cyrilzakka/clinical-trials huggingface dataset:
Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）

Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

Eligibility Criteria:
Inclusion Criteria:

* 1.Age at least 18 years.
* 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
* 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
* 4.ECOG PS : 0 to 1.
* 5.Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

* 1.Prior exposure to any anti-angiogenesis drugs.
* 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
* 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* 4.Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
* 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.
Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney

A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
* Presence of one stone greater than 4 mm and less than 12 mm

Exclusion Criteria:

* Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
* Impaction of stone to be treated
* Staghorn stones
* Failed or inadequate lithotripsy procedure within 3 months prior to study
* Coagulation abnormalities or anticoagulation therapy
* Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
* Can not be positioned correctly for fluoroscopic imaging
Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

The goal of this study is to determine whether a two-page print brochure that delivers individually tailored educational messages about the Human papillomavirus (HPV) vaccine increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters vaccinated against HPV.

This will be a randomized controlled intervention trial for HPV vaccine-hesitant mothers of adolescent (ages 11-15 years old) girls. Mothers will complete a three-item measure that assesses their baseline intentions for having their adolescent daughter vaccinated against HPV. Mothers will then fill out a short, computer-based survey that assesses demographic factors, prior experience with HPV-associated illnesses and views about a variety of potential barriers to HPV vaccination. Following the survey, the intervention group (40 mothers) will receive a two-page print brochure that uses their survey data to generate the brochure such that it addresses each mother's top three concerns about the HPV vaccine. The control group (40 mothers) will receive a generic, two-page brochure that is similar in appearance to the intervention, but contains only untailored, generic information about the vaccine. HPV vaccination intention will be assessed a second time after reading the brochure, using the same three-item measure as before the survey. The vaccine administration records of the adolescent daughters of these mothers will be accessed three months after mothers' participation in the study to assess whether any HPV vaccine doses were provided.

Eligibility Criteria:
Inclusion Criteria:

* Mother is greater than or equal to 18 years of age
* Mother has a daughter who is between the ages of 11-15 years
* Daughter has not received any doses of the HPV vaccine
* When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated."

Exclusion Criteria:

* Cannot read/speak English
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria:

* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Secondary Cardiovascular Prevention Post-acute Myocardial Infarction (AMI) Through a Web-based Empowerment Program

The aim of this study is to assess the efficacy of an innovative program of secondary cardiovascular prevention focused on patient empowerment. This program will be characterized by a blended interaction between healthcare workers and the patients: first, a face-to-face first encounter in-hospital for risk factors profiling, followed by remote interactions through a digital approach. The digital intervention is targeted at promoting the adoption and retention of virtuous behavior (e.g. smoking cessation, healthy eating habits, physical exercise, regular assumption of pharmacological therapies), improving cardiovascular risk factors control. Moreover, an exploratory endpoint will be investigated: the reduction of the residual coronary risk.

The experimental intervention will consist of educational, motivational and coaching actions of patients post-AMI through a web based interaction with the prevention team. This intervention will be: 1) personalized (based on a risk factor profile obtained in-hospital) 2) agreed (planned with the patient with shared decision making), 3) multidisciplinary (physician, nutritionist, psychologist, clinical research nurse), 4) blended, composed of a minimal initial interaction face-to-face and periodical reminders (educational, motivational and supportive) for secondary prevention, through email, a reserved website and a chat box. The intervention contents, targeted at patient empowerment, will take the behavioral change models into consideration as a theoretical basis.

The participants of both groups will undergo conventional cardiology follow-up visits indicated (at 1- 3-12-36-48 months). Blood tests or any other exam other than those indicated by routine clinical practice are not required in this study. Patients with diabetes who already wear the Abbot Freestyle Libre® glucose monitoring device will be asked access to device data within two periods of two weeks, before programmed cardiology visits at 1, 3 and 12 months. At 12 months and 48 months-follow-up visits, all participants will be assessed by the Atherosclerosis Prevention Unit, and the lifestyle questionnaires administered at baseline will be repeated. The intervention group will also take a satisfaction survey at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* STEMI or NSTEMI
* availability of digital communication devices (smart-phone, tablet or personal computer) and internet access

Exclusion Criteria:

* active malignancies (except for skin tumors other than melanoma)
* life expectancy \<5 years
* absolute clinical indication to undergo hospital rehabilitation cycles
* cognitive status undermining digital communication devices use, even after proper training
* low understanding of Italian language, either oral or written, by clinician's judgement
* patient not foreseeing to undergo cardiology follow-up at the site
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

Kidney stone formation due to an excess of calcium in the urine is a common problem. It is treated with thiazide diuretics. These drugs often cause excessively low blood potassium levels that in turn require large doses of potassium supplements. These supplements are often large, unpleasant and easy to forget. We are trying the addition of spironolactone to these patients' medications to see if it allows them to take a lower dose of potassium.

See rationale above

Ten patients who have had multiple kidney stones primarily due to hypercalciuria and who are currently on stable dose of thiazide or thiazide plus amiloride will be enrolled in the study. In addition, pts have to require at least 60mEq of K supplementation a day or be on 40mEq and be hypokalemic and unable to tolerate increased K supplements. We will then give them 50mg a day of spironolactone for four weeks. A complete 24-hour urine stone profile will be obtained before and after the drug is administered. After four weeks the patients' serum potassium will be rechecked, and their dose will be lowered according to a nomogram.

Primary end point is the mean change in serum K before and after spironolactone. Secondary endpoints are the change in urine calcium on and off the drug and the mean reduction in K dose on the drug.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* History of idiopathic hypercalciuria (\>200mg per 24 hours or a Ca/cr ratio of \>140) felt to be the primary etiology of patient's kidney stones
* History of at least three kidney stone events
* On same dose of thiazide diuretic for at least three months
* On stable dose of K 60mEq or more a day to maintain serum K \>3.5 or unable to tolerate an increase in K supplement with dose at least 40mEq a day

Exclusion Criteria:

* Use of ACE inhibitor, ACE receptor blocker or other medication known to effect serum potassium levels
* GFR \<80 by MDRD equation
* Serious cardiac disease, diabetes, CKD , current or planned pregnancy or breastfeeding
* History of hypertension
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for non-cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing spine surgery
* patients undergoing open radical prostatectomy
* patients undergoing hip arthroplasty
* patients undergoing knee arthroplasty

Exclusion Criteria:

* Patients taking oral anticoagulants,
* Patient taking recombinant factor VII a
* pregnancy
Internal Fit Evaluation of Indirect Restorations Using Cone Beam CT (CBCT)

this study was conducted to evaluate the internal fit of indirect restoration fabricated from CAD/CAM composite blocks versus ceramic blocks in badly broken vital teeth using cone beam CT

two parallel groups (n=42 restorations), patient having badly broken vital teeth minimum of two remaining wall will be randomly enrolled in this trial and receive restoration fabricated either from Grandio composite blocks or E-max ceramic blocks. internal fit evaluation of the fabricated restoration over their corresponding casts will be performed using cone beam CT just prior cementation of the restorations. data will be collected and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients with badly broken vital teeth young adult males or females (20-50 years) good oral hygeine cooperative patients approving to participate in the study

Exclusion Criteria:

* patients with acompromised medical history severe or active periodontal disease severe medical complications lack of compliance
Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.

Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.

We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.

Eligibility Criteria:
Inclusion Criteria:

* oesophageal cancer
* Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery

Exclusion Criteria:

* Metastatic disease
Zein Nanoparticles for Glycemic Control

The use of zein nanoparticles as vehicles for drug delivery is under study, but of the effects observed in empty nanoparticles, in laboratory animals, the reduction of glucose levels was something worth studying. Thus, the present research on patients with prediabetes has been proposed. The objective is to assess the efficacy of zein nanoparticles on the glycemic control. For this purpose, a randomized, double blind crossover study has been designed.

Target sample size is 60.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI between 25 and 40 kg/m2
* Presence of prediabetes (fasting glycemia in blood between 100 and 126 mg/dL)
* No weight variations considered relevant (+/- 5%) in the last 3 months
* Metformin treatment is allowed, as far as dose is stable (at least 2 months with unvaried dose).
* Good physical and psychological state.

Exclusion Criteria:

-
The Effect of Frontal Electromyogram (F-EMG) Activity on the Entropy Index Behavior During General Anesthesia

This study evaluates the effect of frontal EMG activity on Entropy index in burst suppression level of propofol anesthesia and surgery

This is an academic observational study, where EEG is recorded during conventional propofol-remifentanil-rocuronium anesthesia and surgery in informed, consenting adults, during their surgical operations in Tampere University Hospital. The patients will be informed about the possibility to participate during their preoperative visit, and the approval will be asked on arrival in the day of surgery, before premedication.

The course of anesthesia will not be changed. The monitoring of the anesthetic state will be conventional: Heart rate, blood pressure, oxygen saturation of blood, Entropy Index, neuromuscular blockade will be monitored, as is the case in all surgical patients under general anesthesia in Tampere University Hospital. Any further monitoring will apply depending on the specific needs of the particular patient. Entropy Index data, EEG data and neuromuscular blockade data will be recorded on computer and analyzed later at GE Healthcare R\&D Department, Helsinki, Finland, by Dr. Mika Särkelä. All data leaving Tampere University Hospital will be anonymized.

Anesthetic induction will be given in a conventional way (intravenous propofol and remifentanil, followed by intravenous rocuronium). EEG waveform is monitored with Entropy module. Neuromuscular blockade will be monitored with EMG-NMT module (GE-Healthcare). The data collection (Entropy, EEG, neuromuscular transmission (NMT) data) will last at least until skin incision.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled elective surgical operation under general anesthesia at Tampere University Hospital
* Written informed consent obtained

Exclusion Criteria:

* Subjects not giving informed consent
tDCS in Post-Acute COVID-19 Patients With SARDs

Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains.

The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.

Currently, there are no studies evaluating the tDCS technique in ARD patients with post-acute COVID-19; therefore, the main objective of the present study is to evaluate the safety and efficacy of the application of acute tDCS in these specific patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with well-defined ARDs (rheumatoid arthritis, sclerosis systemic, Sjögren syndrome, spondyloarthritis, systemic lupus erythematosus, systemic vasculitis, and systemic autoimmune myopathies)
* Fatigue or general pains.

Exclusion Criteria:

* Neoplasia, using heart pacemarker, using visceral metalic clips, infections (HIV, HTLV-1, hepatitis), pregnance, previous historical of convulsions or epilepsies
Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis

the study aims to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.

Rationale: The majority of obstetric emergencies are identified through clinical examination, which cannot be substituted by ultrasound. However, just as a laboratory exam, ultrasonograpy can provide swift point of care information on fetus presentation, viability, placenta position, quantity of amniotic fluid and presence of abdominal fluid to inform the clinical reasoning and therapeutic escalation. Ultrasound literature in low-resource settings has favoured antenatal care (ANC) rather than the emergency setting. Also, hand-held ultrasound machines may not be as performant as traditional machines used by expert operators but to date is still to be tested in a low resource setting.

Objective: to assess the reliability of ultrasound findings measured by hand held ultrasound probes used by operators with variable experience in a low resource hospital.

Hypothesis: There is substantial agreement between simple ultrasound findings identified using hand held ultrasound devices and the reference standard.

Study design: a prospective observational diagnostic accuracy study. Study population: parturients admitted to the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.

Sample size: no formal sample size calculation is performed. Based on current rates of admissions to the PCMH we expect to perform obstetrical ultrasound scan in at least 300 patients during a 2-months study period.

Methods: 4 trained physicians (3 naive and 1 intermediate ultrasound users) will perform the ultrasound investigations using the hand held device and complete a structured predefined report form of obstetric ultrasound findings at patient admission or according to clinical indications after admission. These will be compared with the reference standard, i.e. an ultrasound examination performed by a specialist gynecologist/obstetrician using a conventional apparatus in the hospital ultrasound room.

Main study parameters/primary endpoints: The mean diagnostic accuracy among nine ultrasound obstetric findings collected with hand held devices versus the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the emergency department, outpatient department, in-patient department or antenatal care (ANC) of the PCMH during the study period.
* Fulfills one or more of the five inclusion categories: i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and other high risk pregnancies encountered in ANC.

Exclusion Criteria:

* Ultrasound examination not feasible, e.g., due to electricity breakdown, or physical absence or unavailability of the trained sonographers.
Efficacy of Intraductal Radiofrequency Ablation in Combination With Metallic Biliary Stenting in Advanced Hilar Cholangiocarcinoma

The study aim to evaluate the efficacy of intraductal radiofrequency ablation for unresetable hilar cholangiocarcinoma in addition to biliary stenting. The patient would be randomized into 1:1 ratio of conventional group who received biliary stenting alone, and RFA group who receive intraductal RFA before biliary stenting. Immediate complications as well as long term stent patency and patient survival would be studied.

Study design: randomized single-blind control trial Study population: patient with unresectable hilar cholangiocarcinoma with obstructive jaundice who need hilar biliary stenting Primary endpoint: Biliary stent patency time Secondary endpoint: Patient survival Intervention

1. Recruited patients randomly assigned into 2 groups, conventional and RFA group by sealed enveloped
2. All patients receive endoscopic biliary stenting. Those in RFA group receive RFA before biliary stent.
3. Monitor for adverse event during hospitalization and during follow up
4. Follow up as outpatient in 4-weekly interval with monitoring of serum liver function test as routine

Eligibility Criteria:
Inclusion Criteria:

* Hilar cholangiocarcinoma diagnosed by imaging or pathology
* Considered unresectable or unfit for surgery
* Presence of obstructive jaundice need endoscopic biliary drainage

Exclusion Criteria:

* History of unremovable metallic biliary stent placement
* severe biliary stricture that the instrument was unable to pass through
* unfit for endoscopic under conscious sedation
* loss to follow up and loss contact within 6 months after intervention
Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women

The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 5 years after menopause
* Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
* The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
* The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
* The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion

Exclusion Criteria:

* Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion
* Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
* Personal history or diagnostic of following diseases:

  1. Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
  2. Pulmonary thromboembolism
  3. Chronic heart failure IIa-III
  4. Uncontrolled arterial hypertension (systolic blood pressure \> 145 mmHg, diastolic blood pressure \> 95 mmHg under hypotensive therapy)
  5. Malignancy
  6. Chronic renal failure II-III
  7. Chronic hepatic failure II-III
  8. Liver cirrhosis
  9. Individual intolerance of Karinat or major side effects