cyrilzakka/clinical-trials huggingface dataset:
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004% ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of normal tension glaucoma.
* Must sign an Informed Consent form.
* IOP within protocol-specified range.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant and lactating women, or women who intend to become pregnant during the study period.
* Advanced and serious glaucoma, as specified in protocol.
* Complicated chronic or recurrent uveitis, scleritis or corneal herpes.
* History of ocular trauma, intraocular surgery or laser surgery for the included eye.
* Ocular-infection and severe ocular complication.
* Best-corrected visual acuity (BCVA) worse than 0.2 decimal.
* Difficulty in conducting applanation tonometry for the included eye as determined by the doctor.
* Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study.
* Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic anhydrase inhibitor (Diamox, etc.) during the study period.
* Use of any adrenocorticosteroids during the study period.
* Use of IOP lowering ophthalmic solution within the past 30 days.
* Regarded by doctor as not suitable for study participation.
* Other protocol-specified exclusion criteria may apply.
Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions

Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study

Exclusion Criteria:

* Patients who cannot provide informed consent for the procedure will be excluded from the study.
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)

This study is to assess the safety of Vi-DT vaccine in adults and children.

To describe the safety of this vaccine following first and second dose immunization.

To assess preliminary information of immunogenicity following Vi-DT vaccine immunization.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy
2. Subjects/Parents have been informed properly regarding the study and signed the informed consent form
3. Subject/Parents will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C )
3. Known history of allergy to any component of the vaccines
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
5. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
6. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
7. Pregnancy \& lactation (Adults)
8. Individuals who have previously received any vaccines against typhoid fever.
9. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
10. Individuals who have a previously ascertained typhoid fever.
11. History of alcohol or substance abuse.
12. Subject planning to move from the study area before the end of study period.
Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics

To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia
* Treatment with one atypical antipsychotic\* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.
* Patient takes an AAP according to local SPC and current medical practice
* The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write

Exclusion Criteria:

* Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study
* Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.
* Previous enrolment or treatment in the present NIS
* Known allergy to the prescribed AAP or any of its substances
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma

The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.

see above

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Histologically confirmed primary gastric CD20+ DLBCL
* Written informed consent
* ECOG 0-2

Exclusion Criteria:

* Secondary aggressive Non-Hodgkin's lymphoma involving the gastric area
* HIV positive patients
* Severe organ dysfunction
* Life expectancy of less than 3 months
Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury

A well-managed bowel program is an essential part of daily life for many people with a SCI. Nevertheless, constipation is frequently reported (42-95%). Constipation embraces a spectrum of harms including both physical \& psychological distress. Initial exploratory studies suggest abdominal FES may be useful for decreasing overall bowel management time, decreasing colonic transit time and reducing discomfort. The current study will seek to reproduce previous findings in a 12 week study, using overall bowel management time as a benchmark for establishing proof of principle. The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable condition, one year or more after injury. Participants will be randomised into two groups. One group will receive abdominal electrical stimulation and the other group low dose abdominal electrical stimulation. Participants will be asked to keep a bowel diary and complete questionnaires examining quality of life and bowel management.


Eligibility Criteria:
* Inclusion Criteria:
* People with a diagnosis of spinal cord injury
* Age =\>18 years of age
* Injury level at or above T12
* complete or incomplete spinal cord lesion
* Medically stable condition
* Reflex bowel
* =\>1 year post spinal cord injury
* Exclusion Criteria:
* A history of organic bowel obstruction
* Frequent opioid use,
* Intrathecal baclofen or percutaneous endoscopic gastrostomy
* Inflammatory bowel disease
* Recent abdominal hernia
* Recent gastrointestinal or abdominal surgery
* Lower motor neuron lesions,
* Suspected strictures or fistulae along the gastrointestinal tract
* Physiologic gastrointestinal obstruction.
* Other causes of constipation such as hypothyroidism, hypercalcaemia
* Constipation predominant irritable bowel syndrome prior to diagnosis of SCI
* Involvement in other research trial interventions likely to impact current trial
* Poorly controlled epilepsy,
* Cardiac pacemaker in situ
* Other implanted electrical devices
* Pregnancy or pregnancy planned
* Cancerous tissue in the abdominal region
* Any major skin disorders affecting the abdominal area)
* Severe autonomic dysreflexia (tested at initial assessment).
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy

This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must give written informed consent before any assessment is performed.
* Male or Female patients ≥18 yrs of age
* Patients willing and able to comply with all study procedures

Inclusion criteria for study eye:

* BCVA letter score between 73-24 (approximately 20/40 to 20/320 Snellen equivalent) using ETDRS visual acuity chart measured at 4 meters
* PCV diagnosis confirmed by Central Reading Center
* Greatest Linear Dimension (GLD) of the total lesion area \< 5400 µm (\~9 Macular Photocoagulation Study Disc Areas)

Exclusion Criteria:

* Women of child-bearing potential who are not using one or more reliable contraception methods
* Pregnant or nursing (lactating) women
* History of hypersensitivity or allergy to fluorescein or indocyanine green (ICG), clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components
* Patient with history of porphyria
* Systemic medications known to be toxic to the lens, retina, or optic nerve
* History of which might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications
* Use of other investigational drugs within 30 days of randomization

Exclusion criteria for study eye:

* Concomitant conditions/diseases:
* Presence of angioid streaks, macular fibrosis, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 Diopters or more)
* Active ocular inflammation or infection
* Uncontrolled glaucoma
* Ocular disorders that may confound interpretation of study results

Prior Ocular treatment:

* Prior Verteporfin PDT, external-beam radiation, laser photocoagulation, macular surgery, or transpupillary thermotherapy
* Prior local treatment with Pegaptanib, Ranibizumab, Bevacizumab or other anti-angiogenic compound or any investigational treatment in both eyes or systemic use of bevacizumab within 90 days prior to randomization
* History of intraocular surgery including pars plana vitrectomy and intraocular hemorrhage displacement is not allowed with the exception of uncomplicated cataract surgery that is allowed within 60 days prior to screening
* Ocular conditions that required chronic concomitant therapy within 90 days prior to randomization with topical, ocular, or systemically administered corticosteroids or any herbal medication known to contain steroid-like components

Other protocol-defined inclusion/exclusion criteria may apply
Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.

East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* African American female,
* age 19 - 75yr.,
* with Type 2 diabetes mellitus and
* living in or near Bertie, Edgecombe, and Pitt counties in eastern NC

Exclusion Criteria:

-
A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure

This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure. Subjects who meet the eligibility criteria will be considered for study participation and will be followed through 12 months.

SIPS is a single-anastomosis duodeno-intestinal switch procedure. Preliminary data from Sanchez-Pernaute et al. (Surg Obes Relat Dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. CovidienTM plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the SIPS procedure.

Eligibility Criteria:
Inclusion Criteria:

* The subject must be 18-65 years of age
* The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent
* The subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary SIPS procedure
* The subject has a BMI of 35-40 kg/m2 with at least 1 obesity-related comorbidity or a BMI of 40-60 kg/m2

Exclusion Criteria:

* Any female subject who is pregnant, or is actively breast-feeding
* Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity)
* The procedure is an emergency procedure
* The procedure is a revision/reoperation for the same indication
* The subject is unable or unwilling to comply with the study requirements or follow-up schedule
* The subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (GI) malignancy, history of upper GI surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory)
* The subject has an estimated life expectancy of less than 6 months
* The subject has participated in an investigational drug or device research study within 30 days of enrollment
Foresight Intracardiac Echocardiography (ICE) System

This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.

This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old.
* Patient is undergoing an atrial fibrillation ablation procedure.
* Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
* Patient provides informed, written consent for participation in the study.

Exclusion Criteria:

* Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
* Patients in whom transseptal puncture is relatively contraindicated.
* Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
* Women of child bearing potential, in whom pregnancy cannot be excluded.
* Patients unable to grant informed, written consent for participation in the study.
Validation and Reliability of the Parents Assessment of Protective Factors Survey

Neglect and abuse, which have a devastating effect on children, can be prevented with community-based education programs aimed at strengthening families. The study aimed to validate and determine reliability of the "Parents Assessment of Protective Factors (PAPF) survey" and to develop a culturally appropriate program and educational design for strengthening families.

The American Center for Social Policy Studies (CSSP) Center for Quality Improvement in Early Childhood (QIC_EC) defined protective factors that will form the basis of programs designed to prevent neglect and abuse, with community-based approaches. Community-based programs for primary prevention should be developed to prevent neglect and abuse, before it occurs. Existing studies in our country show that there is rarely a focus on preventing adverse childhood experiences with primary preventive approaches. Most of the studies are school-based, and aimed at increasing awareness of children and families about abuse.

This study aimed to evaluate the Turkish translation of the PAPF survey for validity and reliability and to adapt a culturally appropriate program and educational design for strengthening families, with a multidisciplinary team.

In the first step of the study, Turkish validity and reliability of the Parents Assessment of Protective Factors (PAPF) survey, will be conducted and applied to parents to determinate the protective factors. Turkish version of Adverse Childhood Experience Questionnaire (ACE), will be applied simultaneously with the PAPF survey, to identify adverse childhood experiences of parents that might affect parental resilience, parenting characteristics, and family dynamics.

In the second phase of the study, community-based family education programs that are currently being implemented in different countries will be reviewed by a multidisciplinary team (healthcare professionals, social workers and non-governmental organizations). A culturally appropriate educational primary prevention program for child neglect and abuse will be developed.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children aged between 0 to 8 years
* Ability to read and complete the self-assessment questionnaires

Exclusion Criteria:

* Parents who do not give consent to participate in the study
Trial of Diphenhydramine for Sleep in Children With Autism

The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.


Eligibility Criteria:
Inclusion criteria:

Participants will meet the following

* Outpatients between 8 and 17 years of age at the time of consent
* Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2)
* Males and females
* Availability of polysomnography (PSG) or actigraphy data
* Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher
* care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
* stable medications for at least 2 weeks, with the exception of Prozac which is required to be stable for at least 4 weeks
* no planned changes in psychosocial and biomedical interventions during the trial
* willingness to provide additional saliva samples and participate in key study procedures (i.e.,safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial).

Exclusion criteria:

Participants will be excluded if one or more of the following is met

* active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
* active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology)
* evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis
* pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
* individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, melatonin and antihistamines
* history of hypersensitivity to diphenhydramine
* history of severe side effects from diphenhydramine
* history of adequate trial of diphenhydramine
* current use of any medications known to interact with diphenhydramine such as medications inhibiting CYP2D6
* taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).