cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Individuals considered for entry into the study will be of either sex and any race who have:
* a confirmed diagnosis of dry eye,
* are willing to use no ocular treatments during the study other than study medication,
* have a corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of +0.7 logarithm of the minimum angle of resolution (logMAR) or better in each eye,
* will not use contact lenses during the study,
* Females of child-bearing potential must have a negative urine pregnancy test and be willing to use an acceptable method of contraception to be eligible for, and continue participation in, the study,
* 18 years of age or older,
* able to understand and provide written informed consent

Exclusion Criteria:

* Subjects with any of the following are not eligible to participate in the study:
* Fluorescein corneal staining or conjunctival staining that is too severe
* Conditions requiring the use of ophthalmic prescription or over the counter medications during the study (except for study medications)
* Any type of current punctal occlusion including punctal plugs, intracanalicular punctal plugs or cauterized puncta
* Any type of ocular surgery within 90 days prior to Visit 1 (Day 1)
* Known history of Steven-Johnson's syndrome, Riley-Day syndrome, and/or ocular pemphigoid
* Ocular(including lid)disease/abnormality that may interfere with the study
* Corneal transplant in either eye, at any time prior to enrollment in the study
* Laser refractive surgery less than one year prior to Visit 1 (Day 1)
* Conditions requiring the use of any systemic medication that is not ongoing at a stable dosage for at least 30 days prior to Visit 1 (Day 1)
* Application of isotretinoin within 30 days prior to Visit 1 (Day 1)
* Known allergy or sensitivity to any of the study medication components
* Uncontrolled systemic conditions or other conditions which would confound the study evaluations or endanger the safety of the subject
* A woman who is pregnant, nursing, or planning a pregnancy
* Participation in another investigational drug or vaccine trial, or participation in such a trial within 30 days prior to Visit 1 (Day 1)
Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.

A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-100 years
* Histologically confirmed (according to the World Health Organization (WHO)/EORTC classification) MF/SS stages I-IV
* WHO performance status 0 -3
* Absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
* Written informed consent according to International Conference on Harmonization (ICH)/(Good Clinical Practice (GCP), and Swedish regulations
* No minimum or maximum required routine laboratory data

Exclusion Criteria:

Not applicable. No exclusion criteria are specified.
Ribavirin for Severe Acute and Chronic Hepatitis E Virus Infection.

The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks).

The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 18 years.
* To comply with any of the following diagnoses:
* chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months .
* severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR\> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease.
* Signed informed consent

Exclusion Criteria:

* Terminal illness with a expected life expectancy of less than 6 months
* Patients with contraindications for treatment with Ribavirin:
* pregnancy or lactation.
* Severe hepatic impairment or decompensated cirrhosis.
* hemoglobinopathies (thalassemia, sickle cell anemia).
* history of severe pre-existing cardiac disease, including unstable heart disease.
A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)

The purpose of this study is to evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.


Eligibility Criteria:
Main inclusion criteria:

* The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.
* The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.
* The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study

Main exclusion criteria:

* The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.
* The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability

More inclusion and exclusion criteria may apply
NAD Supplementation Study

This research project aims to determine whether supplementing with a mixture of the NAD+-precursors NA, NAM, and tryptophan can stimulate skeletal muscle mitochondrial function in physically compromised, elderly humans. Outcomes are related to mitochondrial function, energy metabolism, and physical function will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age ≥ 65 ≤ 75 years;
* BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
* Normal physical activity levels: maximum of 1 hour per week engagement in a structured exercise session;
* SPPB score 4-9 and (pre-)frail;
* Subject should be in sufficient health to participate in the experiments, to be judged by the responsible physician based on the subject's medical history.

Exclusion Criteria:

* Not meeting all inclusion criteria;
* Smoking;
* Excessive alcohol use and/or drug abuse;
* Subjects with diabetes mellitus type 2;
* Significant food allergies or intolerances concerning the study products;
* Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
* Medication use known to hamper subject's safety during the study procedures;
* Subjects who use selective serotonin re-uptake inhibitors (SSRI), or selective norepinephrin re-uptake inhibitors (SNRI), or monoamino oxidase inhibitors (MAO-inhibitors), or clomipramine, or St. John's wort (Hypericum perforatum);
* Subjects with contra-indications for MRI;
* Subjects who do not want to be informed about unexpected medical findings;
* Subjects who do not want that their treating physician to be informed;
* Co-morbidities to which the intervention or program the may pose as a complicating factor;
* Inability to participate and/or complete the required measurements.
Pharmacological and Non-pharmacological Interventions in Management of Venipuncture Pain.

To evaluate whether an integration of pharmacological and non- pharmacological interventions is more effective than either one of intervention in pain reduction during pediatric peripheral venipuncture.

Intravenous infusion is a routing practice of drug administration for hospitalized children.However numerous studies have shown that venipuncture is a major source of pain of children during their hospitalization which can lead to moderate to severe pain and cause fear, stress and anxiety in children if there is no effective pain management.

The current pain relieving methods include pharmacological (i.e. topical anesthetic) and non-pharmnacological (i.e. distraction techniques) interventions. pharmacological There are scarce evidences supporting that a combination of pharmacological and non-pharmacological interventions can enhance children's abilities in coping with their pain and stress during the venipuncture. EMLA cream is a main pharmacological intervention in managing needle-related pain which can penetrate the cuticle and epidermal layer of intact skin, enter the dermis where nerve endings are located, and relieve pain. However pharmacological interventions have proven inadequate in mitigating pain and stress.The main non-pharmacological alternatives is distraction techniques. There are extremely limited data studies on merging pharmacological and non-pharmacological interventions to compensate for each other's inadequacies. Hence, this study aimed to evaluate the effect of combining both topical anesthetic and distraction techniques in comparison with either of the interventions applied singly.

This study adopts a randomized, blind, controlled intervention trial. Participants will be randomly assigned to three groups: EMLA group, Distraction group and Combined group (EMLA cream plus distraction techniques). The outcomes will be measured by self-reported pain, parent-reported pain and observer-reported pain. Salivary cortisol level will be measured by the ultra sensitive Cortisol Saliva ELISA Assay Kit. Other physiological metrics like heart rate, SpO2, and other intravenous cannulation factors will be rated and recorded.

Eligibility Criteria:
Inclusion Criteria:

Children aged 3-16 years who receive first peripheral intravenous puncture during hospitalization.

Exclusion Criteria:

1. Emergency peripheral intravenous puncture.
2. Allergic history for lidocaine cream.
3. Presence of cognitive impairment, hearing impairment or visual impairment.
4. Children who were discharged from the hospital after participating in the experiment but were readmitted due to illness.
5. Refuse to participate in the study.
Evaluating the State of Microvessels by Minimum Rise Time (MRT01)

Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. The objective of the current study is to investigate a potential relationship between MRT (minimum rise time, in time units) a measure derived from PPG and the state of microvessels.

This study includes a 1-2 hour single session per subject during which PPG and other microvascular and systemic variables will be monitored in response to non-invasive interventions that are known to elicit microvascular responses.

Photoplethysmography (PPG) is a simple uncalibrated optical method of monitoring variations in skin blood volume. A major limitation of PPG is the lack of a quantitative method for calibrating this signal. A method that provides an absolute measure (in time units) called 'minimum rise time' (MRT) was published in 1985 by Dr. Benjamin Gavish, one of the study investigators. However, a possible relationship between MRT and the state of arterioles that determines the microvascular flow has never been investigated. Such relationship, if validated, could have clinical impact in noninvasive diagnosis of vascular diseases and monitoring microvascular response to treatments that affect at both clinic and home setting.

The objective of the current study is to investigate a potential relationship between variations of MRT (minimum rise time, in time units) and microcirculatory variables induced by interventions that are expected to have acute effect on the state of arterioles and the tissue oxygenation.

This study includes a single 1-2 hour session per subject, during which PPG and other microvascular and systemic variables will be monitored in healthy volunteers in response to a number of non-invasive interventions/device that are approved for clinical use and known to elicit microvascular responses. These interventions are applied consecutively, include breathing at different rates, low power visible light in the red-to-near-infrared range, and local temperature changes. The experimental sessions will be conducted at the Afeka College by the study investigators.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, between 18 and 65 years of age.
2. Willing to sign informed consent.

Exclusion Criteria:

1. Currently smoking
2. Any abnormal skin condition in the area of light irradiation.
3. Pregnant having given birth less than 3 months ago, and/or breastfeeding.
4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
5. Having any illness that might affect the vasculature, such as diabetes (type I or II)
6. Suffering from significant concurrent illness, such as cardiac disorders, , or pertinent neurological disorders.
7. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index

Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes activity which are important in fertility of the individual has been reported.

The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with reduced thiol, oxidized thiol and thiol related enzymes in the seminal plasma of asthenospermic patients.

Eligibility Criteria:
Inclusion Criteria:

* The presence of asthenozoospermia in the semen sample.

Exclusion Criteria:

* The absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.
Repeated Employee Testing for Understanding Our Recovery to Normal

The purpose of this research study is 1) to conduct a prospective longitudinal surveillance research trial, enrolling up to 200 CCHMC employees as they come back to work, and then following their clinical and laboratory parameters for up to 12 months; and 2) to support the ongoing development of diagnostic techniques for COVID-19. The overall goal is to investigate patterns of SARS-COV-2 infection, including immunological recovery and genetic risk factors, among CCHMC employees to better understand how to safely reintroduce the CCHMC work force back into their normal routines.

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. Cincinnati only recently (March 14, 2020) had its first confirmed case of COVID-19, and through shelter-in-place and social distancing efforts, has avoided the community spread experienced by some other large metropolitan areas. As investigators contemplate the gradual reintroduction of the Cincinnati Children's Hospital Medical Center (CCHMC) workforce back into the hospital, it is imperative that investigators determine the current prevalence of infection among CCHMC employees, measure the cumulative incidence of infection over the next 12 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. Investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of SARS-CoV-2 infection at CCHMC, including risk factors for transmission and immunological recovery. RETURN will investigate epidemiological and immunological features of SARS-CoV-2 virus infection in a limited cohort of CCHMC employees, as they return from the current shelter-at-home directive toward a normal work environment. By collecting and analyzing weekly serial samples for SARS-CoV-2 (nasal swab for virus by PCR) and monthly serological exposure (serum antibodies by ELISA), investigators will determine the prevalence and cumulative incidence of exposure to SARS-CoV-2; document the antibody responses over time; identify cases of apparent viral recrudescence or re-infection; and create models of transmission risk among CCHMC employees.

Eligibility Criteria:
Inclusion Criteria:

* Current full-time employees at Cincinnati Children's Hospital
* Age: \>18.0 years of age, at the time of enrollment
* Cell phone that can be used for text messaging or web-based viewing of surveys
* Willing and able to provide informed consent
* Ability to comply with all study related evaluations and follow-up

Exclusion Criteria:

* Previous proven SARS-CoV-2 infection (positive PCR-based molecular test)
* Any condition or illness that makes study participation ill-advised
* Currently or planning to enroll in a COVID-19 vaccine or prophylaxis study
Neonatal Hearing Screening at Neonatal Intensive Care Unit

Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.

Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.

One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.

Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .


Eligibility Criteria:
Inclusion Criteria:

* Neonates of both sexes.
* Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
* Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.

Exclusion Criteria:

* neonates whose parent refuse to participate in the study.
Relation Between Adverse Reactions to Food, Physical Performance and Health in a Mediterranean Population

Since the prevalence of adverse reactions to foodstuffs (ARFS) has been steadily increasing and has become an alarming health concern, the general objective of this study is to analyze the prevalence of ARFS in Spanish adults of different physical condition.

Individuals with associated diseases and symptomatology to ARFS will be selected and will be clinically and physically measured.

Eligibility Criteria:
Inclusion Criteria:

* Diseases and symptomatology associated to ARF.

Exclusion Criteria:

* Participation in other study.
* Pregnancy.
* Antibiotic treatment.
* Active Helicobacter pylori infection.
* Antidepressant, sleeping pill, or anxiolytic treatment.
* Job or lifestyle that potentially interferes with your regular sleep schedule.
* Active Cancer treatment.
Shalamar Institute of Health Sciences

Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore

Objective: To explore the effect of didactic intervention regarding dietary approach to stop hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.

Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of Cardiology (PIC) Lahore. From June 2018 to Oct 2018.

Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at Punjab institute of cardiology Lahore, with systolic \> 130 mm hg, diastolic \> 80 mm hg were selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, only intervention group were given DASH education. Both groups were checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after education session. Pre-tested questionnaire was used for demographic, attitude and knowledge data collection.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patient aged 20-60 years attending regularly at Punjab institute of cardiology outpatient department Lahore
* systolic \> 130 mm hg
* diastolic \> 80 mm hg.

Exclusion Criteria:

* Less than 20 years age
* patient diagnosed with secondary hypertension
* any mental and physical ailment that may interfere the intervention like deafness and blindness.
Treating Post Traumatic Stress Disorder in Children Exposed to Domestic Violence

This study will determine whether trauma-focused cognitive behavioral therapy (TF-CBT) is more effective than child-centered therapy (CCT) in reducing post traumatic stress disorder (PTSD) in children exposed to domestic violence (DV).

Up to 10 million children in the United States are exposed to DV directed at their mothers by intimate partners. DV exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and PTSD. While studies targeting PTSD in DV-exposed children are limited, data indicates that TF-CBT is effective in improving PTSD as well as depression, anxiety, and behavioral symptoms. This study will determine the effectiveness of TF-CBT in reducing PTSD and other DV-related psychological symptoms in children from a community DV agency in Pittsburgh, Pennsylvania.

This study will last 8 weeks. Children and their mothers will be randomly assigned to receive 8 weeks of either TF-CBT or CCT. In TF-CBT, patients recall the events of their trauma and try to deal with the emotions that arise. Supportive treatment empowers children to deal with their emotions in general. Both the children and their mothers will complete questionnaires at study entry and at Week 8. Children will also complete self-report scales at study entry and at Week 8. The questionnaires and self-report scales will be used to assess symptoms of PTSD, depression, anxiety, and behavioral problems. Children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD related to exposure to DV, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry
* Able to read and understand English
* Parent or guardian able to read and understand English
* Parent or guardian willing to give informed consent

Exclusion Criteria:

* Certain psychiatric disorders which preclude participation in cognitive-based treatment