cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Anlotinib in Patients With Advanced Non-small Cell Lung Cancer（ALTER0302）

Anlotibib (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 VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore Anlotinib for the effectiveness and safety of andvanced non-small cell lung cancer who failed two lines of chemotherapy


Eligibility Criteria:
Inclusion Criteria:

1. pathology diagnosed with advanced NSCL with measurable lesions;
2. Have failed for 2 lines of chemotherapy;
3. 18-70years,ECOG PS:0-2,Life expectancy of more than 3 months;
4. Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks;
5. main organs function is normal;
6. must be agreed to take contraceptive measures during the study and within 6 months after end.

Exclusion Criteria:

1. SCLC(including mixed with NSCLC);
2. the central cavity of Squamous cell carcinoma and hemoptysis with NSCLC;
3. patients failed to use the anti-tumor angiogenesis therapy;
4. patients has many influence factors toward oral medications ;
5. Brain metastases patients accompanied by symptoms or symptom control for less than two months;
6. patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc.
7. patients failed to heal wounds or fractures for Long-term;
8. 4 weeks before enrollment, patients appeared NCI CTC AE grading \>1 pulmonary hemorrhage; 4 weeks before enrollment, patients who appeared NCI CTC AE grade\> 2 have other parts of the bleeding; patients has a tendency to bleed (eg active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues;
9. patients occurred venous thromboembolic events within 6 months;
10. patients has HIV-positive or organ transplantation;
Lung SBRT Motion Management (GCC 1619)

Real-time optical surface monitoring data will be acquired from 44 human patients with primary or metastatic lung lesions during and after their 4DCT scan (standard-of-care at our institution). A patient-specific 4D model will be developed using the raw 4DCT projections time-correlated with real-time surface monitoring. In addition, before delivering each dose fraction (3 - 5 for lung SBRT), we will acquire three 15s kV fluoroscopic image acquisitions, time-correlated with optical surface monitoring. The acquisitions will be distributed over three well-spaced beam angles, e.g., every 4th angle for a 12-field plan.

Surface monitoring procedure -The procedure is expected to last approximately 15 minutes after the end of the 4DCT scan, which is the standard-of-care for lung SBRT treatments at our institution. The procedure will consist of real-time surface tracking using the VisionRT system of the thoracic and/or abdominal region. Continuous audiovisual contact will be maintained with the subject during scanning. Each individual will be informed that they can stop the procedure at any point.

Fluoroscopic imaging procedure - Fluoroscopic imaging will be performed in the treatment room with the patient lying in treatment position. Three 15s acquisitions will be performed under free breathing conditions, each from a different beam angle, using the on-board kV imager. Audiovisual contact will be maintained at all times with the patient.

Data collection and management: An ID number will be assigned to each separate patient, and the correlation between ID number and patient name and medical record number will be kept in a password-protected file in Dr. Amit Sawant's office. The database of information extracted from the medical record and radiation treatment records for each patient will be stored in an Excel file on a computer with password protection. All image data will be de-identified by Dr. Sawant before his research team analyzes them.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible disease(s)/stage(s) - Patients with primary or metastatic lung lesions to be treated using stereotactic body radiotherapy (SBRT) will be eligible for this study.
2. Allowable type and amount of prior therapy - Any types and amounts of prior therapy will be allowed for this study.
3. Age restriction and/or gender/ethnic restrictions - Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
4. Life expectancy restrictions - None.
5. ECOG or Karnofsky Performance Status - Karnofsky performance status of 50 or greater
6. Requirements for organ and marrow function - None.
7. Ability to understand and the willingness to sign a written informed consent document.
8. Tumor motion \> 5 mm, maximum GTV dimension \< 50 mm - per guidelines established by the AAPM Task Group 7612 and RTOG 0236.13

Exclusion Criteria:

1. Children (age \<18)
2. Women who are pregnant or trying to get pregnant
3. Pain in supine position
4. Karnofsky performance status \< 50
I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients

* To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients.
* To determine percentage of patients achieving blood pressure control according to their profile (naïve, switch, patient history, etc...) at the end of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proved mild to moderate hypertension.
* Newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension)OR
* Patients who were receiving antihypertensive agents (maximum two - one of them is diuretic) and who in the investigator's opinion would benefit more from switching to the study medication. These patients will undergo a wash out period for not less than 7 days prior to enrollment.

Exclusion Criteria:

* Severe hypertension (Systolic Blood Pressure ≥ 180 mm Hg or Diastolic Blood Pressure ≥ 110 mm Hg).
* Patients with secondary hypertension (for another cause other than type 2 diabetes mellitus).
* Patients with HbA1c \> 10%.
* Significant chronic renal impairment (Serum creatinine \> 2.0 mg/dL).
* Significant liver disease as shown by SGPT/SGOT (ALAT/ASAT) \> 2.5 times the upper limit of the normal range.
* Currently pregnant or lactating females.
* Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
* Any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his physician).
* Known hypersensitivity to irbesartan, other ARBs (Angiotensin Receptor Blockers), hydrochlorothiazide, or other thiazide diuretics.
* Patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):

Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.

Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
* Patients scheduled for elective open colonic mass resection and anastomosis.

Exclusion Criteria:

* Serious cardiac arrhythmia.
* Peripheral artery disease.
* An ejection fraction below 30%.
* A pulmonary pathology.
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

Around 20% of patients with acute pancreatitis (AP) will go on to have acute recurrent pancreatitis (ARP) and 10% progress to chronic pancreatitis (CP). While interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. Although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. Our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis Patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations) group. During the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, BMI, cardiovascular parameters and serum lipid values will be recorded The EFFORT trial will determine the effect of modified dietary fat content on the recurrence of AP, mortality, serum lipids and weight loss in idiopathic cases.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with
* The last episode being idiopathic, who are
* Older than 14 years.

Exclusion Criteria:

* Individuals already receiving regular nutritional guidance (with medical indication),
* Individuals in critical condition or in terminal stage of cancer (with an expected survival \<2 years) ,
* Individuals undergoing treatment for active malignancy,
* Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c \>6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus)
* Individuals with known cholecystolithiasis
* Individuals who are pregnant or nursing
* Individuals with a BMI \< 18.5
* Individuals who are regularly receiving systemic corticosteroids
* Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.
Urinary Catheter 'Fill and Flush' Valve: Safety, Effectiveness, Acceptability and Feasibility Trial

The fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.

The objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term IDC and the feasibility of undertaking future community-based evaluation.

To do this the investigators will

* determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients;
* determine if the valve functions effectively i.e. allows for the complete bladder emptying (\< 100ml post void residual) during rest and daily activities;
* determine if the process of filling and automatic draining is comfortable and acceptable for participants;
* collect preliminary data on the potential for bioburden/biofilm following in human use of the valve;
* assess the feasibility of undertaking a future randomised control trial of the valve.

Group 1 - The investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).This first group will include a safety cohort of participants (n=4). All safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation.

Group 2- The Investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage.

The data collection process and study procedures will be identical for both groups.

After use(in both groups), the valves will be examined microbiologically in the University of Southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.

Eligibility Criteria:
Inclusion Criteria:

* IDC-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine
* Independent with catheter care needs (e.g. bag emptying or valve opening)
* Able to transfer from bed to chair, stand and walk short distances unaided
* Able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter)
* Able to provide informed consent (self-report and research nurse assessment)
* Usual medical provider provides confirmation of suitability

Exclusion Criteria:

* End stages of a terminal illness
* Current treatment of urinary tract infection
* Has been advised by a urologist against using a valve on clinical grounds
* Lack of bladder sensation (e.g. unable to sense when bladder needs emptying)
* Previous bladder surgery that could affect the integrity of the bladder
* At known risk of autonomic dysreflexia
Real Risks of the Online World

Development and validation of questionnaire/scale to assess problematic online dating app (ODA) use in a sub-cohort of the SwissPrEPared cohort study (validation sample: n=229). Longitudinal design to assess the association of problematic ODA use and sexual/mental health and substance use outcomes. No randomised trial, only 1 cohort which will be stratified according to severity/risk of problematic ODA use.

This project may fill an important gap of knowledge in a research area that has taken on major importance over the past few years, and has thus the potential to impact several major public health recommendations. First, considering the high penetrance of dating apps in the men who have sex with men (MSM) population (reaching 78.2% in a recent report), more than 62,000 MSM in Switzerland are estimated to use such applications. How many of them suffer from addiction or problmatic use remains unclear and our project will be the first to provide estimates of the prevalence of problematic ODA use in this particular population. Second, our project will help to clarify the impact of online dating app usage on health outcomes. By identifying drivers of the current HIV/(sexual transmitted infections (STI) epidemic in Switzerland, our project might thus provide critical information to shape future prevention measures aiming at further reducing HIV/STI incidence rates. Third, because sexual risk-taking increases with substance use and depression, it remains crucial to detect mental health outcomes early and provide adequate care to populations at high risk of HIV, or other STI, transmission. Fourth, our study might identify a new phenomenon related to high-risk sexual behaviour that may not be limited to the MSM group, but could also affect other, larger populations interacting and meeting through online communication channels. Considering that more than 41 million people are currently using dating apps in Europe, our findings might have a substantial impact on the general population. Finally, this project might provide the very first insights on the interplay between online dating, substance use, mental health and sexual risk taking. This new understanding could then help Switzerland create additional measures for preventing HIV transmission and reach the UNAIDS targets for HIV elimination by 2030.

Eligibility Criteria:
Inclusion Criteria:

* currently engaging in online dating (i.e., using applications/websites with the aim to meet potential relationship or sexual partners or having used them actively in the past 12 months)
* Participating in the SwissPrEPared study at center Checkpoint Zurich
* German speaking

Exclusion Criteria:

- Potential participants will be excluded if they are unable to follow study procedures.

For Inclusion/Exclusion at the SwissPrEPared study see: NCT03893188 at clinicaltrials.gov
Post-Market Surveillance With a Novel mHealth Platform

This is a study to pilot the feasibility of using a novel patient-led, smartphone-based mobile health platform (Hugo) for real-world surveillance of outcomes of patients after they undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial fibrillation ablation

The plan is to pilot test a novel patient-led, smartphone-based mobile health platform (called Hugo) for real-world surveillance of outcomes in 60 total patients after medical device use. Research associates will be recruiting patients before they undergo a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) and catheter-based atrial fibrillation ablation. Patients will then be queried about specific symptoms related to their procedure. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes. This pilot project will engage patients to report outcomes while also synchronizing data from their electronic health records and pharmacy accounts to ascertain the ability of emerging mobile health technologies to aid in post-marketing surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* English-speaking
* Planned for either a bariatric surgical procedure (either sleeve gastrectomy or gastric bypass) or catheter-based atrial fibrillation ablation
* Participant is willing and able to read and sign consent and participate in study
* Participant has an email account and a mobile device (smartphone or tablet) able to download the necessary applications
* Participant is willing to use the mobile health platform and syncable devices (e.g. Fitbit Charge 2)
* Attending bariatric surgeon or electrophysiologist (as appropriate) concurs that patient is a candidate for enrollment

Exclusion Criteria:

Healthy patients

Patients who refuse participation
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).

This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.

Eligibility Criteria:
Inclusion Criteria:

* Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
* Have zoster-related pain
* Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash

Exclusion Criteria:

* Have multidermal or disseminated AHZ
* Have facial, ophthalmologic or oral manifestations
* Have received Zostavax
Trial of Provider-to-Patient Interactive Voice Response (IVR) Calls to Improve Weight Management in Community Health Centers (CHCs)

This study will test the effect of provider to patient interactive voice response (IVR) calls in local Community Health Centers within a weight management program.

We will randomize providers to three groups. Patients whose provider has been randomized to usual care will not receive IVR calls but do have available a guideline-level weight management service in TCL. Groups one and two will receive pre-visit and post-referral calls. The pre-visit call will invite patients who want to discuss weight at their upcoming visit with their provider to remember to do so. The post-referral call will remind patients that they have received a referral and encourage them to schedule a visit with the community based weight intervention program. Patients whose provider has been randomized to group 1 will receive IVR calls using their scheduled and referring provider's voice. Group 2 will receive IVR calls using a standard IVR voice.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have screened positive for overweight or obesity

Exclusion Criteria:

* Patients who have not screened positive for overweight or obesity