cyrilzakka/clinical-trials huggingface dataset:
JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation and written informed consent.
* ≥18 years;
* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
* Confirmed platinum-resistant relapse.
* According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.
* Expected survival of more than 3 months.
* ECOG performance status score of 0 or 1.
* Adequate organ function.
* Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.

Exclusion Criteria:

* Primary platinum-refractory disease.
* Active central nervous system metastases.
* Uncontrolled pleural effusion.
* Previous treatment with topoisomerase I inhibitor ADCs.
* Other malignant tumors within 5 years.
* Interstitial pneumonia/lung disease requiring systemic corticosteroids or suspected interstitial pneumonia/lung disease.
* Uncontrolled comorbidities.
* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.
* History of allogeneic bone marrow or organ transplantation.
* Allergic reactions or hypersensitivity to antibody drugs.
* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.
tDCS for the Treatment of Migraine

The aim of this study is to evaluate an optimized protocol of tDCS that normalize the lack of habituation and efficiency of inhibitory cortical circuits in migraine patients. For this purpose, migraineurs volunteers will undergo to optimized tDCS protocol or sham tDCS.

A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with optimal protocol (defined in phase 1) and sham tDCS will be conducted to evaluated electrical cortical activity and pain control, number of migraine attacks and quality of life of migraine patients. Electrical cortical activity will be assessed through: (i) motor evoked potential (MEP); (ii) motor threshold (MT); (iii) short interval intracortical inhibition (SICI); (iv) intracortical facilitation (ICF); (v) phosphene threshold (PT) and (vi) visual evoked-potential (VEP-habituation). Clinical outcomes will be evaluated through: (i) headache diary; (ii) visual analog scale (VAS); (iii) Migrainde disability assessment (MIDAS); (iv) Headache Impact Test (HIT-6) and (v) World Health Organization quality of life assessment instrument (WHOQOL BREF).

Eligibility Criteria:
Inclusion Criteria:

* Presented diagnostic of episodic migraine with or without aura or probably migraine with or without aura according to the criteria for diagnosis of International Classification of Headache Disorders (ICHD-III)
* Disease duration of at least 12 months
* Without preventive medication for at least 6 months prior to initiation of treatment

Exclusion Criteria:

* Pregnant women;
* Pacemaker;
* History of seizures;
* Metallic implants in the head;
* Patients with clinical evidence of brain injuries;
* Chronic pain associated to others diseases;
* Use of neuroleptic medications
Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and supine treatment on the even days.


Eligibility Criteria:
Inclusion Criteria:

* female patients
* multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
* minimum 18 years
* informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* mastectomy
* need for axillary irradiation
* bilateral breast irradiation
* previous irradiation at the same time
* pregnant or breastfeeding
* mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan

The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan.

The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan. It can serve as a basis for the government to establish a nationwide vision surveillance system, invest research resources, and make national policies.

This research project also classified the urbanization of sampling school as high, medium and low based on the location of school.This research project explored and analyzed the health status of myopic schoolchildren and associated factors such as families, genetics, school environment, living environment and behaviors among north, south, west and east regions of Taiwan.

Eligibility Criteria:
Inclusion Criteria:

- Students with age between 3 to 18 years old

Exclusion Criteria:

1. Students have any special ocular disease.
2. non-compliance with screening protocol
3. orthokeratology user
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy

Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.

Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Eligibility Criteria:
Inclusion Criteria:

* Patients received BHV within 3 months

Exclusion Criteria:

* Recently throboemblism within 6 months
* Recently bleedings within 3 months
* Evaluated lifetime less than 2 years
Pelvic vs Virtual Reality Simulator

The aim of this study is to evaluate the proper sequence of Pelvic trainer and VR simulator training in order to improve gynecological laparoscopic skills and assess training levels.

In this study, the investigators will determine the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator in order to improve laparoscopic skills of residents with no or little previous laparoscopic experience.

* This study will compare the proper sequence of simulation training. Pelvic Trainer Versus Virtual reality Simulator of two groups: Group A versus Group B.
* Group A will start training on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1). Then at a later time, they will be trained on VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2).
* Group B will start training on the VR simulator (Sim Surgery) (educational intervention 2) and assessment will be via Electronic auto assessment via the Simulator (test 2). Then at a later time, they will be trained on the pelvic trainer (training on educational intervention 1) and assessment will be via assessment via a checklist (test 1).

Eligibility Criteria:
Inclusion Criteria:

* All the residents in Obstetrics and Gynecology department who have no or little previous laparoscopic experience

Exclusion Criteria:

* Residents who have previous good laparoscopic experiences.
* Age below 26 or Above 29 years
Coaching Children With Anxiety and Autism Through Telehealth

This study will examine a telehealth parenting intervention to reduce anxiety in 20 families of children between 4 and 8 years old with autism and anxiety. Caregivers and children complete 12 telehealth treatment sessions. Caregivers and children will complete pre tests, post tests, and 3 month followup assessments that include observations, heart rate monitoring, and caregiver ratings.

This study will examine the feasibility and initial efficacy of a telehealth adaptation of a parenting intervention to reduce anxiety (Coaching Approach behavior Leading by Modeling; CALM) amongst 20 families of children between 4 and 8 years old with autism and anxiety. Our time limited telehealth-delivered adaptation of CALM is called CAT (Coaching Children with Anxiety and Autism through Telehealth). The study will utilize an open trial design with pre, post, and 3-month follow-up assessments including observational measures, physiological measures, and caregiver ratings.

Eligibility Criteria:
Inclusion Criteria:

* Child participants must:
* Be between 4:0-8:11 years old
* Have clinically significant caregiver-report symptoms of anxiety on the Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
* Have a primary anxiety concern on the Anxiety Disorders Interview Schedule for Autism Spectrum and Developmental Disorders: Parent Version (ADIS/ASA)
* Have an ASD diagnosis made by a qualified diagnostician
* Have a cognitive level of 48 months on the Wechsler Preschool \& Primary Scale of Intelligence-Fourth Edition (WPPSI-IV; ages 2:6-7:7) or the Wechsler Intelligence Scale for Children-Fifth Edition (WISC-V; ages 6:0-16:11)

Caregiver participants must:

* Have access to a computer, tablet, or phone with a camera and Wi-Fi access

Exclusion Criteria:

* Primary concern other than anxiety as measures on the ADIS/ASA
The Effect of Baby-Led Weaning and Traditional Complementary Feeding Education on Infant Development

The goal of this \[type of study: clinical trial\] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the BLW method and TCF method given to the mothers of infants who have switched to complementary feeding. The main question\[s\] it aims to answer are:

* Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the feeding and development of the babies in both groups?
* Does the training on the GTB and BLW method given in accordance with the developmental age of the baby in months have an effect on the obesity risk and anemia risk of babies in both groups?

Participants will participate in each session of the complementary nutrition trainings given in accordance with their age on a monthly basis and will provide a diet suitable for the trainings.

Researchers will compare the nutritional parameters, developmental levels, and height and weight gains of infants fed with the BLW and TCF method to see the effect of complementary feeding education on the nutrition and development of infants and whether there is anemia and obesity risk.

Regarding the basic questions that the study aims to answer;

Micronutrient intake, hemoglobin, ferritin and vitamin B12 levels were evaluated to examine the effects of the trainings on infant nutrition.

Physical, cognitive, psychosocial, language, motor and game development levels of infants were evaluated in order to examine the effects of training on infant development.

Weight gain, WLZ, LAZ and WAZ scores of infants were evaluated to examine the effects of the education given on obesity risk.

Hemoglobin, hematocrit and ferritin levels were evaluated to examine the effects of the training given on the risk of anemia.

Eligibility Criteria:
Inclusion Criteria:

for mothers;

* The fact that the mothers came to the center where the research will be conducted for routine baby follow-up and vaccination follow-up.
* Mothers' willingness to participate in the research
* Absence of any communication problems
* The mothers must be at least 19 years old.
* Mothers have no physical or mental disability

for babies;

. Babies must be at least 4 months and maximum 6 months old when they are included in the study.

* Complementary feeding not yet started
* Babies being fed only with breast milk
* Babies not born before 38 weeks of gestation
* Absence of a congenital anomaly
* Absence of any digestive and neurological system diseases that may affect nutrition

Exclusion Criteria:

* Infants and mothers who did not meet the inclusion criteria were not included in the study.
Efficacy Study of Extended-Release Niacin/Lovastatin Versus Usual Care

The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Both LDL and HDL are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (CAD); however, HDL is often ignored in primary care. The combination of niacin extended-release (ER)/lovastatin in a single tablet formulation (Advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce CAD risk. The purpose of this study is to investigate the benefits of combination niacin ER/lovastatin in patients receiving standard care who are not at LDL goal per ATP III guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years old with CAD or risk factors for CAD
2. under standard care at Family Medical Care of Tulsa
3. not at LDL goal per ATP III guidelines

Exclusion Criteria:

1. pregnancy/lactating
2. liver disease
3. allergies to statin or niacin
4. active peptic ulcer disease
5. previous treatment with combination therapy for dyslipidemia
Ultrasonography for Nutritional Assesment in Cirrhotic Patients

Ultrasonography of Rectus Femoris and Anterior Tibialis muscles for nutritional assesment in cirrhotic patients undergoing major abdominal surgery

in the study, the investigator will use ultrasound to assess the nutritional state of cirrhotic patients after major abdominal surgery,The investigator aim to assess reliability of ultrasound as a bedside,non invasive tool,The investigator will enroll 72 patients for or study which is an observational study

Eligibility Criteria:
Inclusion Criteria:

* hepatic patients classified as child A, B undergoing major abdominal surgery (liver resection,whipple,Splenectomy,colectomy, Common Bile Duct exploration,By pass surgery)
* 18-60 yrs old
* no past history of nutritional problems,chronic use of drugs,patients with no orthopedic issues such as skeletal fractures or immobilization

Exclusion Criteria:

* Refusal of the patient to share in the study, relevant comorbidities (renal, heart disease or COPD)
* previous immune abnormalities including treatment with corticosteroids
* neuromuscular diseases
* laparoscopic surgery
* patients on parenteral nutrition
An Online Behavior Change Intervention to Promote Physical Activity in Adults With Asthma

The aims of this study are to investigate the effectiveness of an online behavior change (BC) intervention in increasing physical activity (PA) and reducing sedentary behavior in adults with asthma, as well as, in improving other clinical outcomes, in short and medium term. In this single-blind randomized clinical trial, patients with clinically stable moderate to severe asthma, who are physically inactive and do not have cardiovascular and/or osteoneuromuscular impairments will be randomized into control (CG) or intervention (IG) groups (23 in each group). Both groups will carry out a minimum educational program. Additionally, the IG will receive weekly individual and/or group online sessions for 12 weeks of motivation-based BC intervention to promote PA and reduce sedentary behavior, based on both self-determination theory (SDT) and transtheoretical model (TTM). The IG will also receive a pedometer with specific strategies related to it. Both groups will be reassessed immediately after the intervention as well as 6 months after the end of the intervention. The primary outcomes are PA and sedentary behavior, which will be objectively assessed by a triaxial accelerometer (Actigraph wGT3X-BT). Secondary outcomes are: asthma control, functional capacity, quality of life, sleep quality and symptoms of anxiety and depression.


Eligibility Criteria:
Inclusion Criteria:

* people aged from 18 to 60 years
* diagnosis of moderate to severe asthma, who underwent drug treatment for at least 6 months
* clinical stability for at least 1 month (without hospitalizations, emergency care use or medication changes)
* absence of cardiovascular and/or osteoneuromuscular diseases that could interfere/hinder the performance of tests and physical activity
* absence of lung diseases other than asthma
* preserved cognitive function
* non-smokers or ex-smokers with \<10 pack-years
* report being physically inactive in accordance with current physical activity guidelines
* able to make video calls through any platform and/or free app available

Exclusion Criteria:

* presence of any new orthopedic limitation that hinders the performance of physical activity during the study
* perform ≥150 minutes per week of moderate to vigorous physical activity during the initial assessment
Effects of 'Pinkwashed' Alcohol Ads in an Online RCT

The primary objective of this study is to examine how exposure to "pinkwashed" alcohol advertisements (i.e., ads that associate the company with breast cancer awareness or charities) affects consumers' perceptions that alcohol increases the risk of breast cancer. The investigators will randomize participants to view 3 'pinkwashed' social media advertisements for alcohol or 3 control advertisements for alcohol (i.e., 'de-pinked' standard alcohol advertisements that match the intervention advertisements on overall design but do not mention breast cancer). Each participant will view the 3 advertisements for their arm (presented in random order) and respond to survey questions programmed in Qualtrics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* Less than 18 years old
Swipe Out Stroke (SOS): Feasibility of Using a Consumer Based Electronic Application to Improve Compliance With Weight Loss in Obese Minority Stroke Patients

This pilot study evaluates the use of a mobile application to improve weight loss in obese stroke patients. The investigators hypothesize that acute stroke patients who use the mobile application are more likely to achieve a minimum 5% weight reduction during the critical six months post-stroke, yielding considerable improvement in stroke risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic or hemorrhagic stroke.
2. Age 18-85 years.
3. African-American or Hispanic.
4. Modified Rankin Scale (mRS) of 0-3.
5. Body Mass Index greater than 30 kg/m2.
6. Currently taking prescription medication for diabetes mellitus, hypertension or hyperlipidemia.
7. Willing to follow a healthy eating pattern and NOT use weight loss medications for the duration of the study.
8. Personal ownership or caregiver ownership of a personal computer, SmartPhone or other SmartDevice (iPhone or Android platform) with Internet access.
9. If patient has alexia, agraphia, acalculia, dementia or blindness - caregiver must be willing to complete the intervention.

Exclusion Criteria:

1. Pre-existing disability with mRS \> 4.
2. Contraindications to weight loss (planning to become pregnant, history of an eating disorder).
3. Steroid use for suspected vasculitis.
4. Current or recent (past 6 months) participation in a weight loss program or use of weight loss medication.
Phase 2 Study of EPI-743 in Children With Pearson Syndrome

Treatment of Pediatric Subjects with Pearson syndrome

If effective, treatment with EPI-743 should result in a significant reduction in occurrence of sepsis, metabolic crisis, hepatic failure and transfusion dependence.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Pearson syndrome
* Age less than 18
* Availability of medical history for 12 months prior to enrollment
* Abstention from use of CoQ10, vitamin E, lipoic acid and Idebenone 14 days prior to treatment with EPI-743

Exclusion Criteria:

* Allergy to EPI-743, sesame oil or vitamin E
* Clinical history of bleeding/ abnormal PT/PTT
* Concurrent inborn errors of metabolism
* Use of anticoagulant medications
* Participation in any interventional study within 30 days of treatment
* Use of erythropoietin 30 days prior to trial enrollment
Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects

The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:

* Glucose intolerance despite normalized insulin sensitivity
* Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints

Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* treated acromegaly
* considered suitable

Exclusion Criteria:

* pregnancy
Movement Simulation Techniques and Therapeutic Exercise in Young Nulliparous Women

Both motor imagery and action observation training, either alone or in combination with physical practice, have been shown to improve some clinical variables of interest such as strength and motor control. However, this has not yet been investigated in the pelvic floor musculature.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age and asymptomatic women.

Exclusion Criteria:

* This study will exclude those who presented a respiratory pathology, cardiac, systematic, or metabolic disease, history of recent surgery, vertebral fracture, or osteoarticular disorders of the spine area.