total cholesterol (\>8 mmol/L).
* Diabetes mellitus.
* Being pregnant or giving breastfeeding.
Community Reinforcement and Family Training (CRAFT)

The present study is dedicated to empowering individuals close to an addicted person (i.e. concerned significant others, CSOs) to create changes in their family environment: changes that increase the likelihood of the addicted person seeking treatment.

The Danish National Clinical Guideline for the treatment of alcohol dependence recommends that alcohol treatment centers offer interventions aimed at CSOs, providing them with the support and empowerment that will enable them to motivate the problem drinker to enter treatment. In the US, the Community Reinforcement and Family Training (CRAFT) intervention has been shown to offer the most effective support to CSOs. CRAFT has consistently demonstrated a two to three times' higher impact on getting individual with an alcohol use disorder (AUD) to attend treatment, compared to other kinds of interventions. Studies of the intervention so far have, however, been small, and the format used in the delivery of CRAFT has not been fully investigated.

The aim of the present cluster randomized controlled trial is to implement and investigate CRAFT in a Danish context and with sufficient sample size. Consecutive CSOs will through cluster randomization be randomized to receive either CRAFT in a group format, CRAFT in an individual format, or a control condition, consisting of self-help material only. The primary outcome of the study will be the rate of individuals with AUD entering treatment following the intervention targeted at the CSOs within three months from its initiation. Data will be collected from all CSOs at baseline, three, and six months after baseline.


Eligibility Criteria:
Inclusion criteria:

* 18 years and older
* Being a CSO to a person with AUD who is not currently in treatment for alcohol problems
* Having the intention to maintain the contact during the next 90 days
* Having had regular contact with the problem drinker for the last 90 days (face-to-face contact for several hours on at least a weekly basis) and having the intention to maintain the contact during the next 90 days.
* Being prepared support the problem drinker if he/she chooses to seek treatment, at least to some extent.

Exclusion Criteria:

* Suffering from dementia or other cognitive disorders
* Not speaking Danish
* Being psychotic or otherwise severely mentally ill
* Suffering from AUD in the last three months
* Being concerned about a person who, according to the CSO, mainly use illegal substances
Cataract Refractive Suite Study

The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bilateral cataracts;
* Planned cataract surgery and implantation of ReSTOR +2.5 D multifocal intraocular lens (IOL) in both eyes;
* Clear intraocular media, other than cataract, in study eye(s);
* Willing and able to complete all required postoperative visits;
* Able to comprehend and sign a statement of informed consent;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Significant irregular corneal astigmatism;
* History of or current severe dry eyes, retinal/uveal pathology or concurrent ocular disease;
* Previous intraocular or corneal refractive surgery, corneal transplant, or retinal detachment;
* Any inflammation or edema (swelling) of the cornea;
* Pregnant;
* Other protocol-specified exclusion criteria may apply.
Combined CFRT and SABR in Stage II and III NSCLC With Peripheral Tumors Smaller Than 5 cm.

A phase I trial is being conducted in patients with inoperable locally advanced NSCLC to treat with a combination of Conventional Fractionated Radiotherapy (CFRT) on the mediastinal lymph nodes and Stereotactic Ablative Radiotherapy (SABR)on the primary tumor with concurrent chemotherapy. It is hypothesized that this will lead to an increase of local control and overall survival

In locally advanced NSCLC local control has been poor, but with SABR remarkable high local control rates with low toxicity have been reported. Currently stage III and inoperable II NSCLC patients have been treated with IMRT and concurrent chemotherapy at out institute. In this study we will explore the combination of SABR and CFRT with concurrent chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* Cytological or histological proven NSCLC stage III or inoperable stage II, cT1-2a-3N1-3M0 with peripheral tumors \< 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is \< 5 cm).
* Weight loss \< 10% in the last three months
* WHO-performance status ≤ 2
* Patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine
* FEV1 and DLCO \> 40 % of the age-adjusted normal value
* Minimum required laboratory data bone marrow reserve and hepatic- and renal function
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Before patient registration, written informed consent must be given according to GCP and national regulations

Exclusion criteria:

* Patients with central tumors \< 2 cm of the proximal bronchial tree (Figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura.
* Patients that receive sequential chemoradiotherapy or radiotherapy only.
* Patients with grade 3 dyspnea at baseline (according to CTCAE version 4.03)
* Patients with Pancoast tumors
* Prior radiotherapy treatment to the thorax
* Any contraindications to the administration of thoracic radiotherapy
* Pregnant women
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants

To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.

This prospective randomized controlled study will be conducted among 2 groups, all of them are preterm infants with birth weight less than 1500 g ("very low birth weight" (VLBW)) who are delivered by caesarean section, in the first interventional group an extrauterine placental transfusion (EPT) will be done during neonatal resuscitation with respiratory pressure support. There will be a delayed cord clamping (DCC) of at least 30 - 60 seconds in the control group, before starting neonatal resuscitation with respiratory support.

In EPT approach preterm born infants are delivered by caesarean section with the placenta still attached to the infant via the umbilical cord. Then, placental transfusion is performed up to several minutes by holding the placenta \~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.

Extrauterine placental transfusion may give more blood in babies delivered by cesarean section and may improve perfusion during the fetal-to-neonatal transition with impact on neonatal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1500 gram ("very low birth weight infant")
* Delivery by caesarean section
* Gestational age \> 23+6 weeks

Exclusion Criteria:

* Vaginal delivery
* Fetal or maternal risk (i.e. compromise, emergency c-section)
* Congenital anomalies and/or major cardiac defects
* Placental abruption or previa with hemorrhage
* Placenta accreta or increta
* Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
* Parents declined study
ENLIGHTEN: Exercise and NutritionaL Interventions for coGnitive and Cardiovascular HealTh ENhancement

ENLIGHTEN will examine the effects of exercise, the dietary approaches to stop hypertension diet (DASH), and a combined exercise and DASH intervention on cognitive function among adults with cardiovascular disease (CVD) risk and cognitive deficits. Participants will be randomized to one of the three treatments, or a health education control condition, for 6 months, and will complete assessments of CVD health and cognitive function before and after treatment.

Cardiovascular disease (CVD) is the leading cause of death and disability in the United States, affecting more than 81 million American adults. It is well established that risk factors such as hypertension, diabetes, and hyperlipidemia not only place individuals at risk for CVD, but also place them at risk for neurocognitive impairment and dementia. CVD risk factors have been shown to be associated with a cascade of neurophysiologic and neuroanatomic changes, resulting in cognitive impairment and dementia. Exercise and diet have been shown to improve CVD risk factors and also appear particularly promising lifestyle approaches for preventing dementia among individuals at risk, such as those with cognitive impairment, no dementia (CIND). ENLIGHTEN is a randomized clinical trial of diet and exercise among patients with CIND.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or older
* Sedentary
* Score of 19-25 on the Montreal Cognitive Assessment Battery or verbal fluency score of =\< 12 or animal fluency score of =\<15
* At least one cardiovascular risk factor (hypertension, diabetes, cholesterol, obesity, current smoking, or family history) or a documented history of cardiac disease (myocardial infarction, coronary artery bypass grafting, peripheral vascular disease, \>70% stenosis, or mild stroke without residual deficit)

Exclusion Criteria:

* Any significant neurological disease other than CIND, such as Parkinson's disease, multi-infarct dementia, Huntington' s disease, progressive supranuclear palsy, brain tumor, normal pressure hydrocephalus, subdural hematoma, seizure disorder, multiple sclerosis, or history of head trauma with persistent neurological deficits
* Psychotic disorder within the past two years (DSM IV criteria) or acutely suicidal
* History of alcohol or substance abuse or dependence within the past two years (DSM IV criteria)
* History of schizophrenia
* Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol including a history of systemic cancer within the past 5 years (nonmetastatic skin cancers are acceptable)
* Myocardial infarction (within the past 3 months) or unstable or severe congestive heart failure (e.g. class III-IV heart failure)
* End-stage pulmonary disease; uncontrolled diabetes mellitus or uncontrolled hypertension(systolic BP\>170 or diastolic BP \>100 mm Hg on medication)
* Musculoskeletal disorders precluding the ability to exercise (e.g. severe arthritis)
Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients

Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Eligibility Criteria:
Inclusion Criteria:

* Suspected lung cancer before surgery
* No malignant tumor history within the past 5 years
* The pulmonary nodule is not pure ground glass opacity
* Patients must have given written informed consent

Exclusion Criteria:

* Multiple primary lung cancer
* R1,R2 resection
* Histology confirmed not non-small cell lung cancer
* Unqualified blood samples
Arthroscopic Autologous Chondrocyte Implantation Versus Microfractures

This is a phase III, randomised controlled trial of matrix-encapsulated chondrocyte implantation procedure compared to the microfracture procedure in the repair of symptomatic cartilage lesions of the knee. Eligible patients were asked for informed consent preoperatively and randomised for chondrocyte implantation of microfractures. Those patients allocated to the chondrocyte implantation group will be harvested at time of first arthroscopic procedure and concurrent lesions were treated, as meniscus repair, ligament reconstruction, or malalignment corrected. The patients allocated to microfracture will be treated at the time of the only arthroscopic procedure. Both groups will have the same rehabilitation program. Prospective clinical, radiographic and magnetic resonance imaging will be performed as main outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic single chondral lesions of the knee from 1 to 4 cm2.
* Signed patient informed consent.
* Agree to adhere to rehabilitation protocol.

Exclusion Criteria:

* Inflammatory arthritis, septic arthritis, gout, pseudogout, Paget's disease, ochronosis, acromegaly, hemochromatosis, tumors, collagen mutations.
* Total meniscectomy
* Malalignment
* Evidence of osteoarthritis
Connectivity Alterations After Levetiracetam Application

This study aimed to analyze the connectivity alterations in brain networks of LGG patients with epilepsy who take levetiracetam at short-term preoperatively.

Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas. Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with high-grade gliomas presented with GRE at the onset. Although beneficial for the control of GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered from seizures.

GRE was found to be associated with brain network and functional connectivity. And it has been reported that temporal lobe seizures could induce functional connectivity and decreased network efficiency of brain networks. However, the alterations in functional networks induced by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV) preoperatively, which could effectively reduce abnormal spike activity and further cause connectivity alterations. This makes it more complex to reveal the connectivity alterations of brain networks in LGG patients with GRE.

This study aimed to collect the resting-state functional MRIs of 30 LGG patients who presented with GRE at the onset. Through further applied graph theory analysis, investigators tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The findings of this study will provide a theoretical basis for further study of connectivity alterations of brain networks in patients with GRE.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Histopathological diagnosis with LGG according to the 2016 World Health Organization (WHO) criteria;
* Participants received more than 6 years of school education;
* Presence of GRE, take levetiracetam less than 1 month; or do not take any medicine and receive any treatment;
* No history of biopsy, radiotherapy, or chemotherapy.

Exclusion Criteria:

* Contraindications for MRI;
* Head motion greater than 3 mm in translation or 3° in rotation;
An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence

Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.

Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years to 60 years
* Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
* Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
* Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
* Participants were interesting in reducing or stopping METH use
* Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
* Women of childbearing potential agreed to use contraception during the study.

Exclusion criteria:

* Pregnancy or breastfeeding;
* Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
* Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.