cyrilzakka/clinical-trials huggingface dataset:
Effects of Thoracic Mobility Exercises in Geriatric Individuals

Aging leads to a gradual decline in muscle function and structural changes in the musculoskeletal system, which can affect balance and increase the risk of falls. This study aimed to assess the effects of thoracic mobility exercises on balance, exercise capacity, sleep quality, pain, and daily activities in 28 geriatric individuals (65+ years). Participants were divided into two groups: the Thoracic mobility exercises group performed conventional exercises with additional thoracic mobility exercises, while the Conventional physiotherapy exercises group did not.

Aging is a natural and irreversible process of the human body that involves a gradual decline in physiological, structural and functional activities. the general muscle function in the body decreases, and in this respect, in addition to structural changes in the musculoskeletal system, there are also changes in the internal function of the muscles. This change may cause an increase in the thoracic curvature in the sagittal plane and postural changes, a shift in the center of gravity forward, disrupting balance and increasing the risk of falling. the intervertebral disc spaces narrow, which causes an increase in the kyphosis angle of the spine. Although studies in the literature use thoracic mobility exercises, the investigators found that these studies specifically evaluate effects on respiratory functions. The aim of this study is to examine the effects of thoracic mobility exercises on balance, exercise capacity, sleep quality, pain and daily living activities in geriatric individuals. 28 geriatric individuals aged 65 and over who do not need care were included in this study and were divided into 2 groups as experimental and control by randomization. The Conventional physiotherapy exercises group; While the thoracic mobility exercises group was made to do conventional exercises including warm-up, stretching, strengthening, posture and breathing exercises, in addition to these exercises, thoracic mobility exercises were done. The individuals included in the study were studied for a total of 8 weeks, 1 week for pre-assessment, 1 week for post-assessment and 6 weeks for exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Elderly individuals over the age of 65
* Those who scored at least 24 points on the mini mental test
* Those who did not need care in their daily living activities

Exclusion Criteria:

* Those with uncontrolled Diabetes Mellitus and Hypertension
* Those with severe obesity
* Those who use medications that may increase the risk of falling
* Those with serious auditory and visual problems
* Those with physical and psychological problems affecting physical mobility
* Those who have undergone surgery in the last 6 months
Study of Prognostic Factors in Patients Admitted to ICU for Stroke

Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS \<10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).

The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.


Eligibility Criteria:
Inclusion Criteria:

* acute stroke
* ICU admission for acute stroke
* 1 organ dysfunction : coma, shock, respiratory failure

Exclusion Criteria:

* refuse participation
Immune Response in Patients With Hepatitis B and C Infection

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.

Hepatitis B virus (HBV) and C (HCV) are the leading causes of liver disease worldwide. Approximately 400 million people worldwide are chronically infected with HBV world wide and it is estimated that 3% of the entire world population is infected with HCV and yet there is still no vaccine available.

Chronic viral hepatitis infection is primarily the result of a complex interaction between the virus and an impaired host immune response. The host immune response has a unique role in HBV and HCV infection because it contributes not only to viral control clinical recovery and protective immunity but also to the development of chronic hepatitis and liver cirrhosis. There is currently no cure for most patients who already have chronic HBV and HCV infection and a proportion of patients fail to respond to current antiviral regimens. Since these patient remain at risk for disease progression it is crucial to investigate host immune responses and to determine the precise role of these responses in disease outcome.

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, we hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression. This information can be utilised to develop more effective treatment regimens in order to reduce the current global burden of these diseases.

Eligibility Criteria:
Inclusion Criteria:

Chronic Hepatitis B patients At all stages of infection Treatment naive and previously treated Longitudinal samples from patients treated with antiviral agents and interferon

Chronic Hepatitis C patients All genotypes - treatment naive and previously treated Longitudinal samples from patients treated with interferon and STATIC therapy

Exclusion Criteria:

Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease
Anti-diabetic Effects of Persimmon Leaf Extract

The investigators performed a 8-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of persimmon leaf extract on blood glucose. The investigators measures changes in diabetes associated parameters, including fasting blood glucose, postprandial blood glucose, insulin, C-peptide and HbA1c.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years
* Fasting blood glucose (FPG) 100\~140 mg/dL or postprandial blood glucose (PPG) 140\~250 mg/dL

Exclusion Criteria:

* FPG more than 140 mg/dL
* 2h PPG more than 200 mg/dL
* Type 1 diabetes or HbA1c more than 9.0%
* treatment with corticosteroids within the past 4 weeks
* cardiovascular disease
Skills Learning and Self-confidence in Learning in High-fidelity Simulation

High-fidelity simulation (HFS) has become a favorable innovative teaching-learning method to facilitate students' learning in professional development in nursing. During the simulation, a variety of skills can be improved through HFS. This mixed randomized-control and qualitative study aims to examine the effects of the structured HFS guideline on PS, CR and Student Satisfaction and Self-Confidence in Learning in undergraduate nursing students and understand their learning experience in HFS.

Nurses are facing new challenges of immediate clinical management for safer and higher quality of patient care in the current practice (Levette - Jones et al. 2018). Students are required to have independent learning and higher-intellectual skills, including problem-solving (PS) and clinical reasoning (CR), for pursuing better clinical judgements and decision-making and the most cost-effective practice (Levette - Jones et al. 2018). High-fidelity simulation (HFS) is one of the innovative and effective methods that allow students to apply integrated knowledge and skills in a designed simulated case scenario to develop higher-intellectual skills (Linn et al., 2012) and self-confidence. To allow students to achieve their HFS with enhancement of skill development and self-confidence in learning, a structured guideline is useful. This structured guideline can help course coordinators to maintain consistence in simulation teaching. Therefore, this study aims to understand students' skill development and self- confidence in learning through the HFS.

Eligibility Criteria:
Inclusion Criteria: Students who

* are undergraduate nursing students
* aged 18 or above

Exclusion Criteria: Students who

* are enrolled in the courses with high-fidelity simulation
* Have had clinical placement
Higher Order Aberration and Relationship With Soft Contact Lens Modulus

Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Adults \> 18 years old regardless of gender, race, or ethnicity
* Habitual single vision soft CL wearer for at least 1 week in any modality.

Exclusion Criteria:

* Multifocal soft CL wear
* GP or ortho K wear in the last 3 months.
* Active eye infections and inflammations.
* Current use of ocular medication.
Mellowing Mind: Comparing Two Technology Based Mindfulness Interventions for Stress Impacted by COVID-19 in Underserved Communities

The purpose of this study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic.

The purpose of this randomized controlled study is to examine the comparative effectiveness of two technology-based Mindfulness Based Stress Reduction (MBSR) programs (one via video/teleconference and one via a smartphone app) for reducing worry, anxiety, and/or related mental health effects of stress in members of identified underserved communities, which were highly impacted by the COVID-19 pandemic. Participants will be randomly assigned to a teleconference MBSR program, a MBSR smartphone app program, or a waitlist control group. Each intervention includes participation in a 9-week (8 sessions plus an introduction) mindfulness intervention that consists of instruction and daily practice. Questionnaires and semi-structured interviews will be administered at mid-intervention, post-intervention, and one-month and three-month follow-up points. It is hypothesized that participants in the two intervention groups will show measurable and sustained improvement in the primary outcome, worry, as well as in the secondary outcomes, anxiety and related mental health effects. It is further hypothesized that the smartphone app mindfulness intervention will show similar effectiveness to the teleconference mindfulness intervention.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Significant worry as per the Penn State Worry Questionnaire-Abbreviated \[PSWQ-A\]
* Fluent in English
* Reside in one of the local city zip codes, identified as underserved, and primarily African American, communities

Exclusion Criteria:

* Severe depression as per Patient Health Questionnaire \[PHQ-9\]
* Active suicidal intent as per PHQ-9 question 9
* Diagnosis of psychosis, or bipolar disorder, or moderate or severe substance use disorder in the past month as per self report
* Cognitive impairment as per (modified) Short Portable Mental Status Questionnaire \[SPMSQ\]
* Currently receiving psychotherapy or behavioral counseling, including MBSR
* Change in psychotropic medications within the last month as per self report
* Unable to communicate in a way that would allow for participation in screenings or sessions
Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed acute symptomatic DVT
* Written informed consent

Exclusion Criteria:

* Legal lower age limitations
* Patients with symptomatic pulmonary embolism
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* Other indication for VKA than DVT
* More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \<10mL/min, severe hepatic disease or bacterial endocarditis
* Life expectancy \<3 Months
* Active bleeding or high risk for bleeding
* Uncontrolled hypertension: systolic blood pressure \>180 mm Hg and diastolic blood pressure \>110 mm Hg.
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin
Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Levemir® above 6 yrs
* NovoMix® 30 above 18 yrs
* Patients with Type 1 or Type 2 diabetes, including newly diagnosed

Exclusion Criteria:

* Current treatment with NovoMix® 30 or Levemir®
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia

A randomized controlled trial

This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

Eligibility Criteria:
Inclusion Criteria

* Patient has provided written informed consent using a form approved by the reviewing IRB.
* Patient is 18 years of age or older.
* Patient is willing and able to comply with protocol requirements.
* Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
* CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
* Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
* Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
* Patient is a candidate for an in-office balloon dilation procedure.
* In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.

Exclusion Criteria:

* Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
* Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
* Known history of allergy or intolerance to corticosteroids or mometasone furoate.
* Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
* Active viral illness (e.g., flu, shingles).
* Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
* Currently participating in another clinical trial.
Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury

Patients with mild to moderate traumatic brain injury (TBI) are at risk for secondary neurological deterioration. Their outcome within the first week after injury could be predicted by clinical signs, brain CT scan and transcranial doppler (TCD) on admission to the emergency room. The investigators aim to evaluate the diagnostic performance of TCD to screen patients presented with mild to moderate TBI and mild lesions on CT scan, i.e., Trauma Coma Data Bank, TCDB classification II. The principal outcome measure is the negative predictive value of TCD.


Eligibility Criteria:
Criteria for inclusion:

* 15 years of age or more
* primary admission for mild TBI (GCS 14-15) or moderate (GCS 9-13) TBI.
* with or without multiple injury.
* with no hemodynamic or respiratory distress: SAP \>90mmHg, SPO2 \>92%,hemoglobin \> 8 g/dl.
* with mild brain lesions on CTscan according to the traumatic coma data bank classification (TCDB) II: diffuse injury with cisterns present and no midline shift, mixed density lesions \<25 ml.
* Transcranial Doppler within 8 hours after the trauma.
* patient affiliated to the social security system or equivalent

Criteria for exclusion:

* Severe TBI (GCS\<9)
* Penetrating TBI
* patient with no brain CT scan
* patient with normal brain CT scan (TCDB I), or severe brain CT scan (TCDB III-IV)
* Hemodynamic or respiratory distress
* Patient treated with anticoagulants: oral anticoagulant, heparin, anti-platelet agent (except Aspirin)
* previous intracranial surgery
* Patient with sedation and mechanical ventilation
* transcranial Doppler unable
* patient deprived of freedom by judicial or administrative decision
* Follow up at 7 days impossible
* Refusal consent to use data for statistics
Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function, and quality of life may improve the ability to plan treatment for patients with advanced head and neck cancer and may help doctors find better ways to treat the cancer.

PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated radiation therapy in treating patients with advanced head and neck cancer.

OBJECTIVES:

Primary

* Assess salivary function in patients with advanced head and neck cancer treated with intensity-modulated radiotherapy (IMRT) by measuring stimulated saliva production at 6 and 12 months after completion of therapy.
* Compare salivary function in these patients to salivary function in historical controls.

Secondary

* Assess auditory, swallow, and voice function and quality of life of these patients before and after IMRT or chemoradiotherapy.
* Advance experience with IMRT/tomotherapy and improve field design for irradiating head and neck cancer in an effort to reduce radiation dose and minimize effects on surrounding normal tissue.

OUTLINE: This is a prospective study.

Patients undergo standard of care high-dose intensity-modulated radiotherapy (IMRT) to the head and neck.

Patients undergo baseline and post-treatment testing of auditory, salivary, swallow, and voice function as well as quality of life evaluation.

Patients are evaluated for radiation-induced toxicities at 1, 6, and 12 months after completion of IMRT.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed advanced head and neck cancer
* Indication for radiotherapy or chemoradiotherapy as primary or postoperative therapy AND meets 1 of the following criteria:

  * More than 75% of bilateral parotid glands expected to receive ≥ 45 cGy of radiation using conventional treatment field design
  * Either or both central auditory apparatus predicted to receive \> 45 cGy of radiation

PATIENT CHARACTERISTICS:

* No comorbid medical condition that would preclude radiotherapy
* No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study to Investigate the Efficacy and Safety of OTL-203 in Subjects with MPS-IH Compared with Standard of Care with Allogeneic HSCT

A multi-center randomized clinical trial to compare OTL-203 (gene therapy) with stem cell transplant (standard of care) in patients with MPS-IH (Hurler syndrome).

The study is a multi-center, randomized, active controlled clinical trial designed to evaluate the efficacy and safety of OTL-203 in patients with mucopolysaccharidosis type I, Hurler syndrome (MPS-IH) compared to standard of care with allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 40 patients with a confirmed diagnosis of MPS-IH who meet the study inclusion criteria will be randomized to receive either OTL-203 or allo-HSCT. The trial will comprise of a screening, baseline, and treatment period, with a follow-up period of 5 years post-treatment, and primary analysis performed at 2 years follow-up of the last treated subject.

Eligibility Criteria:
Inclusion Criteria:

1. Norm-referenced cognitive standard score of ≥70 measured by age-appropriate cognitive domains of either Bayley Scale of Infant Development (BSID)-III or Wechsler Preschool and Primary Scale of Intelligence (WPPSI)-IV.
2. Confirmed laboratory diagnosis of MPS-IH as demonstrated by biallelic mutation(s) in the gene coding for IDUA enzyme
3. Final confirmation of MPS-IH diagnosis by a Diagnostic Review Committee (DRC).

Exclusion Criteria:

1. Previous allo-HSCT or gene therapy
2. Current enrollment or past treatment in any other interventional study/trial using a novel investigational agent and/or treated with prohibited medications listed in the protocol
3. Positivity to serological testing for Human Immunodeficiency Virus (HIV)-1 or HIV-2, Human T Lymphotropic Virus (HTLV)-1 or HTLV-2, Hepatitis B Virus (HBV) core, Hepatitis C Virus (HCV), mycoplasma, active tuberculosis (TB) and not meeting the microbiology biological screening requirements.
4. Malignant neoplasia (except local skin cancer).
5. Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
6. History of uncontrolled seizures
7. Subjects with an active infection not responsive to treatment, end-organ damage, or any other disease that contraindicates performance of any of the procedures detailed in the protocol, or medical conditions or extenuating circumstances that, in the opinion of the Investigator, might compromise the subject's well-being or safety, or the interpretability of the subject's clinical data.
8. Subjects, who in the opinion of the Investigator, may not be able to comply with protocol requirements or cooperate fully with the study procedures and necessary long-term follow up