cyrilzakka/clinical-trials huggingface dataset:
Effect of the Virtual Reality Training in Elderly

The study aims to investigate the efficacy of group-based exercises using virtual reality on activities of daily living in elderly population.

As a result of morphological and functional changes that occur with aging, complications such as decrease in muscle mass, flexibility and muscle strength, decrease in sleep quality, social isolation and chronic diseases develop and cause a decrease in independence in activities of daily living (ADL). Increasing physical activity in the elderly is effective in maintaining general health status and maintaining independence during activities of daily living (ADL). However, the level of the participation to physical activities is quite low in old age. It's known that group-based exercises and technology-supported exercise training with virtual reality games increase participation in physical activity and improve motor functions and ADL. But, there is no study examining the effect of technology-supported group exercises on ADLs in the elderly. Therefore, the aim of our study is to find out the effects of technology-supported group exercises on ADLs in the elderly over 65 years of age.

The forty-two participants will be recruited and divided into three equal groups randomly. The group 1(n=14) will perform group-based virtual reality training and group 2(n=14) will receive individual virtual reality training for 45-minutes, twice a week for eight weeks. The third group group 3(n=14) will determined as the control group and they will continue their routine daily activities. Primary outcome measure will be Barthel Index of Activities of Daily Living. Secondary outcome measures will be Physical Activity Scale for the Elderly (PASE), Timed Up and Go (TUG) test, Single Leg Stance Test (SLST), Six Minute Walk Test, Geriatric Depression Scale (GDS), Physical Activity Enjoyment Scale (Paces).

Eligibility Criteria:
Inclusion Criteria:

* Participants who are 65 age or older
* can ambulate independently

Exclusion Criteria:

* elderly individuals who are suffering from any acute or unstable illness or medical condition
* elderly individuals who are unable to understand the treatment protocol.
* elderly individuals who are suffering from any kind of visual, auditory and neural or vestibular system disorders.
* History of surgery in the last 6 months
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control.

The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period.

Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c\<8.5% or HbA1c ≥ 8.5% before randomization.


Eligibility Criteria:
Inclusion Criteria:

1. T2D was diagnosed according to WHO standards in 1999 for at least 2 months
2. Age ≥ 18 when signing the informed consent form
3. The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening
4. Maintain a stable diet and exercise lifestyle during the study
5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol

Exclusion Criteria:

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. Weight change\>5% within 12 weeks before screening (chief complaint)
3. Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening
4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
5. There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
8. The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study
Robotic Assisted Vertebral Body Augmentation - a Radiation Reduction Tool

Modern orthopedic and spine surgeons strive towards minimizing surgical exposure and towards increased precision in the placement of implants. This trend requires an increased use of fluoroscopic guidance, which leads to increased exposure of the patient, surgeon and the operating room staff to radiation.

Robotic assisted spine surgery is routinely performed in the authors' institution for a variety of indications such as degenerative conditions, trauma, tumors , infections and deformity correction11. The objective of this study is to compare the radiation exposure time during robotic guided vertebral body augmentation to the published results for similar surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women
* Ages 18-85

Exclusion Criteria:

* Unwillingness to participate the study
Skeletal Muscle Contractility, Self-reported Pain and Tissue Sensitivity in Females With Neck/Shoulder Pain and Trapezius MFTrPs

In relation to Myofascial Triggerpoints (MFTrPs) of the upper Trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* A clinically relevant MFTrP of the upper Trapezius musculature
* Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
* BMI less than 31

Exclusion Criteria:

* a history of chronic, systemic pathology (e.g. hemophilia)
* pre-existing neck/shoulder pathology/surgical procedures,
* clinical depression
* health-related legal action
* pregnant
* anti-inflammatory and/or chronic pain medication
* had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia
Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)

Proof-of-concept study addressing the feasibility of awake ECMO (v/v) in patients with acute respiratory failure

Pilot study in 6 patients with ARDS addressing the use of awake veno-venous ECMO to avoid endotracheal intubation and mechanical ventilation

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75 yrs with acute respiratory failure due to ARDS or pneumonia fulfilling standard criteria for endotracheal intubation

  * Severe and progressive hypoxemia, i.e. PaO2 \< 60 mmHg or SaO2 \< 90% on O2 \> 10 l/min not tolerating noninvasive ventilation, or
  * PaO2/FiO2 \< 200 not improving or deteriorating on noninvasive ventilation, or
  * Respiratory distress and hypoxemia not fulfilling the criteria above with clinical impression of the ICU attending that intubation and mechanical ventilation are mandated
* Patient considered eligible by at least two investigators of this study

Exclusion Criteria:

* Patient does not fulfill the inclusion criteria
* Uncontrolled malignancy
* Severe and untreatable coagulation or bleeding disorders (INR \> 2,0; aPTT \> 60s, Platelet count \< 50.000/µl, all after substitution)
* Stroke within the past 3 months
* Uncontrolled sepsis or septic shock
* Multiorgan failure involving \> 2 organ systems
* Norepinephrine dose \> 1 mg/h
* Hyperdynamic circulation, indicated by cardiac index \> 4.0 l/min/m2 (measured by PiCCO or Swan-Ganz catheter), or SvO2 \> 80%
* Cardiac pump failure, indicated by echocardiography (EF \< 40%), PiCCO or Swan Ganz catheter (CI \< 2,5 l/min/m2 despite adequate volume management), or SvO2 \< 50% (provided Hb \> 9,0 g/dl and SaO2 \> 90%), or the need for inotropes (dobutamine, epinephrine, levosimendan)
* Clinical or echocardiographic signs of pulmonary hypertension with right ventricular dysfunction
* APACHE-II score15 \< 25
* Other conditions suggesting that the patient would benefit from intubation and mechanical ventilation
* Severe neurological disorders
* Estimated mortality due to severity of acute and/or underlying illness \> 50%
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)

Exclusion Criteria:

* Hypo or hyperthyroidism
* Persistent atrial fibrillation lasting more than 1 year or non-defined duration
* Hypertrophic myocardiopathy
* Implantable defibrillation or pacemaker implanted
* Moderate or severe mitral valve disease or mitral prosthetic valve
* Ejection fraction less than 30%
* Left atrial anteroposterior diameter more than 50 mm.
* Previous atrial fibrillation ablation
* Contraindication to anticoagulation
* Left atrium thrombus
* Current infective disease or sepsis
* Pregnant women
* Current unstable angor
* Acute myocardial infarction in last 3 months
* Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
* Reduced expectancy of life (less than 12 months)
* Patient participating in another clinical study that investigates a drug or device
* Psychologically unstable patient or denies to give informed consent
* Any cause that contraindicate ablation procedure or antiarrhythmic drug
Magnesium Sulfate in Neonatal HIE"

The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management.

Objective:

• To determine the neuroprotective outcomes of intravenous magnesium sulphate in neonates with hypoxic ischemic encephalopathy (HIE) at a tertiary care hospital of Karachi.

Methodology:

* Study Setting: This is a prospective study; and will be conducted at tertiary care hospital of Karachi (Sindh Institute of Child Health and Neonatology, K-5).
* Study Design: Rndomized clinical Trial
* Target Population: The study population will be all term and near term newborns (≥35 completed weeks) with moderate to severe HIE.
* Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.
* Exclusion Criteria:

  * Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
  * Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
  * Congenital anomalies or genetic disorders affecting neurological function.
  * Allergy or known adverse reactions to magnesium sulfate.
  * Participation in another concurrent clinical trial involving investigational drugs or interventions.
  * Inability to obtain informed consent from parents or guardians.
* Medical Intervention: Magnesium sulphate as infusion will be commenced to cases. Control will be treated as per unit protocol.

Sample Size:

Sample size was calculated using WHO software with the following assumptions:

Level of significance α=0.05 Power of study = 80 Anticipated population proportion P1 = 0.657 Anticipated population proportion P2 = 0.3757 Desired precision = 5 Required sample size 51 for each population (cases 51 and control 51) so, the total 102 is the minimum sample

Eligibility Criteria:
Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.

-

Exclusion Criteria:

* Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
* Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
* Congenital anomalies or genetic disorders affecting neurological function.
* Allergy or known adverse reactions to magnesium sulfate.
* Participation in another concurrent clinical trial involving investigational drugs or interventions.
* Inability to obtain informed consent from parents or guardians.
Collection Of Tissue, Blood, and Other Specimens From Patients With Head and Neck Tumors To Study the Causes, Diagnosis, Prevention and Treatment of Cancers

This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.

This is a protocol to collect tissues, blood, and other specimens from patients with malignant or nonmalignant diseases of the head and neck. Collected specimens will be used in laboratory studies to investigate the growth, development, and transformation of normal and abnormal cells in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck diseases are eligible if they have had tissue, serum, urine, or other specimens removed or collected for diagnostic or therapeutic purposes.
* Patients will be entered onto this protocol without preference for any racial or ethnic group.
* Patients may have received prior chemotherapy, radiation, surgical therapy, immunotherapy, or differentiation therapy.
* The specimen collected must be large enough to allow conventional testing necessary for patient care, with the portion of the specimen reserved for research laboratory analysis excised from residual tissue that would otherwise have been discarded.

Exclusion Criteria:

* Patients not giving informed consent will be excluded.
Caries-associated Saliva Biomarkers Among Different Races

discover possible differences and develop effective preventative interventions by examining the relationship between salivary biomarkers and caries prevalence across different racial groups and Detect risk factors involved in caries incidence .

Dental caries is a multifactorial condition that is influenced by both external and internal variables. Tooth decay progression is directly influenced by host factors, including the individual's immune competence, saliva flow rate and buffering capacity, tooth form, and bacterial makeup .

While salivary biomarkers are essential for predicting the risk of dental caries, little is known about how they relate to caries in a variety of populations. By examining the relationship between salivary biomarkers and caries prevalence across several racial groups, this study seeks to close this gap and enhance culturally appropriate preventive approaches . There have been contentious discussions over the causes of differences in oral health during the past forty years. The term "structural inequities" refers to the social, environmental, economic, and cultural determinants of health, which are frequently impacted by racial or ethnic background, gender, work status, immigrant status, and geographic location. Racialized populations have demonstrated greater rates of untreated dental decay (caries), severe periodontal disease, and total or partial edentulism . Typically, "race" refers to an individual's physical characteristics, such as skin tone or hair type, which may indicate their ancestry. White, African American, or Asian descent are some examples of classifications that are frequently used to characterize race .

Eligibility Criteria:
Inclusion Criteria:

* Age : 19-25
* We will have 2 groups according to ICDAS classification : Not severe (ICDAS score ≤3) / Severe (ICDAS score ≥3)

Exclusion Criteria:

* : Those who reported daily use of alcohol or tobacco .
* Those who used antibiotics or other systemic drugs within the previous three months .
* Those who regularly used antiseptics
Chronic Effects of Tendon Vibrations on the Neuromechanical Muscular Properties.

It is a randomized, controlled clinical trial, in healthy volunteers. They are in two groups : the test one will perform the vibration training (1h of Vibrasens 3 times a week, 24 sessions) whereas the control group will not be training. The primary outcome is the maximal voluntary strength.

These last 10 years, a new idea born: vibrations could have potential effects on muscular reconditioning. Researchers have previously demonstrated the effects on plantar ankle flexion, with the increase of the strength, on healthy volunteers. Nowadays physicians would like to demonstrate the effects on another muscular group: ankle's dorsal flexors. 24 sessions are programmed on 8 weeks.

Moreover, the last results showed a modification of the nervous capacities of the cortical voluntary activation. Transcranial Magnetic Stimulation (TMS) is a great tool to explore the neuromuscular function, at the cortical stage. The use of this tool will allow the characterization the effects of the vibration training on the cortical activation state.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years old
* Both gender
* Occasional sportsman (\<4h/week)
* Affiliated to a social security scheme
* Having freely given their written consent

Exclusion Criteria:

* Taking neuro-active substances able to modify cortico-spinal excitability from Day 10 to the end of the study
* Contraindication to magnetic field application
* Previous pathologies susceptible to modify the process of the tests (particularly stakeholders presenting knee or ankle pathologies)
* Participation during the same time in another interventional experimentation
NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema

The objectives of this study are to:

* Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.
* Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.
* Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.

Primary endpoint:

* Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.

Secondary endpoints:

* Determination of Cut-off(s)
* Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema
* Determination of treatment costs of the initial hospital stay
* Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.
* Time to diagnosis.
* Hospitalization rate /Intensive care treatment rate between day 1 and 28
* Duration of initial hospital stay
* 30-day re-hospitalization rate
* 30 day mortality rate and adverse event rate
* 1 and 5 year mortality rates
* 1 and 5 year rehospitalization rates

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years
* Dyspnea or/and peripheral edema
* Informed consent

Exclusion Criteria:

* Renal insufficiency with creatinine \> 2.8mg/dl
* Anemia (hemoglobin \< 8.0mg/dl)
* Pregnancy
Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals

Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.

In this study, it was aimed to compare double assignment, cadence and walking speed in Alzheimer's Dementia and Healthy Geriatric Individuals.

Individuals who can walk independently and who are diagnosed with Alzheimer's Dementia over the age of 65 and healthy individuals will be included in the study. It will be done with 50 people who voluntarily participated in the research.

As a data collection tool; The demographics formula with patient descriptive features is the Timed Get Up and Walk test to turn off double assignment, the 2 Minute Walk Test to evaluate the advertisement, and the Footprint Method to use cadence. It will be assessed with the Mini Mental State Test and the Montreal Cognitive Assessment Test to examine discriminative units.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older,
* Who volunteered to participate in the research,
* Able to walk independently,
* He was diagnosed with Alzheimer's by a physician for the experimental group,
* Having not been diagnosed with Alzheimer's for the control group
* Individuals who have not undergone surgery in the last 6 months
* Individuals who do not have cooperation and communication problems.

Exclusion Criteria:

* Under age 65
* Individuals who do not agree to participate in the research,
* Individuals who have a disability to do physical activity,
* Individuals who have undergone an operation in the last 6 months,
* Individuals with problems of cooperation and communication