cyrilzakka/clinical-trials huggingface dataset:
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder

Exclusion Criteria:

* Patients with Conduct Disorder
* Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
* Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.
Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail

Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.

The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities.


Eligibility Criteria:
Inclusion Criteria:

* Thru-Hikers on the Colorado Trail:
* Individuals planning to commence their thru-hiking journey on the Colorado Trail in early July.

Residence:

* Participants must reside in northern Colorado.
* Thru-Hiking History
* Participants must not have completed another thru-hike in the past 6 months.
* Informed Consent
* Individuals interested in participating in the study must provide informed consent.

Exclusion Criteria:

* Individuals who have completed another thru-hike in the past 6 months
* children below the age of majority, pregnant women, fetuses, and neonates
* prisoners, adults lacking the capacity to consent or with fluctuating capacity, non-English speakers, and illiterate individuals
* employees or students of the researcher
* individuals from undervalued or disenfranchised social groups
* Active members of the military, including Department of Defense (DoD) personnel
* individuals in stressful situations, those disadvantaged in social goods and services and individuals with serious health conditions lacking standard treatments
* those with a fear of negative consequences for not participating and individuals facing circumstances increasing vulnerability to coercion or exploitation
Tissue and Plasma Biomarkers of Lymph Node Involvement in Cervical Cancer

The purpose of this study is to measure the levels of serum proteins and other biomarkers in cervical cancer patients. We believe that some of these markers may be useful in selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

SPECIFIC STUDY AIMS

Specific Aim 1: To use gene expression analysis of primary cervical cancers to identify a gene expression signature that predicts for lymph node metastases in this disease.

Specific Aim 2: To predict lymph node metastases by performing multiplex measurements of cancer-associated proteins and cytokines using proximity ligation assay (PLA) on plasma samples.

Specific Aim 3: To measure circulating human papilloma virus (HPV) DNA in the plasma samples of cervical cancer patients using real-time quantitative polymerase chain reaction (qPCR) and determine its ability to predict for nodal metastases.

Specific Aim 4: To use deep sequencing to evaluate gene and sequence differences between cervical cancer patients with and without lymph node metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a known or suspected cervical cancer.
* Age \>=18 years.
* Patients must have no other active cancer at the time of diagnosis.
* Patients must have no history of a hysterectomy.
* Patients must be able to give informed consent.
* Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue for the study.
* Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes.

Exclusion Criteria:

- Pregnant women
Melatonin-Micronutrients for Osteopenia Treatment Study

The investigators' long-term goal is to employ novel methods to improve bone formation and bone density in women (and men) with osteopenia or osteoporosis while also decreasing signs and symptoms of degenerative joint and disc disease that commonly accompany bone loss as well as improve quality of life (QOL). These conditions generally begin silently as early as the menopause transition and progress to osteopenia and osteoporosis during the post-menopausal years in aging women. The investigators also envision this will be beneficial in aging andropausal men with these conditions. The investigators postulate that melatonin in novel combination with other natural bone-protective agents may act in a "chronosynergy" manner to prevent and correct these perturbations, reducing the risk of bone fractures, and lessening the stiffness and pain associated with bone, joint and cartilage degeneration and improving quality of life (QOL). The objective here, which is the investigators' next step in pursuit of our goal, is to assess the efficacy of an alternative therapy that uses a novel combination of bone-forming agents, melatonin, strontium (citrate)/ vitamin K2 (MK7), and vitamin D3 on bone health in a postmenopausal population. Melatonin is a novel alternative to current treatment(s) because it has multiple bone-protective and sleep-promoting activities within the body, and it is relatively safe so it can be used in an aging population without untoward side effects; strontium and vitamin D3 are shown to enhance bone mineralization and improve post-menopausal osteoporosis. The project goal is to identify if this combination therapy improves bone health and QOL compared to women taking placebo. The investigators' central hypothesis is that combination therapy using melatonin, strontium, vitamin K2, and vitamin D3 will improve bone health and overall QOL in postmenopausal women not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by improving subjective measures of stress, anxiety, depression and menopause-related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal
* must be osteopenic (T-score between -2.5 and -1)
* willingness to participate in the 12-month study
* willingness to undergo testing of bone turnover markers before and after the drug therapies
* willingness to provide a self-assessment on quality of life throughout the program
* willingness to take their treatments right before bed
* willingness to not to consume alcohol with this medication

Exclusion Criteria:

* women in whom osteopenia is a result of some other known process (e.g. hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use).
* women on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine
* women with severe sleep apnea, severe COPD and those with moderate or severe hepatic or renal impairment.
Evaluating Decisional Regret Among Mothers

The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe.
* Mothers who had a documented perinatal consult
* Greater than 18 years old

Exclusion Criteria:

* Potential life limiting fetal diagnoses aside from prematurity and non-English primary language
Evaluation of Peer Specialists on VA PACTs

In August 2014, the White House issued an Executive Action mandating that 25 VA medical centers place Peer Specialists (Veterans recovered from mental illness who are trained to support other Veterans with mental illness) on Primary Care Teams. Research shows that the success of adding new staff to existing teams can be improved by outside aid and facilitation. This quality improvement project will evaluate whether providing expanded support to half of the Primary Care Teams will lead to better outcomes when compared with teams that do not get extra support.

Peer Specialists are individuals with mental illness currently deployed to serve Veterans in specialty mental health clinics based upon their lived experiences. Peer Specialist delivered interventions have been shown to improve patient activation in multiple studies. In August 2014, the White House issued an Executive Action mandating that 25 VA medical centers pilot the deployment of Peer Specialists in their Patient Aligned Care Teams (PACTs). This project expands upon this nationally mandated Peer Specialist pilot with the integration of a cluster randomized implementation trial. This quality improvement project will evaluate the impact of facilitated implementation vs. standard implementation to support on the deployment of Peer Specialists in PACTs.

The 25 sites will be divided into three cohorts (n=8,8,9). Each cohort will begin over three successive six-month blocks beginning in early 2016. Within each cohort, sites will be randomized to receive either facilitated or standard implementation. Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Standard Implementation sites will receive written guidance and limited consultation by the investigators' team. The investigators will compare the groups on 1) the percent of their target population that actually received PS services; 2) ratings on PS workload productivity including ; 3) Peer Implementation and Services scores; 4) assessment of Veteran's change over time on the outcome variables of satisfaction, activation, and functioning ; 5) qualitative analysis of how well PSs were deployed and their impact.

Eligibility Criteria:
Inclusion Criteria:

* Included sites must be VA PACT Primary Care Health teams with existing Peer Specialists who are able to include an existing Peer Specialist on their team for a minimum of 10 hours per week for one year

Exclusion Criteria:

* Non VA PACT teams, VA sites without an existing Peer Specialists, and VA PACT primary care teams that cannot commit a Peer Specialist to Primary Care for a minimum of 10 hours per week are excluded
the Effect of Prenatal Vitamins on the Tooth Structure

the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not

teeth lost due to normal shedding will be collected,it will be classified into mother that take pregnancy vitamins and mother that doesn't take pregnancy vitamins, the female will be from the same population and from the same city to make sure that the environmental condition are almost the same .teeth will be subjected to elementary analysis to determine the different ratio of different component and if there is any change between the two group

Eligibility Criteria:
Inclusion Criteria teeth lost due to normal shedding sound teeth with non hereditary conditions normal children mother that don not suffer from chronic illness ex: diabetes

Exclusion Criteria:

* teeth extracted due to caries or trauma teeth with hereditary anomalies ex: hypoplasia
Study of Prospective Assessment of Living Kidney Donors: Pre and Post Donation

This is a prospective assessment of 80 living kidney donors.


Eligibility Criteria:
Inclusion Criteria:

* Donors are suitable candidate for living donation
* Male or female donors minimum 21 years maximum 65 years of age
* Donors has been fully informed and has given written informed consent

Exclusion Criteria:

* Donors has diabetes mellitus or hypertension.
* Donors is pregnant or breastfeeding.
* Donors is known to be HCV,HBV,HIV positive or has significant liver disease.
* Donors with malignancy or history of malignancy.
* Donors has systemic or localized major infection.
* Donors is participating or has participated in another clinical trial.
The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.

Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events of patients, and compare and evaluate the changes of heart function, heart construction, serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat treatment.

Eligibility Criteria:
Inclusion Criteria:

- Peritoneal dialysis for more than 3 months with hyperuricemia.

Exclusion Criteria:

1. Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)
2. Heart failure (stage IV, NYHA), unstable angina, acute stroke
3. Severe lung disease or cancer
4. unable to sign the informed consent form or disagree following-up.
Study Of Patients With Allergic Rhinitis And Asthma

This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Eligibility Criteria:
Inclusion Criteria:

* Have asthma for at least 3 months prior to the study.
* Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
* Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
* Have a positive allergy skin test.

Exclusion Criteria:

* Have a history of life-threatening asthma.
* Been hospitalized for asthma within the 6 months prior to the study.
* Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.

Subjects with chronic venous leg ulcers are treated 3 times a week in the hospital for 6 weeks with weekly sharp debridement. Wound size, pro-inflammatory cytokines, smears and photo are made weekly. The treatment countinue thereafter in primary care 3 times a week in 12 weeks. Wound size, pro-inflammatory cytokines, smears and photo are made every 14 day at the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Ulcus cruris venosoum
* AAI \> 0.9
* age 18-80
* adress Oslo area
* wound size 2.5-100 cm2
* wound duration \> 6 weeks.

Exclusion Criteria:

* Diabetes mellitus
* Immunosuppresion
* antibiotics \< 14 days
* local antiseptic treatment \< 1 week
* clinical infection.
Iloprost Therapy in Patients With Critical Limb Ischemia

Monitoring efficacy and safety aspects of iv. iloprost therapy of patients with critical limb ischemia by recording clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the internationally defined criteria of critical limb ischemia;
* Patients who are not eligible for vascular surgery or angioplasty interventions and
* Patients who are treated with iloprost infusion.
* The treating physician has decided iloprost treatment before study enrollment.

Exclusion Criteria:

* Exclusion criteria are in accordance with the Summary of Product Characteristics of Ilomedin.
The Effect of Virtual Tour Training Before Orthopedic Surgery

The purpose of the study is to determine the effect of training on surgical environments provided with virtual tour before orthopedic surgical ıntervention on patients' anxiety and satisfaction level.

Although preoperative anxiety is accepted as a normal patient response, severe anxiety can lead to a number of negative physiological, emotional and cognitive consequences for patients and ultimately to prolonged hospitalization. If anxiety is not managed effectively in the preoperative period, recovery time is prolonged and the risk of anesthesia and surgery-related complications increases. Moreover, it can lead to respiratory distress and cardiac problems. It causes life threats by increasing the risk of bleeding with deterioration in hemodynamic parameters and negatively affects surgical outcomes and patient satisfaction. For all these reasons, this study was designed to contribute to the management of anxiety, which is seen as a problem that needs to be addressed in surgical nursing.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65
* Being literate
* No comprehension and perception problems
* No hearing and vision problems
* Not being under psychiatric treatment
* No surgical experience
* To undergo elective orthopedic surgery in the operating room
* Acceptance to participate in the research

Exclusion Criteria:

* To undergo emergency orthopedic surgery
* Wishing to leave at any stage of the study
Critical Respiratory Diseases in Ex-preterm Infants in PICU

Premature birth is the leading cause of death in children younger than 5 years old worldwide, especially in low- and middle-income countries. Premature infants who survive are at greater risk of a range of short-term and long-term health consequences. Common long-term health morbidities among children who are born prematurely include cerebral palsy, infections (particularly respiratory infections), bronchopulmonary dysplasia, feeding difficulties, hypoxic-ischemic encephalopathy, visual and hearing problems. Re-hospitalization occurs frequently during first few years of life among ex-premature infants with respiratory illness. This leads to increased financial burden for health care system and families. The impact of prematurity on the health care system, especially on pediatric intensive care units (PICUs) has mainly been evaluated in high income countries. Little is known about long term health outcomes of ex-premature infants and their impact on the cost to health care system in low- and middle-income countries. This pilot, single institution, observational study aims to determine the prevalence, course of the diseases, and outcomes of ex-premature infants with respiratory illnesses who are admitted to a PICU of a tertiary children's hospital in Vietnam. Investigators will determine the epidemiology of respiratory illness, and the resource utilization for these children in the PICU. To achieve these aims, the investigators will prospectively screen and recruit all children aged less than 2 years old admitted to the PICU with respiratory illness/failure and collect pertinent clinical data. The study participants will be follow-up until PICU discharge.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged ≤ 2 year olds with respiratory diseases admitted to pediatric intensive care unit of Vietnam National Children's Hospital

Exclusion Criteria:

* Nil
Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells

a randomized, investigator-blind, interventinal study will compare the effect of benzalkonium-chloride (BAK) preserved and preservative-free (PF) eye drops on conjunctival goblet cells.

The investigators will conduct a randomized, investigator-blind, interventinal study on 28 subjects. Each subject will apply a benzalkonium-chloride (BAK) preserved eye drop (Xalatan) in one eye and a preservative-free (PF) eye drop (Monoprost) in the other for 3 months. Which eye gets which treatment is randomized. Before and after treatment a conjunctival print will be made and the effect of the eye drops on goblet cell density will be evaluated along with effect on the intraocular pressure.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18years
2. Danish speaking
3. Open angle glaucoma or ocular hypertension
4. Average intraocular pressure equal to or above 22 mmHg

Exclusion Criteria:

a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension d. treatment with steroids within the last 3 months from inclusion e. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination k. ocular surface defects l. need for polytherapy in glaucoma treatment