cyrilzakka/clinical-trials huggingface dataset:
Dietary Advice Training in Nursing Using Simulation and Interactive Fiction

The goal of this randomised controlled trial is to evaluate the effectiveness of training nursing students using interactive fiction and role-play simulations as teaching methodologies in improving learning and decision-making competencies related to dietary advice.


Eligibility Criteria:
Inclusion Criteria:

* First year of the Degree in Nursing at a Spanish university who were enrolled in the subject "Food, Nutrition and Dietetics".

Exclusion Criteria:

* Lack of attendance since the beginning of the course.
Evaluation of Complete Median Nerve Transection With Clinical, Electroneuromyographic and Diffusion Tensor Imaging

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries.

Median nerve is one of three major nerves of hand and forearm and often injure with glass etc, in follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method".

The aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from Electroneuromyography and DTI in postoperative follow up patients who underwent primary repair after the total median nerve injuries.

Median nerve is one of three major nerves of hand and forearm. It is below flexor tendon and retinaculum at the level of the wrist and often injured at this level and subtotally. The primary microsurgical suture technique under a microscope is the gold standard treatment. In follow up of healing; clinical examination and ENMG are often used. Both of these methods are subjective, although ENMG is more objective, however that is an invasive method, and need experienced neurologists. So, noninvasive and objective new method is required. In this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "The recovery of the repaired nerve tissue can be monitored by Diffusion Tensor Imaging method". There is no similar study in the literature.

Ten patients who were operated for median nerve injuries in 2014 will be enrolled. In the sample, correlations between Tinnel Test, motor strength assessment (Medical Research Council (MRC) Scale), static two-point discrimination test (S2PD), Semmes-Weinstein (SW) monofilament test, the Disability of the Arm, Shoulder and Hand (DASH) test, EMG with the DTI results will be assessed.

At the end of the study; it is expected that a significant correlation between conventional methods and DTI. If the results support the hypothesis; DTI may get to the literature as noninvasive and objective method in follow of nerve regeneration.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old
* Total and isolated median nerve transection

Exclusion Criteria:

* Under 18 and over 40 years old
* Partially transection of median nerve
* Median nerve transection with radial or ulnar nerve injury
Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System

Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.

The principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.

Eligibility Criteria:
Inclusion Criteria:

* Patient who received proper information about the study.
* Patient with clinically diagnosed pectus carinatum.
* Treated at Saint-Etienne University Hospital using a dynamic compression system.
* Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
* With more than 6 months of follow-up since the beginning of the treatment.

Exclusion Criteria:

-
CAP48 - Autism in Children and Adolescents

Evaluation and follow-up of children diagnosed with an autism spectrum disorder in French-speaking Belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.

The aims of the research project:

* To collect a wide range of data in order to improve knowledge of children with autism spectrum disorder (ASD) in French-speaking Belgium by prospectively including all children and adolescents making a request to the centres of reference. The creation of a common database will make it possible to collect general socio-demographic, geographical and epidemiological data, to characterise the different profiles and to accurately monitor developmental trajectories.
* Evaluate the feasibility and practical implementation of the treatment proposed following a diagnosis of ASD in a child.
* Implement protocols to improve the quality of care for beneficiaries.
* To enable the development of fundamental research protocols. Many questions remain unanswered about the genetic, neuro-cognitive and linguistic characteristics of autism. Only rigorous studies carried out on large, carefully defined samples can advance research.
* Increase public knowledge and understanding of the ASD.

Eligibility Criteria:
Inclusion Criteria:

* children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center from French-speaking region of Belgium.

Exclusion Criteria:

* refusal by the family to allow their child's data to be included in the database.
Sustainability of Impacts of Cash Transfers, Food Transfers, and Behavior Change Communication in Bangladesh

This study assesses the sustainability of impacts, 4 years post-program, from a pilot safety net program that was implemented from May 2012-April 2014. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers \[north and south\]; (2) cash transfers + nutrition behavior communication change (BCC) \[north only\]; (3) food transfers \[north and south\]; (4) food transfers + nutrition BCC \[south only\]; (4) food-cash split \[north and south\]; and (5) control \[north and south\]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years.

The objective of the study is to assess, 4 years after a pilot safety net intervention ended in April 2014, the sustainability of the intervention's impacts on households, children, and women. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). WFP-Bangladesh implemented the intervention, and the International Food Policy Research Institute (IFPRI) conducted the impact evaluation research. Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers \[north and south\]; (2) cash transfers + nutrition behavior communication change (BCC) \[north only\]; (3) food transfers \[north and south\]; (4) food transfers + nutrition BCC \[south only\]; (5) food-cash split \[north and south\]; and (5) control \[north and south\]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years, from May 2012-April 2014. For the original impact evaluation, longitudinal data on 5000 households were collected from 2012-2015 (ClinicalTrials.gov Identifier: NCT02237144).

For the sustainability study in 2018, given available funding, the sampling frame will include 4000 households. This will include all households that were originally in the following arms: (1) cash transfers \[north and south\]; (2) cash transfers + nutrition BCC \[north only\]; (3) food transfers \[north and south\]; (4) food transfers + nutrition BCC \[south only\]; (5) control \[north and south\].

Eligibility Criteria:
Inclusion Criteria:

* Former participant of Transfer Modality Research Initiative study (in cash, food, cash+BCC, food+BCC, or control arms)

Exclusion Criteria:

-
Care of Critically Ill Patients Enteral Nutrition Guidelines for the Implementation of the Effectiveness of the Intervention

This study is to find out care of critically ill patients enteral nutrition guidelines for the implementation of the effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients elder than 18 years of age
* (APACHE II) score \> 15
* Patients expected to remain in ICU for more than 2 days

Exclusion Criteria:

* Patients that have consented to a Do-Not-Resuscitate document
* Patients not expected survive more than 2 days
* Patients that have returned to ICU due to their condition worsening after previously leaving ICU
* Patients that have transferred from ICU of other hospitals.
Women SHARE Study: Reducing Sexual Risk

This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).

This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-29 years
* Meeting NIAAA definition of "at-risk" drinking (\>3 drinks on any day in the last 3 months18 and/or \>7 drinks per week)
* Sexual risk behavior (i.e., last 3 months: vaginal/anal intercourse with \>1 partner; vaginal/anal intercourse with a partner who has other partners; inconsistent condom use; new relationship (under 3 months))
* English speaking
* Absence of acute intoxication, depression, or suicidal ideation
* No plans for relocation

Exclusion Criteria:

* Male
* Under 18 years old or older than 29 years old
* Non-English speaking
* Suicidal Ideation
* Relocating
* Clinic provider advising against recruitment in the study
* Unwilling or unable to provide consent
Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity

To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.

Exclusion Criteria:

* Body Mass Index \> 28 kg/m2
* Daily epileptic insults.
* Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults.
* Psychological unstable subjects (as judged by the treating neurologist).
* subjects with mental retardation (as judged by the treating neurologist).
* subjects with severe behaviour disorders (as judged by the treating neurologist).
* Pregnant subjects.
* Subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency CT-scans).
* The use of the following medication is an exclusion criterium;

  * ß-blockers,
  * Ketogenic diet
Use of Probiotic Bacteria in Prevention of Allergic Disease in Children 1999-2008

The aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants


Eligibility Criteria:
Inclusion Criteria:

* mother or father fo child with doctor diagnoses allergic disease

Exclusion Criteria:

* prematurity, major malformations
Comparison of Outcomes With Multifocal Intraocular Lenses

The purpose of this study is to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses: SN6AD1, SBL-3, LS-313 MF30, AT LISA tri 839 MP, ART, LS-313 MF30T.

This study is a prospective randomized controlled trial to compare and evaluate the clinical outcomes of 6 kinds of Multifocal Intraocular Lenses, the outcome measurements include postoperative visual acuity, visual quality and complications. Patients enrolled in the study will be randomized to receive one of the Multifocal Intraocular Lenses mentioned above, and the clinical outcomes of each Multifocal Intraocular Lens will be assessed at several visits: 1 day, 1 week, 1 month, 3 months and months post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Age from 40 to 80 years old, either gender;
* Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
* Willing to undergo second eye surgery within 7 days after first eye surgery;
* The potential postoperative visual acuity of 20/40 or better in both eyes;
* Preoperative measurement of corneal astigmatism indicate the subjects are suitable for multifocal intraocular lenses implantation;
* Capability to understand the informed consent and willing and able to attend study

Exclusion Criteria:

* Preexisting ocular diseases or conditions other than age related cataracts, have contraindications for cataract surgery;
* Preexisting systemic diseases or conditions that may confound the results of the study;
* Previous ocular surgery history or ocular trauma that may confound the results of the study;
* Require combined surgery that may confound the results of the study;
* Previous participation in other clinical trial within 30 days of this study start;
* Systemic or ocular medications that may confound the outcome of the intervention
* Pregnant, lactating, or planning to become pregnant during the course of the trial;
Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program

The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility.

The main objectives are:

1. Functional capacity measures (VO2 max).
2. Cardiac risk factors
3. Quality of life assessments.

Study hypothesis:

Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergone:

  * Myocardial infarction
  * Percutaneous transluminal coronary angioplasty
  * Coronary artery bypass graft

Exclusion Criteria:

* Patients with:

  * Severe ischemia or angina
  * Implantable cardioverter-defibrillator
  * Pacemakers transplants
  * Severe left ventricular dysfunctions
  * Uncontrolled arrhythmias
Intervention for the Prevention of Obesity in Preschool

The purpose of this study is to develop, implement and evaluate an intervention focused to change feeding practices and patterns of physical activity of preschool children through providing motivational counseling to the mother. The aim is to prevent obesity in children aged 2 to 4 years 11 months with risk of overweight or with overweight.

Obesity has a multi-causal origin in which participate, in a similar way, the individual behavior and family and community contexts and the social environment.

Participation of primary care services is key to solve the problem. These services have the possibility to detect timely children with high body mass index, and to promote behavior to improve feeding practices and physical activity in both, the child and his family.

The study is divided in two stages:

1. Design of the intervention. The researchers will use qualitative methods to evaluate feeding practices, physical activity and the environment in which such behaviors are generated. In a similar way the care provided by health professionals to overweight and obese children it will be evaluated; this includes the perception that health providers have about this problem. The information will allow identifying risk behavior and healthy behavior, facilitators and obstacles to receive care. The results will serve to define the contents of the intervention.
2. Intervention: The study will take place in four family medicine clinics belonging to the Mexican Institute of Social Security. Two clinics will receive the intervention and two will serve as control. In each clinic, fifty children and their mothers will be recruited. At the intervention clinics, the group of mothers will participate in seven weekly sessions and in two individual sessions at 3 and 6 months after the group sessions finish. During the sessions, the researchers will motivate the mothers to change feeding practices and encourage physical exercise of the children and family, this will improve the chance for their children for healthy growing. The control group will receive the usual care that consists only in the recommendations that the family doctor provides.

The evaluation of the study comprise feasibility and acceptability of the intervention and its effect in the behavior of the mothers in terms of changing feeding practices and practicing physical exercise.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 4 years and 11 months of age at the beginning of the study.
* Overweight children, defined as a BMI score of z \> = 1.5 and \< +3 based on the WHO standards.
* The children's parents accept participation in the study.

Exclusion Criteria:

* Families who plan on changing their address during the study.
* Families whose doctor considers them to be inappropriate for participation in the intervention, as with emotional or mental alterations.
* Children who require a special diet for medical reasons or children with limited motor functioning.
To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate \[β-CDC\]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from dysmenorrhea for at least the previous 3 months prior to Visit 1 with a minimum visual analogue scale (VAS) score of 30 mm with regard to pain during the menstrual period of the screening period
* Good general health (except for findings related to dysmenorrhea) as proven by medical history
* Patients aged 18 years or older at the time of obtaining informed consent; smokers must not be older than 35 years at the time point of informed consent
* Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous six months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains (HPV 16, HPV18).
* Women of childbearing potential must agree that adequate contraception will be used when they are sexually active. This applies from signing of the informed consent form until 2 weeks after the last study drug administration.

Exclusion Criteria:

* Pregnancy (confirmed or suspected) or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
* Patients who wish to become pregnant during the course of the study
* Body Mass Index (BMI) \> 32 kg/m2
* Hypersensitivity to any ingredient of the study drug
* Laboratory values outside inclusion range before randomization
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
WX-0593 Combined With Concurrent Chemoradiotherapy in Unresectable Locally Advanced NSCLC

The aim of this trial is to evaluate the safety of WX-0593 combined with concurrent chemoradiotherapy in unresectable, locally advanced non-small cell lung cancer (NSCLC) with activating mutation of ALK or ROS1. This trial consists of two parts. In Part 1, approximately 8 patients will be included and receive WX-0593 maintenance until disease progression or unacceptable toxicity. In Part 2, approximately 32 patients will be included and receive WX-0593 monotherapy for 1-2 cycles and subsequently with concurrent chemoradiation, followed by WX-0593 maintenance until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older;
* Pathologically confirmed NSCLC who present with investigator-assessed previously untreated, unresectable, locally advanced (Stage II、III) disease (according to TMN staging of AJCC version 8);
* Has active mutation of ALK or ROS1;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Has at least one evaluable lesion (according to RECIST 1.1);
* Have adequate pulmonary function test as a forced expiratory volume in 1 second (FEV1) \>50% of predicted normal volume and carbon monoxide lung diffusing capacity (DLCO) \>40% of predicted normal value;
* Have adequate organ and marrow function;
* If participant is a woman of childbearing potential (WOCBP), must agree to follow the contraceptive guidance from written informed consent until at least 180 days after the last dose of study treatment. The female participant should have negative serum pregnancy test within 7 days prior to the first dose of study drug, and not breastfeeding;
* A male participant must agree to use contraception from written informed consent until at least 180 days after the last dose of study treatment.

Exclusion Criteria:

* Diagnosed other malignant tumor besides NSCLC within 5 years prior to study entry;
* Mixed small cell and non-small cell lung cancer histology;
* Has received prior therapy with any ALK TKI;
* Has a history of extensive diffuse/bilateral interstitial fibrosis, or grade 3 or 4 pulmonary fibrosis or interstitial lung disease prior to the first dose of study drug.

Has a known history of active tuberculosis; severe infection within 4 weeks prior to study entry;

* History of primary immunodeficiency;
* Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.