cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome

The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.

The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.

We plan to address the following issues:

1. To test the hypothesis that a controlled carbohydrate nutrition plan will be superior to the standard ADA diet in controlling blood sugar (as measured by glycosylated hemoglobin \[HbA1C\]), decreasing cardiovascular risk factors (Serum Lipid Levels, Blood Pressure) and decreasing weight in adolescents with metabolic syndrome
2. To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in these patients as measured by the SF-10 for Children, the Brief Symptom Inventory (BSI) and a scaled questionnaire regarding side effects.
3. To compare two different maintenance programs in the group who receive the non- energy restricted very-low carbohydrate diet and compare each group to the group

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults ages 13-18 with a BMI\>95% for age or over 30 for young adults, with pre-existing metabolic syndrome

Exclusion Criteria:

* Subjects on any chronic medication other than antihistamines, asthma medications, oral contraceptives or diabetes medications, smoke more than 5 cigarettes/day, suffer from alcoholism or drug abuse or have any significant abnormality not associated with metabolic syndrome on screening labs will be excluded from randomization.
* Subjects currently taking Byetta will be excluded from the study, as a side effect of the drug is weight loss.
* Subjects with familial hypercholesteremia may be excluded if the investigator considers the history to be severe. The data collected from subjects with a HBA1C greater than 12.5 will be analyzed in a separate group, although they will still be randomized to one of the three treatment groups. This is due to the fact that past experience has shown that these individuals run a high risk of being non-compliant with medication use, diet, and exercise plans. Results from this group will be reported separately.
* Subjects who are pregnant or those desiring pregnancy will be excluded, as the safety of this intervention in pregnancy has not been established.
Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study

Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.

This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* age ranged from 18-25 years old,
* at least 6 months after BS

Exclusion Criteria:

* Patients with nerve root compression
* spine disorders
* spinal fracture
* previous spinal surgery
* pregnancy
* lower limb injury
* Any contraindication to the exercise therapy
Expansion of SCG/GCG-Based CAD Sceering: Inclusion of Healthy Controls and CCTA Patients

This study evaluates a new, non-invasive method for screening coronary artery disease (CAD) using seismocardiography (SCG) and gyrocardiography (GCG). These techniques measure chest vibrations caused by heart activity using highly sensitive sensors.

Participants include patients with known or suspected CAD, as well as healthy individuals and those undergoing coronary computed tomography angiography (CCTA). The goal is to determine whether SCG/GCG testing can accurately differentiate between individuals with significant and non-significant coronary artery stenosis.

SCG/GCG testing will be conducted before standard diagnostic procedures, including coronary artery calcium computed tomography (CAC-CT) and CCTA. The results will be analyzed to compare the performance of this novel method with existing imaging techniques.

This research aims to provide a non-invasive, cost-effective alternative for screening CAD.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 years or older.
* Electively scheduled for CAC-CT and have an indication for CCTA
* Suspected coronary artery disease (CAD) based on the presence of:
* At least two cardiovascular risk factors (e.g., hypertension, smoking, diabetes, dyslipidemia, obesity).
* CAD-related symptoms (e.g., chest pain, dyspnea on exertion).
* Suspected congenital coronary abnormalities.
* Ability to provide informed consent.

Exclusion Criteria:

* Severe cardiac arrhythmias that may interfere with SCG/GCG recordings.
* Decompensated heart failure or severe valvular heart disease.
* Other clinically significant concomitant diseases that may impact study participation.
* History of heart surgery (e.g., recent CABG, valve replacement) that alters chest wall dynamics.
* Contraindications for undergoing CAC-CT or CCTA (e.g., severe renal insufficiency preventing contrast use).
* Inability to remain still in supine or upright sitting positions for testing.
* Inability to provide informed consent due to cognitive or neurological conditions.
Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System

The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.

The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects.
* Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained
* Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a mobile bearing knee system (LCS Complete).
* Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

* Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
* Subjects with a known history of poor compliance to medical treatment.
* Women who are pregnant.
* Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
* Subjects involved in Medical-Legal claims.
* Subjects who have participated in a clinical study with an investigational product in the last month.
* Subjects who are currently involved in any injury litigation claims.
* Revision of an existing knee implant.
Flucelvax Pregnancy Registry

The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
* Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
* Date the pregnancy exposure is registered
* Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)

Exclusion Criteria:

* Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.
Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery

The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.

Eligibility Criteria:
Inclusion Criteria:

* Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Therapy restricted upon admission
* Preoperative liver or kidney disease or dysfunction
* Preoperative coagulation disorder
* Palliative operation or a second operation
* Type 1 diabetes
* Type 2 diabetes
Evaluation of the Relationship Between Dental Caries and Growth Parameters in Preschool Children

Untreated dental caries are very common in preschool children. Pain and inflammation due to dental caries have been reported to affect eating and sleeping disorders, affecting growth and development. The aim of this study was to compare the changes in serum IGF-1 and IGFBP-3 levels, height and weight gain before and after treatment in patients with dental caries-related inflammation and pain in preschool children and to compare these children with children without dental caries. Thirty children aged between 3-6 years with dental caries with pulp were identified using ICDAS II and dmft index as the study group.30 children dental caries including pulp, will be included using the same indices as the control group. In the study group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. In the control group, serum IGF-1 and IGFBP-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. IGF-1, IGFBP-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

In addition to growth parameters, the Children's Sleeping Habits Questionnaire and the Early Childhood Oral Health Impact Scale will be compared before the 6th month of dental treatment and compared

Eligibility Criteria:
Inclusion Criteria:

For study group

1. (3-6 years) preschool children
2. Children whose dental treatments are indicated under general anesthesia
3. Children with primary dentition
4. Children with early childhood caries (dmft index d≥ 3)
5. Children with symptoms of pulpitis or periapical infection in at least one tooth
6. Children with dental problems at least in the last 6 months
7. Volunteering to participate in the study. For the control group,

1- (3-6 years) preschool children 2-Children with primary dentition 3- Children without pulpitis symptoms or periapical infection during dental examination 4-Volunteering to participate in the study.

Exclusion Criteria:

1. Children who do not show adequate compliance during blood sampling
2. Consent form is not signed
3. Children with chronic and systemic diseases that may affect growth and development
4. Children using anti-inflammatory
5. Patients with physical and mental disabilities
6. Patients using corticosteroids in the last 6 months
7. If a child is diagnosed with any of the these diseases during the study
Intraarticular Xylitol Injections for Knee Osteoarthritis

Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* Age over 45
* Tibiofemoral osteoarthritis
* OA stage 2-3 on xray
* Pain VAS \> 40mm
* No NSAIDs for 3 weeks
* No analgetics for 38 hours

Exclusion Criteria:

* Pain VAS \> 80mm
* Pain VAS in contralateral knee \> 40mm
* Inflammatory arthritis
* Severe effusion
* Posttraumatic osteoarthritis
* Unstable knee
* Isolated patellofemoral disease
* Paracetamol hypersensitivity
Comparison of the Effects of Advanced Exercise Treatment Performed Under the Supervision of a Physiotherapist and Provided as a Home Program on Adduction Angle, Pain, Functional Status, Quality of Life and Kinesophobia in Individuals With Hallux Valgus

The aim of our study is to compare the effects of progressive exercise therapy, administered as a home program under the supervision of a physiotherapist, on adduction angle, pain, functional status, quality of life, and kinesiophobia in individuals aged 18-64 years with a hallux valgus angle of 15-40 degrees (mild-moderate).

According to the power analysis, 18 people will participate in the study. Individuals with halluk valgus pain, deformity angle, balance, functional capacity, functionality, quality of life and kinesiophobia will be evaluated.After the individuals are evaluated, they will be randomly divided into 2 groups as the exercise group and the home exercise group.

All patients will be instructed on wearing appropriate footwear (made of soft material, with a wide round toe, with a normal heel height between 1 inch and 1.5 inches (2.5-3.8 cm). In addition, in order to increase the awareness of the participants, they will be asked to focus on how muscle activation feels during exercise and they will be asked to perform this activation during daily living activities.

The exercise program to be given to both groups will be the same, and will be applied with bare feet 4 days a week for 8 weeks. The exercise program will be advanced as recommended in the literature and 30 seconds of rest will be given between sets.

After the evaluation, all exercises will be shown to the home exercise group and it will be ensured that they are applied correctly. An illustrated and narrative exercise program brochure containing information about exercise position, number of repetitions, contraction time, rest time between sets, frequency and exercise diary will be given to the patient for exercise follow-up.

At the end of 8 weeks, the evaluations will be repeated by the same physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer individuals between the ages of 18-64
* Mild to moderate (15-40 degrees) hallux valgus
* Bilateral hallux valgus
* Have not received physical therapy for hallux valgus in the last 6 months,
* Individuals who did not use orthotic devices or dynamic splints for the treatment of hallux valgus will be included in the study.

Exclusion Criteria:

* HVA ≥ 45°
* Rjjit hallux valgus deformity (in cases where the hallux cannot be brought to its normal position manually)
* Obesity (BMI\>30 kg/m2)
* Systemic disease and inflammatory arthritis (rheumatoid arthritis, systemic lupus, diabetes mellitus)
* Neurological disease (eg: neuropathy)
* Vestibular disorder that may affect balance
* History of standing trauma, fracture of the metatarophalangeal joint,
* He has undergone foot-ankle surgery,
* Using NSAIDs or analgesics
Drug Resistance Among Asymptomatic Infection

A cross-sectional study will be conducted in selected 2 sentinel sites for assessment of drug resistance falciparum and vivax among asymptomatic infection in migrant workers in Myanmar.

Although malaria prevalence is decreasing in Myanmar, drug resistance threatens the malaria elimination by 2030 especially high risk persons including migrant population. Previous study indicated that asymptomatic malaria parasite carried drug resistance gene such as K13 mutant that is genetically responsible for artemisinin resistant falciparum malaria. These asymptomatic carries may be a source to spread the disease and it is very important to conduct the surveillance on drug resistance status among high vulnerable persons. Unfortunately, there is no study to assess the drug resistance molecular markers in asymptomatic malaria among migrant workers in Myanmar. Therefore, this study fulfills the gaps of knowledge on important of asymptomatic hidden infection exploring to formulate the recommendation for elimination of malaria in Myanmar.

In this study, asymptomatic infections are screened by rapid diagnostic test, microscopy and molecular methods.

Eligibility Criteria:
Inclusion Criteria:

* Age above 6 year
* Migrant population (moving from their normal residence place and working at a new place such as forest related activities, gold-mines or plantation sites for more than 3 months- 3 years)
* Both sex
* Participant who give informed-consent to participate the study

Exclusion Criteria:

* Known clinical malaria cases regardless of the species detected
* Patients with clinical symptoms of malaria at the time of examination
* Known history of malaria within 14 days
Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease

Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements.

Parkinson's Disease (PD) is a neurodegenerative disease that occurs with the loss of dopaminergic neurons in the basal ganglia (BG) and subsequently affects multiple brain regions. There are studies that evaluate executive functions rather than cognitive functions in Parkinson's patients. However, objective evaluations of the attention parameter are quite rare. Accordingly, our study was planned to examine the effects of motor function, depression and sleep on attention in Parkinson's patients with detailed and objective measurements. Parkinson's patients (n=27) and healthy controls (n=27) aged between 40-85 will be included in the study. Balance evaluation of the individuals participating in the study was carried out by functional reaching test, one-leg standing test and Berg balance scale; Endurance with a 30-second sit-and-stand test; reaction time; with mobile application; muscle strength by hand dynamometer; functional mobility with time up and go test; walking speed, with 10 m walk test; attention with the P300 device; depression, with the Beck depression scale; Sleep quality will be assessed with the Pittsburg sleep questionnaire. At the end of the study, the effects of motor functions, sleep and depression on attention will be examined and compared with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Being 1,2 or 3 according to the Hoehn and yahr scale
* Being between the ages of 40-85
* Being diagnosed with Parkinson's according to UPDS
* Being able to read and write
* Being able to walk independently
* Agreeing to participate in the study after providing detailed information about the research.
* Mini mental test\>24

Exclusion Criteria:

* Having severe hearing/visual impairment-loss
* Having an orthopedic, neurological or metabolic disease that may interfere with working
* Having deep brain stimulation applied
* Those with advanced cognitive impairment
* Individuals with dementia
* Patients taking anticholinergic, antidepressive or anxiolytic medications that may affect cognition, and those with other medical or neurological causes that may cause cognitive effects.
Identification of Visual Dependence in PPPD Patients With the Aid of Virtual Reality.

The aim of this study is to evaluate whether increased visual dependence can be identified with the help of Virtual Reality (VR). Increased visual dependence is a general term for patients with increased dependence on vision in maintaining their balance. Patients suffering from persistent postural perceptual vertigo (PPPD) often suffer from increased visual dependence. This in turn leads to complaints such as visual vertigo, agoraphobia and fear of falling. Visual dependence is normally measured using the optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two tests are performed with the aid of Virtual Reality.

The aim of this study is to evaluate whether increased visual dependence can be identified with the help of Virtual Reality (VR). Visual dependence is normally measured using the optokinetic after nystagmus (OKAN) and the rod and disc test (RDT). In this study, these two tests are performed with the aid of Virtual Reality. The OKAN is measured by eye tracking, a key item already used daily in instruments such as video nystagmography (VNG) and video head impulse test (vHIT). Another test representative of visual dependence is the Rod and Disc test (RDT). In the RDT, patients are asked to complete a visual task so that researchers gain more knowledge about visual dependence. Until now, these tests have been performed using a large set-up and many different materials. Moreover, the exact underlying mechanism of visual dependence in PPPD patients is still unknown. The aim of this study is to investigate whether Virtual Reality can be a useful tool when performing the OKAN and RDT. In this way, a better understanding of visual dependence is sought. This study aims to determine the normative values for the OKAN and RDT performed with the aid of Virtual Reality. Therefore, a healthy group of individuals will be compared with PPPD patients as they suffer from visual dependence. To evaluate the effectiveness of the OKAN and RDT via VR, the results will be compared with the scores of the visual vertigo analogue scale (VVAS), a questionnaire to assess visual dependence.

Eligibility Criteria:
Inclusion Criteria:

* All patients with chronic vertigo (\>3 months)

Exclusion Criteria:

* Minors
* Patients with a history of epilepsy.
* Patients with an alcohol use disorder