cyrilzakka/clinical-trials huggingface dataset:
Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D). Optimal insulin therapy for young children with T1D should provide effective glycemic control while minimizing the risk of hypoglycemia and hyperglycemia. Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control. Objectives: To compare the effectiveness of insulin degludec to insulin glargine and NPH in toddlers and preschool children with T1D in terms of glycosylated hemoglobin(HbA1C) and frequency of hypoglycemic episodes.


Eligibility Criteria:
Inclusion Criteria:

* Toddlers and preschool children with T1D on insulin therapy

Exclusion Criteria:

* patients with other medical conditions (i.e. celiac disease or autoimmune thyroiditis), patients with other types of diabetes mellitus (i.e. maturity onset diabetes of youth (MODY) and type 2 diabetes mellitus), patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes, renal impairment due to cause other than diabetes, hypertension, patients taking any vitamins or food supplements one month before study and participation in a previous investigational drug study within 3 months preceding screening.
Nutritional State and Intake Nutrients Assessment in Ulcerative Colitis

The purpose of this study is to determine the reason patients are deficient in nutrients intake such as antioxidants vitamins.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Ulcerative Colitis in remission
* Age \> 18 yo

Exclusion Criteria:

* Patients with Ulcerative Colitis in activity
* Those patients with food intake trouble
* Those patients with bowel resected
Effects of Combined Cognitive Training and Rhythmic Auditory Stimulation in Treadmill Training After Stroke

The objective of this study is to compare the effects of progressive combined cognitive training and rhythmic auditory stimulation to treadmill training (combined group), cognitive treadmill training (cognitive group), rhythmic auditory stimulation to treadmill training (rhythmic group), and treadmill walking alone (treadmill group) on walking automaticity, executive function, and dual-task coordination for patients with chronic stroke (Aim 1). The second aim of this study is to investigate the factors affecting the results of interventions (Aim 2). The third aim of the study is to examine the characteristics of stroke population who are appropriate for progressive combined cognitive training and rhythmic auditory stimulation to treadmill training.

A single-blinded, randomized controlled trial will be conducted at medical centers. Eighty stroke patients will be randomized to one of the four groups. All groups will receive interventions 30 minutes per time, 3 times a week, for 4 weeks. The combined group will undertake progressive treadmill walking speed and rhythmic auditory stimulation while performing a cognitive task. The cognitive group will receive cognitive training while walking on the treadmill. The rhythmic group will hear rhythmic auditory stimulation while treadmill walking. The treadmill group will train only in progressive treadmill walking. A blinded assessor will administer three assessments. All participants will be examined for gait and cognitive performance under single-task (walking only, Stroop task only) and dual-task conditions (walking while performing the Stroop task) at baseline, post-intervention, and one-month follow-up. The primary outcome measures of gait and cognition are gait speed and cognitive score of the Stroop task under single- and dual-task conditions. The secondary outcome measures are the Mini-BESTest, Walking Ability Questionnaire, 6-minute Walk Test, and Stroke Impact Scale. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between and within the groups.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with first-time stroke;
2. more than 6 months after stroke onset;
3. able to walk 10 meters;
4. no severe vision, hearing, or speech impairments;
5. understand and follow the instructions and sign the Informed Consent Form;
6. older than 20 years old.

Exclusion Criteria:

1. orthopedic problems affecting walking or other diseases that may interfere with study participation;
2. a score of less than 24 on the mini-mental state examination (MMSE);
3. severe balance disorder with a total score of less than 45 points Berg Balance Scale.
Serum Metabolomics Study of Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a complex, heterogeneous disorder, which produces in 5-20% reproductive age women. In this study, a nontargeted metabolomics approach based on ultra high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry will be used to investigate serum metabolic characteristics of PCOS. PCOS women and healthy control will be divided into two distinct groups based on multivariate statistical analysis. The findings of this study will offer a new insight to understand the pathogenesis mechanism, and the discriminating metabolites may provide a prospect for PCOS diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003,4 PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\>10 ml.
* Age between 14 and 40 years
* 2 years after menarche

Exclusion Criteria:

-
An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia

This is a Phase 2, open-label multi-center long-term extension study, with approximately 70 subjects, to evaluate the safety and efficacy of BMN111 in children with Achondroplasia until subjects reach near-adult final height. Eligible subjects will have completed 1 year of BMN111 or placebo treatment in the 111-206 study and once enrolled in the 111-208 extension study will receive a daily dose of BMN111 by subcutaneous injection according to their age as determined by 111-206.


Eligibility Criteria:
Inclusion Criteria:

1. Must have completed Study 111-206 on investigational treatment (BMN 111 or placebo).
2. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any research related procedure. Also, subjects under the age of majority are willing and able to provide written assent (if required by local regulations or the IRB/IEC) after the nature of the study has been explained and prior to performance of any research-related procedure. Subjects who reach the age of majority in their country while the study is ongoing will be asked to provide their own written consent again upon reaching the legal age of majority.
3. Are willing and able to perform all study procedures

Exclusion Criteria:

1. Permanently discontinued BMN 111 or placebo prior to completion of Study 111-206
2. Have a clinically significant finding or arrhythmia on ECG that indicates abnormal cardiac function or conduction or QTc-F \> 450 msec
3. Require any investigational agent (except BMN 111) prior to completion of study period
4. Current therapy with antihypertensive medications, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, diuretics, beta-blockers, calcium-channel blockers, cardiac glycosides, systemic anticholinergic agents, GnRH agonists, any medication that may impair or enhance compensatory tachycardia, diuretics, or other drugs known to alter renal or tubular function
5. Pregnant or planning to become pregnant (self or partner) at any time during the study
6. Concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason
7. Have a condition or circumstance that, in the view of the investigator, places the subject at high risk for poor treatment compliance
Pelvic Floor Dysfunction Among Female Physiotherapy Students: A Cross-Sectional Study

This study aims to:

1. estimate the prevalence of pelvic floor dysfunction among female physiotherapy students at Cairo University.
2. identify potential risk factors that may be associated with pelvic floor dysfunction in this student population.
3. assess the level of awareness regarding pelvic floor health among female physiotherapy students at Cairo University.
4. explore how female physiotherapy students at Cairo University utilize available healthcare resources for managing pelvic floor-related concerns.

Pelvic floor dysfunction (PFD) is a global health problem that affects millions of women worldwide. It encompasses a broad range of interrelated disorders affecting the pelvic region, including urinary incontinence, pelvic pain, constipation, sexual dysfunction, and pelvic organ prolapse. While PFD is often associated with pregnancy, childbirth, and aging, recent studies suggest that these conditions may also affect younger populations, including nulliparous women.

Pelvic floor health is crucial for supporting pelvic organs, maintaining continence, and facilitating sexual function. However, the impact of PFD on women's health and quality of life is significant, with important consequences for physical and mental well-being. These disorders often coexist and compound each other's impact, leading to disabling symptoms, embarrassment, social isolation, impaired task performance, loss of personal and intimate relationships, and reduced participation in leisure activities.

Despite the substantial burden of PFD, there is a lack of comprehensive data on the prevalence, risk factors, and awareness levels of these conditions among specific populations, particularly young women pursuing higher education. Physiotherapy students, who are expected to have a good understanding of musculoskeletal and pelvic health, represent an important group to study in this context.

Eligibility Criteria:
Inclusion Criteria:

* Virgin undergraduate physiotherapy students.
* Their age will range from 18-25 years.

Exclusion Criteria:

* Neurological disorders or injuries that may affect pelvic floor function (e.g., fibromyalgia and multiple sclerosis).
* Mental health or cognitive disorders that could affect data collection.
* Females who have undergone any form of abdominal surgery prior to the time of the study.
* Females with current use of medications that may affect pelvic floor function (e.g., anticholinergics, opioids, antidepressants).
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)

The aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. Abnormal high water distribution is defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.


Eligibility Criteria:
Inclusion Criteria:

The study will cover 50 adults. Men and women in an age range of 18 to 65 years and a Body Mass Index (BMI) range of 18.5 to 35 kg/m2 should be equally distributed. Subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. Patients that are taken before dialysis treatment should have been dialysed two and not three days before.

Exclusion Criteria:

* amputation of limbs
* gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis
* bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia
* electrical implant as cardiac pacemaker
* insulin pumps
* pregnancy or breastfeeding period
* subjects who cannot provide an Informed Consent Form (ICF) by themselves
* subjects who might be dependent from the sponsor or the investigation site
A Bioequivalence Study Comparing Cilnidipine/Valsartan Combination Tablet With Coadministration of Cilnidipine and Valsartan

A randomized, open-label, single dosing, two-way crossover clinical trial to compare the safety/tolerability and pharmacokinetics of the combination of Cilnidipine 10mg and Valsartan 160mg in comparison to each component coadministered in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 40
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension or hyportension
National Heart Failure Registry

A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation.

The study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination.

A control observation group is not intended.

The study will include retrospective and prospective data of patients with an outpatient or inpatient diagnosis of CHF.

The duration of the observation period of an individual patient with CHF is limited by the study period, or the patient's death, and includes the studied retrospective and dynamic prospective parameters. Prospective data of CHF (any stage and FC) subjects are planned to be included sequentially as they appear in inpatient CHF centers and outpatient CHF offices until 12/31/2027 inclusive and further upon extension of the study.

Retrospective data will be provided by chief freelance cardiologists of 33 constituent entities of the Russian Federation (Central Federal District, Ural Federal District, Siberian Federal District, Far Eastern Federal District) (individually, according to agreement)

Eligibility Criteria:
Inclusion Criteria:

* Any stage and/or any class of CHF

Exclusion Criteria:

* Subjects whose source records cant be obtained for the analysis
Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage

The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and electrocardiographical diagnosis of STEMI
* Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)

Exclusion Criteria:

* Known allergy or contraindication for aspirin, ticagrelor or prasugrel.
* Previous PCI or MI less than 12 months ago
* Previous cardiac surgery
* Participation in another clinical cardiology study or study concerning platelet aggregation/ thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))
* Pregnancy and breast feeding
* Concurrent use of oral anticoagulants (OAC)
* The periprocedural use of GPIIb/IIIa inhibitors
* Planned surgical intervention within 12 months of PCI
* Creatinine clearance \<30mL/min or dialysis
* PCI of stent thrombosis
* Suboptimal stent result as judged by the interventional cardiologist.
* Life expectancy shorter than 13 months.
* Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).
Effect of Behavioral Therapy Versus Interferential Current on Bladder Dysfunction in Patients With Multiple Sclerosis

study the effect of behavioral therapy and interferential current on management of bladder dysfunction in patients with multiple sclerosis

Fifty patients with multiple sclerosis (MS) (secondary progressive type SPMS) suffering from bladder dysfunction were divided equally into two groups randomly; Group A received biofeedback training (behavioral therapy) while group B received interferential training. Both groups were assessed by urodynamics for detrusor pressure and maximum flow rate before and after eight weeks of behavioral therapy and interferential training.

Data analysis was managed using SPSS for windows, version 22 (SPSS, Inc., Chicago, IL). The current test involved two independent variables. The first one was the (tested group); between subject factors which had two levels (group A received behavioral therapy and group B who received IF ) .The second one was the (measuring periods); within subject factor which had two levels (pre, post). In addition, this test involved two tested dependent variables (detrusor pressure and maximum flow rate ) .T independent and dependent tests were used to compare between and within groups respectively. Data was considered statistically significant when P \< .05

Eligibility Criteria:
Inclusion Criteria:

* All the patients were referred by a neurologist and the diagnosis was confirmed by the Magnetic Resonance Image (MRI).The duration of being diagnosed as SPMS for both groups were between one to two years. All the selected patients had normal mental examination according to mini mental scale .Also, all the selected patients were medically stable.

Exclusion Criteria:

* Patients with any other neurological deficits or orthopedics abnormalities or with auditory dysfunction were excluded from this study. Patients with history of bladder dysfunctions before the diagnosis of MS or attaining any attack during the treatment period were also excluded.
An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan

The primary purpose of this study is to describe the tolerability of canagliflozin and any sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms of the percentage of patients with at least one episode of hypoglycaemia, in patients with T2DM who fast during Ramadan.

This is non-randomized, parallel-cohort, prospective, multicenter (when more than one hospital works on a medical research study), observational study to describe the treatment of T2DM with canagliflozin during the Holy Month of Ramadan. Observed participants will be participants with T2DM (at the time of enrollment) who are being treated with either canagliflozin or any sulphonylurea, each administered on a background therapy of metformin with or without a DPP-4 inhibitor within clinical practice, and who intend to fast during the Ramadan period. On enrollment, patients will enter one of two parallel treatment cohorts based on their ongoing T2DM therapy: canagliflozin and metformin with or without a DPP-4 inhibitor will be the treatment of interest, while any sulphonylurea and metformin with or without a DPP-4 inhibitor will serve as the reference standard treatment. Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who has a confirmed diagnosis of type 2 diabetes for more than 12 months before enrollment
* Participants who has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a dipeptidyl peptidase 4 (DPP-4) inhibitor, for \>12 weeks before enrollment
* Participants Intends to fast during Ramadan in 2016
* Participants Will be able to continue on the products under study (i.e., canagliflozin or any sulphonylurea, each with metformin with or without a DPP-4 inhibitor) through the Ramadan period, as judged by the participating physician
* Participants who has a glycated hemoglobin (HbA1c) measurement less than and equal to (\<=) 8.5% within 8 weeks before the start of Ramadan.

Exclusion Criteria:

* Participant is being treated with insulin and/or any type 2 diabetes mellitus (T2DM) therapy other than canagliflozin, any sulphonylurea, and metformin with or without a DPP 4 inhibitor, or has changed their T2DM therapy within 12 weeks before enrollment (dose changes of canagliflozin, a sulphonylurea, metformin, and a DPP 4 inhibitor where applicable are accepted)
* Participant is currently being treated with loop diuretics
* Participants who has a history of severe hypoglycaemia events within the 6 months prior to enrollment (defined as a hypoglycaemia event for which the patient required assistance from another person, or which resulted in seizure or loss of consciousness).
* Participants who has heart failure (NYHA 3-4) or advanced cardiovascular disease.
* Participants who has an estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliter/minute (mL/min)/1.73 m\^2.
Reconstructive Surgery For Head And Neck Cancer Patients

The goal of this study is to better understand the changes in symptoms and overall quality of life after head and neck surgery and reconstruction. "Quality of Life" means how you feel about your life as a result of your disease and its treatment. Learning about changes in patients' quality of life will help doctors and future patients make more informed treatment decisions.

This prospective, longitudinal study will evaluate patient-reported quality of life and symptomatology immediately prior to and for up to one year following surgical resection and reconstruction head and neck malignancies.Patients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.Quality of life and symptom relief will be evaluated by both domain and disease specific questionnaires at four time points: pre-operatively, and 3 months (±1 month), 6 months (±1), and 9 months (-1 and +3) post-operatively. These assessment points represent clinically significant events in patients' post-operative course following head and neck surgery. Studies have shown that quality of life decreases significantly at three months after surgery but then reapproaches baseline levels around one year (1). Pre-operative responses will serve as the baseline for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical resection and reconstruction for every stage head and neck malignancies at Memorial Sloan-Kettering Cancer Center.
* Patients at least 21 years of age

Exclusion Criteria:

* Patients who are less than 21 years old
* Patients who do not speak the English language
* Patients who are unable to comprehend the content of the questionnaires due to psychiatric disorders or cognitive impairment
* Patients who cannot complete the pre-operative questionnaires during consent