cyrilzakka/clinical-trials huggingface dataset:
The Effect of Two Different Dual Task Balance Trainings in Older Adults

The aim of our study is to investigate the effect of integrated and consecutive dual-task exercise trainings in elderly people on the balance, fear of falling and gait performance.

For the purpose, the number of 42 participants reached by the power analysis method was determined as 60 people considering the possible separations. 60 participants will be included in the study. Participants should not have any orthopedic, neurological and cognitive disabilities and the Montreal Cognitive Assessment (MOCA) scale score should be 21 or higher. Participants will be divided into two groups as random consecutive and integrated dual activity groups.

In the study sit-up, stand on one leg (eye open-closed), standing 30 sec stop (eye open closed stop), 10 m walk backward, sitting on top of the ball (eye open-closed), transfer of weight on the top-left, walking in straight line, 30 sec. stop on soft ground (eye open-close), balance training which does not force their efforts will be given in two groups.

For the sequential dual activity group, immediately after these trainings, you should expected to find the letters Z in the mixed letters, search for the five words you read on the previous page, find the similarities between the concepts, find the letter in the given tables, derive the fruit names starting with the letter, count the days of the week etc. Attention, memory and arithmetic training will be given the ability to run. For the integrated dual activity group will be given similar cognitive tasks during simple balance training.

The training program will be prolonged 8 weeks and 2 days per week for both groups.

The assessment tests was performed before and after the program. Primer Outcome Measure: Berg Balance Scale, Timed Up and Go Test (Standart-Cognitive), 10m Walking Speed Test (under single and dual task conditions).

Although there are many studies to increase and measure the balance and physical capacity of elderly people in the literature, there is no study using consecutive exercises and comparing the benefits of consecutive and integrated cognitive dual task training.

A major cause of morbidity and mortality is a fall injury in the elderly. Therefore, preventing falls in elderly people and increasing the ability to balance is an important public health priority.

Our study aims to benefit the public health, the reduction of health expenses of our country, the physiotherapists working with elderly people and the literature.

Eligibility Criteria:
Inclusion Criteria:

* Accepts to start routine exercise programs under the supervision of the medical team,
* Over age 65,
* Does not have orthopedic problems that may prevent him from exercising,
* The MOCA score is 21 or higher,
* Participants who have no other neurological problems that may cause loss of balance will be taken.

Exclusion Criteria:

* Having orthopedic problems that prevent him from exercising,
* Being under the MOCA score 21,
* To have any neurological problem that will affect the balance,
* Not wanting to participate in the study.
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D

This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics).

Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks.

Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

This trial will use a single-administration, open-label trial design to assess the ability of a single SC injection of dasiglucagon to increase plasma glucose in pediatric children with T1D with hypoglycemia. A total of 8 children will be included; 4 children receiving a dose of 0.3 mg and 4 children receiving a dose of 0.6 mg. Of the 4 children receiving 0.3 mg, 2 children should preferably be below 2 years at screening. The 2 additional children receiving 0.3 mg should weigh below 15 kg at screening and should preferably be below 4 years at screening. For children receiving the 0.6 mg dose, all must be above 2 years at screening. Before an eligible child is dosed, the dose level (0.6 mg or 0.3 mg) must be confirmed by the sponsor. Each child will be dosed after the safety assessment of the preceding child has been completed and assessed by the Trial Safety Group.

The trial will include the following visits:

* A screening visit (Visit 1) in the period from Day - 50 to Day - 29 (pre-treatment visit)
* A dosing visit (Visit 2), Day 1 (day of single dosing with investigational medicinal product \[IMP\])
* A Safety follow-up visit (Visit 3) at Day 29 +5 days (the end-of-trial visit).

The primary endpoint of the trial is plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous glucose. Pharmacodynamics (PD) i.e., plasma glucose will be assessed at baseline and 15 and 30 minutes after dosing, while the glucose levels will be monitored by continuous glucose monitoring and by a plasma glucose analyzer during the dosing visit (Visit 2). Pharmacokinetics (PK) will be assessed throughout a 300-minute period at the dosing visit (Visit 2). Safety will be assessed prior to dosing and throughout a 300-minute period after dosing and again at the follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI
* Body weight greater than 8 kg
* Child must be \<6 years of age at the time of screening
* Further inclusion criteria apply

Exclusion Criteria:

* Known or suspected allergy to the IMP or related products
* Any condition that in the investigators opinion may result in diminished hepatic glycogen stores (e.g., prolonged fasting (more than 24 hours) at Visit 2
* History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)
* History of hypoglycemic events associated with seizures
* Further exclusion criteria apply
A Clinical Trial of Esophagectomy for Esophageal Carcinoma

Brief Summary The pathological type of esophageal cancer (EC) in most patients in East Asia is esophageal squamous cell carcinoma (ESCC). Surgery is the primary treatment for EC. This study compared the feasibility and safety of mediastinoscopic-assisted transhiatal laparoscopic esophagectomy (MATLE) with video-assisted thoracoscopic esophagectomy (VATE).

Thirty-five eligible patients with ESCC were assigned to the MATLE group, while seventy matched patients were assigned to the VATE group. The study compared perioperative outcomes and lymph node dissection between the two groups. Additionally, the Kaplan-Meier method was employed to estimate Disease-Free Survival (DFS) and Overall Survival (OS).


Eligibility Criteria:
Inclusion Criteria:

* previously untreated
* histologically confirmed
* potentially resectable thoracic ESCC clinically staged as T1b-3N0M0 or Tis-1aN0M0 who was not suitable for endoscopic resection according to the 8th edition of the American Joint Committee on Cancer staging system and National Comprehensive Cancer Network Clinical Practice Guidelines in Esophageal and Esophagogastric Junction Cancers
* age 18-70 years,
* normal hematologic and organ function -Karnofsky Performance Scale (KPS) was assessed as 100 or 90

Exclusion Criteria:

* a history of other malignancies
* severe comorbidities
* active autoimmune disease
* prior non-infectious pneumonitis or interstitial lung disease
French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS.

ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to the National Health Insurance Scheme
* Patient able to assess and understand the risks, benefits and alternative treatments laying of ABSORB, to agree to participate in the study (by signing the informed consent after having read the newsletter)
* Patients for whom a procedure is performed coronary angioplasty with implantation of at least one BVS.
* Patient allowing the follow-up as defined in the study

Exclusion Criteria:

* Pregnant patient
* Patient that can not give informed consent
* Patient with in-stent restenosis or saphenous vein bypass
Application of Ventilator-Associated Events (VAE) in Ventilator-Associated Pneumonia (VAP) Notified in Brazil

Multicentric observational prospective cohort study in 12 (twelve) hospitals representing all Brazilian regions.

The main objective of this project is to evaluate the incidence of Ventilator-Associated Pneumonia (VAP) when using the current ANVISA criteria for VAP versus VAE criteria defined by the National Healthcare Safety Network (NHSN). The diagnostic accuracy of the two criteria for identifying VAP will also be compared, characterizing other events associated with mechanical ventilation that are not VAP, when applicable.

The study also aims to adjudicate ventilator-associated pneumonias reported to ANVISA using current epidemiological diagnostic criteria.

The study will be carried out in about 12 centers, comprising the five Brazilian regions. It will be conducted from 2022 to 2024. Data collection will be performed at each center during six months.

Trained health professionals from Infections Control Committees of each participating center will collect data.

Mechanical ventilation data will be entered daily in the database system from the moment the patient is submitted to mechanical ventilation until the first day after the end of mechanical ventilation.

VAPs notified to ANVISA, according to its own criteria, will be reported monthly in the database system for adjudication.

The VAE definition will be performed automatically in the database system by mans of a specific algorithm. The diagnosis established by the system will be manually validated by a nurse with experience in healthcare-associated infection (HAI) surveillance. Agreement variables (Kappa) between the two criteria will be analyzed.

The adjudication will be carried out by two independent professionals (doctor and nurse) with experience in HAIs surveillance. In case of disagreement, there will be an evaluation by a third adjudicator.

The complete project was submitted to the local Institutional Review Board (IRB)/National Research Ethics Commission (CONEP) system and has ethical approval (CAAE: 52354721.0.1001.0070).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Pacients hospitalized in intensive care units (ICUs) using mechanical ventilation

Exclusion Criteria:

* Patients withdrawn from mechanical ventilation (MV) on the first day (D1) or second day (D2), with D1 being the day of initiation of MV;
* Patients with hospital discharge (discharge, death or transfer) on D1 or D2 of mechanical ventilation
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients

The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients
* smokers or ex-smokers
* post-bronchodilator FEV1 between 30 and 60% of predicted value

Exclusion Criteria:

* Positive serology to HIV and hepatitis
* Known respiratory disorder other than COPD
* Recent COPD exacerbations or hospitalization for COPD
* Treatment with non-permitted concomitant medication
* clinically relevant concomitant disease
* clinically relevant abnormal laboratory or ECG parameters
Prevalence and Prognostic Effects of Thyroid Abnormalities in Patients With Acute Coronary Syndrome.

The goal of this observational study is knowledge of Prevalence of throid abnormalities in patients with acute coronary syndrome And prognostic effects of thyroid abnormalities in patients with acute coronary syndrome as early detection and management of thyroid abnormalities can improve clinical outcomes.

Acute coronary syndrome (ACS) is an umbrella term used to describe a range of conditions associated with sudden, reduced blood flow to the heart. ACS includes conditions such as: Unstable Angina, Non-ST-Elevation Myocardial Infarction (NSTEMI) And ST-Elevation Myocardial Infarction (STEMI). The morbidity and mortality due to ACS are substantial-nearly half of all deaths due to coronary heart disease occur following an ACS .

Thyroid abnormalities, particularly hypothyroidism and hyperthyroidism, are relatively common in patients with ACS. Studies indicate that thyroid dysfunction can affect cardiovascular health, influencing the risk and prognosis of ACS. Reports suggest prevalence rates of Hypothyroidism 10-20% and Hyperthyroidism range from 1-5% in ACS patients .

Hypothyroidism is associated with elevated cholesterol levels, increased vascular stiffness, and heightened inflammation, can lead to reduced cardiac output and heart rate and increased incidence of heart failure and arrhythmias. all of which can exacerbate coronary artery disease and contributing to worse outcomes during ACS event. Hypothyroid patients often have a slower recovery and poorer response to standard ACS treatments, including thrombolytics and antiplatelet therapy.

Hyperthyroidism raises heart rate and contractility, leading to increased myocardial oxygen demand, which can worsen ischemia during ACS, Patients are more susceptible to arrhythmias, which can complicate ACS and lead to higher morbidity and mortality, Hyperthyroidism can cause vascular endothelial dysfunction, increasing the risk of thrombotic events during ACS and Patients may respond differently to standard ACS therapies, necessitating careful monitoring and potential adjustment of treatment strategies.

Patients with concurrent thyroid dysfunction often experience higher morbidity and mortality rates, So thyroid function should be routinely assessed in ACS patients, as early detection and management of thyroid abnormalities can improve clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ACS: (STEMI_NSTEMI)

Exclusion Criteria:

* 1-patients with cardiogenic shock. 2- patients with other endocrinal diseases. 3- patients on dialysis. 4-patients with Acute malignancy. 5-patient with thyroid diseases on treatment. 6- patients with liver diseases. 7-patients with Any autoimmune diseases
The Effect of Breastfeeding Education Via Hybrid Simulation Method in the Antenatal Period on Postpartum Breastfeeding

This study aimed to determine the effect of breastfeeding education given to pregnant women by a hybrid simulation method in the antenatal period on postpartum breastfeeding. This study will be carried out in a family health center in Turkey. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient in the intervention group. Women in the control group will receive only routine breastfeeding education.

The research will be conducted as a randomized controlled trial. The stratified block randomization methods will be used to assign women to the intervention and control groups. The personal information form and Breastfeeding Self-Efficacy Scale Short Form (Antenatal) will be implemented to all women before the intervention. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient to support women in breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education will be given to women in the 32-36 weeks of pregnancy in the antenatal period. The control group will be received the routine antenatal breastfeeding education given to all women by healthcare personnel as part of the family health center procedures. The Breastfeeding Self-Efficacy Scale Short Form (Postnatal) and the LATCH Breastfeeding Assessment Tool will be administered to women in both the experimental and control groups within the postpartum fifth days and at sixth week postpartum.

Eligibility Criteria:
Inclusion Criteria:

* being between 32-36 weeks of pregnancy
* being primipara or multipara
* being at least literate
* being planning to breastfeed
* agreeing to participate in the study

Exclusion Criteria:

* having a physical or mental health problem that would prevent breastfeeding
* preterm labor (before 37 weeks)
* either mother or baby having a health problem after birth
* being with multiple pregnancy
* being with high-risk pregnancy
Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery

Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.


Eligibility Criteria:
Inclusion Criteria:

* Chronic lower limb ischemia 3-6 degree by Rutherford;
* Stenosis or occlusion of no more than 2 tibial arteries;
* Stenosis of the tibial arteries more than 70 %;
* Duration stenosis or occlusion no more than 70 mm;

Exclusion Criteria:

* Diabetes mellitus type 2
* Occlusion or stenosis of all tibial arteries
* Expressed calcification of tibial arteries angioplasty tolerant
* Hemodynamically significant stenosis of the popliteal artery;
* Chronic heart failure of III-IV functional class by NYHA classification;
* Decompensated chronic "pulmonary" heart;
* Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
* Polyvalent drug allergy;
* Cancer in the terminal stage with a life expectancy less than 6 months;
* Patient refusal to participate or continue to participate in the study;
Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo

Patient with relapsing remitting multiple sclerosis taking avonex are included in this double blind randomized control trial. Simvastatin is compared to placebo. end points of edss , total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.


Eligibility Criteria:
Inclusion Criteria:

1. edss\<5
2. \>=1 attack in last year

Exclusion Criteria:

1. \>2 attacks in study
2. drug complication
Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria:

1. Is participating in any concurrent clinical study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Has undergone refractive error surgery;

   * \*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Bisphosphonate Treatment of Osteogenesis Imperfecta

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.


Eligibility Criteria:
Inclusion

* Male or Female children between 3 months and 17 years old
* OI type I, III or IV

Exclusion

* Deformity or abnormality which would prevent spine bone density from being done
* Any surgical bone-lengthening procedure
* Any kidney diseases or abnormalities
* Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.
Examining Parkinson's Disease-Related Retirement: Results of Turkey

Although Parkinson Disease's (PD) is usually associated with an older patient population, 5% of patients are diagnosed at age 50 and 30% before 65 years of age. This shows that many patients with PD have diagnosed during the active study and have long periods of normal retirement. After the diagnosis of Parkinson's patients, the duration of leaving of employment vary between 0 and 25 years. It was found that patients' full-time working capacity decreased by up to 80% and they quitted earlier than the general population. The disability associated with PD is thought to be a factor in this situation. Nevertheless, the reasons for early retirement are not fully known and more information is needed on the specific problems of PD in order for patients to continue their career. The aim of our study is to examine the impact of Parkinson's disease on retirement and to contribute to Turkey's data. Patients with PD admitted to the Parkinson's disease outpatient clinic, which is the biggest clinic of Turkey about neurology, are included in the study. It is planned to meet with 75 patients on 31/12/2018 and to reach the end of the data collection phase.


Eligibility Criteria:
Inclusion Criteria:

* To be between 30-85 aged
* Parkinson Disease diagnosis according to the United Kingdom Brain Bank criteria
* To be treated with antiparkinson

Exclusion Criteria:

* Dementia
* Severe cognitive impairment
* Not willing to participate in the study