cyrilzakka/clinical-trials huggingface dataset:
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.


Eligibility Criteria:
Inclusion criteria

* Has a diagnosis of T2DM.
* Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
* Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Exclusion criteria

* FPG ≥280 mg/dL (15.6 mmol/L).
* Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
* Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
* Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
* Known active proliferative retinopathy.
* History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
* History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
* History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
Improving the Quality of Patient Care by Using a Clinical Expert System.

Aim:

To investigate the quality of history taking by physician and computer-based system.

Patients:

100 inpatients presenting at the RBK for the first time and treated in the departments of nephrology and cardiology.

Methods:

The information obtained by the computer based system is compared with the information acquired by conventional history taking. Study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis.

Study procedure History taking is performed by physicians according to the guidelines of the RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system with the support of a study nurse.

Aim:

To compare the completeness of history taking by physicians and by a computerized system interacting directly with the patients. Historical data recorded in the patient record, including the discharge letter, were compared with the history acquired by computer-based interview of each patient.

Patients:

100 inpatients presenting at the RBK for the first time and treated in the departments of nephrology and cardiology.

Methods:

The information obtained by the computer based system is compared with the information acquired by conventional history taking. Study endpoint is the comparison of historical data organized according to the elements in a standard medical history on a patient-by-patient basis.

Study procedure After informed consent of the patients the procedure of history taking is performed by the physician according to the guidelines of the RBK. Within 2 days thereafter the patient is interviewed with help of the CLEOS system \[a computer-based, history-taking program\] with the support of a study nurse. The physician will be informed about the results immediately after completion of the questionnaire.

Data of medical significance were extracted from the official hospital chart and the computerized history by clinically experienced physicians and tabulated on a patient-by-patient basis. data elements were compared across each category of the history for each patient interviewed. The relevance of the differences of the information obtained by the two systems was rated by an independent reviewer.

Eligibility Criteria:
Inclusion Criteria:

* All inpatients in a hospital environment

Exclusion Criteria:

* Inability to give an informed consent
More Appreciation and Less Criticism Project

The project "More Appreciation and Less Criticism Project" (MALC) is a collaboration between the Tung Wah Group of Hospitals (TWGHs) and the School of Public Health of The University of Hong Kong (HKUSPH), funded by The Hong Kong Jockey Club Charities Trust. The objectives are to develop and test theory-driven group programmes to increase parents' intention and actual behaviours to express more appreciation or less criticism when interacting with their children, thereby enhancing family harmony and happiness.

This study is a cluster randomized controlled trial (RCT) with three arms: More Appreciation (MA), Less Criticism and Fruit and Vegetable (FV) group. Clusters, mostly schools, are the unit of random allocation to one of the three arms. Participants from all three arms will be assessed a total of four times, i.e. baseline (before the intervention workshop; (T1), immediate post-workshop (T2), 2-week post-workshop (T3) and 6-week post-workshop (T4).

"Fruit and vegetable consumption" is a subsidiary study to the More Appreciation and Less Criticism (MALC) Project. The study will take advantage of the cluster RCT design adopted by the MALC study, and aims at testing the active HAPA-based intervention (increasing fruit and vegetable intervention) delivered to the MALC control group. The fruit and vegetable group will serve as the intervention arm, and the groups that received interventions regarding increasing appreciation or decreasing criticism, served as the control arms.

Eligibility Criteria:
Inclusion Criteria:

* Parents who are Cantonese-speaking, able to complete study questionnaire, and who have children attending p.4 to p.6 will be included.

Exclusion Criteria:

* Parents with active psychiatric problems, suicidal ideations, personality disorders, emotional problems, and mental retardartion will be excluded from the study.
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.


Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years of age at the time the Informed Consent is signed.
* Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
* Patient's tumor has been reviewed with confirmed positive MSLN expression on \>/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
* Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
* Patients has an ECOG performance status 0 or 1
* Patient is fit for leukapheresis and has adequate venous access for the cell collection.
* Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol

Exclusion Criteria:

* Inability to follow the procedures of the study
* Known or suspected non-compliance, drug, or alcohol use
MIRT and Rotigotine in the Early Stage of PD

To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in Parkinson's disease (PD) "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.

In the last years different rehabilitation treatments have been proposed to address specific motor deficits in Parkinson's disease. Nevertheless, the evidence of a possible neuroprotective action of exercise in PD has been obscured by the facts that all studies were performed in patients in different disease stages and under a variety of pharmacological treatments. Our objective is to test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in PD "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.

40 Patients at the initial stages of PD (H\&Y stages 1,5-2) treated only with Rotigotine will be enrolled and randomly assigne into two groups. Patients in group 1 (20 subjects) will be undergone 2 MIRT cycle (at T0 and T3). MIRT consist of a 4-week cycle of physiotherapy that entailed three daily sessions 5 days a week (Frazzitta G. et al., Neurorehabilitation \[30\] 2012, 295-301). Patients in Group 2 (20 subjects) will continue with drug therapy alone.

For the group 1, Unified Parkinson's disease rating scale (UPDRS) II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), comfortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (discharge after the first MIRT cycle), T2 (control at 6 months after discharge), T3 (hospitalization for second MIRT cycle), T4 (discharge after the second MIRT cycle) and T5 (end of the protocol, 18 months); For the group 2, UPDRS II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), confortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (check-up at 6 months), T2 (check-up at 12 months), T3 (check-up at 18 months).

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease according to Gelb et al., ability to walk without any physical assistance, no cognitive impairment (MMSE score \> 26), no comorbidity unrelated to Parkinson's disease, no vestibular/visual dysfunction limiting locomotor or balance.

Exclusion Criteria:

* Atypical Parkinsonisms, cognitive impairment (MMSE \< 26), other comorbidities not related to PD, vestibular/visual dysfunction limiting locomotor or balance.
Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

The objective of this study is to test the hypothesis that following the use of intravitreal dexamethasone implant for the treatment of DME, there will be an observable increase in the capillary density plexus as denoted by the quantitative assessment of the superficial capillary plexus on OCTA, as well as a decrease in size of the foveal avascular zone (FAZ).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and Older.
2. Diagnosis of diabetes mellitus (type 1 or type 2).
3. At least one eye meets the study eye criteria listed.
4. Visual Acuity 20/30 - 20/200 Snellen equivalent
5. Have received no previous treatment for diabetic macular edema,(treatment naïve)
6. Mild to Severe Non-proliferative Diabetic Retinopathy
7. Diabetic macular edema present on optical coherence tomography (OCT) central subfield: ≥ 300µm.
8. Able and willing to provide informed consent.

Exclusion Criteria:

1. Have had any prior ocular treatment.
2. Have had prior retinal surgical ( i.e. Pars plana vitrectomy). 3 .Have any clinical evidence of proliferative diabetic retinopathy.

4. Have a HBA1c of greater of 10%. 5. Evidence of Glaucoma or who are labeled glaucoma suspect at screening (defined as C/D \>/= 0.5 with correlated NFLA thinning or IOP\>25mmHg). 6. Have a contraindication to Ozurdex.
Prophylactic Mesh in Cytoreductive Surgery

Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1

Exclusion Criteria:

* Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3
Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption

Purpose:

The overall objective of this study is to learn more about the disease chronic pancreatitis and thus contribute to better treatments. The investigators will gain this by studying the effects of vitamin D in the body immune system and bones. The investigators will also study the uptake of vitamin D through the intestine compared with the amount of vitamin D obtained through exposure to UVB rays.

The investigators have set a series of questions which the investigators want to answer with this experiment:

Do patients with chronic pancreatitis have reduced absorption of vitamin D from the gut?

* Have the two treatment methods with vitamin D, UV radiation and tablets, the same success rate?
* Does the distribution of the white blood cells change when the vitamin D level increases and does it depend on whether the patient have UVB radiation or tablet with vitamin D?
* Will patients require reduced amounts of painkillers when vitamin D level increases?
* Does vitamin D have influence on blood sugar and thus the risk of diabetes or worsening of this?
* Could vitamin D affect the blood content of inflammation markers?
* Does the patient feel better when he takes vitamin D?
* Does bone strength increase when the patients receive grants of vitamin D?


Eligibility Criteria:
Inclusion Criteria:

* Chronic pancreatitis
* Malabsorption
* Age min. 18 y.
* 25-hydroxyvitamin D less than 75 nmol/l
* Body mass index \< 30
* Consent

Exclusion Criteria:

* Acute pancreatitis
* Cirrhosis
* Ionized calcium \> 1.35 mmol/l
* Heart disease
* Former resection of gastro-intestinal tract.
* Pregnancy
* Pancreatic malignant disease
* History of skin cancer
* Other than skin cancer less then 5 y prior to inclusion in study
* Chronic kidney disease
* Type I diabetes
* Hemoglobin \< 5.0 mmol/l
* Participating in other studies
* Not suitable for inclusion
Effect of Broccoli Sprouts Homogenate on SS RBC

The overall purpose of this study is to obtain a better understanding of the biological response of red blood cells to sulforaphane contained in fresh broccoli sprouts that have been put through a blending process. This study will use commercially available fresh broccoli sprouts certified by Brassica Protection Products LLC (BroccoSprouts®). This product can also be purchased at some local grocery stores in the produce section. It is believed that NRF2, a transcription factor encoded by the NFE2L2 gene, plays a role in the regulation of defense against oxidative stress. The detrimental accelerated breakdown of sickle cell disease (SCD) red blood cells (SS RBC) is partially due to reduced anti-oxidative capacity. Previous analysis of SS RBC microRNAs revealed that a reduced level of NRF2, the master regulator of anti-oxidative stress capacity, contributes to reduced resistance to oxidative stress and increased hemolysis; NRF2 also induces fetal hemoglobin (HbF), which is known to prevent SS RBC sickling.

First, erythroid progenitors from normal and SCD subjects will be tested ex-vivo to find out how sulforaphane, a natural NRF2 activator, affects the oxidative stress capacity, HbF expression, and microRNA expression of red cells.

Second, a pilot clinical trial will be conducted to determine the safety and physiological effects of 3 weeks of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients. During this study, subjects RBCs will be assayed for changes in anti-oxidative stress capacity and microRNA composition in mature SCD red blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hemoglobin (Hb) SS or Hb Sβ0 thalassemia by electrophoresis
* Age ≥18 years
* Hematocrit (Hct) ≥ 20% and Hb \> 6.0 g/dL
* Capacity to understand and sign informed consent and can adhere to the daily regimen of BSH

Exclusion Criteria:

* RBC transfusion or change in hydroxyurea dose during the 3 months prior to study entry
* Ongoing pregnancy
* Diabetes
* Renal insufficiency (BUN \>21 mg/dL and/or Creatinine \>1.4 mg/dL)
* History of allergy to sulfonamides
Pilot Study to Determine the Optimal Negative Pressure for Non-invasive Breast Augmentation in Women

Aim is to investigate optimum pressure and evaluate safety and effectiveness of EVERA-RAPHA for breast augmentation

1. Subjects who voluntarily signed a consent form and met all inclusion / exclusion criteria should enroll in this study.
2. Subjects enrolled in the study will be randomized and assigned to either Group1 or Group2 in a 1: 1 ratio.
3. Apply EVERA RAPHA for 4 weeks

3. Measure breast circumference and breast volume at Baseline and 4weeks later 4. Visit after 4 weeks to evaluate safety and effectiveness

Eligibility Criteria:
Inclusion Criteria:

1. A woman over the age of twenty
2. A woman who wants both breast enlargement
3. A person whose difference between chest circumference and lower chest circumference is less than 10 cm.
4. Subject who sign the consent form of the study and agree to participate in the clinical trial
5. Subject who are willing and able to comply with study protocol

Exclusion Criteria:

1. A woman who has a history of great weight-change
2. A case that Breast cancer or mammary tumour found in basic physical examinations
3. A woman with symptoms or history that suggest she has a fibroblastoma, breast pain, periodic congestion, etc.
4. A woman with severe trauma around the breast.
5. A woman with a scar or skin lesion around the breast.
6. A woman with more than breast ptosis of Grade 3 (the nipple is less than 1-3 cm below the breast)
7. A woman with a history of chronic dermatitis, chronic pressure urticaria, contact dermatitis, etc.
8. A woman who disagrees with contraception
9. A woman who has previously undergone a breast reconstruction or breast augmentation
10. A woman with an uncontrolled active infectious disease
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects aged 18 to 75 years old；
2. ECOG performance status 0-1;
3. Life expectancy is not less than 12 weeks;
4. Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
5. Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
6. Adequate function of major organs;
7. Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.

Exclusion Criteria:

1. Confirmed diagnosis of HER2 positive disease;
2. Participants who previously received SHR6390 or VEGFR inhibitors;
3. Allergy to study drug or its components;
4. Participated in other drug clinical trials within 4 weeks before the first dose;
5. Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
6. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention；
7. Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
8. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein \>1.0g;
9. Active HBV/HCV/HIV infection;
10. The investigators determined that other conditions were inappropriate for participation in this clinical trial；
11. Pregnant or breast-feeding women;
12. Central nervous system (CNS) invasion.
3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts

To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

To determine if 3D ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. This has been done in order to reduce portal vein pressure. These shunts are known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female 18 years of age and older
2. Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
3. Have an ultrasound ordered by your physician to evaluate your TIPS.
4. Able to read, understand and sign informed consent

Exclusion Criteria:

1. Under 18 years of age
2. Cannot be pregnant