cyrilzakka/clinical-trials huggingface dataset:
Comparison of Bottle and Cup Feeding on Transition to Full Breastfeeding and Discharge Time

Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle and cup feeding are common alternatives. There is a lack of evidence regarding superiority of either of these methods. This study aimed to evaluate bottle feeding and cup feeding in preterm infants on the outcomes of full breastfeeding and discharge time.

An estimated 20 million infants are born preterm each year (\>37 weeks) and this number is increasing. The preterm newborn population is potentially unable to be fed orally for a long time in the postnatal period.However, it is not a disease that preterm infants cannot be fed orally as soon as they are born. Since the physiological functions are not yet fully mature, their adaptation to the external uterine environment is more complicated.This situation also means a long hospital stay. Therefore, the American Academy of Pediatrics (AAP) has determined oral feeding of the preterm baby as the main criterion for discharge.

In preterm infants, sucking and swallowing coordination occurs in the 32 to 34 gestation weeks.Oral feeding skills are developed by applying various sensorimotor interventions and cue-based feeding protocols to increase oral feeding performance.Tube feeding (orogastric and nasogastric) is widely preferred as their oral-motor skills are still immature.As postnatal age increases, alternative oral feeding methods are often used along with tube feeding.Bottle feeding, cup feeding spoon feeding and syringe feeding are the most popular methods in clinical practice. While determining the most available method of oral feeding in preterm infants, the selection criteria include their capacity to facilitate the transition to full breastfeeding to help sustain breastfeeding to shorten the duration of hospitalization and to ensure sufficient nutrition.

Direct full breastfeeding is the important and most recommended feeding method in new-borns. However, since full breastfeeding is not immediately possible in preterm infants, they definitely need an alternative feeding method.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants (30-34 weeks);
* Considered medically stable
* With no facial deformity,
* Absent of neurological or congenital anomalies,
* Did not require sedation or vasoactive drugs
* Mother is providing breast milk \& plans to breastfeed.

Exclusion Criteria:

* Presence of gastrointestinal conditions that complicate feeding such as NEC,
* Absence of mother,
* Absence of breast milk, and
* Preterm infants fed only formula
Motor Imagery Practice in Neurological Rehabilitation

Motor imagery is a technique widely used in learning skills. Its effectiveness has been proven in various sports and in musicians. A recent review (Braun et al. 2006) suggested that this technique may also be effective in rehabilitation of patients with neurological disease or damage, but that further research was needed.

The main purpose of this research is to discover whether motor imagery practice is beneficial in the rehabilitation of skills in patients who have some disability due to neurological disease or damage. The principal research question is: are physiotherapy and occupational therapy given incorporating motor imagery more effective than standard care (i.e., the same therapies but without integrated motor imagery) in re-training task specific performance for patients with neurological disease or damage?


Eligibility Criteria:
Inclusion Criteria:

* Participating in a rehabilitation program for problems arising secondary to disease or damage affecting the central nervous system (usually stroke, brain injury, multiple sclerosis)
* Over 18 years of age
* Have sufficient language and memory skills to undertake the intervention (i.e. score positive on the first three items of the Sheffield screening test)

Exclusion Criteria:

* Any co-morbidity that would interfere with the ability to perform imagery as judged by the clinician or from the medical notes (e.g., schizophrenia)
Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia

This randomized controlled study is to evaluate the effectiveness of inhaling penehyclidine hydrochloride in reducing perioperative respiratory adverse events in children at risk undergoing minor elective surgery.

Children with high risk factors of perioperative respiratory adverse events (PRAEs) remains a challenge for general anesthesia, inhalation of penehyclidine hydrochloride (PHC) has been showed to reduce postoperative pulmonary complications and enhance the recovery in high-risk surgical patients. Thus, prophylactic PHC inhalation might show promising benefits against PRAEs in pediatric anesthesia. This clinical study is designed to test the hypothesis that pediatric patients who exist at least 1 risk factor of PRAEs prophylactically to inhale PHC have a lower prevalence of PRAEs.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients aged 3 to 7 years.
2. Scheduled to undergo ophthalmic surgery.
3. Judged to be at risk of PRAEs (with at least one parentally reported risk factor for the PRAEs, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke).

Exclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical classification ≥ IV.
2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).
3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);
4. Neurological disorders.
5. Neuromuscular diseases.
6. Contraindication for PHC.
7. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within 1 month before surgery.
8. Allergy to anticholinergic drugs.
9. Use of endotracheal tube (ETT) for ventilation.
10. Known difficult airway.
11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.
12. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.
13. Parents refusing to allow their children to participate.
14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.
Color Doppler Ultrasound to Locate Needle in Labor Epidural

Color Flow Doppler (CFD) utilizes Doppler information obtained from signals sent to and received from a transducer. This information is color-encoded and then displayed as color on an overlay of the two-dimensional image. The color scale represents both speed and direction of flow within a discrete area of the image. CFD has been recently used to determine the position of the epidural catheter. However its role in labor epidural has yet to be defined. This study describes the use of CFD to confirm the position of the tip of the epidural needle in the context of labor analgesia. This study hypothesized that CFD is a feasible method for identifying proper epidural needle placement prior to epidural catheter advancement.

After obtaining approval by the Institutional Review Board and a waiver of informed consent, thirty-five pregnant patients who underwent an ultrasound guided labor epidural between August of 2017 and June of 2018, were included in this retrospective review. The ultrasound guided labor epidural was used in those in which an anticipated technical difficulty with landmark epidural space localization was expected. These included those patients with diagnosis of obesity and lumbar scoliosis, as well as those with poorly defined surface lumbar bone anatomy. Patients with history of spine surgery were excluded. Patient data were obtained from the institutional electronic medical records. Demographic data, intervertebral level of insertion, dermatome level, and failure rate of epidural needle placement using color flow Doppler were noted for each patient.

Labor analgesia was obtained via a combined spinal epidural technique. Sterile preparation and draping of the area was followed by placement of a curvilinear ultrasound transducer in a sterile sheath. The ultrasound was used to identify the interspinous space. The epidural needle was guided with the use of real time ultrasound by the use of an out of plane technique. A two hand technique was used to manipulate the needle and the ultrasound probe. A 17G Tuohy needle (B. Braun Medical Inc, Bethlhem, PA, USA) was advanced until loss of resistance to normal saline was attained. Confirmation of the epidural space with the use of color flow Doppler (CFD) was then obtained after injection of up to 10 mL of normal saline through the epidural needle. A 27G pencil-point spinal needle (B. Braun Medical Inc, Bethlhem, PA, USA) was then introduced through the epidural needle until cerebro-spinal fluid (CSF) was obtained. Use of intrathecal fentanyl or local anesthetic plus fentanyl was then used as a bolus in the spinal space. A 21G epidural catheter (B. Braun Medical Inc, Bethlhem, PA, USA) was then threaded into the epidural space.

Eligibility Criteria:
Inclusion Criteria:

• Pregnant patients who had labor epidural placed for clinical indications, in whom ultrasound was used to assist the procedure.

Exclusion Criteria:

* Poor quality ultrasound images judged by experienced anesthesiologist
* Patients with history of lumbar spine surgery
A Collection of Clinical and Epidemiologic Data Combined With Tissue and Blood From Patients With a Diagnosis of Neuroendocrine Tumors

The purpose of this study is to establish a neuroendocrine tumor registry. A registry is a collection of information. To create this registry, the investigators would like to get information, blood and tumor samples from people with neuroendocrine tumors. By collecting this information and material, the investigators are hoping to learn more about the genetic causes of neuroendocrine tumors. All of this will help us to better understand neuroendocrine cancer, so the investigators can find better ways to treat and diagnose this disease. DNA will be taken from the blood samples and will be used in future studies. This will be an important resource from which the investigators can study genes that may be related to a higher risk of neuroendocrine tumors.

The information collected will include medical information, family history of cancer and your answers to questions about how the cancer affects quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gastroenteropancreatic neuroendocrine tumors or neuroendocrine tumors of unknown primary
* Willing to donate blood samples
* \>= 18years old
* Patients may have received prior hormonal therapy, cytotoxic therapy, irradiation, immunotherapy or surgical therapy

Exclusion Criteria:

* Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent
A Study to Test Lung Function After Radiation Therapy

It is known that radiation damages lung tissue. New human studies at University of Iowa show that the radiation damage is not as expected. The purpose of this study is to document lung function using four-dimensional computed tomography (CT) and quantify changes three months after radiation therapy for malignant lung disease.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of small cell or non-small cell lung cancer or metastatic tumor to the lung being scheduled for localized radiation therapy (including radiosurgery)
* No prior or future planned surgery for the treatment of the lung cancer.
* Age ≥ 18 years
* Karnofsky 60%
* Not pregnant.
* Ability to understand and the willingness to sign a written informed consent document
* Ability and willingness to participate in breathing training and compliance wiht breathing apparatus so that radiation doses are optimally linked to 4D-CT images
* Ability to tolerate CT contrast

Exclusion Criteria:

* No prior thoracic radiotherapy will be permitted
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women
* Severe COPD that requires chronic prednisone or multiple inhalers
* Underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
* Oxygen dependence at baseline
* Recent lung surgery or abdominal surgery (within 3 weeks) that would compromise respiratory pattern.
Pulmonary Hypertension in Left Heart Disease

The goal is to compare patients with and without varying severity of pulmonary vascular disease based upon hemodynamic signatures, echocardiographic measures, and lung ultrasound, in tandem with expired gas metabolic testing and blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason.
* Left Heart Disease, defined as one (or more) of the following:

  * Symptomatic HFpEF, defined by signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF fulfilling at least one of the following criteria: Prior hospitalization for decompensated HF treated with intravenous diuretics; Invasively verified HFpEF defined by pulmonary capillary wedge pressure (PCWP) of ≥15 mmHg at rest and/or ≥25 mmHg during exercise; Clinical diagnosis of HFpEF that does not meet criteria i. or ii. but verified with NTproBNP\>300 pg/ml in sinus rhythm or \>900 pg/ml in AF; H2FPEF score ≥6 or HFA-PEFF score≥5 according to current guidelines.
  * Symptomatic HFrEF, defined by defined by signs and symptoms of HF (dyspnea, fatigue) and reduced EF (\<50%).
  * Symptomatic valvular heart disease (VHD), defined by signs and symptoms of HF (dyspnea, fatigue) in tandem with clinically significant aortic or mitral valve disease (regurgitation and/or stenosis).

Exclusion Criteria:

* Patient inability or unwillingness to undergo noninvasive echocardiography, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.
* WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease)
* Group 3 PH (Hypoxia/Lung disease-related PH)
* Group 4 PH (Thromboembolic PH)
* Group 5 PH (Miscellaneous)
* Clinically significant parenchymal lung disease, hypoxemia, or lung infection
* Amyloid/infiltrative cardiomyopathy
* Acute Myocarditis
* Acute coronary syndrome or revascularization within 90 days
* Use of PH-specific drugs
* Constrictive pericarditis
* High output heart failure
* HF hospitalization within the preceding 30 days
* Severe or greater aortic (AVA \< 1.0 cm2, Mean Gradient \> 40 mmHg) or severe mitral (MVA \< 1.0 cm) stenosis
* Inability or unwillingness to exercise
* Inadequate echocardiographic imaging windows
* Inability or unwillingness to cooperate with breath holding
The Impact of Lower Limb Fractures on Body Mass Index (BMI)

The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury


Eligibility Criteria:
Inclusion Criteria:

* Adults with lower limb fractures

Exclusion Criteria:

* Polytrauma
* Upper limb fractures
* No consent
* Lack of follow up
* Patients opting for weight management treatments
* Patients with pre-existing mobility status impairment
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.

Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

* Eligible for percutaneous coronary intervention (PCI)
* Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
* Documented LVEF ≥25% within the last 6 weeks.
* Eligible for coronary artery bypass graft surgery (CABG)

Exclusion Criteria:

General Exclusion Criteria:

* Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
* Planned treatment with any other PCI device in the target vessel(s).
* MI within 72 hours prior to the index procedure
* Patient is in cardiogenic shock
* Cerebrovascular Accident (CVA) within the past 6 months
* Acute or chronic renal dysfunction (creatinine \>2.0 mg/dl or \>150 µmol/L)
* Contraindication to ASA or to clopidogrel
* Thrombocytopenia
* Active GI bleeding within past three months
* Known allergy to stainless steel or cobalt chromium
* Any prior true anaphylactic reaction to contrast agents
* Patient is currently taking colchicine
A Community-based Resilience Program of Only-child Loss Parents

This is a community-based participatory research aiming at helping the only-child loss parents to be happier and resilient from bereavement. It is a psycho-behavioral intervention research. There are two intervention programs in this study. One is derived from a foreign psychotherapy, developed by an American psychologist and has been testified the effectiveness in promoting happiness. Another one is developed by the researchers based on the previous cross-sectional survey and interviews with those bereaved parents. The researchers will apply randomized controlled trial to testify and compare those two intervention programs in a Chinese community.


Eligibility Criteria:
Inclusion Criteria(made according to the official documents):

1. has given birth to only one child;
2. now has no living birth or adopted child;
3. the bereaved mother is older than 49 years in this family(medically maximum age for fertility in China).

Exclusion Criteria:

1. with serious mental disorders or physical illnesses;
2. are not able to complete the intervention;
3. are not able to finish questionnaire;
4. with chewing functional disorder to collect saliva dehydroepiandrosterone.
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers

The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
MRI - Guided Adaptive RadioTHerapy for Reducing XerostomiA in Head and Neck Cancer (MARTHA-trial)

Radiotherapy is the main treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). Many advances regarding tumor control and patient survival have been made over the past decades. However, treatment-induced toxicity remains a crucial problem, leading to reduced quality of life and permanent impairment for many survivors. Xerostomia is up to this day the leading cause of late toxicity for these patients. Toxicity has been reduced by implementation of modern image guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT), but the low soft-tissue contrast of routine x-ray image guidance does not allow exact planning adaptation and daily imaging is associated with high radiation exposure. Furthermore, despite the routinely use of IMRT, rates of clinically relevant xerostomia (i.e. grade 2 or worse) are still common and reported in approximately 38%. Recently developed hybrid machines (MRidian®-CE approval since 2016), consisting of a linear accelerator and an integrated low-field MRI, could allow a) better visualization of tumor and organs at risk, such as parotid glands during patient positioning and daily treatment, b) daily imaging without additional radiation exposure, c) narrowest established safety margins for the treatment volumes, and finally d) repetitive adaptation of target volumes according to changes in patient weight and tumor anatomy during the radiotherapy course. These procedures would facilitate a high-precision treatment and help reduce dose exposure of critical structures.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the oral cavity oro- or hypopharynx or larynx, Stages II-IVB, requiring definitive or postoperative bilateral neck irradiation
* Age ≥ 18 years, no upper age limit
* ECOG-Performance score \< 2
* The trial is open to both genders
* History/physical examination within 30 days prior to registration by head and neck surgeon and Radiation Oncologist
* FDG-PET-CT-scan within 30 days prior to registration

Exclusion Criteria:

* Not adequately controlled hepatitis or HIV disease (HIV-viral load detectable)
* Second non-controlled malignancy other than basalioma or cervical/genital/anal in situ neoplasia during the last 2 years before enrollment
* Bilirubin \> 2,0 mg/dl, SGOT, SGPT, AP, Gamma-GT \>3x norm, GFR \< 30 ml/min
* leucocytes \<3,5 x 10\^9/l or platelets \< 100 x 10\^9/l or neutrophiles \< 1,5 x 10\^9/l
* Other severe comorbidities or psychic disorders (e.g. myocardial infraction within 6 months prior to registration, permanent cardiac arrhythmia, COPD Gold IV, hepatitis B/C, schizophrenia, ongoing alcohol abuse etc.)
* Lactating and pregnant women
* Previous radiotherapy of the neck
* Contraindications for MRI (e.g. pacemaker/ICD, tattoos, cochlear or other not MR-compatible implants)
* Pre-existing salivary gland disease (e.g. Sjorgen's-syndrome) or xerostomia-inducing medication (e.g. anticholinergic medication like tricyclic antidepressant)
* Claustrophobia