cyrilzakka/clinical-trials huggingface dataset:
Family Networks (FaNs) for Children With Developmental Disorders and Delays

Over 6% of children in Pakistan suffer from a developmental disorder (intellectual disability or Autistic spectrum disorder) and most receive no intervention.In an earlier proof of concept study, the investigators integrated social, technological and business innovations to develop and successfully pilot a sustainable service for such children in one rural population of 30,000. Affected families were identified through a mobile phone-based interactive voice response system, and organised into family networks. 'Champion' family volunteers were trained in evidence-based interventions. A Tablet-based android application was developed for training, monitoring and supervision of the champions, based on the World Health Organization's guidelines. The champions delivered the intervention to other families in the network. The project was sustainable and demonstrated significant improvements in the lives of children and their families in the first 6 months of its operation. The investigators are scaling-up this intervention to a population of 1 million. The investigators aim to evaluate the effectiveness and cost effectiveness of the scaled-up programme using cluster randomized control trial nested within the scale-up study.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2-12 years,
* Screen positive on any of the Ten Questions screen questionnaire items # 1,4,5,7,8,9,10 for developmental disorders and delays.
* Developmental disorder and delay present according to clinical assessment (History \& clinical examination for developmental delay in motor, communication, social, cognitive, daily living skills domains according to mhGAP developmental disorders guidelines for clinical assessment

Exclusion Criteria:

* Co-morbid physical or mental conditions in the child requiring inpatient hospitalization
* Deafness or blindness in the child
* Primary caregiver not available or unwilling to participate in the intervention program for 6 months
* Physical or mental conditions in the primary caregiver needing inpatient hospitalization or frequent outpatient visits (more than two times a month)
* Written consent not obtained for participation in the trial by the primary caregiver
The Impact of Patient Motivational Dialogue (PMD) on Patient Self-advocacy for Hand Hygiene

This exploratory cross sectional cohort study will evaluate the feasibility and fidelity of using an innovative strategy, the Patient Motivational Dialogue (PMD)/PMDPlus that will intentionally motivate and encourage the patient toward self-advocacy for their Health Care Professional's (HCP's) hand hygeine (HH) adherence.

This study will be implemented with two volunteer innovation champion physicians, one in radiation oncology and one in the chemotherapy oncology clinic. If other physicians begin to use the PMD/ PMDPlus in their clinics, the initiation will be considered a positive indication of feasibility and fidelity.

New patients will be enrolled in the study starting September 2016 until the sample size reaches 30 patients per clinic (n=60). Each patient will be followed in each clinic visit longitudinal through March 2017 or until discharged from the clinic treatment depending on which comes first. PMD will be administered in the first clinic visit followed by the PMDPlus each visit thereafter to ensure an adequate treatment dose. The PMD is estimated to take about two minutes of the initial clinic visit and the PMDPlus is estimated to take about one minute of the follow-up clinic visit.

The following steps will be taken based on the innovation decision model:

1. The PI will instruct the physicians, or designee in the use of the PMD/PMDPlus. Script cards with the PMD/PMDPlus will be provided to each physician. The physician will be instructed in use of PMD at the initial visit and the PMDPlus every follow-up clinic visit thereafter until discharge from the clinic.
2. A HCP survey will be conducted pre-intervention asking the HCP: "Has a patient or family ever ask you to clean your hands? If yes, the HCP will be asked to describe the situation.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* Able to understand instructions given by physician
* Receiving care in radiation oncology clinic and/or chemotherapy clinic at Cancer Therapy Research Center at University of Texas Health Science Center (UTHSCSA)

Exclusion Criteria:

* Unable to understand instructions given by physician
Application of Cervical Elastography in Obstetrics

The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.

During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.


Eligibility Criteria:
Inclusion Criteria:

* Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware

Exclusion Criteria:

* \>50 years old
* prior cervical surgical procedures (i.e. LEEP procedure, cold knife cone biopsy)
Adult Influenza Vaccination Text Message Reminders

Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population.


Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years of age,
* at least one visit to the AIM clinic during the previous year
* a cell phone number in the registration system
* fluent in English or Spanish. Exclusion criteria

Exclusion Criteria:

- Receipt of influenza vaccination during the 2013-2014 influenza season prior to randomization.
Effects of Oral Midazolam in Comparison Promethazine With Nitrous Oxide for Uncooperative Children

The purpose of this study is to compare the safety and efficacy of sedation using orally administered midazolam and promethazine with nitrous oxide/oxygen in uncooperative children receiving dental treatments.

The effectiveness of oral midazolam in pediatric dentistry is controversial. Usefulness of midazolam alone is limited to short-duration procedures, and we are needed to identify safe oral conscious regiments which permit longer duration procedures in dental treatments especially in Pediatric dentistry.

Promethazine is a long-acting (4-12 hr) anti-histaminic, H1 antagonist drug which acts as a central nervous system depressant and showing itself to be a weak anxiolytic drug.

The hypothesis to be tested is whether promethazine would improve the patients behavior during dental procedures without affecting vital signs, thus enabling longer periods of moderate or conscious sedation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients who are in ASA class 1 group
* Age of the patients must be between 36-96 months
* Uncooperative children who are in groups 1 or 2 according to Frankel's classification

Exclusion Criteria:

* Tonsil hypertrophy
* History of allergies
* Drooling or nocturnal snoring
Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction

The primary objective is to determine if the Smartphone electrocardiogram (ECG) is an acceptable replacement for a standard ECG in the identification of ST elevation myocardial infarction (STEMI).

Toward this objective, this study involves the following:

* Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting with chest pain in which the STEMI protocol was activated.
* Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent" ECG on patients presenting to the Emergency Department for evaluation of chest pain, not necessarily presenting with STEMI.
* Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are blinded to the initial clinical ECG readings, the type of ECG equipment used, and the patient's clinical information.
* Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG recordings in patients suspected to have STEMI, and
* Determine the possibility of pooling the data obtained from this study with data from other institutions conducting identical studies, and developing a future IRB-approved protocol and statistical analysis plan to compare the sensitivity, specificity, positive predictive value and the negative predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.

There will be no therapeutic interventions. A single research-related procedure will be required, i.e. an iPhone ECG. Effort will be made to ensure that the performance of this procedure will not delay any treatment and/or diagnostic procedures that are part of usual or specialized care that the patient requires. Effort will be made to enroll 1 STEMI patient for every 2 non-STEMI patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 18 years of age.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures (patient or legally acceptable representative).
* Symptoms of chest pain upon presentation at the INTEGRIS Baptist Medical Center Emergency Department

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally-acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Principal Investigator or Co-Investigator(s) may increase risk to the subject and/or compromise the quality of the clinical trial.
Intrapartum Epidural Fentanyl and Breast-feeding in the Immediate Postpartum Period: a Prospective Cohort Study

Intrapartum epidural analgesia has been associated with adverse breastfeeding outcomes. One potential mechanism involves transfer of epidural fentanyl across the placenta and neonatal blood-brain barrier, where it can subsequently attenuate neonatal exhibition of feeding behaviors, such as latching and swallowing, during the immediate postpartum period. Vigorous feeding behavior during the first days of life is a significant predictor of long-term breastfeeding success at 3 and 6 months. In a randomized, controlled, double-blinded study, neonatal Neurologic and Adaptive Capacity Scores (NACS) were significantly lower when mothers received \>150 mcg epidural fentanyl versus bupivacaine-only analgesia, and mean umbilical cord fentanyl concentration was significantly higher in the \>150 mcg versus \<150 mcg group.

The investigators hypothesize that epidural fentanyl-bupivacaine analgesia is significantly associated with decreased breastfeeding rates at hospital discharge and with neonatal deficits in latching onto the breast and swallowing during the first three hours of life, and that a significant dose-response relationship exists with respect to total micrograms fentanyl infused.

The investigators will perform a prospective cohort study of all parturients age 18+ at UHCMC over a three-month period, excluding those with multiples gestation, Cesarean section, or neonatal intensive care unit admission. From patient charts, the investigators will record the following variables: number of neonates delivered; type of delivery (spontaneous vaginal / operative vaginal / Cesarean section); whether the neonate was admitted to the intensive care unit; the mother's age, height, weight, gravity, parity, intention to breast-feed at the time of hospital admission, number of children previously breast-fed, and ethnicity; gestational age at the time of delivery; administration of oxytocin for labor augmentation and in what quantity; duration of active labor; antibiotic administration; neonatal APGAR scores at 1 and 5 minutes postpartum; and whether opioids or antibiotics were administered before and/or after the delivery and at what exact time. We will also record whether each patient received an epidural during labor and, if so, the duration of this epidural infusion and the total micrograms fentanyl delivered; neonatal feeding behavior as quantified by the LATCH scores assigned to each breast-feeding interaction that occurs on the postpartum care floor; whether the mother is breast-feeding her baby at the time of discharge from the hospital, and if not, then her primary reason for not doing so (as communicated during the standard postpartum lactation consultation); and how long mother and baby stayed in the hospital post-delivery.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or over

Exclusion Criteria:

* multiples gestation
* Cesarean section
* neonatal intensive care unit admission
Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia

The purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance.

Hypotension during cesarean section with spinal anesthesia is common. We compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women for elective cesarean section

Exclusion Criteria

* Shorter than 160 or taller than 180 cm
* Pre-pregnant body mass index (BMI) over 32
Tolerance and Practicality of Module AOX

The primary objective of this clinical trial is to test the tolerance and practicality of the new device Module AOX.

The secondary objective is to determine the changes in oxidative, antioxidative status, plasma free amino acids, and various immune parameters in critically ill patients receiving the enteral nutrition with and without using Module AOX.

Surgery and trauma induce hypercatabolism accompanied by a systemic immunoinflammtory response and massive production of reactive oxygen species at the site of injury. In these situations, requirements for certain amino acids (glutamine, cysteine) and antioxidant micronutrients (zinc, vitamin E, vitamin C, beta-caroteen, selenium) are markedly increased and may not be covered by the levels normally present in standard enteral diets, especially in the early phase when enteral nutrition is introduced gradually. Thus, supplementation with amino acids and antioxidant micronutrients may be appropiate in order to optimize nutritional support in such patients.

The administration of selected nutrients via modular devices added to a standard enteral formulation is an attractive means of providing optimized nutrition support for specific disease states. Module AOX is intended for supplementation of patients requiring nutritional support for a condition in which oxidative stress is expected. The module contains:

* Glutamine: to support gut mucosal and immune function, to minimize early depletion of glutamine stores and preserve body protein
* Cysteine: to support synthesis of glutathione, an important cellular antioxidant, and to support the synthesis of acute phase proteins
* Vitamin E, vitamin C and beta-caroteen: water- and lipid-soluble antioxidant micronutrients to boost antioxidant defenses
* Zinc: to compensate for increased losses and to support protein synthesis, immune function and wound healing
* Selenium: to compensate for increased losses, support antioxidant defenses and immune function

Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo major surgery of esophagus, stomach or pancreas
* patients who will be eligible for jejunostomy feeding
* age \>18 and \<75 y
* BMI \< 35
* having obtained his/her or his/her legal representative's informed consent

Exclusion Criteria:

* patients with a history of main cardiovascular or kidney disease
* weigth loss \>10% during the last 6 months
* patients who have received corticosteroids, or investigational drugs, in the last 6 weekd prior to surgery
* patients with HIV infection
* patients who are participating in another clinical trial
Fortified Skimmed Mother's Milk in the Management of Chylothorax

The purpose of this study is to determine if the use of fortified skimmed mother's milk is a safe alternative to specialized formula in the treatment of chylothorax following cardiothoracic surgery.

A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery. The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has time to heal. This formula is generally not well tolerated and mother's of our patients have expressed a desire to continue using breast milk. A few case reports have been published, but there have not been any studies to date looking at this. Data will be collected to include information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge information.

Eligibility Criteria:
Inclusion Criteria:

* Infant birth to 12 months of age
* Undergo cardiothoracic surgery
* Develop a chylous effusion
* Be a breastfed or formula fed infant

Exclusion Criteria:

* Infant over 12 months of age
* Infant in state custody (foster care)
* Infant with milk protein allergy
* Infant born with congenital chylothorax
* Infant who develops chylothorax from other surgeries (non-cardiac
Effectiveness of Two Oral Appliances for Managing Oral Self-biting Injuries in Patients With ALS

This study assesses to determine the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. Thirty-one patients with amyotrophic lateral sclerosis will wear two devices, a hard occlusal splint (HOS) and a flexible customized mouthguard (FCM), for two weeks each one. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the HOS, and the other half wearing the FCM. The participants will rate the degree of satisfaction with the device and the degree of improvement or worsening of oral self-biting injuries in a 10-point scale. They will also rate the degree of change in their quality of life because of changes in their oral self-biting injuries. Finally they will rate the compliance and report the adverse effects.

This crossover intervention study aims to assess the most effective type of device on the degree of satisfaction of patients with amyotrophic lateral sclerosis for managing oral self-biting injuries. Thirty-one patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital will participate in this randomized crossover trial. Two devices will be prepared for each patient, a hard occlusal splint (HOS) and a flexible customized mouthguard (FCM). They will wear one type of device for the first two weeks, followed by a week off, and the other type of device for the fourth and fifth week. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the HOS, and the other half wearing the FCM. The participants will rate the degree of satisfaction with the device in a 10-point scale, considering 0 extremely dissatisfied and 10 completely satisfied, and the degree of improvement or worsening of oral self-biting injuries, considering 0 an extreme worsening and 10 completely improved. They will also rate the degree of change in their quality of life (nothing, a bit, quite, a lot) because of changes in their oral self-biting injuries. Finally they will rate the compliance as the percentage of time the device was used with respect to the recommended time and report the adverse effects (excessive salivation, dry mouth, tooth pain, mucosal irritation, temporomandibular joint (TMJ) pain, TMJ sounds, bite change, other).

Eligibility Criteria:
Inclusion Criteria:

* Patients with amyotrophic lateral sclerosis diagnosed in the ALS Functional Unit at Bellvitge University Hospital.

Exclusion Criteria:

* Patients who cannot be treated due to the advanced evolution of their disease.
Safety of Pentoxifylline and Vitamin E With Stereotactic Ablative Radiotherapy (SABR) in Non-small Cell Lung Cancers

The objective of this prospective phase II protocol is to assess the toxicity and efficacy of pentoxifylline and SABR in the re-treatment of recurrent or new lung cancers


Eligibility Criteria:
3.1 Inclusion Criteria: - Eligibility Criteria

3.1.1 Age \>/= 18 years

3.1.2 ECOG performance status 0-1 3.1.3 Histologically proven diagnosis of a prior thoracic malignancy treated with thoracic external beam radiotherapy with or without systemic chemotherapy

3.1.4 Pathologic or clinical diagnosis of a new or loco-regional recurrent lung malignancy. A reasonable attempt should be made to make a pathologic diagnosis of malignancy (ie. bronchoscopy, CT guided lung biopsy)

* Loco-regional is defined as recurrence within the region of the primary tumor or adjacent draining lymph node regions.
* The new lesion or loco-regional recurrence must be within or adjacent to the previously irradiated treatment volume.

3.1.5 Imaging as follows:

* CT scan of the chest with IV contrast within 8 weeks of registration
* Whole body PET scan within 8 weeks of registration

3.1.6 Pulmonary function test (PFTs), including diffusion capacity within 8 weeks of registration

3.1.7 Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.

3.1.6 Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control

3.1.7 Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

- 3.2 Exclusion Criteria

3.2.1. No previously reported thoracic radiotherapy

3.2.2. FEV1 \<20% predicted and/or DLCO \<20% predicted

3.2.2. Pregnant women or lactating women

3.2.3 Chemotherapy within 4 weeks of the initiation of SABR

3.2.4 Plans to administer systemic chemotherapy overlapping with radiotherapy