cyrilzakka/clinical-trials huggingface dataset:
This is a Multicenter, Prospective and Retrospective and Descriptive Epidemiology Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Korea

This study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study.

This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.

This study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months.

The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.

The 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment will be analyzed.

The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and COPD medications of retrospective and prospective studies for the 2 years as well as mortality rate.


Eligibility Criteria:
Inclusion Criteria:

1. Over 40 years old
2. Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
3. Patient with having past 1 year medical record at the investigational site
4. Patient who signed Informed Consent Form

Exclusion Criteria:

1. Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
2. Patients currently diagnosed with cancer
Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics

To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).


Eligibility Criteria:
Inclusion Criteria:

1. type 2 diabetes
2. between 21 and 75 years of age
3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
4. BMI is \> 18.5 kg/m2 and \<35 kg/m2
5. If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

1. Hemoglobin A1c value at screening of greater than or equal to 9%.
2. Uses exogenous insulin or exenatide for glucose control.
3. type 1 diabetes.
4. history of diabetic ketoacidosis.
5. current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
6. active malignancy
7. significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
8. end-stage organ failure or is status post organ transplant.
9. history of renal disease.
10. current hepatic disease.
11. history of severe gastroparesis.
12. chronic, contagious, infectious disease
13. taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
14. clotting or bleeding disorders
15. allergic or intolerant to any ingredient found in the study products.
16. habitual user of tobacco products (
Hostility and Coronary Risk--Role of Weak Vagal Function

To determine whether deficient vagal antagonism of sympathetic nervous system (SNS) actions on the heart contributed to increased coronary heart disease risk in hostile persons.

DESIGN NARRATIVE:

Sophisticated electrophysiologic monitoring approaches were used to: 1) show greater sensitivity in nonhostile young men to T-wave attenuation effects of isoproterenol infusion following vagal blockade; 2) show that vagal enhancement reduced and shortened the T-wave attenuation effects of isoproterenol infusion more in hostile young men; 3) evaluate these effects of vagal blockage and enhancement in middle-aged men and in young and middle-aged women; and 4) relate the T-wave effects in these studies to other measures of vagal tone and other biobehavioral mechanisms of coronary-prone behavior.

Four studies were conducted in normal young and middle-aged men and women selected as high and low on hostility, evaluating vagal tone measures and effects of isoproterenol infusion on EKG T-wave and ST response after pretreatment with saline, neostigmine, and atropine. Demonstration that hostility was associated with deficient vagal anatagonism of SNS effects on the heart, especially in middle-aged as compared to younger persons, suggested that diminished vagal tone was one pathway whereby high hostility contributed to increased CHD risk. Clinical studies were then conducted to determine whether weaker vagal tone predicted increased myocardial ischemia and/or poorer outcomes in coronary heart disease patients.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Expanded Access to Rovalpituzumab Tesirine

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Rovalpituzumab Tesirine prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* The participant must not be eligible for a Rovalpituzumab Tesirine clinical trial.
* Pediatric participants may be evaluated on a case by case basis.

Exclusion Criteria:

* None.
Systemic Reactions to Allergen Immunotherapy Amd Skin Testing

Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there is risk of systemic reactions associated with these procedures.

The systemic reaction rate to skin testing for aeroallergens is significant lower than the rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2 patients who had systemic allergic reactions to skin testing for respiratory allergies in 10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a systemic reaction rate of 6% of patients receiving skin testing.6 It is important to recognize the risk of systemic reactions seeing skin testing is commonly done. It is also imperative to recognize the treatments for these reactions to prevent progression.

Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely occur with allergen immunotherapy and skin testing.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.

Exclusion Criteria:

* NON Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.
Physical Activity, Mediterranean Diet and Maternity Blues: a Multidisciplinary Approach

This study aims to evaluate the levels of physical activity, sedentary time, eating habits, and emotional well-being in a group of women after giving birth.

The study involves the enrollment of 544 subjects and the overall expected duration is 24 months.

The study is observational, as it only involves collecting and recording information and clinical data according to the times and methods of treatment to which women are subjected in normal hospital practice.

In particular, the collection of information about:

* general nature;
* the pregnancy;
* participants' levels of physical activity and sedentary lifestyle;
* participants' nutritional habits;
* factors that influence participants' emotional well-being. The data will be collected in digital format, through filling out an online questionnaire. The data obtained will be organized in a digital file and processed in aggregate and anonymous form. Access to the data will be permitted only to personnel authorized for the study.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects, aged ≥18 years and with adequate knowledge of spoken and written Italian.

Exclusion Criteria:

* Presence of pathologies that contraindicate the practice of physical activity.
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data
* A disorder treated with anti-TNF therapy
* Whose physician made the decision to initiate adalimumab treatment prior to the study

Exclusion Criteria:

* Patients participating in an interventional therapeutic trial at the time of inclusion
* Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French
Effects of Action Observation Therapy and Mirror Therapy in Children With Unilateral Cerebral Palsy

The aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. In the study, the 1st group is the Action Observation Therapy group and will receive 18 sessions of practice. The second group is the mirror therapy group and will receive a total of 18 practice sessions. To evaluate the outcome measures of children's upper extremity functions; Canadian Occupational Performance Mesure (COPM), Goal Achievement Scale (GAS), Shriners Hospital Upper Extremity Function Scale (SHUEE), Melbourne Unilateral Upper Extremity Function Evaluation Test and ABILHAND Questionnaire will be used. The satisfaction of the families with the therapy process will be evaluated with the Visual Analog Scale (VAS).

The aim of this study was to examine the effects of action observation therapy and mirror therapy on upper extremity functions in children with unilateral cerebral palsy. In the study, the 1st group is the Action Observation Therapy group and will receive 18 sessions of practice. The second group is the mirror therapy group and will receive a total of 18 practice sessions. To evaluate the outcome measures of children's upper extremity functions; Canadian Occupational Performance Mesure (COPM), Goal Achievement Scale (GAS), Shriners Hospital Upper Extremity Function Scale (SHUEE), Melbourne Unilateral Upper Extremity Function Evaluation Test and ABILHAND Questionnaire will be used. The satisfaction of the families with the therapy process will be evaluated with the Visual Analog Scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 5 and 15
* Being diagnosed with unilateral cerebral palsy
* Be in one of the levels 1,2 and 3 according to the MACS dexterity classification
* Upper extremity Modified Ashworth Scale score less than or equal to 2 attending primary school

Exclusion Criteria:

* Having a visual impairment recorded in the health report
* To have any neurological, orthopedic, and psychiatric diagnosis in addition to the diagnosis of cerebral palsy
* Difficulty understanding and applying verbal and visual commands
* To have undergone any surgical intervention or botox in the last 3 months
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
* Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
* Male or female patients aged 18-70 years.
* An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
* Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
* Naïve to treatment with fingolimod.

Exclusion Criteria:

* A manifestation of MS other than those defined in the inclusion criteria.
* A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
* History of malignancy of any organ system.
* Diagnosis of macular edema during Screening Phase.
* Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
* Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
* Patients who have received total lymphoid irradiation or bone marrow transplantation.
* History of selected immune system treatments and/or medications.
* Any medically unstable condition, as assessed by the investigator.
* Selected cardiovascular, or hepatic conditions
* Selected abnormal laboratory values.
* Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
* Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
* History of hypersensitivity to the study drug or to drugs of similar chemical classes.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Swaddling on Infants During Feeding

The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.

Once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research OT randomly choosing an envelope with the assignment enclosed. The intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the NICU. Infants will be assessed at each nursing care time for feeding readiness by the research OT and feeding OT according the policies of the NYU Langone Medical Center NICU, which utilizes the Infant-Driven Feeding Scale-Readiness (Appendix B) (Ludwig \& Waitzman, 2006). When the infant demonstrates readiness, the first condition will be initiated. At the next feeding when the infant demonstrates readiness, the opposite condition will be applied. If the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.

Eligibility Criteria:
Inclusion Criteria:

* all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
* infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
* Infants who are multiples will be included but restricted to twins and triplets.
* Infants will only be included if their parents provide informed consent for participation of their infant in the study.

Exclusion Criteria:

The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:

* Infants who are exclusively breastfed
* Higher order multiples than twins and triplets (ie. quadruplets)
* Infants with conditions that may affect feeding performance:

  1. Grades III and IV intraventricular hemorrhage
  2. Necrotizing enterocolitis
  3. Congenital cardiac anomalies (except medically managed patent ductus arteriosus)
  4. Genetic syndromes
  5. Craniofacial abnormalities
Plasma Transfusion in Liver Transplantation

The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

Three types of plasma are transfused in bleeding patients undergoing liver transplantation:

* quarantined plasma,
* methylene blue treated plasma,
* solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.

In addition, the correction of coagulation abnormalities are studied.

Eligibility Criteria:
Inclusion Criteria:

* age 18 yo and above
* consent is signed,
* liver transplantation is indicated,
* plasma is transfused

Exclusion Criteria:

* multiorgan transplantation (except combined kidney and liver transplantation)
* allergy to methylene blue.
Comparison of Post Facilitation Stretch and Maitland Mobilization in Post-traumatic Stiff Elbow

This research study aims to bridge the gap in the existing literature by comparing the efficacy of Maitland mobilization and PFS techniques in the treatment of post-traumatic stiff elbow. While existing research has shown the favorable effects of joint mobilization and muscle energy techniques in other musculoskeletal conditions, there is a notable gap in understanding their efficacy in post-traumatic stiff elbow, particularly in Pakistan where no such study has been conducted. By investigating the comparative outcomes of these techniques, this research will contribute valuable clinical insights, potentially guiding clinicians in selecting the most effective treatment approach and laying the foundation for evidence-based treatment protocols tailored to patients with post-traumatic stiff elbow.

The elbow being a highly constrained synovial hinge joint has a high propensity for degeneration and stiffness. There could be functional losses seen with even less severe loss of range of motion (ROM) at the elbow. The stiff or contracted elbow is defined as an elbow with a reduction in extension greater than 30 degrees, and/or a flexion less than 120 degrees. Although supination and pronation are often reduced as well, this will not be considered further as contracture of the elbow is not related to forearm rotation. The elbow is more prone to stiffness because Brachialis muscle lies directly over the anterior capsule, the anterior capsule tends to tear more frequently than posterior, all 3 elbow articulations exist in 1 capsule, the elbow is prone to development of Heterotrophic Ossification. Loss of terminal extension is less disabling than loss of the same degree of terminal flexion. It was a randomized, controlled trial, conducted among post-traumatic stiff elbow patients. Sample size was 32 by using G Power Calculator. Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope. All participants in both groups were evaluated on two occasions: (i) baseline (ii) After 4 weeks of intervention

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 35 years
* Both male and female
* Patients with a limitation of elbow joint range of motion greater than 30 degrees in extension and less than 120 degrees in flexion.
* 2-3 months after POP, splinting
* Patients having bone ossification on X-ray findings will be included.

Exclusion Criteria:

* Patients with a history of rheumatoid arthritis or other inflammatory joint diseases
* Mal-union or non- union elbow fracture.
* Patients with a history of neuromuscular disorders or other conditions affecting muscle tone.
* Patients with a history of previous elbow surgery or joint replacement.
* Patients with a history of traumatic brain injury or other neurological conditions affecting upper limb function.
* Patients with open reduction
* Patient with elbow dislocation
* Elbow joint mal-alignment
* Heterotopic ossification
* Myositis ossification or posttraumatic ankyloses.
Sensitivity and Specificity of the Home Macular Perimeter (HMP)

The primary objective of this study is to estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD, and differentiate them from intermediate AMD subjects.

It is a one encounter visit in which patients are enrolled and complete the study on the same day. This will allow recruiting and testing of patients with CNV which is a dynamic disease that is most often treated on that same day. Following enrollment, patients will go through an examiner supervised tutorial followed by a self-performed HMP examination. In addition patient will undergo an Amsler grid examination, biomicroscopy, color fundus photography and fluorescein angiography. The HMP output shall be a test result that can be within or outside normal limits. Inherent to the test are reliability criteria which help to determine if the patient performed the test reliably. These consist of false positive and false negative errors. All criteria for normal limits and reliable performance are set prior to study initiation. The outcome measures for the study are the sensitivity in identifying visual functional defects in patients with CNV.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* subjects with AMD related lesions: New onset (up to 60 days) non-treated CNV or Intermediate AMD patients (defined as the presence of at least one large drusen or more than 20 medium size drusen)
* Age \>50 years
* VA with habitual correction \>20/200 in study eye
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the targeted eye
* Inability to tolerate intravenous FA
* GA in the study eye
* Participation in another study with the exclusion of AREDS study