cyrilzakka/clinical-trials huggingface dataset:
A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate

The purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

This is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. Patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. This study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. The patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. Patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. Each cycle of treatment will be 28 days. Investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. No efficacy data are being collected. Safety will be monitored throughout the study for a maximum duration of 9 years. End-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets.

Exclusion Criteria:

* Medical conditions that require hospitalization.
* Any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine

Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

Primary efficacy endpoint:

The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).

Key secondary endpoint(s):

1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
2. Individual dimensions of the Oswestry Disability Index (ODI)
3. Time until radiological adjacent instability and comparison to the clinical outcome
4. Capacity of work at the time of surgery and after surgery, time until return to work

Assessment of safety:

1. Treatment complication in control and intervention groups (SAE-management)
2. A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

Eligibility Criteria:
Key inclusion criteria:

1. Male or female \>30 years of age
2. Lumbar spine pathology with indication for monosegmental PLIF
3. Radiological signs of a degeneration of the adjacent segment without instability

Key exclusion criteria:

1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine

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The Effectiveness of Non-Invasive Ventilation Use in Preterm Infants.

Prospective observational study of SNIPPV use in preterm infants of less than 32weeks of gestation from January 2012 to December 2015. Previous respiratory status is analyzed as well as respiratory outcomes and possible secondary side effects.

SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP \> 10 cmH2O and FiO2\>35%).

SNIPPV is used to prevent Intubation in Infants in which nCPAP has already failed (Infants that met intubation criteria) and also is used electively for extubation when nCPAP extubation has previously failed or infants with Prolonged mechanical ventilation (more than 15 days) with high respiratory parameters (PMAP \> 10 cmH2O and FiO2\>35%).

Eligibility Criteria:
Inclusion Criteria:

* Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied for nCPAP failure.
* Preterm Infants of less than 32 weeks of GA in which SNIPPV is applied electively for extubation.

Exclusion Criteria: None
Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear

Our study is aimed to observe the long termed effect of contact lens wear on ocular surface, especially focused on visual function and ocular inflammation mediators.

Contact lens fitting are important treatments for many ocular diseases as they provide three main therapeutic applications: visual correction, protection of ocular surface, and cosmetic or sport purposes. The ophthalmology department of NTUH has set up contact lens special clinic as one of our comprehensive refractive services. The investigators provided corneal lenses or Rose K lenses for optical correction of keratoconus patients; the investigators also fitted large scleral lenses for the correction of irregular astigmatism for post-penetrating keratoplasty and post-refractive surgery patients. In addition, contact lenses can be an adjuvant therapy for ocular surface disorders as severe dry eye and limbal insufficiency. There were researches that proved the inflammatory mediators and neutrophils increased after long-termed wear of silicon hydrogel soft lenses or over night orthokeratology lenses. They also concluded that lens wear affected corneal epithelial proliferation. However, the physiological changes after long-termed wear of large diameter scleral lenses are still pending. In addition, we still do not understand the lens effects on high order aberration and ocular surface structures. The purpose of our study is to analyze the epidemiologic data and treatment results of the patients fitted with specialty lenses in our contact lens clinic from Aug 2016 to Aug 2018. Patients will be categorized into different groups by the diagnoses and the type of lens wear. After 6 months of follow up, the change of visual acuity, visual function related quality of life, the changes of ocular surface structures and physiology will be analyzed. The investigators hope to share the experiences of specialty contact lens fitting and understand the effects of long-term contact lens wear on ocular surface.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 65
* contact lens wear
* willing to be followed for at least 6 months

Exclusion Criteria:

* active ocular infection
* active corneal melting
* inability to follow lens cleaning instructions
* pregnancy
Acute Study on Muscle Soreness, Damage, and Performance

The acute study will evaluate pre- and post-exercise ingestion of a multi-ingredient supplement in a randomized, double-blind, placebo-controlled, crossover design. Participants will complete one enrollment visit, in which they will sign a consent form and complete a health history questionnaire. Participants will complete two interventions, with three visits each (6 visits total), in which a treatment beverage (pre/post supplement, or non-caloric placebo) will be consumed within 30 minutes prior to exercise and within 15 minutes post-exercise, in random order. Total time from enrollment to completion will be at least 14 days. Testing visits will be separated by a minimum of 7 days of rest to allow for recovery and washout, based on a half-life of ≤8 hours for all ingredients present in the supplement.


Eligibility Criteria:
Inclusion Criteria:

* Participant is an adult between the ages of 25-50 years
* Participant has a recorded BMI of 20-35 kg/m2
* Participant exercises less than 3 hours per week for at least 8 weeks preceding the study
* Participant has provided written and dated informed consent to participate in the study
* Participant is willing to and able to comply with the protocol
* Participant is apparently healthy and no reported metabolic disorders, heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire
* Participant agrees to maintain current diet and exercise routine during the study
* Participant agrees to refrain from taking any anti-inflammatory supplement 48 hours prior to exercise (acute) or medications to prevent any further nutritional or drug related protection against exercise induced muscle damage
* Participant has a resting (seated for 5 minutes) blood pressure of systolic pressure between 140-90 mmHg and a diastolic pressure between 90-50 mmHg

Exclusion Criteria:

* Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement
* Participant is using, or has consistently used one of the following dietary supplements within 12 weeks prior to enrollment: Beta-alanine, Creatine, HMB, Carnosine, Vitamin D
* Participant has consistently consumed whey protein/plant protein and/or 1,000 mg of fish oil within the previous 4 weeks prior to enrollment
* Participant has gained or lost ≥ 8 lbs in the previous month
* Participant has a known allergy or sensitivity to the placebo or active ingredients
* Participant has used tobacco more than three days per week (on average) in the previous 6 months, or refuses to abstain from all tobacco use for the duration of the study
* Participant is pregnant or planning to become pregnant
* Participant has any musculoskeletal condition prohibiting them from participation
Immediate Skin-to-skin Contact After C-section

At birth, the passage from intrauterine to the aerial life can be considered as one of the most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to provide numerous virtues and World Health Organisation (WHO) recently supported the introduction of such care among healthy, term-born neonates. Here, the investigators hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section born neonates that received either immediate STSC with mother (intervention) or classical support and monitoring (control).

Women are recruited before elective c-section.

Randomizatiion is performed just before the operation.

Control group:

The operation is performed as usual, with observation of the newborn by medical staff. The newborn is then wrapped in a blanket and given to the father.

Intervention group:

The newborn is given to the mother in the first minute of life, placed on her chest to allow complete skin-to-skin contact. Observation of the baby is performed in this position. The skin-to-skin contact lasts as long as the operation is not completed or the mother is not able anymore to keep her baby on her chest.

Sampling (in both groups):

* salivary samples are obtained with salivettes from the mother 1)before the operation and 2) after the operation, in the recovery room (90 minutes after birth).
* salivary samples are obtained with salivettes from the newborn 1) 20 minutes after birth and 2) 20 minutes after the vitamin K injection (performed at 60 minutes of life)
* A cord blood sample is obtained for prolactin, ACTH and cortisol analysis.

Video recording:

The newborn is video recorded at the vitamin K injection (from 1 minute before the injection to 5 minutes after) for analysis with the Neonatal Infant Pain Scale.

Satisfaction:

The mother's satisfaction is evaluated with a questionnaire 24 to 48 hours after birth.

Breastfeeding:

The breastfeeding is evaluated by a research nurse 1) at the hospital and 2) by phone interviews, up to 6 months after birth.

Eligibility Criteria:
Inclusion Criteria:

* elective C-section
* term pregnancy
* signature of an information and consent form

Exclusion Criteria:

* multiple pregnancy
* labor
* fetal distress
* abnormal anticipated birth weight
* congenital malformation
* diabetes
* fever
* rapid management of the new born required
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)

To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.

This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics in healthy adult participants after single and multiple subcutaneous injections of pegilodecakin.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18 and 55 years of age, inclusive
2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening
3. Must be HIV negative by HIV 1/0/2 testing
4. Must be Hepatitis B (HBV) surface antigen negative
5. Must be Hepatitis C (HCV) antibody negative
6. Females must have a negative serum pregnancy test
7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the study and continuing for at least 30 days from date of last dose of study drug

Exclusion Criteria:

1. Pregnant or lactating subjects
2. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing
3. Have poor venous access and are unable to donate blood
4. Have been vaccinated within 90 days of study dosing
5. Current alcohol or substance abuse judged by the Investigator to interfere with subject compliance
6. Have history of significant drug sensitivity or drug allergy.
A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.

Background: A lot of children with cancer suffer from emotional distress, fatigue and relational difficulties. Their parents are also impacted by the disease: their responsibilities increase and they can feel more distressed and tired. Different psychological interventions designed for ill children and their parents seem to be efficient to improve their social functioning, coping strategies and well-being. However, more research is needed in this field. Hypnosis is often used in paediatric oncology, mostly to decrease procedure-related pain and distress. It has been used efficiently to improve the well-being of adults with cancer. This paper describes a pilot study designed to assess the feasibility and interest of a group intervention combining self-care and hypnosis for children with cancer and their parents, and a quasi-experimental protocol aimed at assessing the efficacy of this group intervention to improve the quality of life of children and their parents.

Methods: Our pilot study showed that our intervention was feasible and positive for the participants. To test the efficacy of the intervention, two groups will be set up: one with children with cancer and their interested siblings, and one with their parents. Data will be collected for each group before and after the intervention by questionnaires and a semi-structured interview.

Discussion: There is a growing interest in hypnosis in oncology settings. The results of this study should improve knowledge about the efficacy of a group intervention combining self-care and hypnosis to improve quality of life of children with cancer and their family.


Eligibility Criteria:
Inclusion Criteria:

* Children and their siblings:

  * To be 8 to 18 year-old
  * To suffer from cancer (all localisations, stage and treatments accepted) or to have a sibling who suffer from cancer
  * To speak french
* Parents:

  * To have a child who suffer from cancer
  * To speak french

Exclusion Criteria:

* /
HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (\<or = 3 months) in spasticity improve functional and motor tests compared with late injections (\>or = 6 months).


Eligibility Criteria:
Inclusion Criteria:

* Minimum age 18
* Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
* Antispasticity medication stabilized for the last 30 days
* Severe cognitive impairment such that patient is unable to provide scale assessment.
* Significant spasticity impeding improvement by re-education for 2 months or less
* Lack of muscular retraction defined by a minimal range of articular motion as :

  * finger : complete extension and rolling up
  * wrist : extension 40°/flexion : 45°
  * elbow : extension - 10°/flexion : 120°
  * shoulder : Enjalbert score 2 or more
* Antagonist muscles (to spasticity) activity score 1 or more
* Social Security benefits

Exclusion Criteria:

* Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
* Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
* Absence of mobility in proximal part of upper limb that does not predict a functional gain
* Minor stroke with non-disabling deficit or rapidly improving motor symptoms
* other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
* Treatment of spasticity by previous administration of botulinum toxin, if known
* Known allergy to botulinum toxin
* Currently participating in other research studies
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.


Eligibility Criteria:
Inclusion Criteria:

1. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
2. Emergent, exsanguinating hemorrhage, from abdominal source as defined by:

   * Class III or IV hemorrhagic shock or
   * Assessment of Blood Consumption (ABC) score ≥ 2
3. Confirmation of abdominal hemorrhage by:

   * Direct visualization or
   * Positive Focused Assessment with Sonography in Trauma (FAST) or
   * Diagnostic Peritoneal Aspiration (DPA)
4. No other known, uncontrolled active sources of hemorrhage
5. Subject is intubated and sedated per local guidelines
6. Decision to administer foam is made within 30 minutes of admission to the emergency department.
7. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
8. Definitive surgical care is expected to occur within three hours of foam deployment
9. Subject must also be receiving concurrent transfusion of fluids or blood products.

   Exclusion Criteria:
10. Known or suspected major diaphragm injury
11. Known or suspected untreated pneumothorax
12. Known or suspected untreated hemothorax
13. Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
14. Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
15. Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
16. Patients with Pulseless Electrical Activity
17. Known allergy to isocyanate
18. Known or suspected pregnancy
19. History of prior abdominal surgery or evidence of abdominal surgery (scars)
20. Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
21. Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
22. Known Prisoners
23. Subjects with burns \> 20% of total body surface area
24. Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
25. Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
26. Known enrollment in another randomized, interventional study
Early Antenatal Support for Iron Deficiency Anemia

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Gestational age \<24 weeks
* Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia

Iron deficiency anemia diagnosed (at any point in patient history) by:

* Hb\<11.0
* Ferritin\<30 and/or total iron saturation \<20

Exclusion Criteria:

* Sickle cell Disease (NOT sickle cell trait)
* Evidence of acute anemia requiring transfusion or IV iron therapy
* Major congenital or chromosomal anomaly
* Previous use of IV iron in this pregnancy
* Severe cardiac, renal, or liver disease
* Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
* Allergy or contraindication to either study drug
* History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products
Effect of Non-invasive Vagus Nerve Stimulation on Cognitive Functions in Diabetic Polyneuropathy Patients

Diabetic peripheral neuropathy (DPN) occurs due to long standing hyperglycemia and associated metabolic derangements. Cognitive impairment is a common complication in diabetes mellitus. It is associated with a faster rate of cognitive decline.

This research aims to

* determine the effect of non-invasive Vagus nerve stimulation on cognitive functions in diabetic peripheral neuropathy.
* investigate the correlation between cognitive function and severity of diabetic neuropathy.
* investigate the correlation between cognitive function and quality of life in diabetic peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* patients with diabetic polyneuropathy
* Female patients.
* age ranges from 40 to 55 years old.
* Duration of diabetic illness started since at least three years.
* Patients with mild to moderate neuropathy according to Toronto clinical neuropathy score
* Patients with cognitive function ranges from 24 - 15 score according to Mini mental state examination
* Patients with HbA1c ranges from seven to nine score.
* Ambulant patients with or without walking aids.
* Medically and psychologically stable patients without cardiac problems, confirmed by Electro Cardiogram (ECG).
* able to understand instructions.

Exclusion Criteria:

* Type I diabetes mellitus.
* Severe visual, verbal or acoustic impairments.
* Sever cognitive dysfunctions or that caused by other cause rather than diabetes mellitus.
* Polyneuropathy caused by other cause rather than diabetes mellitus.
* Other neurological problem as stroke.
* Cardiovascular problems.
* Metallic implants
* Illiterate patients.
* Uncooperative patients.