cyrilzakka/clinical-trials huggingface dataset:
Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay

Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.

A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 6-years-old children
* clinical diagnosis of DD and other related disorders

Exclusion Criteria:

* unstable physiological conditions
* progression or regression symptoms
Differentiating Between Brain Hemorrhage and Contrast

The goal of this observational study is to use artificial intelligence to differentiate cerebral hemorrhage from contrast agent extravasation after mechanical revascularization in ischemic stroke.

The main question it aims to answer is: Whether artificial intelligence can help differentiate brain hemorrhage from contrast agent extravasation.

Patients with intracranial high-density lesions on CT scans within 24h after mechanical revascularization will be included. Expected to enroll 500 patients. The type of high-density lesion is determined according to dual-energy CT images or follow-up images. Patients will be divided into training group, validation and testing groups by stratified random sampling (6:2:2). After the images and the image labels are obtained, deep learning artificial intelligence will be used to learn the image characteristics and establish a diagnostic model, and the model performance and generalization ability will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

(1) patients underwent non-enhanced head CT after mechanical vascularization; (2) initial post-operative non-enhanced head CT was performed within 24 h after mechanical vascularization; and (3) intracranial hyper-intensity, which was defined as an objectively higher density than the surrounding grey or white matter in the parenchyma or higher density than cerebrospinal fluid in ventricles and cisterns, could be seen on the initial non-enhanced head CT after mechanical vascularization.

Exclusion Criteria:

(1) the follow-up time of non-enhanced head CT after mechanical vascularization was less than 24 h; (2) artifacts (e.g. metal artifacts or motion artifacts) affected the hyper-intensity in CT images; and (3) patients underwent craniotomy after mechanical vascularization, which made it difficult to identify the area of hyper-intensity.
Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.

This is a Phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA with inadequate response to methotrexate. All subjects will be required to complete a safety follow up visit 30 days post last study medication administration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
* DAS28-CRP ≥3.2 defined as moderate to high disease activity.
* Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
* hsCRP ≥5 mg/L at screening.
* Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
* On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.

Exclusion Criteria:

* Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
* Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
* History or evidence of active or latent tuberculosis.
* Active infection requiring treatment with antibiotics.
* Blood pressure levels (in supine position after at least 5 minutes rest): \<90 mmHg or \>140 mmHg for systolic blood pressure or \<40 mmHg or \>90 mmHg for diastolic blood pressure.
* Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
* Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
* Patients with history of stroke.
* Any joint procedure in the past 90 days prior to screening.
Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis

This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.


Eligibility Criteria:
Inclusion Criteria:

* History of Pseudomonas aeruginosa colonization of the lung
* Transferrin saturation (TSAT) less than or equal to 21%
* Hemoglobin concentration \<15.5 gm/dl (men)
* Hemoglobin concentration \<13.6 gm/dl (women)

Exclusion Criteria:

* Use of iron-containing vitamin or supplement
* Pregnancy
* Lactation
* Cirrhosis
* History of chronic visible (gross) hemoptysis
* Hereditary hemochromatosis
* History of transfusion-related iron overload
* Use of iron chelator(s)
* Withdrawal of informed consent
* Contraindication to phlebotomy
Symptom Assessment With Patient Surveys

The primary purpose of the proposed research is to explore methods of obtaining symptom assessments from pediatric oncology patients and/or their caregivers in hopes of improving the accuracy and thoroughness of these reports. Additionally the researchers hope to simply staff efforts in obtaining detailed medical histories from pediatric oncology patients.


Eligibility Criteria:
Inclusion Criteria:

* Approximately 150 patients ages 0-18 years (75 for each group-intervention and control) will be enrolled.
* These patients will be pediatric oncology patients who have received chemotherapy within the prior four weeks and being seen in the oncology clinic for an out-patient visit.
Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses


Eligibility Criteria:
Inclusion Criteria:

* o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs

  * Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment
  * Potential acuity measured post-operatively 20/25 or better in both eyes
  * Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision

Exclusion Criteria:

* o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc.

  * Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK
  * Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities
  * Total HOA cutoff of ≤0.5, coma ≤0.3
  * RLE patients
Susceptibility to Pathological Gambling

The goal of this study is to assess the risk factors for the development of pathological gambling.

This study will track up to 600 young adults (ages 18 to 29) for a two-year period, collecting variables such as gambling behavior, drug and alcohol use, psychiatry and medical history, family history, impulsivity, quality of life, self-esteem, and cognition. For some individuals who meet criteria as being impulsive, they will be randomized to receive an intervention to help reduce their impulsivity.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the procedures and provide written consent
* Gambled at least 5 times in the past year
* Between the ages of 18 and 29 at intake

Exclusion Criteria:

* Inability to understand the procedures and provide written consent
Pudendal Nerve Block in Vaginal Surgery

The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery
* Ability to read VAS Scores
* Specific vaginal procedures include, but are not limited to:

Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele

Exclusion Criteria:

* History of chronic pelvic pain
* Currently taking sedatives
* Liver disease
* Renal disease
* Women who did not consent for the study.
* Intraoperative concern for increased blood loss
* Unable to speak English
* Unable to understand VAS Scores
* Undergoing concomitant abdominal or laparoscopic procedures
* Allergy to bupivacaine or triamcinolone
* Planned abdominal or laparoscopic procedures.
* Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs
Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women

The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain and Satisfaction Related to First Vaginal Examination in Women: A Randomised Controlled Study

Many women feel anxiety and pain about gynecological examination. The aim of the study was to investigate the effect of gynaecological drape and specially developed gynaecological shorts used for the first time in vaginal examination on anxiety, pain and satisfaction related to examination.

Eligibility Criteria:
Inclusion Criteria:

* Literate,
* 18 years of age or older,
* Can speak and understand Turkish,
* You are a woman who is having a vaginal examination for the first time
* Women who volunteered to participate in the study

Exclusion Criteria:

* Physical or mental illness that prevents them from communicating,
* Vaginal examination by a health professional other than the designated gynaecologist,
* Those who answered the research questions incompletely and
* Women who want to withdraw from the study
Is Breast Massage Necessary to Find Sentinel Lymph Node?

Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.

This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI\>30 and age\>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.

Eligibility Criteria:
Inclusion Criteria:

* the diagnosis of breast cancer by biopsy
* participants voluntarily participated in the clinical trial and signed informed consent

Exclusion Criteria:

* had previous sentinel lymph node biopsy or axillary surgery
* had neoadjuvant chemotherapy
* had clinical hints of axillary lymph node metastasis
Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study

The Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Duke will perform a secondary analysis of the data collected as part of the Active Older Adults prospective cohort study run by Miami-Dade County Parks and Recreation.

The Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Active Older Adults is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. It is a low-cost, evidence-based group exercise and falls-prevention program. The program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. Data are collected at eight Miami Dade Department of Parks, Recreation and Open Spaces (MDPROS) park locations where the program is offered every four months (fall, winter, spring).

Active Older Adults is a park-based fitness program offered by the Miami Dade Department of Parks, Recreation and Open Spaces (MDPROS) that is designed to provide older adults of all fitness levels with physical activity, and aims to promote participant's abilities to maintain independent lifestyles. It is a low-cost, evidence-based group exercise and falls-prevention program. The program entails one-hour sessions two or three times per week including aerobic workout, strength training, balance and flexibility exercise delivered online or in-person. Exercise classes at each park location are offered by bilingual (English/Spanish) licensed instructors and program classes had a consistent format across all parks.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or older, residing in Miami-Dade County
* All participants enrolled in the Miami-Dade Active Older Adults study will be included in this secondary analysis

Exclusion Criteria:

* Aged less than 50 years, not residing in Miami-Dade County
* Anyone not enrolled in the Miami-Dade Active Older Adults study will be excluded from this secondary analysis
AC105 in Patients With Acute Traumatic Spinal Cord Injury

The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury.

To determine safety and tolerability of AC105 following a regimen of 6 intravenous doses over 30 hours in patients with acute non-penetrating traumatic spinal cord injury (SCI).

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years of age, inclusive
* Acute traumatic SCI, at a neurological level between C4 and T11
* No evidence of penetrating or transection injury (e.g. caused by projectile or stab wound)
* Neurological ASIA Impairment Scale A, B or C
* Patient is able to provide written or verbal witnessed consent. If unable to provide either, consent may be provided by legally authorized representative (LAR)
* Patient is able to initiate treatment within time window of injury

Exclusion Criteria:

* Known allergy or hypersensitivity to polyethylene glycol
* Mental impairment or other conditions that would preclude a reliable ASIA exam or adequate consent
* Positive urine pregnancy test result
* Serum creatinine level ≥ 2 mg/dL
* History or active renal failure or dialysis
* Mean arterial blood pressure \< 60 mmHg despite vasopressor treatment
* On a current regimen of digoxin
* Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or the use of magnesium salts in the acute care setting prior to the administration of investigational product
* Any other medical condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, or unreasonably complicate follow-up or the interpretation of study outcome data or may otherwise interfere with achieving the study objectives
* In the judgment of the Investigator, cannot adequately provide informed consent, is likely to be non-compliant, or may be unable to cooperate with study requirements
Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

Participants responding well in Study FE200486 CS06 (NCT00117949) were given the opportunity to continue treatment with degarelix under a clinical study until FE200486 was available on the market or until the study was discontinued.

Study FE200486 CS06A was to provide knowledge of the long-term safety and tolerability of FE200486.

The data include participants from both the main study (FE200486 CS06; NCT00117949) and the extension study FE200486 CS06A.

Eligibility Criteria:
Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study:

* Has given written consent before any study related activity is performed. A study related activity is defined as any procedure that would not have been performed during the normal management of the patient.
* Has had sufficient testosterone suppression (as defined in the withdrawal criteria of FE200486 CS06) for at least 28 days.

Exclusion Criteria:

Any patient meeting any of the following exclusion criteria will not be entered into the study:

* Has been withdrawn from Study FE200486 CS06 due to an adverse event, failure to achieve at least 28 days of testosterone suppression, insufficient prostate-specific antigen (PSA) suppression as defined in Study FE200486 CS06 in the absence of concomitant rise in testosterone level or non-compliance with protocol required procedures.
* Requires hormonal therapy for neoadjuvant purposes.
* Requires treatment with any other drug modifying the testosterone level or function.
* Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy, within 6 months after Visit 1.
* Has a history of severe asthma requiring daily treatment with inhalation steroids, angioedema or anaphylactic reactions.
* Has hypersensitivity towards any component of the investigational product.
* Has had a cancer disease within the last 10 years except for prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin.
* Has a clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, dermatological or infectious disorder or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study, as judged by the investigator.
* Any clinically significant laboratory abnormalities which, in the judgment of the investigator, would interfere with the patient's participation in this study or evaluation of study results (liver transaminases and bilirubin must be within normal limits).
* Has a mental incapacity or language barrier precluding adequate understanding or co-operation.
Comfort Operative Ocular Light Study

Digital 3D microscopes require less light and may be more comfortable for patients requiring cataract surgery under topical anesthesia compared to conventional microscopes.

To date, no studies have evaluated the comfort and subjective visual sensations related to the light of the 3D digital microscope in cataract surgery patients.

The purpose of this study is to evaluate the effectiveness of the Ngenuity 3D digital operating system (Alcon, Fort Worth, TX) compared to conventional microscopes on the comfort and subjective visual sensations related to of patients undergoing initial cataract surgery under topical anesthesia (pure or combined with intravenous sedation).

Patients will be recruited during the preoperative consultation where the indication for cataract surgery. The allocation of the management arm (3D digital microscope or conventional microscope) will be randomized in a stratified way on the center.

Prior to his or her operative session, the surgeon will set up the microscope with his or her usual parameters.

The light intensity will be measured at the beginning of the operating session with a calibrated light meter. The type of anesthesia (pure topical or associated with intravenous sedation), the duration of the operation, intraoperative complications (frequency and type), and the possible use of an anesthesiologist to inject additional intravenous anesthetic will be collected.

Before the patient is discharged from the ambulatory surgical unit, the clinical study technician will ask the patient the 4 questions of the standardized questionnaire assessing comfort and subjective visual sensations related to the microscope light.

Eligibility Criteria:
Inclusion Criteria:

* Indication for a first surgery (= first eye to be operated) of cataract alone under topical anesthesia (pure or associated with intravenous sedation)
* Express consent to participate in the study

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Patient with comprehension problems or who does not understand French well
* Pregnant or breastfeeding woman
* Indication for another surgery on the operated side (e.g. vitrectomy combined with cataract surgery)