cyrilzakka/clinical-trials huggingface dataset:
Do Video Materials Help Parents to Support Infant Development?

The aim of this project is to assess whether video materials from the BBC Tiny Happy People (THP) campaign are effective in terms of improving the language skills of socioeconomically disadvantaged children before they start school. This project will also look at how useable the service is for parents in terms of acceptability, effects on self-efficacy and implementation of advice.

The current study will evaluate BBC Education's Tiny Happy People initiative (https://www.bbc.co.uk/tiny-happy-people) which seeks to reduce the impact of social and economic disadvantage on children's language skills before they arrive at primary school. BBC Education have created videos for parents and other caregivers with information about child development, tips and activities as well as other content of interest. The aim of the evaluation is to find out how parents feel about the materials and whether the videos promote a) caregiver confidence at 12, 18 and 24 months, b) caregiver-infant interaction at 12, 18 and 24 months and c) child language at 18 and 24 months. The primary outcome is expressive vocabulary size at 17-18 months. Families with 4- to 9-month-old infants who would like to take part will be randomly allocated either to a language support group or a physical health active control group and sent short, age-appropriate advice videos by text message three times a month until their children are 18 months old (with follow up videos for children until the age of 2 years where possible given study time limits).

Eligibility Criteria:
Inclusion Criteria:

Families must:

* be raising their child as a monolingual English speaker (at least 80% of the language they hear in the home is English)
* have a postcode in deciles 1-5 of the Office of National Statistics Index of Multiple Deprivation
* have access to the internet and a device to watch videos (via smart phone)

Infants must:

* be full term
* have a healthy birthweight

Exclusion Criteria:

Neither caregivers nor infants must have any significant known physical, mental or learning disability
Dry Eye and Irritation Comparison of Latanoprost With the Preservative Versus Travoprost Without Preservative

Although Benzalkonium chloride (BAC) has been used as a preservative for many years, many studies have demonstrated that prolonged use of topical ocular medications preserved with BAC may exacerbate sequelae associated with ocular surface disease. These effects could lead to the induction of subclinical inflammation,1 reduction of corneal epithelial barrier function, 2, 3 destabilization of the tear film, 4 cataract formation, 5 and an overall higher incidence of patient complaints of dryness and irritation. 4-6 This study will compare the efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of latanoprost 0.005%with BAC in patients with dryness and irritation and open-angle glaucoma or ocular hypertension. A double blind comparison will be used to assess whether those two different formulations will affect the tear breakup times, corneal staining, and baseline tear secretion tests in patients that are already taking latanoprost regularly with complaints of dryness and irritation. Patients included in the study will be given two bottles, one labeled for their right eye and the other for their left eye. Each pair of bottles will be identical in appearance and randomized with either latanoprost or travoprost and each pair will be assigned a number to aid in future analysis of the final results.


Eligibility Criteria:
Inclusion Criteria:

* patient must already be using xalatan for at least 1 month prior to study enrollment in both eyes and have complaints of dry eye and/or irritation.
* study population:
* any race and of either sex, diagnosed with open angle glaucoma (OAG) (with or without pseudoexfoliation or pigment dispersion components) or ocular hypertension (OHT)
* tear break up times (TBUT) \< 6 seconds on xalatan monotherapy.

Exclusion Criteria:

* unequal baseline measurements (i.e. difference in cup to disc ratio of .1 or greater, intraocular pressure difference of 2 or more mm Hg),
* difference in subjective symptoms of dryness/irritation between the patient's two eyes;
* history of ocular trauma or intraocular surgery within the past 6 months in either eye;
* ocular infection, ocular inflammation, or ocular laser surgery within the past 3 months in either eye;
* severe hypersensitivity to study medications or vehicle;
* any abnormality preventing reliable applanation tonometry;
* anterior chamber angle less than 10 degrees in either eye,
* severe central visual field loss in either eye;
* cup-to-disc ratio greater than 0.80 in either eye;
* contraindications to pupil dilation; previous diagnosis of autoimmune diseases;
* chronic glucocorticoid use within 1 month of and during the eligibility phase or intermittent glucocorticoid use within 2 weeks of the eligibility phase;
* any type of glaucoma other than OAG or OHT;
* therapy with another investigational agent within 30 days of study start;
* use of any other topical or systemic ocular hypotensive medication during the study.
Direct to Smoker Outreach in a Health Care Setting

Tobacco use is the leading preventable cause of death in the United States. Effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. The health care system is a key channel for delivering this treatment to smokers. Brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by U.S. Public Health Service. However, physicians and other clinicians often fail to provide them. Clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit.

A health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. A population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. This study tests the effectiveness of a population-based Direct-to-Smoker (DTS) outreach program provided to smokers in one community health center in Revere, MA, that is part of an integrated health care system. It uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. A randomized controlled trial will compare the effectiveness of the DTS program to usual primary care. The hypothesis is that adding the DTS program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>= 18 years)
* made an office visit to a primary care physician (PCP) at Revere Health Center in the year prior to May 2009
* has a telephone
* listed as a smoker in the past 5 years in the electronic health record

Exclusion Criteria:

* severe psychiatric or neurologic diagnosis (e.g., psychosis, dementia) on problem list of electronic health record
Passive Dietary Intake Assessment Study

Currently, there is no accurate measurement of dietary intake. All current methodologies of assessing dietary intake have inaccuracy rates of 30 -70%. Accurate assessment of dietary intake is critical in understanding individual and population nutritional status and monitoring the effectiveness of public health interventions to maintain nutritional health. Estimating dietary intake in low and middle-income countries (LMICs) is remarkably challenging, albeit the high presence of malnutrition and the critical need for evidence-based data to inform policies and programmes on nutrition and health.

This study aims to develop and validate a low-cost and robust system for accurate measurement of an individual's dietary intake in households in LMICs. This innovative system passively recognises food, records intake, and estimates nutrient content of food. The system will be validated in field trials in Ghana and Kenya.

This protocol describes the process of developing and validating a passive dietary monitoring system for the assessment of an individual's dietary intake in households in Ghana and Kenya.

The first phase of the study involves preliminary testing of identified dietary monitoring camera/video devices in a lab setting at Imperial College London under conditions similar to those anticipated in Ghana and Kenya. These conditions may include low lighting, unique foods common to certain regions, communal eating (where more than one person eats from a shared plate of cooked food) and placement of the devices on the body. This is important to guide the design of a suitable passive dietary monitoring system.

The second phase of the study involves an in-depth understanding of household set-up, composition and eating behaviour and testing the feasibility and acceptability of using passive dietary monitoring devices/system in communities in Ghana and Kenya. The data gathered in this phase of the study will inform the choice of the passive dietary monitoring system and configuration to use in the field validation study.

Finally, in the validation phase of the study, the passive dietary monitoring system developed will be set up to record food intake and estimate nutrient content of food across 88 households in Ghana and Kenya. In addition, 24h dietary recall (a commonly used method of collecting dietary intake data in population studies) and weighed food records will be used to estimate food intake in the households. The dietary intake data obtained through the passive monitoring system will be compared to 24h dietary recall and weighed food record data to validate its accuracy.

Eligibility Criteria:
Inclusion Criteria:

1. Household comprising of both parents (mother and father) and at least a child/children under 5 years of age and/or an adolescent child
2. Members of the household eat the same prepared meal
3. Willingness to use a camera/video recording device to capture household food preparation and consumption.

Exclusion Criteria:

* Households not meeting the above inclusion criteria will not be recruited
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial

Vasoconstrictive agents are increasingly being used in order to decrease blood loss during vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al. They demonstrated a significant decrease in the amount of blood lost during the surgery but also demonstrated a significant increase in the risk of post-operative infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent studies using vasopressin as the vasoconstrictive agent have also found the same significant decrease in blood loss while not demonstrating a difference in the rate of post-operative infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were larger, better designed studies and are considered more credible. More surgeons are therefore injecting vasopressin intracervically preoperatively.

Some surgeons believe that the injection of vasopressin intracervically prior to the initial incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical dissection more difficult. This is thought to possibly both add to operative time and increase the rate of complications. The aforementioned studies used the injection of saline as a control for the injection of vasopressin or epinephrine. To date, no study has compared the use of vasopressin versus no injection in a controlled, randomized manner. We do not know if the injection of saline intracervically may actually increase the amount of bleeding over the baseline and therefore the decreased blood loss caused by the injection of vasopressin my actually be overestimated.

We propose to compare the effects of injecting vasopressin intracervically preoperatively versus no preoperative medication. We will not only evaluate the amount of operative blood loss, but also compare operative time and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures

Exclusion Criteria:

* women with a significant medical condition, including severe liver disease, congestive heart failure, documented coronary artery disease, impaired renal function determined by an elevated serum creatinine, asthma with steroid use in the past year, and migraines
Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery

The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 14 years after abdominal emergency surgery.

Exclusion Criteria:

* Lack of consensus of the patient
* Concurrent extra-abdominal surgery
* Short bowel or other clear indication of parenteral nutrition
* Inability to feed orally (eg, decreased level of consciousness)
* Interventional procedure
* Esophageal surgery
* Reoperations
* Pancreatitis
Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.


Eligibility Criteria:
Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history \>10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio \<70%., FEV1 \>/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation

This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.

It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving.

Eligibility Criteria:
Inclusion Criteria:

* Critical ill hematological cancer patient
* Requiring mechanical ventilation

Exclusion Criteria:

* Patients with acute coronary syndrome.
* Patients with cancer remission more than 5 years.
Effects of a Time Restricted Eating Protocol on Resistance Training Men

The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males

Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem) and 8:00 PM. During the experimental period, training loads were similar and standardize in the two groups. partecipants were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured. After the completition of the first two months of study, subjects were ask to volunteer to continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each group (TRE or ND) continued and completed the second part of the study.

Eligibility Criteria:
Inclusion Criteria:

* continuously engaged in resistance training for at least 5 years
* at least 3 years experience in split training routines
* male

Exclusion Criteria:

* adherence to special diets
* use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
* use of steroids
* use of medications
Study Comparing the Effect of Ligamentum Teres Cardiopexy on de Novo GERD Post LSG

The aim of this study is to investigate the effect of ligamentum teres cardiopexy on incidence of de Novo GERD.

Laparoscopic Sleeve Gastrectomy (LSG) is now the most commonly performed bariatric surgery world wide. The results of LSG on outcomes of GERD are conflicting. It has been reported to increase the severity of pre existing GERD and also to cause new onset GERD in considerable number of patients.

In this study the effect of adding a novel procedure i.e. ligamentum teres cardiopexy,(LTC) to regular LSG on occurence of de Novo GERD will be investigated. de Novo GERD has been found to occur in 20% of cases post LSG.

This study is a randomized, prospective, parallel group, controlled trial to compare the effect of LSG versus LSG with LTC on occurence of de Novo GERD.

This is a single center based trial, being conducted in GEM hospital and research center, Coimbatore, Tamil Nadu, India. The trial has been approved by GEM research ethics committee.

Investigators are planning to enroll patients who are not having any objective or subjective evidence of GERD. The participants will be optimized as per institutional bariatric surgery protocol. After complete evaluation and optimization, participants will be randomized by computer generated random numbers into either LSG or LSG with LTC group.

The demographic data, preoperative GERD - Q scores, 24 hour pH study, intra operative details will be recorded. Post operative details during each follow up will be recorded, which will include excess weight loss, GERD - Q scores. At 6 months follow up repeat 24 hour pH study will be done to assess the status of GERD objectively.

The trial duration is expected to be of 1 year where in investigators will be recruiting patients for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* candidate for bariatric surgery according to IFSO - APC guidelines
* No evidence (objective and subjective) of GERD

Exclusion Criteria:

* Presence of GERD either by history or by 24 hr pH study
Comparison Between Laser, Synthetic Gel and Herbal Gel as Topical Agents After Gum Surgery

This study would be conducted to assess the effectiveness of low-level laser therapy, hyaluronic acid gel and herbal gel as adjunctive aids in the healing of gingivectomy wounds. As the gingivectomy wound heals by secondary intention, this study aims to compare the healing potential of low-level laser therapy, hyaluronic acid gel and herbal gel when applied topically at baseline, 1st day,3rd day and 7th day after gingivectomy procedure.

Low-level laser therapy applied to soft tissues stimulates specific metabolic processes in healing wounds. Major changes observed in wounds treated with low-level laser therapy(LLLT) include increased healthy granulation tissue formation with early epithelization, increased fibroblast proliferation and matrix synthesis.

Hyaluronic acid is a polysaccharide gel and it has many properties that make it a potentially ideal molecule for assisting in wound healing by inducing early granulation tissue formation, inhibiting inflammation, providing epithelial turnover and also aiding in connective tissue angiogenesis.

Hiora gel is a herbal astringent gel which helps in wound healing, reduces inflammation and also alleviates pain.

Eligibility Criteria:
Inclusion Criteria: Gingival enlargement index greater than or equal to 2mm

Exclusion Criteria: Infrabony Pockets Diabetic patients Smokers.

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