cyrilzakka/clinical-trials huggingface dataset:
99mTc-DARPinG3 SPECT/CT for Non-invasive HER2-AX in Breast Cancer With Metastatic Lymph Nodes Before Targeted Therapy

An open-label, single center study with 99mTc-DARPinG3 SPECT/CT and biopsies of primary tumour and metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPinG3 SPECT/CT and standard histopathology from relevant tumor and lymph node biopsies.

Overall goal of the project: To determine HER2 expression level in primary breast cancer and axillary lymph node metastases before chemo/targeted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age
* Diagnosis of primary breast cancer with lymph node metastases
* Availability of results from HER2 status previously determined on material from the primary tumor and metastatic LN, either a. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or b. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
* Hematological, liver and renal function test results within the following limits: White blood cell count: \> 2.0 x 109/L; Hemoglobin: \> 80 g/L; Platelets: \> 50.0 x 109/L; ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal; Bilirubin =\< 2.0 times Upper Limit of Normal; Serum creatinine: Within Normal Limits.
* A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
* Subject is capable to undergo the diagnostic investigations to be performed in the study
* Informed consent

Exclusion Criteria:

* Any system therapy (chemo-/targeted therapy)
* Second, non-breast malignancy
* Active current autoimmune disease or history of autoimmune disease
* Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C
* Administration of other investigational medicinal product within 30 days of screening
* Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Leflunomide for Henoch-Schonlein Purpura

This study conducted a prospective, multicenter, one-arm clinical trial on the combination of leflunomide and steroid therapy for refractory skin Henoch-Schonlein Purpura in children on the basis of ethical principles. A one-year follow-up was conducted to evaluate the changes in the main indicators (frequency of rash recurrence) and secondary indicators (proportion of kidney damage, proportion of joint involvement, T lymphocyte subpopulations, and inflammatory factors) before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of refractory skin type HSP in children, it is expected that leflunomide combined with conventional treatment can improve the remission rate of HSP children's skin purpura and reduce HSP recurrence. The research results are expected to bring new treatment methods and strategies for this group of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from 1 to 18 years old;
2. Patients meet the HSP diagnostic criteria;
3. Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization.
4. Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion Criteria:

1. Individuals who are allergic to leflunomide;
2. Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery);
3. Patients with other digestive system diseases;
4. Those who have previously used flumiphene in clinical trials;
5. Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases.
6. Other situations where the researcher deems it inappropriate to participate in the study.
COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH

Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably.

Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.


Eligibility Criteria:
Inclusion Criteria:

1. Adult.
2. JHAH employee
3. Housekeepers (this group of staff are outsourced at JHAH)

Exclusion Criteria:

1. Any participant exhibiting COVID 19 symptoms
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80

Exclusion Criteria:

* Known active infectious disease or chronic inflammatory disorder
* Hypercalcemia
* Chronic kidney disease
* Pregnancy
Pregabalin for Alcohol Dependence

The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity

This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence

Eligibility Criteria:
Inclusion Criteria:

* Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

* Severe co-morbid psychiatric and somatic diseases
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.


Eligibility Criteria:
Key Inclusion Criteria:

* Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
* Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply
AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES

Our smartphones can recognize the pictures of our family, loved ones and friends. Face recognition software leverages artificial intelligence (AI), image recognition and other advanced technology to map, analyze and confirm the identity of a face.

We humans do a poor job when classifying the injury related to a patient sustaining a proximal humeral fracture. In consequence, there is great heterogeneity in the treatment of proximal humerus fractures. Moreover, offering relevant information to patients regarding the risk of complications or fracture sequelae is challenging, given that the current series are based on obsolete classifications, and the published series bring together just over hundreds of patients analyzed. With these limitations, patients have few opportunities to participate in decision-making about their injury.

The present project aim is to integrate new technologies for the prediction of relevant clinical results for the patients presenting a proximal humeral fracture. In brief, AI can help identify similar fracture patterns without human inference, while humans can feed the algorithm with variables of interest such as the functional outcomes and complications related to this particular type of fracture.


Eligibility Criteria:
Inclusion Criteria:

Patients sustaining a proximal humerus fracture treated nonoperatively under the criteria of the treating surgeon and patients' preference.

Subjects evaluated within the first 3 weeks after the injury. Patients between 18 and 90 years of age. Patients who have been studied with simple shoulder radiographs in anteroposterior and scapular outlet projections.

Participants who accept 1-year time follow-up.

Exclusion Criteria:

Patients with dementia or difficulty completing the evaluation after one year of follow-up.

Patients who have previously received surgical treatment on the affected limb. Patients who have suffered a previous fracture in the affected limb. Surgically treated patients.
Predicting the Outcomes of Labor Induction

Pre induction assessment using bishop scoring system and Manipal cervical scoring system performed on 105 pregnant females

preinduction cervical assessment using The Burnett modification of Bishop score with

1. Cervical dilatation in centimeters will be given a score of zero if dilatation less than 1cm, a score of 1 if 1-2 cm dilated, a score of 2 if more than 2 cm dilataion.
2. Length of the cervix will be given a score of zero if more than 2 cm, a score of 1 if 1-2 cm, a score of 2 if less than 1 cm.
3. Station of fetal head will be given a score of zero if -2 or higher , a score of 1 if -1, a score of 2 if zero or lower.
4. Consistency of the cervix will be given a score of zero if firm, a score of 1 if soft and a score of 2 if soft and stretchable.
5. Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.

and also preinduction cervical assessment using transvaginal ultrasound and Manipal system where:

1. Length of the cervix will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm.
2. Length of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
3. width of the funnel will be given a score of zero if absent, a score of 1 if ≤ 0.5 cm, a score of 2 if more than 0.5 cm.
4. cervical position and shape will be given a score of zero if curved, a score of 2 if straight
5. Distance of presenting part to external os will be given a score of zero if more than 3 cm, a score of 1 if 2-3 cm, a score of 2 if less than 2 cm

Eligibility Criteria:
Inclusion Criteria:

1. Singleton gestation at 37 completed weeks or greater .
2. Cephalic presentation.
3. Longitudinal lie.
4. Living fetus.
5. Intact membrane

Exclusion Criteria:

1. Previous cesarean delivery or rupture uterus.
2. Antepartum hemorrhage including (abruptio placenta, placenta previa or vasa previa).
3. Abnormal fetal lie or presentation.
4. Pervious uterine surgery as myomectomy.
5. Category II, III non stress test.
6. Pelvic structural deformity.
7. Intrautrine growth retardation or macrosomia (estimated fetal weight ˃ than 4kg).
8. Patients who received any pre induction ripening.
9. Active genital herpes.
10. Invasive cervical carcinoma
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female (under effective contraception: pill, implant, IUD, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (DN4 ≥ 4) for more than 3 months, of intensity ≥ 4 on a numerical scale from 0 to 10, and whose analgesic treatment has been stable for more than a month,
* Patients affiliated to the French Social Security system,
* Patients whose free and informed consent has been obtained.

Exclusion Criteria:

* Pregnancy (βHCG+ blood) or breastfeeding,
* Neuropathic pain due to spinal cord or brain injury, phantom limb pain or algohallucinosis,
* Fibromyalgia or algodystrophy,
* Chronic pain syndrome that the patient cannot distinguish and/or is more intense than peripheral neuropathic pain,
* Significant abnormalities in liver (transaminases \> 3N, cholestasis) and renal (MDRD \< 60 mL/min) tests,
* Ongoing comorbidities: cancer, neurodegenerative pathology
* Severe depressive disorder in progress (as determined by the clinician), history of suicide attempts or hospitalization for depression,
* Diabetic patients (contraindicated due to the high sugar concentration of ethosuximide, 3g / 5 ml),
* Patients who have previously received ethosuximide (epilepsy or clinical trial),
* Surgery planned throughout the entire trial,
* Medical and surgical history incompatible with the study,
* Dependence on alcohol and/or drugs (for compliance purposes),
* Known allergy to succinimides (ethosuximide, methsuximide, phensuximide),
* Psychotic disorders,
* Epileptic patients,
* Patients benefiting from a legal protection measure (curatorship, guardianship, deprived of liberty or subject to judicial safeguard).
Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss

Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.

This is a descriptive, prospective study. Women aged 18-40 years admitted for surgical evacuation in cases of early missed abortion in a single university affiliated medical center are being recruited. All procedures performed under general anesthesia following cervical ripening with vaginal Misoprostol.

Before the evacuation, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall. Subsequently, ultrasound guided suction and curettage directed to the implantation wall is done. Finally, the uterine cavity is evaluated by hysteroscopy for RPOC. Participants are scheduled for follow-up diagnostic office hysteroscopy 2 months after termination of pregnancy for assessment of IUA and RPOC. However, due to restrictions on elective surgical procedures brought on by the Covid-19 pandemic, the follow-up hysteroscopy examination was postponed until 5 to 6 months after termination of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment

Exclusion Criteria:

* incomplete and complete abortions, gestational age\>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.
Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.

This study aimed to explore using an APP in post oral cancer surgery to affect patients' needs and quality of life.

Methods Quasi-experimental Research Design used purposeful sampling from January 1 to December 31 of the Far Eastern Memorial Hospital oral maxillofacial surgery ward and the otolaryngology ward requirement met post-treatment oral cancer patients who agreed to participate. Self-administered structured questionnaires, including basic personal information, cancer needs table short version (CNQ-SF), head and neck cancer quality of life scale (EORTC QLQ-H\&N35), were used to collect information. Results were statistically analyzed to understand the distribution of variables and their relationships.

Scientific or Clinical Implication of the Expected Results Using an APP intervention in post-operative patients with oral cancer may be the better way to promote health and enhance one's quality of life.

The malignant tumor has been consecutively ranked as number one of the top ten causes of death over the past 33 years, and the incidence of an increase in oral cancer year by year. The average age of death was 55-57. With this average age compared to other cancer patients under 10 years of early life, it's necessary to care about the burden of disease from oral cancer. The main treatment of oral cancer is surgery and a combination of radiotherapy and chemotherapy. Patients often got severe treatment complications with varying degrees of physical functions and uncertainty due to poor cognition or less clarification in a complex course of treatment that affects medical decisions in the illness process. Both domestic and foreign research show that the majority of oral cancer patients expressed the need for and attention to health information. "Treatment information" was the most needed and important. When information needs are met, it can effectively reduce the anxiety and unease of unknown events. Relevant domestic and foreign research do not provide accessibility and convenience of health education for post-operative patients with oral cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with oral cancer and were the first-time receiving oral cancer surgery within 1 week.
* Conscious and able o communicate
* Patients agreed to participate in this study and had a smart phone.

Exclusion Criteria:

* Patients without oral cancer
* Patients with oral cancer but had received oral cancer surgery before 1 week or more.
* Unconscious or unable to answer questions from questionnaire or APP
* Patients with cognitive impairment, dementia o intellectual disability.
Sentry Study: Raman Spectroscopy on Ex Vivo Lungs

In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

Lung cancer is the most prevalent form of cancer worldwide and the leading cause of cancer-related deaths. Despite recent advances in treatment, the five-year survival rate remains below 25% \[State of Lung Cancer Report 2021,American Lung Association. This is largely due to the fact that most patients are diagnosed only at advanced stages of the disease when treatments are ineffective and the prognosis is poor. The National Lung Screening Trial demonstrated the utility of lung cancer screening by low-dose computed tomography (CT) to improve early detection\\ and reduce lung cancer-related mortality by 20%. Earlier detection of lung lesions in turn created an increased need for better early diagnosis modalities.

Reveal Surgical is developing medical devices for tissue characterization based on Raman spectroscopy technology.

In this proof-of-concept, ex vivo study, the study team will investigate whether Raman spectroscopy technology is a good candidate for the identification of cancerous lung tissue.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above,
* With suspected or confirmed diagnosis of lung cancer,
* Scheduled for lobectomy surgery,
* Able to give informed consent.

Exclusion Criteria:

* Suspected or confirmed diagnosis of mucinous adenocarcinoma of the lung
* Undergoing neoadjuvant therapy. (This exclusion criterion is intended to minimize confounding optical signals such as fluorescence or near-infrared Raman signals that could arise from the presence of chromophores derived from neoadjuvant medication.)
* Previously diagnosed with cystic fibrosis or other lung disease, with the exception of Chronic Obstructive Pulmonary Disease (COPD) and ILD (Interstitial Lung Disease), i.e., patients with COPD or ILD will not be excluded from the study.
* Tumor size below 1cm3
* Resected lobe does not allow Surgical Pathology team to section two study specimens of minimal size 1.5cm × 1.5cm. In this case the patient will be found ineligible after consent.
Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls

The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.

Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.


Eligibility Criteria:
Inclusion Criteria:

a) Patients Falling into PCOS as per Rotterdam criteria

Exclusion Criteria:

1. Systemic diseases like atherosclerosis,
2. Diabetes mellitus
3. Hypertension
4. congenital adrenal hyperplasia, androgen secreting tumors
Wellnara Post-marketing Surveillance in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Wellnara for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)

The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
* \> 18 years
* signed ICF

Exclusion Criteria:

* Persons deprived of liberty
* Patients with history of allergy to patent blue
* Pregnant women or breastfeeding women