cyrilzakka/clinical-trials huggingface dataset:
The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders

Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.

We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.

Eligibility Criteria:
Inclusion Criteria:

* ED of more than 6 months
* Rigidity score ≤ 2 during PDE5i therapy
* Stable heterosexual relationship for more than 3 months
* Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

* Prior surgery or radiotherapy in pelvic region
* Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Cardiovascular conditions that prevent sexual activity
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
* Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
* Child in care.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean a dose equivalent to either \> 2 mg/kg/day of body weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when administered for more than 2 weeks. Inhaled and topical steroids are allowed.
* Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within six months preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute disease and/or fever at the time of enrolment.

  * Fever is defined as temperature ≥ 38.0°C/100.4°F by any route.
  * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.

This clinical study is aimed at :

1. evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
2. evaluating the pharmacokinetic (PK) profile of cidofovir after local application.


Eligibility Criteria:
Inclusion Criteria:

* women aged between 18 and 50 years old
* volunteers
* informed consent signed
* cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
* no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)

Exclusion Criteria:

* pregnancy or breast feeding
* subtotal hysterectomy
* current or ancient renal impairment
* current immune disorder
* current use of drugs interfering with renal function
* current treatment for any cancer
* current use of treatment interfering with immunity
* current use of anti-viral treatment
* current or recent participation to another experimental study during the last 3 months before the screening visit
* current vaginal application of drugs or cosmetics
* local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)

Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction. The incidence of complications may exceed 30%. It has been speculated that an exaggerated inflammatory response to surgical trauma and the CPB machine are likely causes for this morbidity. Factors predisposing organ dysfunction include tissue injury, endotoxemia, and oxidative stress. High risk patients can be identified preoperatively through the validated Parsonnet Additive Risk Score. CTI-01 has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. These findings support its clinical use in critical care medicine including cardiac surgery. Patients will receive a total of six doses, administered intravenously just prior to and after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Parsonnet additive risk score greater than or equal to 15
* Scheduled CABG (coronary artery bypass grafting) and/or cardiac valve repair or replacement surgery using cardiopulmonary bypass

Exclusion Criteria:

* Emergency cardiac surgery
* Significant concomitant surgery
* Minimally invasive or thoracic surgical approach
* Preoperative mechanical assist device
* Body weight \<50 kg or \>140 kg
* Active systemic infection
* Creatinine \>3.0 mg/dL
* History of hematologic or coagulation disorders
* History of malignancy (past year)or organ transplantation
* Use of immunosuppressive drugs or current immunosuppressed condition
Optimizing Quality of Life in Women Living With Metastatic Breast Cancer

The purpose of this study is to develop and tailor an intervention program to improve the quality of life in women living with metastatic breast cancer. In the first phase of this study, we conducted patient focus groups to gather information about the unique challenges of living with MBC and what kinds of support women would like to receive in a tailored Acceptance and Commitment Therapy (ACT) intervention. In the second phase of the study, we will conduct a three-arm randomized controlled trial to the tailored ACT intervention with both a Cognitive Behavioral Stress Management (CBSM) intervention and usual care. The CBSM and ACT intervention groups will meet with a trained facilitator and 8-9 other patients, once per week via videoconference for 90 minute sessions over the course of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with metastatic (stage IV \[M1\]) female breast cancer, via physician diagnosis and confirmed through staff review of electronic medical record (i.e. imaging, surgical pathology reports, etc.).
* Patients must be comfortable speaking English for participation in group sessions.
* Patients must be age ≥ 18 years.
* Patients taking part in the 8 week online pilot trial must have a physician-anticipated life expectancy of \> 6 months.
* Patients must have the ability to understand, and the willingness to sign, a written informed consent prior to registration on study.

Exclusion Criteria:

* Patients who have severe or impairing psychiatric illness/social situations that would limit compliance with study requirements are not eligible to enroll.
* Patients with early stage/non metastatic breast cancer (Stages I-III) are not eligible to enroll.
Evaluating the Relationship Between Tobacco Use, Anxiety Sensitivity, and Panic in Adolescents

This study will determine whether there is a relationship between tobacco use and a heightened response to panic-producing events among adolescents. This study is fundamental research. It was not a Clinical Trial.

Growing up is hard enough, and adolescence can be a particularly stressful time in people's lives as they adjust to the transition from childhood to adulthood. Peer pressure can add to this anxiety, making it more likely for teens to take part in risky behaviors such as smoking cigarettes. Every day, more than 4,000 teens smoke their first cigarette and nearly half of those teens will become regular, daily smokers. Cigarette smoking is associated with a multitude of health risks, including an increased likelihood of experiencing panic attacks, anxiety disorders, and depression. This study will evaluate a group of teens, ranging from those who have never smoked to those who smoke daily, to determine whether there is a relation between adolescent smoking history and their vulnerability to panic-producing situations.

Participants in this study will undergo a brief medical screening, followed by a short interview that will include several questionnaires regarding emotions, experiences, and personal habits. Participants will then attend a series of laboratory assessments for 1 hour. The first assessment will include a 3-minute voluntary hyperventilation procedure in which participants will be directed when to breathe in and when to breathe out, at a faster rate than normal. Participants will then take part in two computerized tasks: one will be a computerized task that involves blowing up a balloon and deciding when to quit before the balloon pops; the other task will involve choosing hypothetical amounts of money now or after a period of delay. During the laboratory assessments, all participants will have electrodes attached to their bodies and sensors around their chests to measure heart rate, palm sweating, and muscle tension. Results from this study will be used to evaluate the association between smoking and increased panic levels under stressful conditions among adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents, ranging from those who have never smoked to those who smoke daily

Exclusion Criteria:

* Current or past diagnosis of a panic disorder
* Acute or chronic cardiopulmonary or respiratory illness (e.g., asthma or bronchitis)
* Pregnant
Prevalence of Conjunctivitis and Indentification of Risk Factors With and Without Prophylactic Antibiotic Treatment in Neonates

The French guidelines for the use of Rifamycine eye drops in delivery room to prevent neonatal conjunctivitis have been actualized. Only newborns exposed to risk factors of conjunctivitis should be treated, compared to previous guidelines, treating all newborns. currently, there are no data describing risk factors for neonatal conjunctivitis. This study evaluated the incidence of conjunctivitis with or without Rifamycine eye drops treatment in the delivery room. Then risk factors for neonatal conjunctivitis where analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Newborns at the University Hospital of Amiens\> 36SA,
* Admitted in maternity at the exit of nursery

Exclusion Criteria:

* Newborns at the Amiens University Hospital \<36SA
* Eye drops for any medical reason within the first day of life.
Sleep-wake Patterns in Preterm Infants

The development of sleep-wake behavior is considered to be one of the most important maturation processes occurring in the first year of life. Sleep-wake behavior is related to neurobehavioral regulation of the infant and cognitive function, and gives important information about infant's health. It is suggested that the identification of sleep-wake patterns in preterm infants is critical to the detection of future disorders, early diagnosis and planning of intervention studies In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks of gestational age over six month in the Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital. Sleep wake cycles of these premature infants will be assessed at 32 weeks corrected age by actigraphy, sleep diaries, direct observation and Amplitude integrated electroencephalography (aEEG). We also aimed to investigate the maturation of sleep patterns of these infants included in the study at postconceptional 40th weeks of age, and 12th, and at 24th weeks corrected age, by sleep diaries and actigraphic measurements at their home environment. Development will be assessed by Bayley and Ages and Stages Questionnaire.

Studies show that the patterns of sleep-wakefulness reflect the maturation of the central nervous system in preterm infants and are indicative of behavioral development. It is emphasized that the identification of sleep-wake patterns in preterm infants is critical to the detection of future disorders, early diagnosis and planning of intervention studies.

The primary objective of this study is to assess factors affecting the maturation of sleep wake cycles in preterm infants by actigraphy, sleep diaries, direct observation, and aEEG. Our secondary objectives were to assess the neurodevelopment of these infants.

In this study we aimed to recruit a total of 25 premature babies born between 28 to 37 weeks of gestational age over a six month period in the Neonatal Intensive Care Unit of Marmara University Pendik Training and Research Hospital. Sleep architecture will be assessed at 32 corrected age by actigraphy, sleep diaries, and aEEG. Simultaneous video recording and direct observation will be performed and sleep stages will be defined. Anderson Behavioral State Scale will also be applied. Philips Respironics Actiwatch-2 devices will be used. The follow up will be at post conceptional 40 weeks, 12 and 24 weeks corrected age. Development will be assessed by Bayley test and Ages and Stages Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Being preterm admitted to Neonatal Intensive Care Unit
* Gestational age must be between 28 to 37 weeks

Exclusion Criteria:

* Preterm still receiving invasive mechanical ventilation at the time of data collection,
* Major congenital anomalies,
* Critically ill babies (sepsis),
* Major cerebral injuries (intraventricular hemorrhage grade III, and IV, periventricular leukomalacia)
* Retinopathy of prematurity grade III and IV,
* Necrotizing enterocolitis
* Infants using sedative or anticonvulsant drugs
Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light

This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..


Eligibility Criteria:
Inclusion Criteria:

Potential subjects must satisfy of all the following criteria to be enrolled in the study.

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 years of age (inclusive) at the time of screening.
4. By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:

   1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
   2. Cylinder powers (DC) -0.75 and -1.25
   3. Axes (degrees) 170, 180, 10, 80, 90, 100
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have an ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact lenses.
7. Be currently wearing lenses in an extended wear modality.
8. Have a history of strabismus or amblyopia.
9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
The Effectiveness of Progressive Relaxation Exercises

The purpose of this study is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA. Seventy patients with TKA are going to randomly assigned to intervention group and control group.

Total knee arthroplasty (TKA) is applied in end-stage osteoarthritis to reduce pain, improve functional ability, and provide greater health related quality of life. However, evidence showed that presence of severe pain, impaired functional outcomes and reduced muscle strength continue up to 6 to 12 month after surgery. Relaxation techniques such as progressive muscle relaxation exercise and rhythmic breathing have long been used in treating postoperative pain and for various health-related purposes. Although the number of studies that include relaxation techniques in treating postoperative pain is increasing, there isn't any study that investigate the effectiveness of progressive muscle relaxation exercise on pain, functional outcomes and muscle strength in patients with TKA.

The aim is to investigate the effectiveness of progressive muscle relaxation (PMR) exercise on pain, functional outcomes and muscle strength in patients with TKA.

Eligibility Criteria:
Inclusion Criteria:

* 30 years older above
* Preoperative diagnosis have to be knee osteoarthritis
* Have a primary total knee arthroplasty
* Able to understand Turkish instructions
* Willing and able to attend study

Exclusion Criteria:

* Revision total knee arthroplasty
* Unable to understand verbal and written instructions
* Having previously orthopaedic or neurological disorder that causes gait disturbance
Red Blood Cell Distribution Width and Charlson Comorbidity Indeces in the Frail Polytraumatized Patient.

In this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from January 2012 to December 2015. Patients with an ISS\>16 points, an AIS \>3 in one body region and at least 2 different body regions affected were included. RDW values on admission as well as preexisting comorbidities were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ISS \>16 points
* AIS \>3 in one body region
* at least 2 body regions affected

Exclusion Criteria:

* patients younger than 18 years of age
* isolated traumatic brain injury
* minor injuries (AIS \<3 or ISS \<16 points)