cyrilzakka/clinical-trials huggingface dataset:
The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients

The aim of this double-blind randomized clinical trial is to determine the effects of synbiotic supplement on cardiovascular disease risk factors and bone metabolism markers and depression, in transplanted kidney patients on chronic post-kidney transplant phase diet.This study is a double-blind, randomized controlled clinical trial with two parallel groups. 44 patients will be randomly assigned into synbiotic and control group. Transplanted kidney patients referring to the hospital clinics will be invited to participate. After assessing the entrance criteria, 7 cc blood samples are taken. The food recall is completed. Supplements are given to patients for 10-12 weeks. Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; N-telopeptide; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; blood nitrogen urea; creatinine; and also systolic blood pressure; diastolic blood pressure; Weight; Body mass index; Waist circumference; Hip circumference; and questionnaires including quality of depression.


Eligibility Criteria:
Inclusion Criteria:

* : More than one year has passed since the last kidney transplant
* Having serum creatinine less than 2.5 mg/dL in the last three months
* Being in the age range of 18-75 years
* BMI\<35 kg/m2

Exclusion Criteria:

* Receiving synbiotic supplement
DEB-TACE Prior to Liver Transplantation in the Treatment of HCC

The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for living donor liver transplantation receive DEB-TACE 2 weeks prior to the surgery.

The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing living donor liver transplantation; 4) Adverse events related to DEB-TACE.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. Subjects with viral hepatitis or cirrhosis are clinically diagnosed according to AASLD standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced CT, MRI, second-generation ultrasound contrast agents). When the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. If the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (AFP) is greater than 400 ng/ml. For subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis.
3. Child-Pugh score A-B grade;
4. Tumor present in the right lobe of the liver;
5. Liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7;
6. ECOG-PS score 0-1;
7. Scheduled for living donor liver transplantation as the primary treatment;
8. Signed informed consent form.

Exclusion Criteria:

1. Presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct;
2. Severe hepatic encephalopathy;
3. Coexisting pulmonary arterial hypertension (moderate to high risk, WHO Grade III-IV);
4. Severe contrast agent allergy;
5. Irreversible hepatic artery to hepatic vein shunt;
6. Special types of anatomical variations (Asan portal vein type III);
7. Extrahepatic metastatic tumors;
8. Concurrent active hepatitis or severe infection;
9. Tumor dissemination or distant metastasis, expected survival \<3 months;
10. Renal dysfunction, creatinine \>176.8 umol/L or creatinine clearance rate \<30ml/min;
11. White blood cell count \<3.0x109/L, platelet count \<50x106/L, and unable to correct;
12. Inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease);
13. Severe psychiatric illness;
14. Other reasons deemed unsuitable for participation by the investigator.
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer

This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.

The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Any ethnic origin
* Acquired with devices from two manufacturers: Hologic and GE
* 4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography)

Exclusion Criteria:

* Previous core needle biopsy in breast for past 2 years
* Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast
* Previous breast cancer
* Lactating when taking screening mammograms
* Presence of a breast implant in screening mammograms
* Presence of a pacemaker in screening mammograms
* Inadequate quality status such as insufficient anatomical coverage of screening mammograms
Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease

The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease.


Eligibility Criteria:
Main Inclusion Criteria:

* The patient has a diagnosis of probable Alzheimer's Disease (AD) consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* The patient has a pattern of antibodies in cerebrospinal fluid (CSF) consistent with an amyloid plaque load
* The patient is a man or a woman, and between ≥60 and ≤85 years of age
* The patient has an MRI (performed within 3 months before screening) with results consistent with the diagnosis of probable AD
* The patient has a mild severity of dementia
* The patient has a knowledgeable and reliable caregiver who will be available and able to: accompany the patient to all clinical visits, monitor IRE after each immunization, and participate with the patient at all phone visits during the study AD
* Patients must have completed Part A before being eligible for continued immunisations in Part B

Main Exclusion Criteria:

* The patient has evidence of mixed etiology of dementia (i.e. absence of other neurodegenerative, neuroinflammatory or cerebrovascular disease, or another neurological, mental or systemic disease or condition likely contributing to cognitive decline)
* The patient has clinical and radiological findings that fulfil the standards of the National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences (NINDS-AIREN) criteria for vascular dementia
* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-5-TR) Axis I disorder other than AD; including amnestic disorders, delirium, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress disorder and/or cognitive disorder not otherwise specified, (note: patients may be included if treated with a stable dose of antidepressants for at least 2 months and not fulfilling DSM-5-TR criteria for depression at Screening)
* The patient's eligibility MRI scan (1.5T) shows findings that correspond to more than 4 brain micro haemorrhages
* The patient has extensive white matter lesions as shown on the screening MRI scan (1.5T)

Other protocol-defined inclusion and exclusion criteria do apply
A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with type 2 diabetes
* On a stable dose of metformin of at least 1500 mg per day

Exclusion Criteria:

* History of type 1 diabetes
* Pregnant
* HIV positive
* On a weight loss program or medication
* Has a history of blood disorder, certain cancers, heart, liver or kidney disease
Ultrasound Percapsular Nerve Group Block VS Fascia Iliaca Block for Hip Fracture

Spinal anesthesia (SA) is a widely accepted anesthetic technique for hip fracture repair among elderly. Positioning for SA can be extremely painful. Effective management of pain is important for these patients comfort.

Fascia Iliaca block (FIB) and Femoral nerve blocks are commonly used for analgesia in hip fracture patients. However, they often provide a modest reduction in pain.

The Percapsular Nerve Group block (PENG Block) has the advantage that it covers the accessory obturator nerve.

Aim of the study: compare FIB with PENG prior to positioning hip fracture patients for standardized SA.

In a prospective randomized double blind we included 80 patients aged more than 65 years old, for whom pain was felt when raising the affected limb to 15 degrees. Patients were assigned to receive either ultrasound guided Fascia Iliaca block or Percapsular Nerve Group block using 20 mL Lidocaine 1.5% in both groups. We compared pain on positioning for spinal anesthesia using Verbal Rating Scale (VRS 0 = no pain , VRS 1 = mild pain, t 2= severe pain) for both groups. We also recorded different times to perfom block.

The purpose of the study was to compare analgesis effect of Percapsula nerve group block to fascia iliaca block prior to positioning hip fracture patients for standardized SA. We included 80 patients reporting pain with Verbal Rating Scale at 2 when raising the affected limb to 15 degrees. All patients admitted to induction room, were given standard monitoring and we randomized to receive either: ultrasound fascia iliaca block using linear high frequency ultrasound probe (10-15MHz) placed in a transverse direction over the anterior thigh below the inguinal ligament. A 50 mm needle was advanced until the tips placed underneath the fascia iliaca and 20 mL 1.5% Lidocaine was injected or ultrasound Percapsula nerve group block A curvilinear using low-frequency ultrasound probe (2-5MHz) that was initially placed in a transverse plane over the anterior inferior iliac spine and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees. In this view, the iliopubic eminence , the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed and than a 100 mm needle was advanced to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly and 20 mL 1.5% Lidocaine.We compared pain on positioning for spinal anesthesia and also different time to realise both blocks.

Eligibility Criteria:
Inclusion Criteria:

* - Patients aged ≥ 65 years old and undergoing hip fracture surgical repair under continuous spinal anesthesia (CSA).
* Patients for whom pain was felt when raising the affected limb to 15 degrees (VERBAL PAIN SCALE =2)

Exclusion Criteria:

* - ASA physical status ≥ 4.
* Impaired cognition or Dementia.
* Multiple fractures.
* Contraindication to regional anesthesia.
* Patient's disapproval.
Behavioral and Neurophysiological Effects of Multichannel Executive Network tDCS Combined With Preferred Music Stimulation

This study aims at comparing the effects of transcranial direct current stimulation combined with music on neurophysiological outcomes in healthy participants. This study also aims to evaluate the effects of tDCS combined with music on cognition.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* neurological disorders
* psychiatric disorders
* contra-indication to tDCS (eg, metallic brain implant, pacemaker)
* pregnancy
* alcool abuse
* active smoker
A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period) planned for each subject is approximately 29 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least half a year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months

Exclusion Criteria:

1. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
2. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
3. Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)
4. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
5. Received allergen specific immunotherapy within the 3 months before randomization.
6. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)

Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes.

A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two 0.12% CHX mouthwashes: with or without anti-discoloration system (ADS). Twenty-two healthy subjects will be enrolled. Briefly, the study includes two sequential stages: in the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic and questionnaire-based analyses will be recorded, at baselines and after each 21-days-long cycle of mouthwash. A wash-out period between the cycles of 21 days will be performed.

In the second phase, a long-term (after 6 months) subjective evaluation of dental discoloration will be obtained by means of clinical photograph visual analysis and new questionnaires.

In the first phase, the "immediate" objective and subjective evaluation of dental discoloration by spectroscopic (CIE L\*a\*b\* data analysis with DeltaE evaluation) and questionnaire-based analyses will be recorded. Immediate visual analysis of tooth pigmentation will be evaluated by volunteer him/herself, using a mirror, and by a single dentist soon after the end of each treatment. Participants will indicate the presence/absence of dental pigmentation, and to quantify it with a numeric scale (0= no pigmentation to 10= very strong pigmentation).

These analyses will be performed at baselines and after each 21-days-long cycle of mouthwash.

A wash-out period between the cycles of 21 days will be performed. In the second "late" phase, a long-term subjective evaluation of dental discoloration will be obtained by means of the visual analysis of clinical photograph and new questionnaires. After 6 months from clinical trial (second stage of the study), frontal dental images of volunteers, collected during the first phase, will be printed on photographic paper and, then, visually analyzed, in blind, by the 22 volunteers themselves, as well as by 14 dentists and 13 oral hygienists ad hoc recruited. Dentists and oral hygienists, in particular, will be asked to observe two images of all the 22 subjects, i.e. after treatment with A or B mouthwash, and to answer to the question: "Which picture shows the most pigmented teeth?" Possible answers will be: "A, or B or no difference between the two images". Pigmentation will be also quantified using the numeric scale (0= no pigmentation to 10=strong pigmentation).

The observer will be not instructed in how the color of the teeth should appear in case of CHX pigmentation.

Eligibility Criteria:
Inclusion Criteria:

* to be free from oral mucosa conditions affecting its integrity
* to avoid drug or mouthwash intake during the study and in the previous month

Exclusion Criteria:

* specific allergy to mouthrinses
* presence of periodontitis
* frequent use of Chlorhexidine-based oral hygiene products
Safety, Tolerability, Patient Satisfaction and Cost of 16.5% Subcutaneous Immunoglobulin (Cutaquig®) Treatment

Patients with primary or secondary immunodeficiency disease who have developed adverse reactions to products available on the market such as Cuvitru® (Shire), Hizentra® (CSL Behring) or 10% Gammunex® (Grifols), may benefit from utilizing 16.5% Cutaquig® (Octapharma).

This is a prospective interventional study before and after clinically driven change in treatment formulation.

Polyvalent immunoglobulin treatment is used in patients with primary or secondary antibody deficiency diseases to prevent and lower the risk of infection. There are multiple products available in the market. Most products are administered via intravenous route such as Privigen® (CSL Behring), Gammunex® (Grifols), and Panzyga® (Octapharma). Up until recently, there have been only two products that are licensed for subcutaneous administration - 20% Hizentra® (CSL Behring) and 10% Gammunex® (Grifols).

In our clinical experience, approximately 10% of patients treated with 20% Hizentra® developed adverse reactions. Some are mild and tolerable. Some are moderate to severe and required alteration of treatment plan: For example, changing the product from 20% Hizentra® to 10% Gammunex®. However, this results in a 100% increase in the injection volume due to the lesser concentration of the product, but a decrease in viscosity - both of which might alter overall tolerance. Likewise, any new treatment may bring new adverse events such as rash.

In 2018, there will be two additional subcutaneous immunoglobulin products available in Canada - 16.5% Cutaquig® (Octapharma) and 20% Cuvitru® (Shire).

Even though both new products are licensed and proven to be efficacious regarding preventing significant infection (1,2), the relative safety, tolerability, patient satisfaction, treatment-associated cost has not been studied in patients using the 16.5% Cutaquig®. The study product will be provided through the Canadian Blood Service (CBS) on a special request basis which is a standard procedure for any patients who are intolerable to inventory products.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Patients with primary or secondary immunodeficiency disease who are currently on subcutaneous immunoglobulin treatment but have developed adverse events and are willing to change the treatment product.

Exclusion Criteria:

* Pregnant Women
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. The motivation is a cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following spontaneous reports of liver toxicity in people taking Xenical or Alli.


Eligibility Criteria:
Inclusion Criteria:

1. The trial must be randomized and placebo-controlled
2. The orlistat dose must be 60mg or 120mg
3. Data on ALT or BIL must be available
4. The nominal treatment period must be 16 weeks or longer

Exclusion Criteria:

1. If cross-over trials are found, data from other than the first period will be excluded.
The Effect of Coronal Restoration Type on Satisfaction Patients.

This study aimed to evaluate the impacts of coronal restorations of endodontic treated posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and files of patients who received endodontic treatment in our faculty between 2018 and 2020 were reviewed and chosen. The patients included in the study had been treated by the same endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the data of patient files and database systems were combined, 76 patients were deemed fit for this study. The patients were contacted by phone to request participation in the study. A rendezvous was created for the patients who agreed to get involved in the study, and those who came to the appointment filled in the questionnaires. Demographics, the semantic differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18 software.

This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan University and conducted both at its Endodontics and Restorative Departments of Dentistry Faculty. A query of the Nucleus database (a patient management software) was performed to identify dental charts of patients who received endodontic treatment between December 2018 and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and then selected the same endodontic specialists' patients. A total of 400 teeth were identified for screening. Next, a specified restorative dentistry specialist's patient searched within these patients, and 150 patients were obtained. The study was completed with 68 participants (n=34 each). Then data and radiographs of patients were checked out for the eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients who received only one nonsurgical, single visit primary root canal therapy to one posterior tooth (premolar/molar) which has no periapical lesion and Class I/II coronal restoration, (2) patient's restoration had occlusal function for a minimum of 1 year, (3) patients who were ≥18 years old and no pregnancy or breastfeeding status (4) patients who had good oral hygiene and full dentition (5) patients who were on the American Society of Anesthesiology I and II.

Exclusion Criteria:

* Patients with physical disabilities and communication difficulties, periapical abscess, sinus tract, dental caries were excluded from the study. Patients who had other dental treatments such prosthetic crowns, implants, dental bleaching, filling were not included in the study. Those with open apex teeth were also excluded from the study.