cyrilzakka/clinical-trials huggingface dataset:
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)

An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).

The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in MIDAB trial

Exclusion Criteria:

* None
Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance

To answer the question: What are the differences in intraoperative fluid administration volumes between PPV and CVP-guided strategies during posterior fossa tumor resection in the park bench position?

Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 18 years and above
2. American Society of Anesthesiologists (ASA) I and II
3. Diagnosis of posterior fossa tumor requiring surgical resection in the park bench position, under general anesthesia at our hospital
4. Willing to participate in the study

Exclusion Criteria:

1. Arrhythmia
2. Significant cardiac diseases
3. Chronic obstructive airway disease
4. Elevated intra-abdominal pressure
5. Tumors prone to precipitate diabetes insipidus
6. Peripheral vascular disease
7. Pulmonary hypertension
8. Patients in sepsis
Registry of Multicenter Brain-Heart Comorbidity in China

This study is a multi-center, prospective, registry study. This research was supported by the National Key Research and Development Program. To establish a domestic multi-center, large-scale "brain-heart comorbidity" dynamic database platform including clinical, sample database, image and other multi-dimensional information requirements, through the construction of a multi-center intelligent scientific research integration platform based on artificial intelligence.

Any of newly diagnosed cardiovascular related diseases were identified via ICD-10-CM codes: I21, I22, I24 (Ischaemic heart diseases) \[i.e., ACS\], I46 (cardiac arrest), I48 (Atrial fibrillation/flutter), I50 (Heart failure), I71 (Aortic disease), I60 (subarachnoid hemorrhage), I61 (intracerebral hemorrhage), I63 (Cerebral infarction), I65 (Occlusion and stenosis of precerebral arteries), I66 (Occlusion and stenosis of cerebral arteries), I67.1 (cerebral aneurysm), I67.5 (moyamoya diseases), Q28.2 (Arteriovenous malformation of cerebral vessels).

The data is stored on the brain-heart comorbidity warehouse via a physical server at the institution's data centre or a virtual hosted appliance. The brain-heart comorbidity platform comprises of a series of these appliances connected into a multicenter network. This network can broadcast queries to each appliance. Results are subsequently collected and aggregated. Once the data is sent to the network, it is mapped to a standard and controlled set of clinical terminologies and undergoes a data quality assessment including 'data cleaning' that rejects records which do not meet the brain-heart comorbidity quality standards. The brain-heart comorbidity warehouse performs internal and extensive data quality assessment with every refresh based on conformance, completeness, and plausibility (http://10.100.101.65:30080/login).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Any of newly diagnosed cardiovascular-related diseases were identified via ICD-10-CM codes: I21, I22, I24 (Ischaemic heart diseases) \[i.e., ACS\], I46 (cardiac arrest), I48 (Atrial fibrillation/flutter), I50 (Heart failure), I71 (Aortic disease), I60 (subarachnoid hemorrhage), I61 (intracerebral hemorrhage), I63 (Cerebral infarction), I65 (Occlusion and stenosis of precerebral arteries), I66 (Occlusion and stenosis of cerebral arteries), I67.1 (cerebral aneurysm), I67.5 (moyamoya diseases), Q28.2 (Arteriovenous malformation of cerebral vessels).

Exclusion Criteria:

·refuse to participate in the registry
Investigation of Krill Oil in Women with Premenstrual Syndrome

In this study the effects of different dosages and preparations of krill oil in comparison to placebo on symptoms of premenstrual syndrome in healthy, female adults will be assessed.

The study is a randomized, placebo-controlled, double-blind, parallel group trial, in which the effect of krill oil is investigated in healthy female volunteers showing premenstrual symptoms. The study period covers a time period over 6 menstrual cycles of women under which the first two cycles are recorded to assess baseline conditions followed by a 4-cycle supplementation phase. Volunteers are randomly allocated to the 5 study groups including placebo and 4 different dosages and formulations of krill oil. Over the whole study period, volunteers report daily their symptoms in the validated questionnaire DRSP. Mood state and quality of life are assessed at baseline and after two and 4 cycles of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Age: 20 - 50 years
* Sex: female
* Premenopausal
* Regular menstrual bleeding
* History of and presence of PMS symptoms of at least 6 months
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology

Exclusion Criteria:

* BMI: \< 19 kg/m2, ≥ 30 kg/m2
* Heavy smoker \>15 cigarettes / day
* Known pregnancy, breast feeding or intention to become pregnant during the course of the study
* No use of acceptable contraceptive method during the study
* Menstrual cycle lasting less than 24 / longer than 35 days
* Hormone treatment because of premenstrual symptoms
* Diagnosed premenstrual dysphoric disorder (PMDD), a severe form of PMS
* Regular consumption of omega-3 fatty acids (e.g. nutritional supplements) within previous 3 months or during the study course
* Fish consumption of more than 1 serving of fatty fish (e.g herring, mackerel, salmon) per week
* Relevant allergy or known hypersensitivity against compounds of the study preparations
* Unstable medical illness or relevant history or presence of any medical disorder, potentially interfering with this study (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke in the last 6 months or psychiatric disorders / psychoactive medication)
* Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
* Intake of medication potentially interfering with this study
* Known malabsorption / maldigestion
* Drug-, alcohol- and medication abuses
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 2 weeks prior to study start (day 1) or during study
* Participation in any other clinical study within the last 30 days prior to study start or during the study
* Any other condition that, based on Investigator's judgement, makes the subject unfit for inclusion into study
* Anticipating any planned changes in lifestyle for the duration of the study
Substudy of Change in Cardiometabolic Disease (CMD) Risk Factors During an Interactive Fitness Program

Substudy examining cardiovascular and metabolic risk factor change in children at high risk for future atherosclerosis who are enrolled in a pilot intervention using novel gaming and exercise activities to increase physical activity.

Childhood obesity is increasingly common and is predictive of adult type 2 diabetes and cardiovascular disease (CVD). Recent pediatric studies suggest exercise reduces cardiometabolic risk factors. Despite evidence of its benefits, exercise training prescribed by pediatricians is traditionally vague, developmentally inappropriate, and/or fraught with psychological, financial and practical barriers. There has been recent interest in the use of interactive technologies, also termed "exer-gaming" as a way to translate known positive benefits of exercise into increased physical activity in youth. Initial adult studies demonstrate benefits, yet there are few studies of exer-gaming involving children at increased CVD risk. This project involves a partnership between Children's Hospital Boston and the GoKids Boston Youth Fitness Research and Training Center at UMass Boston, featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, prevention, nursing, exercise physiology, and behavior change. Participants are eligible for this substudy based on enrollment in a pilot project evaluating the effects of a state-of-the-art exercise training facility incorporating the latest technology-based exercise games ("exer-games") in Boston Public School elementary children. Effects on CVD risk factor levels including lipids, blood pressure, body composition vascular reactivity, insulin resistance pre and post intervention will be compared to an Advice-Only condition and correlated with activity level. Eligible participants will be identified as part of the baseline measurements of that study and will be offered the chance to participate in the CHB Sub-Study, a two visit observational design.

Eligibility Criteria:
Inclusion Criteria:

* Participation in main intervention study

Exclusion Criteria:

* Unwillingness to comply with study requirements including two visits and data collection procedures
Evaluation of Cardiac Function in Acutely Decompensated Cirrhosis

This project aims to investigate cardiac function in patients with cirrhosis in the acute setting. Acute decompensation and acute-on-chronic liver failure are major events in the life of a patient as they herald disease progression and negative prognosis. Cardiocirculatory function will be assessed by serial assessments in patients admitted for acute decompensation of cirrhosis.

In this project we aim to investigate the dynamic role of cardiac function in the short-term evolution of patients with AD of cirrhosis through noninvasive and accessible tests and validate prognostic imaging and serum biomarkers. The main objectives are:

1. To describe changes and evolution of cardiac function in AD of cirrhosis
2. To investigate associations between echocardiographic parameters and serum biomarkers
3. To investigate the association between ACLF and cardiac dysfunction
4. To assess the short-term prognostic impact of cardiac function in AD and ACLF;
5. To evaluate the added predictive value of cardiac markers to current scores (CLIF-C).

Eligibility Criteria:
Inclusion Criteria:

* proven cirrhosis with acute decompensation

Exclusion Criteria:

* screening after \> 72 hours from admission
* previous severe cardiac conditions (e.g. ischemic heart disease, atrial fibrillation, congestive heart failure, ICD)
* concomitant severe disease (e.g. active neoplasia, severe COPD, etc)
* lack of informed consent
* intubated/ comatose patient
Attachment and Biobehavioral Catch-up for Depression

The overarching goal is to pilot the Attachment and Biobehavioral Catch-up (ABC) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.

Exposure to maternal depressive symptoms increases children's risk for developing anxiety and depressive symptoms ("internalizing symptoms"). Maternal depressive symptoms and children's internalizing symptoms may be reciprocally related over time. Optimal interventions for children's internalizing symptoms may involve treatment components for mothers, children, and the maternal-child relationship. The Attachment and Biobehavioral Catch-up (ABC) intervention is a empirically-supported, family-based treatment program that has been shown to be beneficial for children in varied high-risk family environments, but has yet to be tested among mothers and children recruited on the basis of heightened depressive and internalizing symptoms, respectively. The overarching goal is to examine the acceptability, feasibility, and preliminary effects of the ABC program on a sample of mother-child dyads (n = 20) with heightened depressive and internalizing symptoms. Our specific aims are:

1. To evaluate the feasibility and acceptability of ABC for mothers with depressive symptoms and their offspring with internalizing symptoms
2. To explore whether children who receive ABC show improvement in internalizing symptoms from pre- to post-intervention
3. To explore whether mothers who receive ABC show improvement in depressive symptoms from pre- to post-intervention
4. To explore whether parents and children who receive ABC show more adaptive physiological responses to stress from pre- to post-intervention

Eligibility Criteria:
Inclusion Criteria:

1. Mothers between 18 and 50 years of age with heightened depressive symptoms as determined by a score of 16 or higher on the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
2. Biological children (of mothers described above) between 2 and 4 years old with heightened internalizing symptoms as determined by a T-score of 60 or higher on the Childhood Behavior Checklist (CBCL)

Exclusion Criteria:

* Self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt
* Current pregnancy
* Child diagnosis of autism
* Pacemaker implant, cardiac problems, cardiac medication
Partnership and Dignity: a Mixed-methods Survey on Supporting and Retaining Uganda's Village Health Teams

For more than a decade, Uganda's Ministry of Health has led a community health worker program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the task of delivering preventative health services and education to their local communities. Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health outcomes; however it is known that VHTs are not optimally supported, and there has been VHT attrition in recent years. The Ministry of Health has recognized the inadequate support of VHTs thus far and is aiming to "expand VHTs to all local governments and explore ways of sustaining VHTs." The objective of this study is to evaluate the extent to which material support is a deciding factor in the efficiency and durability of Uganda's VHT initiative. Material support may take the form of monetary stipends, regular payment, transportation assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study will review existing literature and gather novel data through surveys of VHT members and VHT stakeholders. The quantitative and qualitative survey data will be analyzed for trends that may point to a conclusion in the context of existing health policy discourse on community health worker remuneration. The purpose of this study is to strengthen the knowledge base on whether or not the current absence of material support significantly limits the potential for Uganda's VHTs to be sustained and expanded. This information can be used by governmental and non-governmental organizations in their work to strengthen and sustain VHTs throughout the country.


Eligibility Criteria:
Inclusion Criteria:

VHT subjects must have been actively working as a VHT member for at least 6 months. Stakeholders, that is, program managers, health administrators and policy makers, must be involved in managing, administrating, or guiding policy for VHT programs as part of their official job description. These persons must also have been acting in those roles for at least 6 months. All study subjects will be 18 years of age or older. All study subjects will be literate and able to be informed to give or withhold consent of participation.

Exclusion Criteria:

There will be no exclusion or inclusion based on gender, race, tribal or ethnic affiliation, religion, or health status.
Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery

this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block

on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia

Exclusion Criteria:

* parent refusal
* spinal and meningeal anomalies
* mental retardation
* blood disease
* infection at site of injection
* drug allergy
Transcatheter Aortic Valve Intervention-Live Transmission

The primary objective of this clinical trial is to evaluate safety of patients who underwent Transcatheter Aortic Valve Intervention (TAVI) during a live case or video-taped transmission as compared to those without procedure transmission.

A series of sites from outside the US, where the Edwards-Sapien and CoreValve devices are approved for commercial sale and implantation, will be recruited to retrospectively identify and extract in-hospital data of a patient who underwent TAVI during a live or video-taped procedure and a matched patient who underwent TAVI without transmission of the procedure.

Eligibility Criteria:
Cases Inclusion Criteria:

* Subjects \> 18 years of age, male or female
* Subject had live case or video-taped transmission of TAVI procedure with:

Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach

Controls Inclusion Criteria:

* Subjects \> 18 years of age, male or female
* Subject underwent TAVI without procedure transmission and had:

Edwards-Sapien transfemoral approach, Edwards-Sapien transapical approach, or CoreValve transfemoral approach

* Subjects will be matched to Cases upon the following:
* STS SCORE +/- 2points
* Date of TAVI procedure +/- 4weeks
* The first attending for the TAVI procedure
* Access site for TAVI
Long-term Safety of PF-00345439 (Oxycodone)

Long-Term Safety Of PF-00345439 (Oxycodone) In Patients With Moderate To Severe Chronic Low Back Pain Or Osteoarthritis

This study will evaluate: (a) the long-term safety of PTI-821 during a 12-month period; and (b) the long-term efficacy of PTI-821 by assessing pain intensity (PI), the quality of analgesia, and the global assessment of study medication.

Eligibility Criteria:
Inclusion Criteria:

* Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while regularly taking one or more of the following types of oral analgesic medication(s) prior to the Baseline Visit.
* Patient agrees to refrain from taking any opioid medications other than study drug during the study period. Patients must agree to report all non-opioid analgesic medications taken.
* Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control. Acceptable methods of birth control include surgical sterilization, hormonal contraceptives, or double-barrier methods (condom or diaphragm with a spermicidal agent or IUD). If practicing an acceptable method of birth control, a negative urine pregnancy test result has been obtained at the Baseline Visit.

Exclusion Criteria:

* Patient has a positive urine drug screen at the Baseline Visit.
* Patient currently is on an opioid regimen with a daily opioid dose equivalent of oxycodone \> 160 mg.
* Patient has major surgery planned during the proposed study period.
Levobupivacaine During Cholecystectomy

The purpose of this study is to determine the effects of intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* cholelithiasis
* chronic cholecystitis

Exclusion Criteria:

* hypersensitivity to local anesthetics
* acute cholecystitis
* morbid obesity
A Randomized Controlled Study of Family Based EF Training for Schoolage Children With ADHD

The goal of this study is to provide a new treatment approach for schoolage children with ADHD, which could facilitate the EF developing well to achieve better outcome.

ADHD in preschoolers has become established as a valid psychiatric disorder with characterized core deficits of executive function (EF). The EF impairments occurred in preschool period could persist to childhood, adolescent and adulthood, causing extensive and deep damage of individual's academic and career achievement, social function, and peer relationship. Although medication showed significant effectiveness in controlling the core symptoms of ADHD, it failed to help patients master compensatory strategies to cope with functional impairments in learning and life events. The family intervention program for school-age ADHD children is still rare, and it is a blank field in China. At present, most of these related studies have not integrated task training in realistic scenarios with parent training, and lack of randomized and controlled Settings, which makes the effect of intervention less convincing. Therefore, the investigators conduct this randomized and controlled study to find out the therapeutic efficacy of Family-based Executive Function Training for Schoolage Children with ADHD, and follow the subjects to observe whether the therapeutic efficacy would persist. In the mean time, the investigators also observe the factors which can influence the therapeutic efficacy. The goal of this study is to provide a new treatment approach for schoolage children with ADHD, which could facilitate the EF developing well to achieve better outcome.

Eligibility Criteria:
Inclusion Criteria:

1. meet both the criteria of ADHD based on the interview by the CDIS and clinical diagnosis with DSM-5;
2. full-scale IQ estimated bythe Wechsler Intelligence Scale for Children-Revised Form (WISC-R) above 80;
3. their parents volunteered to participate in this study.

Exclusion Criteria:

1. child with severe mental disorder or physical disease that might interfere the assessment and intervention, such as Autistic Spectrum Disorder(ASD), Schizophrenia, epilepsy, traumatic brain injury, etc.;
2. parents with severe mental illness, such as schizophrenia, mood disorder (period of onset), etc..