cyrilzakka/clinical-trials huggingface dataset:
Preterm Neonatal Feeding Protocol Comparing Feed Administration Time

Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.

The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.


Eligibility Criteria:
Inclusion Criteria:

* Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.

Exclusion Criteria:

* Any infant who has major anomalies including but not limited to \*gastroschisis

  * omphalocele
  * bowel obstruction or atresia
  * tracheo-esophageal fistula
  * Hirschsprung's Disease
  * congenital diaphragmatic hernia
  * congenital heart disease and other major syndromes
  * infants who have started enteral feeds prior to entering the study
* Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
* Any infant whose gestational age is greater than 32 weeks.
Telemedical Coaching for Weight Loss

Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching have the potential to support lifestyle change and weight loss. Therefore, the aim of our randomized controlled trial is to examine the effect of telemedicine with and without coaching in comparison to a control group on weight loss in overweight participants.

In an occupational health care setting employees with overweight and/or metabolic syndrome will be randomized into a three arm 12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got a weighing machine and a step counter, with automatic transfer into a personalized online portal, which could be monitored from both, the participant and the study centre. The TMC group weekly will get care calls from the study centre aiming to discuss measured data and to fix target agreements. The control group will remain in routine care.

Eligibility Criteria:
Inclusion Criteria:

* employed at Boehringer Ingelheim Pharma GmbH for at least 2 years
* older than 40 years
* overweight or obese or metabolic syndrome

Exclusion Criteria:

* not willing to participate
EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair

The purpose of this study is to collect and compare EndoSure and EndoSure s2 Wireless AAA Pressure Sensor measurements with measurements from CT scan imaging, ultrasound, and other tests used to measure your AAA sac size and endoleaks following AAA repair, and during follow-up visits with your physician. An antenna is held over the patient's abdomen to measure pressure inside the aneurysm sac. The reading does not cause any discomfort, and dye or radiation is not needed to take the pressure measurement. To qualify, the patient must have a previously implanted EndoSure Sensor.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from subject or legal guardian
* Males or females, at least 18 years of age
* Subjects who are post-EndoSure Wireless AAA Pressure Sensor implantation, with pressure measurements at implant.
* Subjects willing to comply with the site-specific follow-up requirements of the investigator.

Exclusion Criteria:

* Subjects whose clinical condition, in the Investigator's opinion, would not allow them to complete participation in the registry.
Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache

Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.

Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.


Eligibility Criteria:
Inclusion Criteria:

* Patients with postdural puncture headache;
* Patients partially improved on conservative treatment and required a definitive pain relieving management;
* Patients who were intolerant to conventional analgesics;
* Patients who did not receive or did not improve on conservative therapies.

Exclusion Criteria:

* Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
* Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
* Patients dependent on routine analgesia for other causes were excluded from the study;
* Patients refused to participate in the study or to sign the written consent;
* Patients missed during follow-up were not included in the study.
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation

The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and \<15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of \>= 5 years and \< 15 years old age at the start of study treatment

Exclusion Criteria: -None
Falls Risk Questionnaire in Older Adults With Cancer

The purpose of this research study is to look at the use of a series of questionnaires evaluating risk for falls in order to collect information that might be used to develop a larger study aiming to recognize who is more at risk for falls and how to best intervene to prevent falls in older adults with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older; 5 patients will be enrolled in each of the following age cohorts: 65-69, 70-74, 75-79, 80 and older
* Diagnosis of cancer, any type
* Currently receiving or anticipated to initiate systemic cancer therapy within 1 month, including endocrine therapy, chemotherapy or targeted therapies
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Unable to understand written English
* Psychiatric illness/social situation that would limit compliance with the study requirements
* Unable to walk.
Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects

This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or healthy females of non-child bearing potential
* Age 18 to 65 years of age
* Body mass index of 18.0 to 32.0 kg/m\^2 and weight between 50 kg and 120 kg, inclusive

Exclusion Criteria:

* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
* History of any drug or alcohol abuse in the past 2 years
* Current smokers and those who have smoked within the last 12 months
* Females of childbearing potential
* Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
* Current disease requiring treatment with systemic corticosteroids
* Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients
Muscle Elastography in Spastic Cerebral Palsy

To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.
* Consent may be obtained from a parent or legal guardian, as applicable.

Exclusion Criteria:

* Prior surgical procedure in the affected upper extremity
* Unrelated orthopedic injury to the affected upper extremity
* Current oral or intrathecal antispasticity therapy
* Prior Botulinum toxin type A injection in preceding 6 months
Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.

The observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between July 2012 and December 2014. The patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of Marshall.

Eligibility Criteria:
Inclusion Criteria:

* Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
* Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
* Signing of the informed consent

Exclusion Criteria:

* Age below 40 and over 80 years of age
* Left ventricular ejection fraction below 25%
* Left atrium diameter over 60mm
* Permanent atrial fibrillation
* Polymorbidity (Euroscore II over 10)
* Emergency surgery
* Renal insufficiency (creatinine over 200 umol/l)
Longitudinal Registry for Advanced Heart Failure Patients

The purpose of this study is to gather information to better understand the characteristics, medical management techniques and outcomes of patients with chronic severe Heart Failure (HF).

This objectives of this observational registry are: to assess changes in patient quality of life as a function of medical management and disease progression as measured by the rate of death and rehospitalization, and assist with the optimization of heart failure (HF) management by providing information on the use of therapies proven to be effective and to describe practices of standard of care for chronic treatment of symptoms of HF outside the hospital and during hospitalization for acute episode with intravenous vasoactive medication (drugs which affect the blood vessels and muscle of the heart). Additional information which will be gathered include patient characteristics (age, sex, race, medical history, symptoms), infusion setting, type of medication, dose and frequency of medication and worsening of congestive heart failure disease. Participants in the study receive an unique patient-specific identifier and all available data will be analyzed. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Age older than or equal to 18 years at the time of entry into the Registry
* Severe symptoms of HF at rest with marked limitation of physical activity continuously for at least 60 days prior to inclusion in the Registry
* Patient has been hospitalized 2 times in the past 12 months with a primary diagnosis of HF
* Patient's HF is refractory or relatively refractory to usual non-IV medications, as defined by having received one of the two following regimens for the treatment of HF in that last 60 days: 2 complete IV infusions, each lasting at least 2 hours, of either vasoactive (drugs having an effect on veins or arteries) or inotrope medications (drugs that makes the heart works better), or 3 IV diuretic (drugs that increase the elimination of urine) treatments

Exclusion Criteria:

* History of any organ transplantation
* Patient is expected to die within the next 5 days
* Patient is seen for consultation or evaluation only, and is unlikely to receive follow-up care at the participating clinic/hospital
* Participation in a clinical study of the drug Natrecor
Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients;
2. 18 yrs and older, and 80 yrs and younger;
3. Histologically or cytologically proven prostate adenocarcinoma;
4. Imaging examinations including Emission Computed Tomography (ECT),Positron Emission Tomography (PET),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
5. Not yet receiving hormonal therapy;
6. Not yet receiving chemotherapy previously;
7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
8. Patients are willing to participate and can be followed up regularly；

Exclusion Criteria:

1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
3. Patients received chemotherapy previously;
4. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years);
Repeatability, Reproducibility and Comparison of Cirrus OCT, RTVue OCT, MS-39 OCT, and Insight 100 VHFDU

The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such as the epithelium (the layer of skin on the surface of the cornea). A commercially available instrument, known as the Artemis, has been used in routine clinical practice since 2001. The ArcScan Insight 100 VHF digital ultrasound scanner is an updated version, which obtained CE mark in 2016.

Optical coherence tomography (OCT) is another method of measuring the thickness of the cornea and the corneal epithelium. OCT has been used for measuring corneal thickness since 1997 and the technology had evolved to also measure epithelial thickness since 2012. There are currently three OCT scanners capable of measuring epithelial thickness; Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT.

The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) for each of the four devices for measuring corneal thickness and epithelial thickness.

Eligibility Criteria:
Inclusion Criteria:

Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.

As general inclusion criteria the following aspects are defined:

* Subjects should be 21 years of age or older.
* Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
* Patient will be able to understand the patient information and willing to sign an informed consent.

For the normal eye populations:

* Eyes with no ocular pathology
* Eyes with no previous ocular or corneal surgery

For the post-op eye populations:

• Eyes between 3 and 9 months after LASIK or SMILE

Exclusion Criteria:

* Previous ocular or corneal surgery (for normal eyes)
* Patient not being able to tolerate local or topical anesthesia
* Patient has active conjunctivitis or any active ocular infection or inflammation
* Patient has a corneal ulcer
* Patient has an open wound on the corneal epithelium
* Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
* Pregnancy
A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia

A major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. The aim of this work is to determine whether the provision of lockable storage containers to poor households in rural Asia can reduce the incidence of intentional pesticide self-poisoning. Secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.

We will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning.

The study will be based in Anuradhapura District where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed.

The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clustering and stratification, for the analysis.

The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia.

Eligibility Criteria:
Inclusion Criteria:

* Any village in the study area that gives consent to the study

Exclusion Criteria:

* None
Conversion From Total Intravenous Anesthesia Technique to Desflurane Anesthesia for Long Duration Neurosurgery

Since neurological testing during neurosurgery, such as somato-sensory evoked potentials, motor-evoked potentials, auditory evoked potentials and visual evoked potentials are well maintained their wave-form reactivity with total intravenous anaesthesia technique better than inhalational anesthetic techniques, the standard anesthesia method for neurosurgery is usually total intravenous anaesthesia technique. Nonetheless, after finishing recording the evoked potential responses during surgery, facilitation of recovery from general anesthesia is getting important, because the real neurological physical examination is much more sensitive than above electrical evoked potentials to evaluate the results of surgical operation.

We propose to evaluate the recovery parameters after conversion from total intravenous anaesthesia technique to Desflurane anesthesia during long term neurosurgery procedures. The conversion will be initiated upon completion of the neurophysiological electric evoked potentials assessment. Based on the pharmacological properties of desflurane, we hypothesize that recovery after conversion to Desflurane will be faster compared to recovery after total intravenous anaesthesia alone.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective craniotomy
* American Society of Anesthesiology Physical Status Ⅰ, II and III
* Age: between 20 to 65 years
* Sex: male or female
* Patients who are postmenopausal or surgically sterilized
* Expected Operation time is longer than 4 hours.

Exclusion Criteria:

-
A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block

Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

Methods: In this randomized, controlled clinical trial, one hundred and twenty ASA physical status of class I and II patients undergoing below-knee surgery were involved. These patients were divided into three equal groups at randomly based on the route assigned for the US-guided popliteal block: the posterior, lateral, and medial approach groups. In this study, technical characteristics \[number of attempts to get the proper injection site and block performance time\], anesthetic and analgesic characteristics \[success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia\], discomfort rate in respect to position and needle insertion and the associated complications were recorded.

Eligibility Criteria:
Inclusion Criteria: This study included

* ASA physical status (PS) class I and II
* weighing 70-85 kg,
* undergoing elective below knee surgeries

Exclusion Criteria:

* patients who refused to participate in the study
* those having an allergy to local anesthetics
* peripheral neuropathy, coagulopathy
* diabetes mellitus
* severe hepatic
* renal impairment
* infection, mass and crush injury or open wound at the nerve block site
* patients receiving chronic analgesic therapy.