cyrilzakka/clinical-trials huggingface dataset:
The Early Childhood Friendship Project - Phase 3

The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* A child is eligible if attending one of the participating child care centers in the greater Buffalo region of Western New York and planning to enter kindergarten in the fall.

Exclusion Criteria:

* None
Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.

Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age between 18 - 75 years.
* Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
* CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/mL.
* CKD patients have been followed up more than 6 months.

Exclusion Criteria:

* Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
* Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
* Known history of parathyroid or other neoplasias in the neck region.
* History of neck irradiation.
* Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
* Pregnant or lactating woman.
* Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.
* Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.
* Patients who are currently participating in another clinical trial.
* The expected live time is less than 1 year.
* Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
* Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Influence of Proximal Motor Control in Treating Lateral Epicondylitis

This study will be conducted to investigate the effect of scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening on pain, pain free hand grip strength and functional outcome added to conventional physical therapy in patients with chronic Lateral Epicondylitis.

This study will try to investigate if scapular muscles strengthening have an effective role on pain, pain free hand grip strength and function when added to conventional physical therapy in patients with LE.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms of lateral epicondylitis from at least the past 3 months.
2. Pain in at least two of the following four tests; Tomsen test, Maudsley test, Mill's test and handgrip dynamometer test.
3. Their ages range from 30-50 years old.

Exclusion Criteria:

Subjects will be excluded from the study if they have:

1. Peripheral neuropathy.
2. Lesions of upper limb nerves.
3. History of surgery in the affected elbow 6 months ago.
4. Cervical radiculopathy.
An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged at least 18;
* Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
* Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria:

* Any prior cavo-tricuspid isthmus ablation;
* Unstable angina;
* Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
* Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
* At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
* Implantable devices such as ICDs, CRTS and pacemakers in the body;
* Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
* Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
* Previously received tricuspid metal valve replacement;
* Thromboembolic events (including transient ischemic attacks) within the past 6 months;
* Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
* Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
* Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
* Acute systemic infection;
* Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
* Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
* Enrollment in another clinical trial evaluating other devices or drugs during the same period;
* Life expectancy less than 12 months (e.g. advanced malignancy);
* Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.
A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
2. Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
3. Have measurable disease based on RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 3 months.
6. Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
7. Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria:

1. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
2. Have known history of prior malignancy in the past 3 years.
3. Have active pulmonary tuberculosis.
4. Have clinical symptoms of the heart or heart diseases that are not well controlled.
5. Have hypertension which cannot be well controlled by antihypertensives
6. Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is \> 1.0 g.
7. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
8. Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
9. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
10. Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
11. Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
12. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
Does a Transabdominal Plane Block Decrease Patient Pain After Ventral Hernia Repair?

The purpose of this study is to determine if a Transabdominal Plane Block will decrease patient pain and pain medication use after a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh.

Patients coming in for a laparoscopic ventral (ventral, umbilical, incisional) hernia repair with mesh are randomized to either receive a Transabdominal Plane Block injection or a placebo saline injection. The injection will be performed by surgeons under direct visualization during laparoscopic surgery prior to mesh placement. Patients will be followed up post-operatively and after hospital discharge to assess for opioid usage and pain score. Patients in both arms are medically cleared by the surgeon. Currently there are no studies that look at the use of Transabdominal Plane Block in ventral hernia repairs.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* elective laparoscopic ventral (ventral, umbilical, incisional) hernia repair at Mount Sinai Hospital

Exclusion Criteria:

* age younger than 18
* allergic reaction to bupivacaine
* allergic reaction to opioids
* opioid substance abuse
Markers of Bone Turnover in Saliva and How This Compares to Urine and Blood

Study is being done to determine if it is possible to use saliva to measure bone specific proteins and predict bone turnover which could be used in the treatment of osteoporosis.

Prevention and treatment of osteoporosis require sensitive and specific assays of bone turnover. Presently, serum or urinary assessments are used. However, the development of other procedures that are more patient-convenient, non-invasive and cost-efficient would significantly facilitate a clinician's ability to determine bone turnover. The objective of this application is to determine the feasibility of using saliva for this measurement. We will compare serum, urinary and salivary levels in 50 pre- and 50 post-menopausal women. Markers to be measured are bone alkaline phosphatase, osteocalcin, procollagen type propepties hydroxypyridinium crosslinks of collagen and crosslinked collagen telopeptides. Collection of saliva, serum and urine will be done at a single visit. We expect to observe reasonable good correlation between serum and saliva levels and poorer correlation between urine and saliva levels.

Eligibility Criteria:
Inclusion:

* 50 pre-menopausal females (25-40 yo)
* 50 post-menopausal females (55-70 yo)
* Good systemic health
* Good oral health

Exclusion:

* arthritis
* active periodontitis
* history or actively smoking
* diabetes
* HIV positive
* anti-coagulant therapy
* bone fracture within the past year
* pregnancy
* known metabolic bone disease
Oestrogen Treatment for COVID-19 Symptoms

The aim of this trial is to determine whether oestrogen treatment mitigates disease progression and severity in confirmed COVID19.

It is known that (i) women are relatively protected from the impacts of other respiratory viruses, and that oestrogen may partly mediate this effect (ii) Oestrogen protects rodents from SARS-CoV-1 related mortality (iii) Women are relatively protected from developing or dying from severe COVID-19 and (iv) Postmenopausal women taking oestrogen replacement appear less likely to suffer Covid19-related critical illness. These effects may be mediated through oestrogen-related immunomodulation. In addition, however, 17β estradiol reduces expression of ACE2 (the receptor protein through which SARS-CoV-2 gains cellular entry) in tissues such as the kidney. As such, supplemental oestrogen may represent an effective therapy for Covid19.

We will randomise adult men and postmenopausal women with confirmed Covid19 disease to receive 10 days of transdermal oestrogen (3mg/day). The primary endpoint will be evidence of disease progression, indicated by hospitalisation (mild cases) or need for mechanical ventilation or death within 28 days of randomisation for those hospiatlsied. Secondary outcomes will include hospital mortality, duration of hospital admission, admission to ICU/ HDU facility, ICU/ HDU length of stay, need for renal replacement therapy, receipt and duration of invasive mechanical ventilation, cause-specific mortality and time to being fit for hospital discharge

.

Eligibility Criteria:
Inclusion Criteria:

* Acute Covid-19 disease (PCR-confirmed or clinically diagnosed with high certainty)
* Adult males \> 18 years of age OR
* Post-menopausal women (spontaneous amenorrhoea for \>12 months in the absence of any other cause)

Exclusion Criteria:

Women:

* taking oestrogen supplements or oestrogen receptor antagonists
* with abnormal genital bleeding
* with a history of breast cancer
* with a history of endometrial or ovarian cancer
* with untreated endometrial hyperplasia

Men:

• taking hormone therapies (e.g. for prostate cancer)

Any subject:

* failure to obtain consent
* taking lamotrigine
* with a thromboembolic disorder (e.g. Protein C or Protein S deficiency, antithrombin III deficiency)
* with pre-existing liver or renal disease
* with known allergy to exogenous oestrogens
* with a history of porphyria
* with a history of thromboembolic event including deep vein thrombosis, thromboembolic stroke or pulmonary emboli
* taking part in another interventional clinical trial
Spine Deformities in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis.

Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis. aged 4-16 years will include in the study. Trunk rotation measure with scoliometer by applying forward bending test. Children with more than 5 rotations will send to the X-ray. 28 questions will asked, which evaluate the demographic characteristics of children, their educational status, their participation in sports activities, and the physical appearance of families about their children. These questions will asked if the parents had heard of scoliosis before, where they heard it, and whether anyone had scoliosis in the family. Families who complained of posture disorder will asked which shoulder is high without looking at their children and whether they see any height when they leaned forward and the pain situation in their children. Statistical analysis of the data using the SPSS 24.0 (Statistical Package for Social Sciences) program. In all analyzes, p≤0.05 consider statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with rheumatology age between 6-16,
* to be diagnosed at least 6 months ago;
* ability to walk independently; ability to read and write in Turkish; able to follow simple instructions
* no pathology in visual ability and hearing

Exclusion Criteria:

* a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder);
* severe musculoskeletal, neurological or cardiovascular disorders that limit mobility;
* use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines
* participate in scoliosis rehabilitation in the lasts 6-months.
A Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With IBI305 (Anti-VEGF Monoclonal Antibody) Compared to Sorafenib as the First-Line Treatment for Advanced Hepatocellular Carcinoma.

The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.


Eligibility Criteria:
Inclusion Criteria:

1. Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
2. ECOG performance status between 0 and 1
3. No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
5. At least 1 lesion with measurable disease at baseline by RECIST V1.1.
6. Child-Pugh: \<=7
7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
2. Have a history of hepatic encephalopathy or have a history of liver transplantation.
3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
4. Central nervous system (CNS) metastasis.
5. Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment.
6. Local treatment for liver lesions within 4 weeks.
Evaluation of Clinical Performance and IVD Test of LifeOS Digital PCR Liquid Biopsy Kits for EGFR T790M Mutation

Liquid biopsy plays a pivotal role in cancer therapeutics, encompassing critical applications such as early cancer detection, disease progression monitoring, and tailored treatment plan formulation, heralded as a pivotal avenue for the future of cancer management. Established in 2015, LifeOS Genomics Co., Ltd. stands among the select few domestic enterprises pioneering the autonomous development of digital Polymerase Chain Reaction (PCR) technology. The company's automated nucleic acid amplification quantitative analysis platform (QLoci™ md1000 Analyzer) demonstrates outstanding proficiency, featuring sixty thousand wells per PCR chip. Integrating digital PCR technology, it elevates analytical sensitivity beyond 0.1%. LifeOS commissioned the Core Laboratory of Pharmacogenomics at the National Taiwan University to conduct clinical validation assessments for their developed "EGFR T790M Mutation Detection Assay Kit." This assay kit secured official registration by the Taiwan Food and Drug Administration (TFDA) as a Laboratory Developed Test (LDT) in 2023, permitting the issuance of medical testing reports.

This initiative aims to validate the detection capabilities of LifeOS Genomics Co., Ltd.'s "EGFR T790M Mutation Detection Assay Kit" prospectively clinically in clinical lung cancer patient plasma samples, addressing unmet clinical needs for early cancer detection, disease progression monitoring, and aiding physicians in diagnosis and pharmacotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years old.
2. Patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) with EGFR mutations.

Exclusion Criteria:

1. Pregnant women.
2. Any condition that, in the opinion of the doctors, may pose a severe risk to the patient or interfere with trial results or participation.
Pharmacogenetics of Cannabinoid Response

This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".


Eligibility Criteria:
Inclusion Criteria:

* 18 and 55 years (extremes included) on the day of the first dosing.

Exclusion Criteria:

* Cannabis naïve individuals.