cyrilzakka/clinical-trials huggingface dataset:
Effect of Aerobic Exercise Versus Resistance Exercise on Bone Density in Postmenopausal Diabetic Women

Osteoporosis is a significant public health issue, especially among postmenopausal women with diabetes, and its prevalence is increasing. This trial aims to determine the influence of moderate intensity aerobic exercise vs resistance exercise on bone mineral density among postmenopausal diabetic women.

has diabetes. Postmenopausal Osteoporosis (PMO) is an increasingly serious metabolic bone disease in the world, which generally develops in middle-aged and elderly women and postmenopausal women, and it is characterized by low bone mass and microstructure degradation of bone tissues. there are complex pathophysiological effects between them: T2D directly affects bone metabolism and strength. Some antidiabetic drugs affect bone metabolism, and diabetes complications are related to the risk of falls and subsequent fractures. Patients with T2D have higher trabecular and lower cortical bone density, leading to lower bone intensity. Exercise is considered a highly relevant component in the prevention and treatment of osteoporosis and fracture reduction. Exercise greatly affects bone geometry as it increases periosteal apposition through increasing osteoblast formation. In addition to influencing bone mineral density, exercise can improve muscle function to potentially decrease fall risk through improved balance and strength.

The purpose of this study was to investigate the effect of moderate-intensity aerobic exercise versus resistance exercise on bone mineral density in postmenopausal diabetic women.

Eligibility Criteria:
Inclusion Criteria:

* Fifty women postmenopausal obese women
* (BMI) 30 -35 kg/m2
* their age ranges from 50 to 60 years old and
* complain of diabetic type 2 for 10 years ago.

Exclusion Criteria:

* women with renal or liver disease,
* cardiac or chest disease psychological problems,
* cognitive problems are excluded from the study.
* Any women who have therapeutic problems that will interfere with performing exercise or affection BMD will be excluded from this study.
Working Memory Training in Children With Cerebral Palsy, a Pilot Study

The purpose of this pilot study is to assist the preparation of a larger multi-center study. The main aim is to determine the feasibility of conducting computerized working memory training in a group of children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Born at term with unilateral spastic CP
* Born preterm with bilateral spastic CP

Exclusion Criteria:

* Children with Gross Motor Function Classification Scale (GMFCS) level V
* Severe visual or hearing impairments
* Photosensitive epilepsy
Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit

Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years of age
* Admitted following cardiac surgery
* Stay in the ICU expected to be \> 20h
* Blood glucose \> 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment

Exclusion Criteria:

* Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* Known or suspected allergy to insulin
* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures)
* Patients participating in another study
* Moribund patients likely to die within 24 hours
* Patients after organ transplantation within the last three months
* Patients under high dose cortisol treatment (cortisol \> 1000 mg/day or equivalent doses of hydrocortisol)
E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness

In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.


Eligibility Criteria:
Inclusion Criteria:

* Currently smokes 5 or more CPD
* Willingness and ability to provide informed consent
* Age of at least 21 years
* Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
* Interested in reducing CC smoking but not necessarily trying to quit
* Own a mobile phone or have regular access to a mobile phone
* Able to provide an additional contact to improve follow-up rates

Exclusion Criteria:

* Is pregnant or breastfeeding
* Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
* Currently engaged in an attempt to quit CC
* Change in dose of their psychotropic medication(s) in the last 30 days
* Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
* Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
Exposure Initializes Therapy - Treatment Of Homebound Patients Extended

Cognitive behavioral treatment of homebound patients with severe agoraphobia.

Homebound patients with severe agoraphobia are treated with an exposure focussed cognitive behavioral therapy. The treatment begins at home. With a quick onset of guided exposure, patients get the possibility to develope the capability to reach the regular Treatment Location on their own very rapidly.

Eligibility Criteria:
Inclusion Criteria:

* agoraphobia with/without Panic disorder

Exclusion Criteria:

* psychotic disorders
* bipolar disorders
* acute substance dependency
Exploring the Cortical Hemodynamic Variability of Prefrontal ITBS: a Concurrent TBS/fNIRS Study

An increasing number of studies have used the intermittent theta-burst stimulation (iTBS) protocol to investigate neural plasticity non-invasively in the prefontal cortex in healthy humans and in patients with psychiatric disorders. However, the variability in the neurophysiological response to iTBS stimulation is high. The cause of this variability is multifactorial and to some degree still unknown. Therefore, the current study explores inter- and intra-individual factors that are potentially moderating iTBS-induced excitability changes. A greater understanding of these determinants would be highly valuable for optimizing the therapeutic application of iTBS.

The investigators will measure the cortical excitability induced by iTBS with concurrent TBS/fNIRS technique in the same healthy individuals on multiple testing days. Meanwhile, several potential inter- (age, gender, etc.) and intra-individual factors (daily mood, daily physical activity levels, etc.) recently identified in non-invasive transcranial brain stimulation studies will be assessed before applying iTBS to the same individual on each testing day.

Eligibility Criteria:
Inclusion Criteria:

* healthiness based on history and psychiatric assessment
* being able to hear and understand the verbal instructions
* completed at least 6 years of formal education

Exclusion Criteria:

* a current or past diagnosis of psychiatric, neurological disorders, or severe internal illness
* any conditions that will contraindicate to iTBS or fNIRS
* psychiatric disorders in their first-degree relatives
* pregnancy
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.

High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, there is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically confirmed glioma
2. Age18-65
3. Participants had undergone maximal surgical resection
4. Amount of dexamethasone was not more than 2mg/ days
5. Ability and willingness to sign informed consent
6. Karnofsky Performance Score of 70 or more
7. Normal liver and kidney function
8. Not accepted other treatment plan during the immunotherapy

Exclusion Criteria:

1. Not conforming to the standard
2. Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
3. Received other drugs for glioma therapy 60days before participated
4. Allergy to immune adjuvant
5. Nervous system disease and diffuse leptomeningeal disease
6. Amount of dexamethasone was more than 2mg/days during the immunotherapy
7. Pregnant or lactation
FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE

950 / 5.000 Çeviri sonuçları Celiac disease is an autoimmune proximal small bowel disease that develops as a persistent intolerance to gluten-like gluten in cereals, mainly wheat gluten and other cereal proteins such as barley, rye, and oats in genetically susceptible individuals. Fibromyalgia syndrome (FMS) is a chronic musculoskeletal disease characterized by chronic widespread body pain, fatigue, morning stiffness, subjective swelling, sleep disturbance, intestinal problems, multiple somatic and cognitive problems, especially in the back, neck, shoulders and hips. In terms of intestinal symptoms, very similar findings can be observed between celiac disease and fibromyalgia. For this reason, the presence of celiac disease in FMS patients has been investigated in many studies and its frequency has been found to be high. However, the frequency of FMS in patients with celiac disease is not clear, and an overlooked diagnosis of fibromyalgia may leave many symptoms untreated.


Eligibility Criteria:
Inclusion Criteria:

Patients who agreed to participate in the study, signed the informed consent form, had the cognitive capacity to fill in the questionnaires and scales, and were followed up with a diagnosis of celiac will be included.

Exclusion Criteria:

Patients whose celiac diagnosis is uncertain, who do not agree to participate in the study, and who do not have sufficient cognitive capacity will be excluded from the study.
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled

Primary Objective:

-To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus.

Secondary Objective:

To assess the effects of the fixed combination of glimepiride and metformin at week 24 on:

* Percentage of patients reaching HbA1c \<7%
* Percentage of patients reaching HbA1c \<6.5%.
* Fasting Plasma Glucose (FPG)
* Safety and tolerability

The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.

Eligibility Criteria:
Inclusion criteria:

* Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry.
* Signed informed consent, obtained prior any study procedure

Exclusion criteria:

* Age \< legal age of adulthood
* HbA1c \< 7% or ≥ 11%
* BMI \> 35 kg/m2
* Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit.
* Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit.
* Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis

The purpose of this study is to determine if AzaSite Plus is effective and safe for the treatment of blepharoconjunctivitis compared to AzaSite alone and Dexamethasone alone.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of blepharoconjunctivitis
* Must be willing to discontinue contact lens wear for the duration of the study
* Have best corrected visual acuity of 6/24 in both eyes
* Have IOP less than or equal to 25 mmHg in either eye

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the study medications
* Have a history of eyelid and/or ocular surgery and/or have had ocular surgical intervention within 6 months prior to visit 1 or during the study and/or a history of refractive surgery within 6 months
* Have worn contact lenses 72 hours prior to visit 1 and/or need to wear contact lenses for the duration of the study
* Have used any topical ophthalmic solutions including tear substitutes within 2 hours of enrollment
* Use of any eye make-up during the study
* Have any uncontrolled systemic disease or debilitating disease
* Have been diagnosed with glaucoma
* Have any clinically significant cardiovascular disorders
* Have any history of liver or kidney disease resulting in persisting dysfunction
* Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry

Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.

The electronic Clinical Decision Support tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). It predicts risk for persistent symptoms and prompts referral to specialty care for those who are high-risk. The eCDS tool consists of a validated, age-appropriate symptom scale, risk stratification with indication for specialty referral, personalized return to activity guidance based on symptom exacerbation, and guidance on minimizing prolonged rest and promoting active management.

Each year for three years, the eCDS tool will go live at a new pair of sites (1 urban, 1 suburban). Training will be provided to the primary care providers at these sites on utilizing the eCDS tool. Anonymous questionnaires will be administered among providers who used the eCDS tool in order to evaluate its appropriateness and acceptability. A medical record review will be conducted of mTBI patients evaluated with the eCDS tool.

Eligibility Criteria:
Inclusion Criteria:

* 5-18 year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe

Exclusion Criteria:

* Evidence of moderate or severe TBI
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids

Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and daidzein) on glucose metabolism. This double-blinded, randomized, placebo-controlled trial will examine the effects of purified genistein and daidzein on glucose metabolism in prediabetic or diabetic women. One hundred and eighty eligible women age 30-70 years(without any treatment of diabetic drugs) will be recruited and randomly allocated into the following three arms: Placebo (10g isolated soy protein, ISP); Genistein (10g ISP + 50mg genistein); Daidzein (10g ISP + 50mg daidzein) per day for 6 mo. Fasting glucose, lipids, insulin, inflammation marks and post-load for glucose and insulin will be determined at 0, 3th, and 6th month. Changes in these indices will be compared among the three groups.

Subjects were Chinese adult women, age 30-70 year, with an FG concentration ranging from 5.6 to 7.0 mmol/L or 2-h PG concentration ranging from 7.8-11.0 mmol/L or with newly diagnosed diabetes not requiring medication treatment according to a doctor's suggestion or participants did not willing to take medication themselves, and managed their diabetes just with a stable diet and exercise. Women were excluded if they had a history of coronary heart disease, stoke, thyroid disease, severe liver, lung, or gastrointestinal tract diseases; were currently or in the past 8 weeks used hypoglycemic or lipid-lowering or weight-reduction agents; were occurrence of diabetic complications; use of hormone replacement therapy; allergy to soy;were long-term antibiotics users.

Eligibility Criteria:
Inclusion Criteria:

* Chinese women aged 30-70 y
* Fasting glucose \>=5.6 mmol/l; post-load glucose \>=7.8 mmol/l

Exclusion Criteria:

* Diabetes renal diseases
* Confirmed CVD, chronic liver,kidney diseases,Thyroid disease
* Medications affecting glucose or lipid metabolism
Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University

This study will be conducted in the Department of physical therapy, College of Applied Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in smart phone addiction among students of jazan university

Four hundreds students with age 19 to 26 years old, and right dominant hand, will be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be randomly assigned to into a heavy user group (n=300; female and male students) and a control or regular use group (n=300; female and male students) according to their smartphone addiction proneness scale.

Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New York, USA) is used to measure the hand grip strength and pinch strength.

Algometer Commander (JTech Medical Company) is used on the location of the trigger point to assess the amount of pressure the patient could sustain before the patient registered the pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle

Eligibility Criteria:
Inclusion Criteria:

1. The participant will be right-handed.
2. No abnormal findings confirmed through physical and neurological examination.
3. No congenital abnormalities in either the cervical or the lumbar spine.
4. No history of severe surgical procedures ( Park et al., 2015) .

Exclusion Criteria:

1. History of a neurological disease.
2. History of musculoskeletal injury of neck and lumbar region.
3. Unstable medical condition.
Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation.

The two sequences are:

* Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
* EGD followed by Colonoscopy

120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* Scheduled EGD and colonoscopy on the same day
* Scheduled to Anaesthesiologist administered sedation during the procedure

Exclusion Criteria:

* Age below 18
* Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
* Medical contraindication to Anaesthesia
* Sleep apnea
* American Society of Anesthesiologists classification (ASA) \>3
* Inpatient status
* Pregnant or lactating women
* Known cirrhosis
* Chronic Kidney Disease (stage 4 or 5)
* Known psychological disorder
* Known cognitive dysfunction
* Significant gastroparesis
* Gastric outlet obstruction
* Ileus
* Known or suspected bowel obstruction or perforation
* Having a stoma
* Compromised swallowing reflex or mental status
* Prior colon resection or gastric surgery
* Age above 75 years
* Chronic use of more than 1 psychoactive drug (Benzodiazepines, Tricyclic antidepressants, antipsychotics, selective serotonin receptor inhibitors, serotonin norepinephrine receptor inhibitors, Monoamine oxidase inhibitor)