cyrilzakka/clinical-trials huggingface dataset:
Hydroxyurea Optimization Through Precision Study

Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical Center and from additional pediatric sickle cell centers within the United States.

The trial will recruit patients who have decided to initiate hydroxyurea therapy. All participants will have pharmacokinetics studies performed at baseline, following a 20 mg/kg oral dose of hydroxyurea. Pharmacokinetic sampling will use a sparse sampling approach, requiring collection of blood at 3 time points (15 minutes, 60 minutes, 180 minutes) following the hydroxyurea dose. Enrolled participants will be randomized to receive either hydroxyurea using a starting dose of 20 mg/kg/day (Standard Arm) or a personalized PK-guided dose (Alternative Arm) to target an area under the curve (AUC) of 115 mg\*h/L based to approximate hydroxyurea exposure seen when patients are escalated to maximum tolerated dose (MTD).

Following randomization and selection of the initial dose, participants in both arms will follow the same procedures of laboratory medication holds for hematological toxicity. The primary endpoint is fetal hemoglobin (HbF) six months following the initiation of hydroxyurea therapy with the hypothesis that participants starting with a PK-guided dose will achieve HbF at least 5% greater than those starting with a 20 mg/kg dose. Based upon the estimated number of new hydroxyurea starts at each site, it is anticipated that it will take 24 months to enroll the 116 participants required to achieve sufficient power to assess the primary endpoint. The study will conclude for each participant 12 months following hydroxyurea initiation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or similarly severe SCA genotype)
* Age 6 months to 21 years at the time of enrollment
* Clinical decision by patient, family, and healthcare providers to initiate hydroxyurea therapy

Exclusion Criteria:

* Current treatment with chronic, monthly blood transfusions or erythrocytapheresis
* Treatment with hydroxyurea within the past 3 months
* Hemoglobin SC disease, HbS/β+-thalassemia
* Current treatment with other investigational sickle cell medications
* Current known pregnancy or lactation
Attitudes About Smoking: A Telephone Survey

This study involves telephone surveys of parents of young urban children with and without asthma to assess attitudes about smoking including personal smoking bans in their homes and cars, and beliefs about public policies regarding smoking.


Eligibility Criteria:
Inclusion Criteria:

* Child with asthma OR a matched child without asthma from the Rochester City School District

Exclusion Criteria:

* Non-english speaking family / parent
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.

A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
* Age 40 and older
* Astigmatism of at least 0.75Diopters in one eye
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Diabetes mellitus
* Pseudoexfoliation syndrome
* Systemical anticoagulation
* Antiphlogistic therapy
* Antiglaucomatosa
* Uncontrolled systemic or ocular disease
* Preceding ocular surgery or trauma
* Intraoperative complications
* Pregnancy/Nursing
* Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days
Effectiveness of the Walking Intervention Walkadoo: A Randomized Controlled Pilot Trial in an Employee Population

This study evaluates the product Walkadoo to determine whether it effectively increases walking behavior in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older;
* Healthways employees based in Franklin, TN with an email account with the company;
* Provide informed consent and complete eligibility questionnaires

Exclusion Criteria:

* Current or prior use of the intervention Walkadoo
* Presence of a chronic condition that affects walking
* Projected inability to access the internet for 4 consecutive days or longer during the study
* Non-adherence to device wear during baseline
Prevalence of Attention Deficit Hyperactivity Disorder and Its Comorbidities

Estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in New Valley governorate.

ADHD (attention deficit hyperactivity disorder) is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention. Its prevalence ranges between 5.9 and 7.1% worldwide. Etiology of ADHD included combinations of genetic, neurological, and environmental factors. ADHD is more often a complex disorder with a high rate of associated comorbid conditions. Comorbid conditions are prevalent among people with ADHD and increase its burden and complexity of management. Children with ADHD are at a higher risk than children without ADHD for developing other psychiatric disorders. Most children with ADHD also have at least one comorbid condition, the presence of which contributes to poorer long-term outcomes. The pattern of comorbidities is influenced by age and sex; externalizing disorders are more common in younger ages and male participants, in contrast, internalizing disorders are more prevalent among older ages and female participants. Comorbidity involving ADHD and learning disorders is frequent, ranging from 25 to 40%. Other disorders likely to co-occur with ADHD are: bipolar disorders (11-75%), tic disorders (20%), obsessive compulsive disorders (6-15%). Children with ADHD may show several motor problems: longer and more variable reaction times, increased variability in speed and less accurate response reengagement, and impaired orienting responses, and increased number of responses with very long reaction times. Neurological soft sign have been associated with inattention and behavior difficulties for decades. Some researchers argue that these signs should be included in the diagnosis of ADHD.

Eligibility Criteria:
Inclusion Criteria:

Age: 6-17 years. Sex: both sexes will be included in the study.

Exclusion Criteria:

Age: less than 6 years or more than 17 years. Patients with major neurological deficits, cerebral palsy. Patient who refusing to participate in the study or their caregiver refusing to give informed consent. Mentally retarded children.
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Four to fifteen AKs on the face
* histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
* at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years

Exclusion Criteria:

* Pregnancy
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* Subject is immunosuppressed
* unsuccessful outcome from previous ALA-PDT therapy
* currently enrolled in an investigational drug or device study
* has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
* use of the following topical preparations on the extremity to be treated:

  * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days
  * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
* use of systemic retinoid therapy within 6 months
Phone Breastfeeding Support for Premature Babies

It was observed that premature babies had the risk of insufficient milk intake and a lower rate of breastfeeding compared to term babies. Various problems may occur at home, especially after breastfeeding training in the hospital. After discharge, support and counseling should be provided to eliminate problems that may stop breastfeeding or to prevent events that may prevent breastfeeding. The aim of this study is to examine the effect of "Telephone Breastfeeding Support" given to mothers of premature babies discharged from the neonatal intensive care unit on breastfeeding results.

The study was planned as a randomized, parallel two-group, controlled experimental design. This research will be conducted between June 2021 and June 2022 with premature baby mothers. The sample of the study will be mothers (n = 62) of premature babies discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. The discharge routine procedures of all mothers participating in the study will be completed and a breastfeeding guide prepared for premature babies will be sent to the phone. On the 3rd day after discharge, a reminder message will be sent to support the mother in the intervention group (n = 31) and to encourage breast milk. Throughout the program, 21 messages will be sent to the mothers in the first month after discharge, via the messaging application (whatsapp, bip, telegram, etc.) In addition, seven phone calls will be made once a week in the first month after discharge, and once a month in the eighth, twelfth and sixteenth weeks. Data will be collected by Mother-Baby Introductory Information Form, Breastfeeding Self-Efficacy Scale (short form) (BSES), Infant Feeding Attitude Scale (IIFAS) and Breastfeeding Time Assessment Form. The pre-test will be taken with the Mother-Baby Descriptive Information Form, BSES and IIFAS during the discharge routine procedures, and the post-test will be taken with the BSES, IIFAS and Breastfeeding Time Assessment Form when the baby is six months old. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p \<0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is anticipated that new information from research data will improve breastfeeding results of premature babies and guide new research.

Eligibility Criteria:
Inclusion Criteria:

* Whose baby was born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
* Does not have severe congenital anomalies in her baby (according to hospital records),
* Breastfeeding her baby,
* Reading and writing,
* Can speak and understand Turkish,
* Mothers who agreed to participate in the study,
* Mothers having a smartphone.

Exclusion Criteria:

* Mothers with previous experience of breastfeeding a premature baby,
* Plural baby,
* Mother's breastfeeding disability (according to hospital records).
The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing

The aim of the project is to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia.

Hypercapnia causes changes in physiological parameters at various levels throughout the body. The study aims to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia. It is an intervention prospective study that will be conducted at the Faculty of Biomedical Engineering on healthy volunteers. All the volunteers undergo three different phases in random order. The individual phases differ in the breathed mixture of oxygen, nitrogen and carbon dioxide gases. Non-invasive measurements of physiological parameters, especially blood oxygen saturation, perfusion index and cardiac output, will be performed continuously during the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension
Innovation in Mammography: Tomosynthesis Pathways

The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice.

It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.

The IMPETO trial is a population-based, multicentre, randomised trial aimed at evaluating the clinical accuracy of Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM) compared to standard two-dimensional digital mammography alone (2D) in a screening programme.

45-46 year-old women resident in the screening centre catchment area of Florence and South-Est Local Health Unit are invited to attend for mammography screening and asked for informed consent to be included in the study. Women are then randomly allocated either to an usual care group (2D mammography) or to the intervention group. In the intervention group, DBT combined with sDM is proposed in order to reduce radiation exposure. The next year women of both groups will be invited to attend the usual screening examination (2D mammography). The enrolment will last 12-18 months; the whole study 36 months. The estimated sample size is 6000 women, 3000 per arm. Data will be pooled with the trial "Screening for Breast Cancer With Digital Breast Tomosynthesis", ClinicalTrials.gov Identifier: NCT02698202.

Eligibility Criteria:
Inclusion Criteria:

* 45-46 years old women resident in the screening area

Exclusion Criteria:

* previous breast cancer
* written refusal to participate in the screening programme
* pregnancy, breastfeeding
* presence of prostheses;
* ongoing chemotherapy;
* impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent;
* verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor;
* previous known tomosynthesis.
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.


Eligibility Criteria:
Inclusion Criteria:

* Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
* Liver biopsy with histology consistent with CHC and no other etiology.
* Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
* Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
* Weight between 40 kg and 125 kg, inclusive
* Of 'local' ancestral descent
* Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Exclusion Criteria:

* Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus.
* Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon.
* Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening.
* Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity.
* Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit.
* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
* Diabetes and/or hypertension with clinically significant ocular examination findings.
* Any condition the could interfere with participation in and completion of the trial.
* Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin).
* Pregnant or breast-feeding.
Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children

The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.

The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* aged 2 to 6 yr
* American Society of anesthesiologists I or II
* scheduled to have general anesthesia and to have skin incisions on the abdomen

Exclusion Criteria:

* anemia or abnormal preoperative electrolyte concentrations
* a history of cardiovascular or central nervous system diseases
* a history of pulmonary disease
* known hepatic or renal disease
* a body weight exceeding 50% of the upper limit of ideal body weight for height
* taking drugs with cardiovascular or central nervous system effects
* use of any experimental drug within the past 30 days
* allergy to any drug that may be administered during the study
* exposure to general anesthesia within the previous 7 days
* second- or third-degree atrioventricular block
* taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids or sedatives)
"Up-Armoring" At-Risk Military Couples: A Stepped Approach to Early Intervention and Strengthening of Military Families

The study tested whether giving young, partnered military service members access to an online relationship help website would help prevent future relationship problems compared to partnered service member who did not have access to the website

This study tested whether access to a self-directed, online couple intervention offered preventively lessened the occurrence of future negative relationship outcomes (i.e., relationship dysfunction, infidelity, intimate partner violence (IPV) for partnered service members in comparison to the usual resources for relationship assistance in the military. Participants were active-duty military in a committed romantic relationship of at least 6-months duration (N = 581; 37.2% married) who had recently completed basic military training and were transitioning into technical training to learn a specific job skill set. Participants were randomly assigned by in-processing week to the intervention or the control condition. The intervention effect was modeled using both Intent to Treat (ITT) and Complier Average Causal Effect (CACE) approaches.

Eligibility Criteria:
Inclusion Criteria:

* To be included in the study, participants had to be: (a) in a committed romantic relationship for at least six months and (b) on active duty (not Guard or Reserve).

Exclusion Criteria:

* Participants with prior military service (i.e., not new to the military who were retraining into a different career field) were excluded.
Guidance for Elderly With Cognitive Disorders

The purpose of the programme is to facilitate the anticipation of dementia both in elderly patients suffering from this disease and in their carers and to diminish care burden in order to improve quality of life and daily functioning.


Eligibility Criteria:
Inclusion Criteria:

* elderly (\> 70 years) with mild dementia in presence of a carer.