cyrilzakka/clinical-trials huggingface dataset:
A Mediterranean Intervention on Prediabetic Children

Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. Recently, it has begun to be detected in children, with family eating habits becoming more critical. Therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of the Mediterranean Diet Quality Index (KIDMED).


Eligibility Criteria:
Inclusion Criteria:

* Presence of HbA1c levels between 5.7 and 6.4% in the blood tests
* Signed informed consent by the minor
* Signed informed consent by the minor's parents or guardians.

Exclusion Criteria:

* Presence of HbA1c levels below 5.7%
* Presence of HbA1c levels above 6.4%
* Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
* Lack of the signed informed consent by the minor and legal guardian
Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris

The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.

The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults.

All patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris.

Detection of H. pylori infection:

Blood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody.

An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum.

A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.

Eligibility Criteria:
Inclusion Criteria:

* Acne vulgaris patients
* Healthy volunteers (control)

Exclusion Criteria:

* Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.
Trial of Asthma Patient Education (TAPE)

The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma.

This is a study of the effects of education and drug presentation on efficacy of montelukast and placebo in asthma. This trial will answer the following questions: 1) Is there a true placebo response in asthma that is not due to non-specific factors? 2) Can the placebo effect in asthma be augmented by interventions that increase expectancy of benefit? 3) Can interventions that increase expectancy augment the effect of active treatment? 4) Are placebo effects additive or interactive with treatment effects?

Eligibility Criteria:
Inclusion Criteria:

* age 15 or older
* physician diagnosed asthma
* regular use of prescribed asthma medication over preceding year
* post-bronchodilator FEV1 of at least 75% of predicted
* inadequate asthma control over preceding two months

Exclusion Criteria:

* current or past smoking (greater than 10 pack-years)
* serious asthma exacerbation within previous three months
* regular use of oral corticosteroids
* history of respiratory failure due to asthma
* current use of montelukast or history of adverse reaction to montelukast
* concomitant interfering medical condition
* participation in another clinical trial
* inability or unwillingness to perform study procedures
* pregnancy, lack of effective contraception (when appropriate), lactation
Task Oriented Training in Post Stroke Patients

This study will be observe the effect of Task-oriented training on the dexterous movements of hands in hemiparetic post-stroke patients. Patient will be recruited that meet the inclusion criteria, with unilateral hemiplegia referred by Neurophysician having stroke for the first time, between age 47-70 year, both males and females, score of spasticity for upper extremity (shoulder, elbow) below and equal 2 based on the Modified Ashworth Scale (MAS), ability to comprehend simple instructions (Mini-Mental State Examination with a minimum score \> 24), Brunnstrom stages ≥ 4, not submitted to other upper-limb rehabilitation programs during the participation in this study. The individuals with recurrent stroke episodes and transient ischemic attack, other neurological diseases (Parkinson's disease, multiple sclerosis,), hemineglect, no sitting balance and comorbidities are excluded. Outcome measures used are FuglMeyer assessment scale (wrist and hand) and Wolf motor function test for upper extremity while Barthel index to assess the activities of daily living. All procedures will perform by taking informed consent. All Ethical standards for both patient and institution will be followed. After collecting data, will apply Shapiro Wilk test to check the normal distribution of data. For analysis use SPSS version 25


Eligibility Criteria:
Inclusion Criteria:

Unilateral hemiplegic stroke patients referred by Neuro-physician (both ischemic and hemiplegic stroke patients).

* Patient with first time stroke (within 6month of onset).
* Age between 45-70 years of age.
* Gender both male \& females.
* Ability to comprehend simple instructions (Mini-Mental State Examination with a score of \>24 ).
* Score of spasticity for upper extremity (shoulder, elbow) below and equal 2 based on the Modified Ashworth Scale (MAS).
* Motor recovery of upper limb Brunnstrom stages ≥ 4.
* Not participated to other upper-limb rehabilitation programs during the participation in this study.

Exclusion Criteria:

Recurrent stroke attacks, Transient ischemic attacks(TIA).

* Previous injury, disease, or contracture of the upper extremity and no sitting balance.
* Any comorbid neurological disease or condition such as multiple sclerosis, Parkinson disease, spinal cord injury, traumatic brain lesions, brain tumor, epilepsy, or dementia,
* Had Hemineglect phenomena.
Added Value of N Acetyle Cysteine to Clomiphene Citrate in PCO

PCO is one of the factors associated with delayed conception

In an attempt to induce ovulation Clomiphene citrate can be given in conjunction with N acetyle cysteine

Eligibility Criteria:
Inclusion Criteria:

* women with PCO

Exclusion Criteria:

* women who donot have PCO
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis

Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.

Visit 1 (Day 0): Screening visit. Assessment of outcome measures

Visit 2 (Day 7): Enrollment visit after a 1-week wash-out period. Enrolled to the Study are only patients who show a severe enough and stable disease (SNOT score \>20 and change of SNOT score \<15% compared to Visit 1, respectively).

Visit 3 (Day 21): Assessment of outcome measures after 2-week treatment phase

Visit 4 (Day 49): Follow-up visit

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed chronic allergic rhinitis or chronic sinusitis with no or a mild status of nasal polyp activity
* Disease lasting 12 weeks or longer
* Patients with moderate or severe symptoms (SNOT-22 score \>20)
* Male or female at least 18 years old
* Females in childbearing age are requested to make a pregnancy test and to confirm in writing to take contraceptive measures until Follow-up Visit (Day 49).
* Patient understands German

Exclusion Criteria:

* Severely purulent forms of sinusitis
* History of medication during the last four weeks

  * not allowed: antibiotics, systemic or topical steroids
  * allowed: nasal saline spray or irrigation, analgesics, decongestants, antihistamines
* Patient has a status of moderate or severe polyp activity in the nose
* Patient had sinus surgery in the past 6 months
* Patient needs O2 substitution
* Patient has cystic fibrosis
* Patient has primary ciliary dyskinesia
* Patient is demented or otherwise incapable of judgement
Evaluation of Social Robot Usability for Pediatric Patients and Carers

This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.

This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.

This study is conducted for a mixed methods study. Subjects are 20 child patients and 20 their carers. First, Participants use and interact with a social robot. The robot is controlled by researcher with the wizard of oz. method. And another researcher observes the participants-robot interaction. The interaction is video-recorded for the later analysis of the child's engagement through amount of his vocalization and sentences. After using social robot, a survey and an in-depth interview will be done.

This study investigates the usability, satisfaction, emotion, and other dimensions of social robots of pediatric patients and carers and evaluate the degree of interaction with them with the recording data, survey and in-depth interview. This study is a basis for using social robots to pediatric patients in the hospital environments.

Eligibility Criteria:
\<Pediatric patients\>

Inclusion Criteria:

* Patients visiting Samsung Medical Center (Age 5\~12)
* A person who voluntarily agrees to participate in the study
* Patients who are able to agree with a consent

Exclusion Criteria:

* Those who disagree with the study
* Patients and carers who find it difficult to interact with the robot

\<Carers\>

Inclusion Criteria:

* Caregivers of the patient participant
* Adults over 19 years of age
* A person who voluntarily agrees to participate in the study

Exclusion Criteria:

* Those who disagree with the study
* Patients and carers who find it difficult to interact with the robot
Use of Construal Level Theory to Inform Messaging to Increase Vaccination Against COVID-19

This study aims to increase uptake of the COVID booster vaccine through messaging informed by Construal Level Theory. Patients in the Mass General Brigham (MGB) health system aged 18 and older who are eligible for the COVID booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). Messages will be sent via the electronic patient portal a few days in advance of their office visit. The primary outcome will be the rate of booster vaccination at the targeted visit. The secondary outcome will be the rate of receipt of a COVID booster vaccine within 6 weeks of the targeted visit. Subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the Mass General Brigham system
* Aged 18 and older
* Are eligible for the COVID booster vaccine but have not received a dose at time of upcoming primary care clinic visit

Exclusion Criteria:

* Documented allergy to a COVID vaccine or its components
* Home address outside of Massachusetts
* Did not receive full set of primary COVID-19 vaccination series
Stereolithographic Technique for Dentures

The aim of this observational study is: producing complete dental prosthesis with the aid of CAD-CAM (Computer aided design \& manufacturing) - 3D printing (Stereolithography) technology - using as printable material Poli(methylmetacrylate) - PMMA - with Nano TiO2 nanoparticles composite completely characterized.

In order to improve complete dentures fabrications an experimental model for optimizing the composite material and the execution technique for the 3D printed dental prosthesis was developed.

* A new polymer - nano-TiO2 composite system for dentures printing was obtained by adding 0,4-1%TiO2 nanoparticle in the commercially available E-Dent 100 (EnvisionTEC, Germany).
* The new polymer was completely characterized and biocompatibility tests were perform.
* A stereolithography technique was set-up for CAD-CAM complete dentures manufacturing.
* 3D printed dental prosthesis will be inserted to a number of 35 complete edentulous patients from a target group;
* Clinical follow-up at 6, 12 and 18 months and quality assessment of the dentures will be recorded in a specific chart.
* A statistical evaluation of data recorded during the entire follow-up period will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mobile or removable dentures after establishing diagnosis and treatment plan, following initial clinical and laboratory examinations,
* Persons having mental competence, decision-making capacity, legal competence.
* Patients willing to accept complete denture treatment.
* Patients with good systemic health, able to attend all the follow-up sessions.
* Patients accepting the participation in the study, including the 18 months follow-up and signing the consent form.

Exclusion Criteria:

* Patients do not agree the CAD-CAM technique for denture manufacturing.
* Patients refusing participation in the study and signing consent form.
* Patients not willing removable dental restorations.
* Patients not willing to participate at 18 months follow-up evaluation.
Acupuncture in Prevention of Postoperative Sore Throat Due to Classical Laryngeal Mask

the aim of our study is to investigate if stimulation of the P6, LI4 and LI11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.

Our study is planned as a prospective, randomized, controlled, single blind. The details of the study are explained to the patients and their written informed consents are obtained.

Using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). Preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. In Group1, laser acupuncture is applied to each of the previously described P6, LI4 and LI 11 points on both arms with laser acupuncture device (Sedatelec Premio 32) for 30 seconds. In Group 2, same procedure is performed for 30 seconds while laser acupuncture closed. Then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. Maintenance anesthesia is provided with sevofurane and remifentanil infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients who recieved general anesthesia with LMA
* surgery duration \< 2 hours
* between 18-60 years of age
* ASA1-2 scores

Exclusion Criteria:

1. Being younger than 18 years old or being over the age of 60
2. Patients with an ASA score of 3 and greater than 3
3. Active infections in the area to be acupuncture.
4. Prolonged bleeding time
5. Liver failure
6. Renal insufficiency
7. Pregnancy
8. Heart failure 9 . Patients less than 30 kg

10. Uncontrolled hypertension

11. Uncontrolled diabetes, pheochrocytoma, thyroid dysfunction

12. Those who do not have the ability to read and sign the consent form

13. Patients with gastroesophageal reflux

14. History of any herbal medicine use

15. Patients who do not want to sign the consent form

16. Patients with difficult LMA placement

17.Patients who cannot have LMA placement at one time

18. Intubated patients in whom LMA could not be placed

19 Patients whose operation time exceeds two hours

20 .Patients whose operation time is less than 30 minutes
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

This study will evaluate the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin. The primary hypothesis of the study is that the addition of ertugliflozin reduces hemoglobin A1C (HbA1C) more than the addition of placebo after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Has diabetes diagnosed by one of the American Diabetes Association (ADA) criteria.
2. Has body mass index (BMI) ≥85th percentile at screening OR participant has a history of being overweight or obese at time of diagnosis of Type 2 diabetes mellitus (T2DM).
3. T2DM for ≥2 years, OR T2DM for \<2 years and a fasting C-peptide value \>0.6 ng/mL at Screening.
4. On stable metformin monotherapy (≥1500 mg/day, for ≥8 weeks prior to Screening, OR on a stable metformin dose (≥1500 mg/day, for ≥8 weeks prior to Screening and a stable dose of insulin for ≥8 weeks prior to Screening.
5. Contraceptive use by male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Is a non-sterilized female who is currently not sexually active OR who agrees to abstain from heterosexual activity OR who agrees to start contraception prior to initiating sexual activity and who agrees to use an adequate method of contraception. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
7. Have a family member or adult who, along with the participant, will be closely involved in the participant's daily activities (in the opinion of the investigator) and in the participant's treatment and study procedures.

Exclusion Criteria:

1. Has known type 1 diabetes mellitus or documented evidence of positive diabetes autoantibodies performed when participant was diagnosed with diabetes.
2. Has known monogenic diabetes, or secondary diabetes.
3. Has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of another antihyperglycemic agent, including insulin.
4. Has a known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor.
5. Is pregnant, or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study medication.
6. Has previously taken an SGLT2 inhibitor (such as canagliflozin, dapagliflozin, empagliflozin, or ertugliflozin) or was enrolled in a study for these agents.
7. Has a history of idiopathic acute pancreatitis or chronic pancreatitis.
8. Has a history of severe hypoglycemia while on insulin.
Presenting Summary Information From Cochrane Systematic Reviews: Protocol for Research of Infographics Presentation vs. Plain Language Summary

The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS format, in presenting information, in terms of understanding and remembering research results by consumers.

The investigators will conduct a randomized controlled trial (RCT) with two different formats of the same systematic review summary (Infographics, PLS). The content of these two formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language and plain language only. The interventions will be delivered online in November 2016, with members of the consumers' groups for pregnancy and parenting - RODA ("Roditelji u akciji", engl."Parents in action"), which gathers different types of consumers: pregnant women, young mothers and parenting and pregnancy advisors; and the members of the Association for Patients' Rights. The trial will be voluntary and anonymous. The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be members of RODA and Association for Patients' Rights (women) .

Exclusion Criteria:

* Male members of RODA and Association for Patient's Rights
Fibrinogen and Bleeding After Cardiac Surgery

The study hypothesis is that prophylactic fibrinogen infusion reduces postoperative bleeding and transfusion requirements after coronary artery bypass surgery (CABG) in patients with endogenous fibrinogen levels in the lower normal range. 60 patients will be included in a prospective, randomized double-blind placebo-controlled single center study.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age 18 years and above
* Patients eligible for a first-time coronary artery bypass(CABG) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/L
* Signed informed consent to participate in the study

Exclusion Criteria:

* Patients undergoing redo surgery
* Clinical or laboratory signs of bleeding disorder
* Clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
* Any medications with agents which may interfere with hemostasis within 14 days prior to study start. Clopidogrel and warfarin are withdrawn at least 24 hours before surgery. Oral aspirin is allowed co-medication.
* Administration of other investigational drugs within eight weeks preceding the preentry examination
* Pregnant or lactating women