cyrilzakka/clinical-trials huggingface dataset:
Direct Resin Composite Restoration of Primary Anterior Teeth Using Custom 3D Printed Templates

Esthetic restoration of primary anterior teeth is challenging. Aim of the study: Evaluation of the 12-month clinical performance of direct resin composite restoration of carious vital primary anterior teeth using custom 3D printed templates compared to conventional strip crowns. Subjects and methods: A parallel arms randomized controlled clinical trial was performed in which 98 carious vital primary anterior teeth in 32 children were directly restored with resin composite either with the help of custom 3D printed templates (Group: A) or strip crowns (Group: B). Restorations were assessed for surface luster, anatomical form, material fracture, marginal adaptation, and periodontal response using the revised FDI criteria on three occasions; a week after placement (T0), after six months (T1), and after twelve months (T2). Comparisons between groups were evaluated. A statistically significant level was considered when p value less than or equal 0.05. The tooth was the unit of analysis.

The present study is a single-center randomized controlled clinical trial with 1:1 allocation ratio. This trial entailed directly restoring carious primary anterior teeth with resin composite either with the help of custom 3D printed templates obtained from digitally waxed-up patients' dental models (Group: A) or conventional strip crowns (Group: B). Restorations were assessed for clinical performance on three occasions; postoperatively (T0), after six months (T1), and after twelve months (T2).

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least two vital carious primary maxillary incisors.
* Teeth had at least two carious surfaces requiring complete coronal restoration.

Exclusion Criteria:

* Children with malocclusion or parafunctional oral habits
* Teeth beyond restoration.
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.


Eligibility Criteria:
Inclusion criteria:

* Age \>= 18 years
* Signed informed consent
* Histologically or cytologically confirmed colorectal adenocarcinoma
* Metastatic or locally advanced disease not amenable to curative surgery and/or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status = 1
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1
* Progression on standard therapies or withdrawn from standard treatment due to unacceptable toxicity. Previous standard treatment must include all of the following:
* - fluoropyrimidine
* - oxaliplatin: Patients treated with oxaliplatin in adjuvant setting should have progressed within 6 months of completion of adjuvant therapy or they must have been treated with oxaliplatin for metastatic disease
* - irinotecan
* - bevacizumab or aflibercept
* - cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours
* - The remaining standard available therapy as recommended by investigator is best supportive care (note: previous treatment with regorafenib and TAS 102 are allowed and these agents should be administered before study if available to patient according to local standards)
* - Life expectancy of at least 12 weeks
* - Hepatic function: aspartate aminotransferase (AST)/ Alanine Amino Transferase (ALT) = 1.5 X Upper Limit of Normal (ULN) and bilirubin = ULN for patients without liver metastases. AST/ALT = 2.5 X ULN and bilirubin = ULN for patients with liver metastases. Patients with Gilbert syndrome and bilirubin \< 2 X ULN and normal AST/ALT are eligible
* Coagulation parameters: International normalised ratio (INR) \< 2 and partial prothrombin Time (PTT) = 2xULN

Exclusion criteria:

* Previous treatment with nintedanib
* toxicity attributed to previous anticancer therapy that did not resolve to Common Terminology Criteria for Adverse Events (CTCAE) grade =1
* History of other malignancies in the last 5 years, in particular those that could interfere with interpretation of results.
* Serious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,
* Significant cardiovascular diseases
* History of severe haemorrhagic or thromboembolic event in the past 12 months
* Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring
* Gastrointestinal disorders or abnormalities that would interfere with absorption of study drug
* Patient with brain metastases that are symptomatic and/or require therapy.
* Patients of childbearing potential who are sexually active and unwilling to use a highly effective method of contraception
* Pregnancy or breast-feeding.
The Influence of NPPA/NPPB Haplotype on Natriuretic Peptide Plasma Levels

Crosssectional study to analyse the genetic influence on levels of cardiac biomarkers (BNP, NT-proBNP).

Background

Natriuretic peptides play an important role in risk stratification and management of patients undergoing non-cardiac surgery. However, due to genetic variability, the levels of these biomarkers may differ in individual patients with cardiac derangement. In the preoperative setting, genetic contribution to natriuretic peptide plasma level variability has not yet been determined.

Objective

The aim of this study is to assess genetic contribution to NP plasma level variability in a Swiss cohort.

Methods

Cross-sectional association study in a cohort of non-cardiac surgery patients.

This study is a Subproject of a prospective cohort study registered under the ID 041/09.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Scheduled surgery

Exclusion Criteria

* No informed consent
* Cognitive impairment
Electroacupuncture for Hypertension Patients With Chronic Kidney Disease

1. To observe the Efficiency of Electroacupuncture for Hypertension Patients With Chronic Kidney Disease.
2. To observe if different-time treatment having an impact on Hypertension Patients With Chronic Kidney Disease.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients with Hypertension

Exclusion Criteria:

* renal replacement therapy
* heart failure
* severe valvular disease
* sustained arrhythmias
* secondary hypertension excluded from renovascular hypertension
* acute cardiovascular events
* infection
Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Chemotherapy is an important means to prolong the survival time of advanced breast cancer. As a new type of microtubule inhibitor, eribulin has a unique mechanism of action. Compared with single drug chemotherapy, it can improve the overall survival time of 2.5 months, increase the clinical benefit rate by 5 times, and the tolerance of eribulin is good. Therefore, the guidelines at home and abroad recommend eribulin for the rescue of advanced breast cancer.

However, up to now, there is no large sample data on the efficacy of eribulin combined with anti HER2 targeted therapy in HER2 + metastatic breast cancer, and the efficacy of combined immunotherapy in triple negative metastatic breast cancer. Moreover, as a newly marketed chemotherapy drug in China, the efficacy and safety data of eribulin in Chinese population are relatively lacking. Therefore, we plan to include different types and line numbers of advanced breast cancer patients based on the Chinese population through real-world research, and receive the treatment regimen containing eribulin respectively. In HR + / her2-mbc, we use eribulin monotherapy; in HER2 + MBC, we use eribulin + anti HER2 targeted therapy; in TNBC, we use eribulin + immunotherapy / chemotherapy, The efficacy and safety of eribulin were evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Adult female patients (aged 18-80 years, including 18 and 80 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
2. The starting time of eribulin treatment was between January 2021 and December 2021;
3. They received no more than 2-line chemotherapy in the past;
4. In HR + / her2-mbc, patients were treated with eribulin monotherapy; in HER2 + MBC, patients were treated with eribulin + anti HER2 targeted therapy; in TNBC, patients were treated with eribulin + immunotherapy / chemotherapy; in patients with HER2 + MBC, patients were treated with eribulin + immunotherapy /chemotherapy;

Exclusion Criteria:

1. Patients without pathological diagnosis;
2. Patients with central nervous system metastasis;
3. She has received more than two chemotherapy regimens for metastatic breast cancer;
4. Participating in any intervention drug clinical trials.
5. Those who have been known to have allergic history to the components of this regimen;
6. The patient, the patient, or the person with serious harm to the safety of the study.
7. Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)
Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants

The purpose of this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.

This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with subclinical hypothyroidism (otherwise healthy volunteers)
* Adults aged 25 - 70 yrs.
* Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study.
* Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study.

Exclusion Criteria:

* Taking drugs that interfere with thyroid function
* Planning pregnancy in the next 6 months
* Taking drugs that lower lipids, blood pressure, or sensitize insulin
* Regular consumption of soy products (\>20 g/wk)
* Consumption of soyfoods within 90 days prior to enrollment.
* Known history of soy or milk allergy or intolerance.
* Taking antibiotics during the intervention
* Active viral infections such as Human immunodeficiency virus (HIV) positive or hepatitis
Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer

In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer(adenocarcinoma) proven biopsy
* Operated by same surgical team
* Presence of distant metastasis

Exclusion Criteria:

* Patients who underwent palliative resection
* operated by a different surgical team
* ASA score: 4
Safety and Diagnostic Yield of Cryobiopsy Versus Forceps Biopsy in Endobronchial Lesions:Assiut University Experience

The purpose of this study is to assess the diagnostic yield and show the feasibility and safety of endobronchial biopsies using the flexible cryoprob and to assess the sensitivity of cryobiopsy compared with forceps biopsy

Flexible bronchoscopy is the diagnostic tool of choice to diagnose endobronchial malignancies. It allows inspection and biopsy of any endobronchial abnormalities under direct vision.

One of the main goals of diagnostic bronchoscopy, besides visualization of endobronchial abnormalities, is obtaining an adequate tissue samples from the suspicious lesions for cytohistological examination. Several techniques could be applied through the working channel of the ﬂexible bronchoscopy such as forceps biopsy, brush, bronchial washing and transbronchial needle aspiration.Flexible bronchoscopy and the associated tissue sampling techniques are the most widespread procedures in the diagnosis of central lung cancer. Even though the specimens are obtained under direct vision, there is a significant failure rate, which therefore, requires repeated bronchoscopies. Concurrent application of different sampling techniques at bronchoscopy has been shown to improve the yield.

Diagnostic bronchoscopy with endobronchial forceps biopsy is primarily practiced in patients with suspected thoracic malignancy and visible endobronchial.

The major drawback of the forceps biopsy technique is the relatively small amount of tissue obtained, which is determined by the size of the forceps. Additionally, mechanical compression or crush artefacts from the instrument tip cause alterations of the tissue samples, which affect the quality of the histological analysis. Flexible cryoprobes were introduced as a new tool for bronchoscopic tissue sampling. It is used primarily for debulking and cryoextraction of malignant airway stenosis.

With this technique, the sample is collected while still being frozen with the tissue attached on the frozen tip of the probe. By this way, larger tissue samples can be taken from endobronchial lesions and artifact free. The molecular markers are also ions. Tissue samples obtained with cryoprobes are of good quality, size better preserved and well represented.

Eligibility Criteria:
Inclusion Criteria:

- 1. Exophytic endobronchial tumor (endoscopically visible lesion)

3.Age\>18 years old

Exclusion Criteria:

- 1.Patients, who refused to be included in this study or unfit for flexible bronchoscopy 2.patients with hemorrhagic diathesis (prothrombin concentration \<50% and platelet count \<80,000/mm 3).

3.Suspected connection of the lesion to large pulmonary blood vessels as seen on chest computed tomography scan
AK-R215 Pharmacokinetic Study Phase I

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers

Eligibility Criteria:
Inclusion Criteria:

* BW is above 50kg and BMI is between 18.5 and 30.0
* Subject who agreed and signed on informed consent form prior to the study participation

Exclusion Criteria:

* Presence or history of clinically significant disease
* Treatment history of any drug which might affect IP within 10days
* History of other study drugs within 12weeks
Conjunctival Flora Patterns After Serial Intravitreal Injections in Diabetic Patients

The aim of this study is to investigate the conjunctival bacterial flora and antibiotic resistance patterns following serial intravitreal injections of anti-VEGF in diabetic patients, using a povidone-iodine preparation without preinjection or postinjection topical antibiotics.

The study is designed to enroll patients with Diabetes Mellitus over 18 years of age with diagnosis of diabetic retinopathy and diabetic macular edema, who were determined by their treating physician to require at least 3 serial injections with an anti-VEGF agent.

After signing an informed consent, conjunctival cultures will be performed from the participants' both eyes at baseline and at each subsequent injection. Prior to each injection and the use of povidone-iodine drops, a conjunctival culture will be taken by swabbing the inferior fornix. Another culture will be taken twenty minutes after the injection. We will culture the swab samples on blood and chocolate agar plates.

All patients will be asked to complete a questionnaire regarding their signs and symptoms after the injection (like burning sensation, itching, discharge, tearing etc). The following routine procedure will be used in all intravitreal injections: local anesthesia using Oxybuprocaine hydrochloride, ocular surface and eyelids sterilization with topical povidone-iodine 4%. Intravitreal injection of 3.5 mm will be performed posterior to the limbus in pseudophakic patients and 4 mm injection will be performed posterior to the limbus in phakic patients using a 30 gauge needle.

The exclusion criteria will consist patients who had received a prior intraocular injection in either eye, current use of contact lenses, chronic use of any ophthalmic medication, ocular surgery within the past 6 months, use of systemic antibiotics within the past 6 months and known allergy or contraindication to povidone-iodine or proparacaine.

The study is planned to enroll 50 patients.

Eligibility Criteria:
Inclusion Criteria:

* age above 18
* patients with diabetes mellitus
* patients with diabetic macular edema

Exclusion Criteria:

* patients who had received a prior intraocular injection in either eye,
* current use of contact lenses,
* chronic use of any ophthalmic medication,
* ocular surgery within the past 6 months,
* use of systemic antibiotics within the past 6 months,
* known allergy or contraindication to povidone-iodine or proparacaine.
A Phase III Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
4. The TBS size \< 21 cm2/3.3 in2.
5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.

Exclusion Criteria:

1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
2. Congenital or acquired disorders of coagulation.
3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
4. Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) \> 1.5.
5. Acute major bleeding during surgery.
6. Participant with TBS in an actively infected field.
7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.

This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.

Eligibility Criteria:
Inclusion Criteria:

* heroin-dependent adults
* new admissions to buprenorphine outpatient treatment

Exclusion Criteria:

* pregnancy
* acute medical or psychiatric illness
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)

This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.

This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active comparison therapy called Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will be randomly assigned to receive 8 weeks of group therapy in either MBCT or MRT treatments. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide saliva samples. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.

Due to COVID precautions, treatments shifted from in-person to remotely-delivered ("Zoom" video-conferencing) modality.

Eligibility Criteria:
Inclusion Criteria:

* Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder) or subsyndromal PTSD (has qualifying trauma, has intrusive and avoidant symptoms, and at least one negativity and one arousal symptom, and significant impairment); type of trauma shall be interpersonal violence, combat, and/or sexual assault, etc.

Exclusion Criteria:

* Dissociative PTSD
* Delayed-onset PTSD
* Magnetic Resonance Imaging (MRI) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.)
* Serious medical or neurologic conditions (e.g. stroke, seizures)
* Suicide risk
* Psychosis
* Life history of schizophrenia
* Life history of bipolar disorder
* Current substance dependence
* Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team