cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.

In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;
* Tanner stages of breast in female patients ≥ Tanner III stage，diameter of mammillary nucleus ≥ 3cm;
* B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;
* Bone age: compared the chronological age, the bone age is more than 1 year and the bone age \<11.5 years old;
* It progresses rapidly, ratio of bone age difference to chronological age difference\> 1;
* No GnRH analogs or sex hormones were administrated in the past;
* All above are needed at the same time.

Exclusion Criteria:

* Precocious precocity caused by the central nervous system organic diseases;
* Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;
* Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;
* Pseudo sexual precocity and partial precocious puberty.
Preeclamptic Pregnancy Care Education

The aim of this study is to evaluate the effect of simulation training in nurses and midwives on knowledge and self-efficacy regarding preeclamptic pregnancy care.

It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. The interests and needs in these environments are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and supported with feedback.

Preeclampsia is clinically defined as a blood pressure of 140/90 mmHg or above after the 20th week of pregnancy and the addition of proteinuria (300mg / 24 hours). It can develop in about 5-10% of all pregnancies. It is defined as a nulliparous disease since it is seen in approximately 85% of women during their first pregnancy. Preeclampsia constitutes 15% of the causes of maternal mortality in our country.

In studies evaluating the effectiveness of simulation training in planning the follow-up and care of preeclampsia, it was determined that this method increases the knowledge and self-confidence of nurses. For example; Christian and Krumwiede's study they found that the self-efficacy rates were significantly higher in the post-simulation test. In his study, Olubumno investigated the importance of simulation in increasing the critical thinking of perinatology nurses in the care of preeclamptic pregnant women, he found that the pre-test and post-test scores increased by 0.75 points, and this difference between the scores is statistically significant. Tabatabaeian et al., In their study comparing the effects of simulation-based education, coeducation and theoretical education on the performance of midwives in preeclampsia and eclampsia, found that the mean of the simulation group was higher than the other two groups.

Preeclampsia is an important obstetric emergency in women's health and disease nursing. Thus, when they start working in the clinic, it is aimed to be able to suspect preeclampsia with the anamnesis they received from the pregnant who applied to them, and to gain them with the simulation method what they should pay attention to and how to do in the follow-up of the pregnant woman hospitalized with the diagnosis of preeclampsia. Studies conducted in our country did not include studies involving students and healthcare professionals in the management of preeclampsia with simulation methods. Therefore, it is aimed to contribute to the literature with this study.


Eligibility Criteria:
Inclusion Criteria:

* Working for 1-5 years.
* Working in the gynecology inpatient services and delivery rooms of hospitals.
* To be a graduate nurse or midwife.
* Volunteering to participate in the study.

Exclusion Criteria:

* Being a high school graduate working in the related field
* Having just graduated from a related field
MemoryXL Effects on Mild Cognitive Impairment Patients

A vitamin nutriceutical, Memory XL, has been shown to provide maintenance of cognitive status in mild, moderate, and severe Alzheimer's disease patients (2 publications by T. Shea). Because this nutriceutical is now patented by the Univ. of Mass., other trials at that institution may be considered a conflict of interest. Therefore, a study of its effects on Mild Cognitive Impairment (MCI) patients will be conducted by PI who is not affiliated with Univ. of Mass. or with Dr. Shea. The study hypothesis is: Memory XL will maintain or improve the cognitive and behavioral status of patients diagnosed with MCI during the year of participation in the study; normally, 10-25% of MCI patients convert to mild Alzheimer's dementia each year.

This IRB-approved study is a randomized double blind study of patients diagnosed with Mild Cognitive Impairment (MCI) in the Center for Alzheimer's and Neurodegenerative Disorders (CANDO) at VAMC in Oklahoma City. Dr. Shea provided the pills (nutriceutical and placebos) from the same batches he used in former studies of Alzheimer's disease patients (produced by Nutricap Labs, Farmingdale, NY). Pills were dispensed by the OKC VAMC research pharmacist, using a random numbering system. The PI completed five cognitive testing sessions, lasting 1 to 1.5 hours, for each subject during the 12 months of participation in the study. Subject's spouse or family member completed 4 questionnaires about the subject's behavioral changes, and kept daily records of the times each day when the subject ingested the study pill assigned by the pharmacist. All subjects are patients in the VAMC memory loss clinic (CANDO) who are monitored by their neurologists (2 co-investigators in this study).

Eligibility Criteria:
Inclusion Criteria:

* MCI patients diagnosed at the VAMC Center for Alzheimers and Neurodegenerative Disorder (CANDO).
* Clinical Dementia Rating (CDR) score of 0.5.
* fluent in English.
* able to ambulate to the outpatient clinic and research laboratory
* have sight and hearing levels sufficient to complete neuropsychological testing.
* free from bipolar disorder and terminal illnesses such as cancer.
* must live with a spouse or adult relative who will record nutriceutical ingestion daily.
* subjects will be consecutively diagnosed patients from all ethnic groups.

Exclusion Criteria:

* patients from protected categories such as prisoners and pregnant women.
* any MCI subject who develops a life-threatening disease such as terminal cancer, stroke, brain trauma, debilitating heart attack, etc.
* indication of inability to make decisions regarding study participation.
Anxiety and Symptom Burden in Hemodialysis Patients

Anxiety has been identified as a prevalent and significant co-morbid condition in patients with End Stage Renal Disease (ESRD) being treated with hemodialysis. In particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life.

The proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. The primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.

Additional analyses will examine the relationship of elevated anxiety and depression scores on symptom burden, QOL, and other measures of dialysis adherence. Retrospective data of the preceding three months will be used to calculate measures of dialysis adherence (shortening and skipping) and clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Receiving In-center hemodialysis

Exclusion Criteria:

* Non-English speaking
A Survey of Adults and Children With Allergic Rhinoconjunctivitis (MK-7243-021)

This study will gather information on allergic rhinoconjunctivitis from surveys completed by adults and children.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hay fever, rhinitis or nasal and/or eye allergies and display symptoms of sneezing, itching, watery eyes, nasal congestion, or other nasal or eye allergy symptoms over the past 12 months OR take any medication for their hay fever, rhinitis, nasal or eye allergies
* 5 years of age or older
* Have a telephone

Exclusion Criteria:

* If less than 18 years old and there is no adult available that is knowledgeable about the participant's health
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening

Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized by problems with sustaining attention, organization, planning, procrastination, daydreaming, restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis meeting all inclusion criteria and not meeting any of the exclusion criteria.

One purpose of this trial is to extend the evidence basis for Mydayis in adult ADHD to include efficacy with a clinical ADHD symptom measure validated for DSM-5 adult ADHD. Another purpose of this trial is to re-examine the clinical efficacy of Mydayis later in the day on ADHD symptoms; the data on ADHD symptoms via the TASS 1 (Spencer et al. 2008) is a decade old and has not been examined in subsequent trials.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18-60 of all races and ethnicity.
* Meets DSM V-TR criteria for a primary diagnosis of ADHD (including predominantly inattentive presentation, or combined presentation) as diagnosed via the Adult ADHD Clinician Diagnostic Scale version 1.2 (ACDS v1.2)

Exclusion Criteria:

* Meets DSM V-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD as diagnosed via the ACDS v1.2.
* Any other current psychiatric disorder, determined via the M.I.N.I, which requires pharmacotherapy treatment.
* Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS)
* Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I
* Pregnant, breastfeeding or women planning to become pregnant.
* Positive urine drug toxicology are excluded.
* Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Serum NGAL as a Predictor of Clinical and Endoscopic Activity of Inflammatory Bowel Disease

Ulcerative colitis (UC) and Crohns disease (CD) represent the two major forms of inflammatory bowel disease (IBD), characterized by epithelial cell damage and prominent mucosal infiltration by inflammatory cells including granulocytes, macrophages, lymphocytes, and plasma cells.


Eligibility Criteria:
Inclusion Criteria: IBD patients diagnosed by endoscopy.

Male and female gender. Disease activity proven clinically and endoscopy . Assiut university hospital patients

Exclusion Criteria:

* Patients who refuse to contribute in this study Pregnancy and breast feeding Cancer patients Renal pathology Diabetes Mellitus Cardiovascular patients Pancreatitis COPD patients
Single Patient Compassionate Use / Expanded Access L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment of Diffuse Midline Glioma

F. 50y.o. 77kg, DS confirmed 18 Nov. 2022 Received treatment: 11 courses of TMZ (240mg) Radiotherapy 30 courses of 1.8Gr (total 54 Gr, TMZ 140 mg on RT). Bevacizumab intravenously -400 mg -0-14-28-42 (December-February 2023). Severe side effects. The attending physician discontinued bevacizumab after 4 courses. In remission for 11 months. According to the results of the MRI dated April 28, 2024, continued growth.

Neurological status is good. Reflexes are not impaired. To date, treatment options have been exhausted. Participation of the patient in Clinical Trials is impossible. As of April 2024, negative dynamics. The patient signed an informed consent agreement. Information on taking L-S-Gboxin (Lyophilisate) as part of a compassionate program - explained.

Written consent of the attending physician for the patient's participation in the Compassion Program (TRIANGLE) with L-S-Gboxi (Lyophilisate) - received.

(medical documentation will be available on clinicaltrials.gov within a month from the date of publication - patient's consent to publish the medical history and examination results has been obtained)

TREATMENT PLAN

Оn days 1 to 3 of treatment, the patient will receive a sublingual form of the lyophilized form of L-S-Gboxin at a dose of 5 mg/kg.

If there is no toxicity, on days 4 to 14 the patient will receive a sublingual form of the lyophilized form of S-Gboxin at a dose of 10 mg/kg.

The first course of treatment is 14 days. On day 20, MRI + PET-CT monitoring is carried out to assess the dynamics of tumor growth. Based on the results of the examination plan, the attending physician and the main investigator make a decision on the continuation of treatment and the duration of the second course of therapy.

Eligibility Criteria:
Inclusion Criteria:

unacceptable for single patient

Exclusion Criteria:

* unacceptable cardiotoxicity
* cerebrospinal fluid dissemination
* systemic infection or viral disease, other associated symptoms that may jeopardize the patient's safety (at the discretion of the treating physician)
High Pain Intervention in Cesarean Sections

In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.

This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective cesarean section
* age \>/= 18 years old
* not allergic proposed study medications
* predicted to experience high pain postop based on preoperative evaluation

Exclusion Criteria:

* allergy to study medications
* known hepatic disease
* weight \> 300 lbs
Tick-borne Illness and Clothing Study of Rhode Island

Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. This study is a double-blind randomized controlled trial of outdoor workers in Rhode Island and the surrounding area that will address the following study aims: 1) Evaluate the effectiveness of LLPI clothing in preventing tick bites among outdoor workers in Lyme endemic areas; 2) Measure the urine levels of permethrin metabolites in study subjects; and 3) Measure the loss over time of knockdown activity against ticks and of permethrin in LLPI clothing.

Lyme and other tick-borne diseases pose a significant health threat to outdoor workers. In a double-blind randomized controlled trial (RCT) in North Carolina outdoor workers, the investigators previously showed that long-lasting permethrin-impregnated (LLPI) clothing provided \>80% protection for one year against Lone Star tick bites among outdoor workers in North Carolina. But there are three issues that need to be addressed before this finding can be translated into policy: 1) Do LLPI clothing protect against black legged ticks, the vector for Lyme disease, babesiosis and anaplasmosis? 2) What levels of permethrin and its metabolites are absorbed, and are they potentially toxic? 3) Why did the LLPI clothing in our previous study lose efficacy after a year?

Participants: The investigators will recruit 250 outdoor workers. The investigators anticipate recruiting 80, 80, 40,30, and 20 participants from NationalGrid, the RI Department of Environmental Management, the Massachusetts Department of Conservation \& Recreation, the National Park Service, and the US Fish \& Wildlife Service.

Procedures (methods): This will be a randomized controlled trial. All study subjects will fill out weekly tick logs, collect attached ticks for later speciation and pathogen detection, and submit annual serum samples to test for exposure to tick-borne pathogens. A randomly selected subset of 60 subjects also will be asked to submit urine samples for permethrin metabolite analysis at several time points during follow-up. An additional randomly selected subset (n=30) will be asked to submit worn items of clothing for tick knockdown testing and permethrin content analysis at the end of the first and second years of field testing.

The results of this study could help protect hundreds of thousands of outdoor workers with exposure to ticks and tick-borne pathogens.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* spending an average of 10 or more hours of outdoor work per week during peak tick season, and
* completion of written informed consent.

Exclusion Criteria:

* pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved),
* non-English speakers, or
* having a known allergy or sensitivity to insecticides
Bone Mineral Density Status in Pediatric and Adolescent Survivors of Childhood Cancer With History of Bone Fracture

This research study is evaluating bone mineral density in childhood cancer survivors who have a history of bone fracture.

The purpose of this research study is to learn more about the status of bones in children and young-adults who have had bone fractures after treatment for childhood cancer. Bone complications including fracture can be important issues for some childhood cancer survivors. In this study we are measuring bone mineral density in children and young adults who have had bone fracture after treatment for childhood cancer. We will measure bone mineral density in two ways. We will use: 1) dual energy x-ray absorptiometry (also known as DXA), and 2) peripheral quantitative computed tomography (also known as pQCT).

Eligibility Criteria:
Inclusion Criteria:

* History of childhood cancer
* Age ≥ 8 years and \< 20 years at time of enrollment
* ≥ 2 years since completion of cancer-directed therapy for first cancer
* Received chemotherapy for treatment of childhood cancer
* History of bone fracture after the conclusion of chemotherapy\*
* Not currently receiving cancer-directed therapy
* Signed written informed consent (by parent if patient is \< 18 years of age, or by patient, if he or she is ≥18 years of age)
* Patient assent for those ≥10 years of age and \< 18 years of age for whom a parent provides informed consent (\*History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible.)

Exclusion Criteria:

* Current treatment with bisphosphonates (as of time of enrollment)
* Current treatment with the anticonvulsant depakote (at time of enrollment)
* Currently pregnant
Healthy Bodies Project to Prevent Childhood Obesity

The goal of this study is to evaluate components of a preschool-based intervention designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. The long-term goal is to help children develop healthy habits that reduce risk for obesity.

Findings from intervention studies designed to prevent obesity among preschool children are mixed. One approach to stemming the development of obesity in childhood is to alter children's choices and environments in ways that promote food literacy, acceptance of healthy foods, physical activity and self-regulation. Research on factors that influence the development of obesity in children has identified factors in children's environments that are potential targets for prevention programs. The goal of this study is to evaluate the efficacy of components designed for a preschool-based approach to preventing obesity in children. Using an innovative approach to optimizing behavioral interventions, the multiphase optimization strategy (MOST), we will examine the effects of a 28-week, randomized set of experiments designed to (1) increase children's nutrition knowledge, (2) increase physical activity in childcare settings, (3) increase emotional, behavioral and eating-related regulation, and (4) provide guidance to parents/caregivers about appropriate parenting and child-feeding strategies that promote healthy eating behaviors, dietary patterns and physical activity in preschool-aged children. Participants will include over 1300 predominantly low-income preschool children ages 3 to 5 years attending center-based childcare settings in Pennsylvania (\~100 classrooms). The proposed study will provide information on the most efficacious components that produce measurable changes in children's nutrition knowledge and obesity-related behaviors. The results of this study will be used to inform the design of a randomized controlled trial to prevent obesity in children.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 3 to 5 years enrolled in full-day, center-based childcare programs
* Caregiver ≥ 18 years of age
* Caregiver responsible for providing meals for child at least half of the time
* Fluent in English (caregiver and child)

Exclusion Criteria:

* Developmental delays or disorders that affect learning, mobility and eating