cyrilzakka/clinical-trials huggingface dataset:
Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan

Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children but they were not generally used by dentists, especially in developing countries due to its demand of high clinical skills with the conventional technique (CT). The biological approach, Hall technique (HT), requires less training and can be placed by less experienced dental operators including therapists. Previous studies were mainly carried out in developed countries. The aims were to investigate and compare the efficacies and cost-effectiveness of PMCs placed by these two techniques.

A prospective randomised control trial design was used. The study was carried out in a dental practice in Sudan, an under-developed country with lower social economic group. Children between 5-8 years were invited and selected if they met the inclusion criteria. Only those who had 1-2 carious primary molars needing PMCs were randomised. The PMCs were placed by a dentist in the CT arm and by a therapist in the HT arm. The children were follow up every 6 months up to 2 years. The demographic details, periodontal health, occlusion, children anxieties, and procedure time were recorded. The Kaplan-Meier survival rates for each arm were calculated. The incremental cost effectiveness ratio (ICER) was calculated using the results and the local salaries

Eligibility Criteria:
Inclusion Criteria:

* Healthy children with Class I or class II carious primary molars

Exclusion Criteria:

* Had a compromised medical history
* Were pre- or un-cooperative to have clinical examinations
* Lived in remote villages and were unlikely to return for follow-up
* Had teeth with pain or sepsis
* Had teeth with caries extended in pulp either from clinical or radiographic examinations
Using a Thermal Imaging System to Evaluate the Wound of Port-A and the Relationship Between Thermal Images and Infection

Permanently implantable venous ports (Port-A) is very important to patients receiving chemotherapy. It not only provides a reliable route to administrate intravenous drugs, and it also requires minimal care when it is not in use. However, catheter related blood stream infection(CRBSI) is one of the serious complications of Port-A. The diagnosis of CRBSI relies on limited tools, including blood culture or symptoms and signs of active infection. In the stage of CRBSI, Port-A removal is necessary and pose the risk for the patients to re-implant the Port-A. Thus, it is crucial to early detect the infection and give appropriate treatment. Among the pathogens, some pathogens are related to skin contaminants. Before systemic spreading, these pathogens may colonize or cause minor infection subcutaneously. This investigation is to utilize a non-invasive dual spectrum infrared imaging system to evaluate the Port-A wound and to detect the infection.

Aim: 1. To build the database of infra-red thermal images of Port-A wound healing. 2. To investigate the thermal images of skin contamination related CRBSI and to compare with the thermal images of the CRBSI of unknown foci


Eligibility Criteria:
Inclusion Criteria:

* clinical requirement of chemotherapy with Port-A

Exclusion Criteria:

* not able to maintain posture during acquiring the thermal images
* with other wounds over the nearby area of the Port-A wound
* with other severe underlying disease and too weak to mobilize
Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up

The early diagnosis of active tuberculosis in close contacts have not yet been established. To evaluate the early detection of active pulmonary tuberculosis using ULDCT, the investigators will establish the observational cohort of close contacts living in the same space with active pulmonary tuberculosis. Participants will visit our center at enrollment, after 3 months, and 12 months and will be received ULDCT, chest X-ray and Interferon-gamma assays at each visit. One chest radiologist will interpret findings of ULDCT and chest X-ray.

Patients diagnosed with active tuberculosis will be excluded from the study and treated based on World Health Organization guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Close contacts of active pulmonary tuberculosis
* Family members of active TB patient who has lived together for more than one month, or work colleagues of active TB patient who has been working in the same office for more than 8 months
* Participants who received explanation of the research plan, understands and writes agreement.

Exclusion Criteria:

* Vulnerable subjects with mental retardation or severe mental illness
* Patients who could not receive chest CT
* Pregnancy
* Close contacts who diagnosed active pulmonary tuberculosis
Prospective Multicentric Cohort Study of Severe and Very Severe COPD Patients in Brazil (SCOPe).

Chronic obstructive pulmonary disease (COPD) is prevalent (8-20%) and is one of the leading causes of mortality. In 2019 according to WHO it was the third highest cause of death worldwide. In 2019 in Brazil respiratory diseases (Chapter J in the ICD10) were the third cause of death (176.073) with COPD (J44) accounting for 45.163 deaths (25,6% of respiratory and 3% overall). There is an upward trend for COPD mortality worldwide.

The disease also has a high morbidity leading to impairment in daily activity and quality of life.

Patients with severe and very severe disease are at a higher risk for negative outcomes, including exacerbation (up to 2-3 per patient per year). This in turn increases the risk of future exacerbations and mortality, with heightened risk lasting up to two years after each event. It is impertive to evaluate which sub-groups are at an even higher risk and could be potential targets for intervention.

"The PLATINO study" was conducted on 2004 and evaluated the prevalence of COPD in 5 cities, only one in Brazil - Sao Paulo. As the data is 20 years old it might not reflect the current epidemiological status and might not be representative of Brazil as a whole.

Understanding this population, their clinical and laboratorial characteristics can help identify sub-groups with higher risk and potential for intervention. The current prevalence, causing agent and characteristics are not known in Brazil as well as detailed outcome data.

This is a prospective multicentre cohort, non-interventional study. The design is to have multiple medical centres representing the regions of Brazil. Each region has a different exposure to risk factors like tobacco smoke, biomass burning and environmental pollution, has a different population composition and density, degree of urbanization and education level. There are also some inferred genetic differences due to previous colonization and miscegenation. \*CAT (COPD Assessment Test) OU CAAT (Chronic Airway Assesment Test).

The patients will be enrolled in non-random consecutive method and will be followed up for 12 months. There will be on-site visits at inclusion (V0), 6 and 12 months. There will tele-consults at 3 and 9 months to gather relevant clinical data, with special interest at exacerbation.

There will be 8 participating centres in Brazil, representing all 5 regions (North, Northeast, Midwest, Southeast and South). They will be Teaching Hospitals, Regional Reference Hospitals, Tertiary Hospitals or High Complexity Hospitals. The data will be collected on each site and will be adjudicated by the ARO Team.

Eligibility Criteria:
Inclusion Criteria:

Severe, very severe and symptomaitc COPD, according to GOLD definition: exposure, FEV1/FVC ratio \<0,7:

* GOLD B (mMRC\>=2, CAT\>=10), OR
* GOLD E (\>=2 moderate exacerbations or 1 severe), OR
* GOLD 3 and 4 (FEV1 \<50%).

Exclusion Criteria:

Severe interstitial lung disease (extent \>50% on HRCT), OR Severe pulmonary hypertension (on triple therapy), OR Active cancer - undergoing systemic therapy.
3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer

To verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (KGOG criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection


Eligibility Criteria:
Inclusion Criteria:

* endometrioid type
* anticipated surgery omitting lymph node dissection for endometrial cancer
* pelvis MRI, CA125 - satisfying KGOG criteria
* no distant metastasis
* age 19 or more

Exclusion Criteria:

* other cancer within 5 yr
* previous hysterectomy
* previous therapy for endometrial cancer
Evaluation of Some Risk Factors Associated With Colorectal Cancer

1. Evaluation of some risk factors (e.g. smoking, heavy metal exposure, and organophosphorus exposure) on CRC.
2. Estimation of KRAS and BRAF genes mutations associated with CRC.
3. Association between different risk factors and gene mutations on different types of CRC.

* Colorectal cancer (CRC) ranks as the third most common cancer globally and second in terms of mortality (Bray et al., 2018). CRC is the 7th commonest cancer in Egypt, representing 3.47% of male cancers and 3% of female cancers (Metwally et al.,2018).
* Studies have provided that rising CRC rates are associated with increased alcohol use, physical inactivity, high intake of fat, red and processed meat, and processed foods; and low intake of fiber (Zhou and Rifkin, 2021).
* Smoking is an established risk factor for colorectal adenomas as well as CRC incidence and mortality, which suggests that it may affect the prognosis of CRC patients as well (Walter et al., 2014).
* Heavy metals are natural components of the earth's crust, which, if released into the environment, can persist for many years (Wu et al., 2016). The most toxic elements are arsenic, cadmium, chromium, copper, mercury, and lead with the majority of them being classified as certainly or probably carcinogenic (Forte et al., 2020).
* Pesticides that are applied to farms can remain in the environment for longer than intended (Sjerps et al., 2019). Pesticides increase the risk of cancer through a variety of mechanisms including genotoxicity, epigenetic effects, hormonal action, and immunotoxicity (Lyons and Watterson, 2010).
* Of the key genes of CRC, KRAS mutations are the most widely known, as they are mainly localized in codons 12 and 13, which were among the first linked to the pathogenesis of colon cancer (Kudryavtseva et al., 2016). BRAF is an oncogene located on chromosome 7 for which gain of function mutations in multiple solid tumors, such as colon cancer (Frisone et al., 2020).

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients who are recently diagnosed with CRC based on clinical and pathological examinations.

2. Control subjects will be CRC-free, based on the clinical history and physical examination.

Exclusion Criteria:

1 - Patient refuses to be enrolled in the study. 2. Subjects with cancer metastasized from other tissues to the colon. (colon is the site of metastasis)
A Safety and Efficacy Study of SHR4640 and Febuxostat in Subjects With Hyperuricemia

The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a body mass index ≥18 and ≤30 kg/m2;
* Screening sUA value ≥8mg/dl;
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

* Subject known or suspected of being sensitive to the study drugs or its ingredient；
* ALT、AST、TBIL\>1.5ULN;
* History of kidney stones or screening kidney stones by B-ultrasound；
* History of malignancy；
* History of xanthinuria；
* Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
Drug Interaction Study of Isavuconazole and Digoxin

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
* Results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be ≤ upper limit of normal and total bilirubin must be ≤ 1.5 mg/dL
* The female subject agrees to sexual abstinence, or is surgically sterile, postmenopausal (defined as at least 2 years at Screening without menses), or using a medically acceptable double barrier method (e.g. spermicide and diaphragm, or spermicide and condom) to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study; and is not lactating or pregnant as documented by negative pregnancy tests at Screening and Day -1
* The male subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method from Screening until 3 weeks after the follow-up visit at the end of the study

Exclusion Criteria:

* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
* The subject has a known or suspected allergy to any of the components of the trial products including digoxin or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
Improving Contraceptive Counseling in the United States

This project develops a contraceptive counseling protocol (CCP) grounded in scientific evidence and evaluates the CCP for promoting behaviors conducive to preventing unintended pregnancy among women. The project develops and refines the CCP using focus groups and in-depth interviews with (a) key administrators in the national office of Planned Parenthood (b) key administrators in participating Title X clinics, (c) contraceptive counselors, and (d) clients of the health centers. The CCP uses scientifically grounded principles for guiding effective decision making and provider-client communication. Ten Title X clinics are randomly assigned to one of two conditions (5 clinics per condition): (1) treatment as usual (TAU) or (2) implementation of the CCP. Approximately 150 women are selected for study participation in each clinic, yielding about 1,400 participants (half control and half CCP). Immediately following their counseling session, women complete a computer-administered interview that serves as a fidelity check and permits evaluation of the effects of the CCP on variables associated with counseling satisfaction. All women are re-interviewed by phone 6 months later and 12 months later. The effect of the CCP on method-choice effectiveness, method switching, gaps in protection, and use accuracy are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Must be seeking contraception from clinic on day of recruitment

Exclusion Criteria:

* Not seeking contraception from clinic on day of recruitment
Miniinvasive Corneal Neurotization. A Pilot Study.

Neurotrophic keratitis (NK) is a degenerative disease of the cornea due to the impairment of the nasociliary branch of the ophthalmic nerve. Reduced corneal sensation lead to several corneal lesions including spontaneous ulcerations, delayed wound healing, corneal scarring, neovascularization, thinning, perforation or infection. An important and permanent visual loss of is frequently associated with the condition. NK can be congenital or acquired. Its acquired forms can be due to traumatic, infectious (herpes, zoster), neoplastic or iatrogenic causes. There is currently no specific medical treatment. Surgical reconstruction techniques of sensory neurotizations have recently been described in young patients suffering traumatic, congenital or neoplastic NK using supratrochlear nerves as the sensory donor nerves and sural nerve as healthy graft. A neurotization involves the transfer of a healthy donor nerve segment into a tissue to reestablish either motor or sensory innervation. The aim of the present study is to assess the outcomes of a novel sensory neurotization technique for the treatment of severe NK in adult patients (Stages 2 and 3 of Mackie classification). Corneal neurotizations will be performed using either ipsilateral supraorbital nerve as donor nerve (direct neurotization) or contralateral supraorbital nerve as donor nerve and a segment of the lateral antebrachial cutaneous nerve as graft. Small-size skin incisions (less than 3 centimeters) will be made in one or both eyebrow and an endoscopic device will help the surgeons to localize and dissect the supraorbital nerve. Donor nerves or graft will be sutured to the neurotrophic corneas. Adult patients with unilateral NK due to infectious, traumatic or iatrogenic causes will be included.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18.
* NK stages 2 and 3 (Mackie's classification).
* Non-response to maximal medical treatment (lachrymal substitution, autologous serum).
* Postherpetic or post-zoster NK (Group 1).
* Postoperative NK (neurosurgery and trigeminal thermocoagulation) (Group 2).
* Posttraumatic NK (orbital trauma, ocular burn) (Group 3).
* No ocular hypertony in both eyes.
* Visual acuity \> 20/40 on the contralateral eye.
* Written consent of the patient.
* Patient benefiting from national health coverage (either as a direct user or beneficiary).

Exclusion Criteria:

* Impossibility of general anesthesia.
* Herpetic or zoster recurrence in the 6 months prior surgery.
* Length of NK evolution \> 5 years.
* Congenital NK.
* Bilateral NK.
* Other causes of NK: diabeta mellitus, amylosis, sarcoidosis, multiple sclerosis, vitamin A or B12 deficiency, Sjögren syndrome, GVH disease, topical NSAID, topical beta-blockers, history of refractive surgery.
* Mental illness.
* Adult with legal guardian or guardianship.
* Pregnancy.
* Breast-feeding.
* Patient's unable to understand informations.
Lipotecan Based Concurrent Chemoradiotherapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.

Protocol number: TLCTLC388A1008

Primary objective:

To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment.

Secondary Objective:

The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be males or females

   * ≥20 years of age in Taiwan
   * ≥18 years old in China
2. Patients with histologically confirmed HCC or patients who do not have histological diagnosis, but the lesion is larger than 1 cm in a cirrhotic liver with typical HCC image of contrast enhanced CT scan or MRI. If the image characteristic is not typical of HCC, another contrast enhanced image modality should be confirmed for diagnosis.
3. Patients with PVTT (BCLC stage C) who are not suitable for local therapies
4. Patients with a measureable targeting lesion
5. Patients with an anticipated residual life expectancy ≥3 months
6. Patients who have adequate organ function
7. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2
8. Patients who are willing to follow birth control requirements during the study treatment and continue until 2 months after the completion of study treatment
9. Patients willing and able to comply with the study procedures and to sign a written ICF

Exclusion Criteria:

1. Patients with infiltrative type HCC
2. Patients with evidence of any extrahepatic metastasis, including but not limited to inferior vena cava thrombosis, bone metastasis, brain metastasis, or regional lymph node metastasis
3. Patients with a history of West Haven criteria grade III-IV hepatic encephalopathy or ascites
4. Patients with a history of other malignancy except primary HCC within 3 years prior to the screening visit, excluding skin squamous cell carcinoma or basal cell carcinoma
5. Patients who fail to follow the radiation dose constraint in any critical organ in the radiotherapy planning
6. Patients with an inadequately defined hepatic tumor margin for RT planning on MRI or CT that may impact treatment or safety based on investigator's judgment
7. Patients who have experienced significant allergy or hypersensitivity to the contrast medium for CT or MRI that makes it unsafe to perform the delineation for RT planning
8. Patients with a history of liver transplantation
9. Patients with a significant concurrent disease
Irreversible Electroporation(IRE) For Unresectable Hilus Pulmonis Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Hilus Pumonis Neoplasms.

By enrolling patients with unresectable Head and Hilus Pulmonis adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Hilus Pulmonis Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Hilus Pumonis Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Personalized Evidence-based Medicine in Patients With Atrial Fibrillation

A retrospective analysis

4200 EMR of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (CDSS MedicBK) utilizing a core laboratory.

Eligibility Criteria:
Inclusion Criteria:

EMR only if an ECG diagnosis (12-lead ECG, 24-h Holter, or other electrocardiographic documentation) confirming AF was made in patients at high risk for stroke by CHA2DS2-VASc (≥2 in men and ≥3 in women).

Exclusion Criteria:

No