cyrilzakka/clinical-trials huggingface dataset:
The Effect of Light Level Applied During Breastfeeding on Maternal Stress, Anxiety, Psychological Well-being and Breastfeeding Motivation

To determine the effect of the light level applied during breastfeeding on the mother's stress, anxiety, psychological well-being and breastfeeding motivation. This research was planned as a single-blind randomized controlled experimental type study comparing separate groups as intervention-placebo controlled. Data will be collected with the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI) and Breastfeeding Motivation Scale (For Primiparous Mothers). The effect of two different light levels on mothers will be examined.


Eligibility Criteria:
Inclusion Criteria:

* being 18 years of age or older, volunteering.

Exclusion Criteria:

* Having any problem that prevents communication
Compare the Scapular Muscular Endurance, Stabilization and Dyskinesis Parameters of Sedentary Individuals

The aim of this study was to compare the parameters of scapular muscular endurance, scapular stabilization, scapular dyskinesia, upper extremity functional status and postural alignment of adult women aged between 40-65 years old who were performing clinical pilates exercises regularly compared with sedentary adult women in the same age group and to determine whether regular exercise had an effect on these parameters.

The aim of this study was to compare the parameters of scapular muscular endurance, scapular stabilization, scapular dyskinesia, upper extremity functional status and postural alignment of adult women aged between 40-65 years old who were performing clinical pilates exercises regularly compared with sedentary adult women in the same age group and to determine whether regular exercise had an effect on these parameters. A total of 70 individuals were included in the study, including 35 individuals performing regular clinical pilates exercises and 35 individuals with sedentary lifestyles. Clinical pilates group was selected from the individuals who participated in the exercise program under the control of a physiotherapist regularly for 1 hour, 2-3 days a week for at least 6 months. Socio-demographic characteristics, health status and exercise habits of the participants were recorded. For scapular muscle strength assessment, digital hand dynamometer; for scapular muscular endurance assessment, Scapular Muscular Endurance Test (SMET) and Shoulder External Rotation Fatigue Protocol; for the assessment of scapular dyskinesia, Lateral Scapular Slide Test (LSST) and Lennie test; for assessment of upper extremity functional status, Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); for the assessment of postural alignment, the New York Posture Assessment Test were used.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who perform clinical pilates exercises regularly for at least 6 months and at least 2 days a week (pilates group)
* Individuals who are not actively involved in any sports and do not exercise / physical activity regularly (sedentary group)

Exclusion Criteria:

* Individuals diagnosed with scoliosis or any other orthopedic and neurological problems
* Individuals who have had any diagnosis / treatment or had previous surgery due to shoulder and shoulder circumference problems in the last 6 months
* Individuals with shoulder elevations less than 140 degrees
Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.


Eligibility Criteria:
Inclusion Criteria:

1. Moderate to severe ARDS with a P/F ratio \< 200 mmHg
2. On invasive mechanical ventilation
3. The onset of ARDS \< 72 hours

Exclusion Criteria:

1. Age \<20 years
2. Receiving systemic glucocorticoid therapy
3. Uncontrolled gastrointestinal bleeding
4. Terminal cancer
5. Post-operation or with large wound
6. Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy
7. Anticipating to receive chemotherapy and immunotherapy in 3 months
8. Uncontrolled fungal infection
9. Post solid organ or bone marrow transplant
10. Severe influenza without anti-viral therapy
Role of Early Point of Care Ultrasound in Management of Sepsis in Emergency Department

Aim of the study is to determine the diagnostic accuracy of point-of-care ultrasound and to determine its role in sepsis management .

Two groups of patients will be studied one group will undergo POCUS examination and the other will not undergo POCUS examination then comparison between them will be done regarding accuracy of diagnosis and time taken to reach diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the Emergency Department (ED) of Alexandria Main University Hospital (AMUH) with sepsis.
* Patients presented with septic shock.

Exclusion Criteria:

* Age less than 18
* Trauma patients.
* Pregnant females.
* Patients with terminal malignancy.
* Patients taking immunosuppressive drugs or chemotherapy.
Positive End-expiratory Pressure and Alveolar Recruitment for One Lung Ventilation

Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .

outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* age: 20-75 years

Exclusion Criteria:

* moderate to severe impaired respiratory function,
* heart failure,
* patients' refusal
Mindfulness-based Stress Reduction for Urban Youth

Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.

A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.

Eligibility Criteria:
Inclusion Criteria:

* 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.

Exclusion Criteria:

* Significant developmental, behavioral, substance abuse, or psychiatric disorders
The Effect of Fractional Co2 Laser Either With Tacrolimus, Calcipotriol or NB-UVB in Stable Generalized Vitiligo

Vitiligo is an acquired disorder of the skin and mucous membranes characterized by well circumscribed depigmented macules and patches that occur secondary to selective destruction of melanocytes (Zhang et al., 2009).

Generalized vitiligo is the most common clinical presentation and often involves the face and acral regions (Alikhan et al., 2011).

Combined vitiligo treatments have been found to be superior to monotherapies regarding efficacy, early response and safety (Kandaswamy et al., 2013).

Fractionated lasers represent a new modality for skin resurfacing based on the theory of fractional photothermolysis introduced by Manstein et al (2004). These lasers were shown to be efficient in treating facial photo aging changes as well as scars, and have an improved safety and recovery profile compared with traditional CO2 laser resurfacing. Fractionated lasers do not ablate the entire epidermis and thereafter leave intact skin between coagulated necrotic columns. This characteristic facilitates the skin healing process (Bogdan et al., 2010)

Eligibility Criteria:
Inclusion Criteria:

* patients with stable vitiligo
* nonsegmental vitiligo will be recruited
* A patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the previous year

Exclusion Criteria:

1. Patients with active infection.
2. Reported histories of koebnerization.
3. History of keloid formation or hypertrophic scars.
4. Pregnant or lactating females.
5. Bleeding tendency.
Personalized Patient and Caregiver Education After Stroke

This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.


Eligibility Criteria:
Inclusion Criteria:

* Admitted for ischemic stroke
* At least 18 years old
* Patient or caregiver has access to a smart phone, tablet or computer
* Being discharged to either home or acute rehab

Exclusion Criteria:

* Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer
* Being discharged to a skilled nursing facility
* moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.

Exclusion Criteria:

* Patients with local invasion or metastatic foci in salivary glands, detected by MRI and PET-CT prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.
The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.


Eligibility Criteria:
Inclusion Criteria:

1. Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
2. Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
3. Requests of clinical research program can be obeyed
4. No other protective product is inoculated in last week
5. Axillary temperature below 37 degrees Celsius

Exclusion Criteria:

1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
3. History of progressive or severe neurologic disorder
4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
10. Guillain-Barre Syndrome
11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
14. Any conditions may influence the evaluation
Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 1 Patients

The study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 1 (SMA 1) patients.

The purpose of this trial is to evaluate safety and efficacy of gene therapy drug GC101 in SMA 1 patients. Open-label, dose-escalation clinical trial of GC101 will be conducted in multiple centers in China.

GC101 will be administrated intrathecally. Short-term safety will be evaluated in 52 weeks and enter long-term follow-up study of 5 years at will. Patients will be tested at baseline and followed up on various time points.

The primary analysis for efficacy will be assessed when all patients reach 18 months of age on the motor milestone of sit unassisted for at least 10 seconds.

Eligibility Criteria:
Inclusion Criteria:

* Six months of age and younger on day of vector infusion with Type 1 SAM as defined by the following features:

  * Diagnosis of SMA based on gene mutation analysis with bi-allelic SMN1 mutations (deletion or point mutations) and 2 copies of SMN2;
  * Onset of disease before 6 months of age
* The patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed.

Exclusion Criteria:

* Patient who has participated in a previous gene therapy research trials;
* Patient who has received Nusinersen and Risdiplam treatment;
* Patient who has AAV9 neutralizing antibody titer ≥1:200;
* Patient who requires non-invasive ventilatory support averaging≥16 hours/day;
* Patient with a point mutation in SMN2 (c.859G\>C);
* Patient who requires non-invasive ventilatory support averaging≥16 hours/day at screening;
* Patient who use invasive ventilatory support or pulse oximetry \< 95% saturation while awake and calm at screening;
* Patient who is positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C antibody, or treponema pallidum antibody;
* Abnormal laboratory values considered clinically significant, including gamma-glutamyl transferase(GGT), Aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin \> 3x upper limit of normal (ULN), Hemoglobin (Hgb)\< 110 or \>150 g/L, platelet \<183x10\^9/L or 614x10\^9/L;
* Class IV patient based on Modified Ross Heart Failure Classification for Children;
* Patient with a history of glucocorticoid allergy;
* Contraindication that would interfere with the lumbar puncture procedures;
* Presence of an untreated active infection requiring systemic antiviral therapy at any time during the screening period;
* Vaccination less than 2 weeks before infusion of vector;
* Patient who has any concurrent clinically significant major disease or any other condition that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study.

Note: Other protocol defined inclusion/exclusion criteria may apply.
Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.


Eligibility Criteria:
INCLUSION CRITERIA:

1. Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.
2. Patients must have been diagnosed with idiopathic PD at \> 30 years of age.
3. Patients must have predictable motor fluctuations of the wearing "OFF" type.
4. Patients must rate between II-IV on the Hoehn \& Yahr scale when in an "OFF" state.
5. Patients must be taking optimized levodopa therapy.

EXCLUSION CRITERIA:

1. Pregnant or lactating women.
2. Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.
3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
5. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)

Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Implantation with a wireless-enabled ICD

Exclusion Criteria:

* Age \<18yrs
* inability to sign an informed consent
* pacemaker dependancy
COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS

This study aims to compare the pain experienced by patients undergoing orthodontic treatment with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment with conventional braces. Because the aligners are removable, nearly invisible and don't involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign Treatment and less affectation of the quality of life.

The aims of the study are to determine:

the presence of pain, the magnitude of pain, the duration of pain, and the location of pain.

The hypotheses of this study are:

* Treatment with Invisalign ® aligners result in less pain than the braces
* Treatment with Invisalign ® aligners result in less irritation to the soft tissues with braces
* Pain should increase each time the aligners are put in the mouse and decrease until disappearing on the third day.
* The quality of life will be most affected by treatment with braces than with Invisalign ®.
* Null Hypothesis: There is no difference at all points between the two treatments.

Eligibility Criteria:
Inclusion Criteria:

* In permanent dentition;
* Age less than 30 years;
* No medical contraindications or presence of systemic diseases (including nervous system disorders);
* No missing teeth except the third molars;
* Orthodontic treatment without extraction.
* Relationship skeletal cl. I (or slightly cl. II or cl. III)
* Speak and understand French without help.

Exclusion Criteria: lack of compliance with appointments.

-
Detection of Topographic Residual Acuity in Patients With Age Related Macular Degeneration

Standard perimetry provides information on topographical retinal sensitivity to light stimuli, however the said locus is not necessarily the preferred locus for fixation. Standard perimetry could also be used as a way for macular scotoma mapping, indirectly showing the fixation locus. Topographic acuity at the preferred retinal locus can be determined if correlation between loci with high sensitivity, eccentric fixation loci and potential visual acuity measurements are correlated.

PURPOSE OF THE STUDY:

Determination of visual acuity at preferred retinal locus in Low Vision patients with ARMD using eye standard automated and computerized perimetry methods.


Eligibility Criteria:
Inclusion Criteria:

* AMD with documented pathology
* Low Vision both eyes
* BCVA 20/50-20/400 in best eye

Exclusion Criteria:

* Cognitive impairment
* Other retinal pathology
* Previous retinal surgery
* Significant media opacity