cyrilzakka/clinical-trials huggingface dataset:
Follow-up of NAFLD Patients With MRI-PDFF

The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.

This study aims to define

* The effects of PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA on liver biomarkers and liver steatosis in type 2 diabetic patients.
* Studying PTX, Empagliflozin as an example of SGLT-2 inhibitors and UDCA efficacy and safety as add-on therapy in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing to participate in this study
* Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM who are on sulfonylurea for the last 6 months at least and diagnosed with NAFLD.

Exclusion Criteria:

* • Patients who refused to participate in this trial

  * Patients diagnosed with Type 1 diabetes
  * Previous history of alcohol intake
  * history of recurrent attacks of ketoacidosis in a diabetic patient
  * Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis
  * Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics)
  * Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis)
  * Lactating/pregnant female or children ≤ 18
  * Any contraindication for Empagliflozin including:

    1. History of recurrent attacks of UTI or Genital infection in females
    2. History of recurrent foot injuries or infections
    3. Type 2 diabetic patient with CV disease especially NYHA classes III/ IV
    4. Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases.
  * Any contraindication for PTX including:

    1. Hypersensitivity to PTX
    2. Patients with peptic ulcer disease or tendency for bleeding
  * Any contraindication for UDCA including:

    1. Hypersensitivity to UDCA
    2. Patients with biliary disease or hepatobiliary disease (ascites, jaundice)
    3. Patients with hepatic encephalopathy or gallstone pancreatitis
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
* Aged ≥ 18 years, ≤ 75 years;
* Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
* Measurable disease according to RECIST Version 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
* Expected survival 12 weeks;
* Adequate organ function;
* For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose;

Exclusion Criteria:

* Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
* A history of other malignancies within two years, except for cured Localized tumor;
* Participants with any prior allogeneic solid organ or bone marrow transplantations;
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable);
* Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
* Active clinical severe infection;
Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.

IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.

An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.

Eligibility Criteria:
Inclusion Criteria:

* All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old

Exclusion Criteria:

* History of HPV vaccination
* Pregnancy
* Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
* IBD patients who don't meet immunosuppression/non-immunosuppression criteria
* Inability to obtain informed consent from patient
* Previous diagnosis of ASIL or anal/rectal cancer
Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy

A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.

Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.

Subject Population: Patients with clinical symptoms consistent with unilateral ureteral or renal stone fragments ≤ 2mm, post-uncomplicated ureteroscopy (UURS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are \> 18, \< 80 years of age; inclusive of males and females.
2. Patients with unilateral ureteral or renal stone fragments \< 2mm, post-uncomplicated ureteroscopy (UURS).
3. Patients with a height and body size able to accommodate a 20, 22, 24, 26, 28, or 30 mm long ureteral stent, as judged by the Investigator.
4. Patients with the ability to understand the requirements of the study, who have provided written informed consent, and who have agreed to return for the required follow-up assessments.

Exclusion Criteria:

1. Patients with a known contraindication for treatment with the Uriprene® Stent.
2. Patients with a history of an anatomical abnormality of the urinary tract.
3. Patients with a known upper or lower urinary tract infection at the time of stent insertion.
4. Patients with known renal insufficiency or chronic impairment.
5. Any condition, in the opinion of the investigator, in whom patients would not be eligible for treatment with the Uriprene® Stent.
6. Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator.
7. Patients who consume more than 14 drinks of alcohol per week (as this may affect degradation of the stent).
8. Presence of ureteral blockage or stricture
9. After failed guide wire placement or failed ureteroscopic access
10. Impacted ureteral stones still in place
11. Patients predisposed to urinary stasis e.g. neurogenic bladder, bladder outlet obstruction, known pregnancy
12. Patients with a solitary kidney
13. Presence of ureteral fistula
14. Presence of ureteral tumor
15. Presence of extrinsic compression of the ureter
16. Urinary tract infection
17. Staghorn calculi
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function

The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.

This study is seeking participants who:

* Have less than 25% difference in kidney function between 2 screening visits.
* Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is filtering.
* Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to.

Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.


Eligibility Criteria:
Inclusion Criteria:

1. Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
2. Meet the eGFR criteria for cohort placement during the screening period.
3. Body mass index (BMI) of 16-40 kg/m2; and a total body weight \>45 kg (99 lb.).
4. For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.

Exclusion Criteria:

1. Participants with acute renal disease.
2. Participants who are clinically nephrotic.
3. Participants requiring hemodialysis.
4. Renal allograft recipients.
5. Participants who have previously received a kidney, liver, or heart transplant.
6. Urinary incontinence without catheterization.
7. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
8. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
9. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Factors Associated With Pregnancy Loss in IVF Women

Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.

Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.

Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Exclusion Criteria:

* abnormal uterine cavity induced abortion for medical problem
Vascular Photobiomodulation on Sleep Qualityand Stress

Randomized clinical trial to evaluate the effect of vascular photobiomodulation on sleep quality, relaxation and stress when compared to placebo.

The quality of sleep is directly linked to the quality of human life. Irradiation of blood in the transcutaneous vascular technique is believed to decrease blood viscosity and platelet aggregation; activates superoxide dismutase; promotes increased oxygen content and stimulates microcirculation, it also stimulates increased serotonin production and cortisol reduction. Serotonin functions include sleep initiation, mood improvement, anxiety and depression. Therefore, the objective of the present project is to evaluate the effect of ILIB on salivary biomarkers related to stress and sleep. Therefore, participants with problems related to sleep quality will be selected and divided into 2 groups, group 1 undergoing ILIB Therapy twice a week for 30 minutes and group 2 the same frequency and time of application, but with placebo equipment. At the end of 10 sessions, salivary biomarkers related to stress and sleep and the patients' perception will be evaluated through specific questionnaires on the effect of ILIB on sleep, stress and relaxation.

Eligibility Criteria:
Inclusion Criteria:

* poor sleep quality.
* Participants who for at least six months have had poor sleep quality (score \> 5 points), measured using the PSQI,

Exclusion Criteria:

* use medications or perform treatments that may affect the sleep cycle
* treatment for hypertension
* asthma,
* attention deficit disorder,
* diabetes.
CHESS Caregivers Study: Web-based Support for Informal Caregivers in Cancer

Web-Based Support for Informal Caregivers in Cancer Brief Summary (including hypothesis):

Informal caregivers need information, skills and emotional support to address physical, spiritual, and emotional needs associated with chronic illnesses including late stage cancer. Unfortunately, current conditions force clinicians to reduce their interaction time with patients and informal caregivers. Complimentary methods must be developed to provide needed information and support to caregivers. The proposed research will measure and explain the impact of two computer-based support systems that meet caregiver needs and facilitate information exchange with clinicians. The system, CHESS (Comprehensive Health Enhancement Support System) is a non-commercial computer system that provides patients with disease specific information, emotional support and skill building tools. In the expanded form to be tested in this study, CHESS with Caregiver Support (CGCHESS) will also provide the caregiver with more information, support and skills training related to palliative care. CGCHESS will be further enhanced to communicate essential patient and caregiver information to clinicians prior to a scheduled clinic visit and when patient symptoms exceed a threshold.

The investigators' primary hypothesis is that CGCHESS + Clinician Report (CR) will reduce caregiver burden more than CGCHESS because of the additional support caregivers and patients receive from clinicians who have access to the CHESS clinician report. Secondary analyses will study the mechanisms of the CHESS effect. Specifically the investigators anticipate that the CHESS effect on caregivers will be mediated by the CHESS effect on interaction patterns with clinicians, satisfaction with clinical visits and by the CHESS effect on four patient outcomes (quality of life, negative affect, average severity of nine common late-stage cancers).


Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast or prostate cancer patients and their primary caregivers

Exclusion Criteria:

* Cannot be homeless
The Impact of an Art and Philosophy-based Intervention on Children's Eco-anxiety

Objective: To examine the impact of climate change on children's mental health by comparing the effectiveness of an arts only intervention (ABI) and an arts and philosophy-based intervention (APBI) on children's eco-anxiety, tolerance to distress and hope for the future in school settings. The investigators hypothesized that the children assigned to the combined arts and philosophy intervention would show reductions in self-reported eco-anxiety, as well as increases in tolerance to distress and hope for the future in the context of climate change, when compared to children assigned to the arts-only intervention.

Setting: This study is conducted in public primary schools from England. Participants: Participants are students in grades 3 to 6. Main Outcomes and Measures: The primary outcome is self-reported eco-anxiety scores. Secondary outcomes are self-reported tolerance to distress, hope for the future and mental health (depression and anxiety symptoms).


Eligibility Criteria:
Inclusion Criteria:

* being an elementary school student

Exclusion Criteria:

* not being an elementary school student
Patient Adherence to Acupuncture Treatment

Adherence to treatment recommendation remains low among acupuncture patients. This study aims to examine whether implementing a post-initial visit follow-up strategy can improve adherence rate. Adult patients visiting the acupuncture clinic for a new treatment will be randomized to receive a telephone call or a text-message three days after their initial visit against a control group. We will enroll up to 160 participants between February and December 2017, to ensure we can reach 120 subjects in the analysis who completed the baseline survey. Participants recruitment will take place at the Emperor's College of Traditional Oriental Medicine Acupuncture Clinic. Assessments will be conducted via surveys at four times points, Day 0 (date of enrollment), Day 3, Day 10 and Day 30. Additional data will also be collected via chart review. Primary outcome will be assessing whether participants return for any follow-up visit within 30 days after the initial treatment. Secondary outcomes will examine if factors such as expectations, intention, satisfaction, and potential barriers would predict the primary outcome.

This randomized controlled trial will deliver two interventions: (1) telephone call reminder and (2) text messaging reminder.

Participants who meet study eligibility criteria based on intake assessment will be recruited and complete baseline assessment immediately after they receive acupuncture treatment. There will be 40 participants in each of the two intervention groups and the no intervention control group.

Participants will be adults who visit the Emperor's College Acupuncture Clinic for a new treatment consultation on the date of the enrollment.

The telephone call and text messaging intervention is a one-time reminder system delivered to the participants based on the study random assignment, three days after the initial visit. A research assistant will be contacting the participants based on the assigned interventions.

There are three data collection points, 1) baseline (during initial visit), 2) 10 days after the initial visit, and 3) 30 days after the initial visit. Data will be collected via a tablet (baseline) and online survey (Day 10 and Day 30) through a secure online survey platform. Baseline assessment will occur prior to randomization, and post-intervention assessments will occur at 10 to 30 days after the initial visit.

Number of follow-up treatments for the same health concern will be collected for all enrolled participants from the participants' clinical record.

Eligibility Criteria:
Inclusion Criteria:

* Outside patients seeking acupuncture treatment at Emperor's College Clinic
* Age 18 and above
* English-speaking
* Starting a new treatment at the day of recruitment
* Own a mobile device
* Mobile device has text-messaging capability
* Visiting the Master's Clinic at Emperor's College

Exclusion Criteria:

* Emperor's College's students or staffs seeking acupuncture treatment
* Patients visiting the faculty observation theater, ear acupuncture clinic and private clinic
* Patients returning for a follow-up acupuncture visit at the day of recruitment
Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.

It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* Diagnosis of patients with CD
* Disease in the activity: CDA Ⅰ \> 150 points, endoscopic see active lesions
* Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance

Exclusion Criteria:

* Fiber stenosis caused by gastrointestinal obstruction symptoms
* Fistula exclude anal fistula
* Pregnancy or lactation
* Period of women have fertility program during the study
* Treatment not foot eight weeks after last IFX
* Central or peripheral nerve disease
* Abnormal in liver and renal function
* Heart function failure
* Malignant tumor
* Active tuberculosis
Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair

In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Severe STR, amenable to percutaneous treatment with T-TEER
* Acceptance to be part of this study by signing the informed consent
* Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
* Availability for clinical, CCT and, echocardiography follow-up visits

Exclusion Criteria:

* Pregnancy
* Severe chronic kidney disease (GFR \&lt;30 mL/min)
* Hypersensitivity reactions to contrast media
* Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
* Bad acoustic window with inadequate echocardiographic images.