cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma

This phase IB study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess toxicity,efficacy and pharmacokinetics in patients wiht advanced hepatocellular carcinoma (HCC) .

Eligibility Criteria:

* 18 -70 years old;
* Patients with measurable, histologically proven, inoperable HCC;
* Child-Pugh (CP) score of A;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
* Patients received prior systemic treatments for HCC before 4 weeks;
* Patients received operate before 3 months;
* Patients received TACE before 4 weeks;
* Life expectancy at least 3 months;
* Adequate hepatic and renal function;
* Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter);
* Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.

Exclusion Criteria:

* Patients had prior treatment with sorafenib;
* CNS involvement.

Method:

* open-label,randomized,multiceters study;
* 2 dose cohorts: 200mg bid and 300mg bid;
* Patients with advanced HCC(inoperable) and Child-Pugh (CP) A , randomized,receive continuous donafenib either 200mg bid or 300mg bid in 4 weeks cycles;
* Sample size:106 patients(53 patients in each dose cohort).

Endpoints:

* Safety: toxicities are assessed according to CTCAE 3.0;
* TTP:Tumor response is assessed every two cycles using RECISIT1.1 criteria;
* Donafenib pharmacokinetics is measured in plasma samples.

Eligibility Criteria:
Inclusion Criteria:

* 18 -70 years old
* Patients with measurable, histologically proven, inoperable HCC
* Child-Pugh (CP) score of A
* Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
* Patients received prior systemic treatments for HCC before 4 weeks
* Patients received operate before 3 months
* Patients received TACE before 4 weeks
* Life expectancy at least 3 months
* Adequate hepatic and renal function
* Adequate hematologic function (platelet count,≥70×109per liter;hemoglobin ≥8.5 g per deciliter)
* Prothrombin time international normalized ratio≤2; or prothrombin time ≤16 seconds;or APTT≤43s;or TT≤21s.

Exclusion Criteria:

* Patients had prior treatment with sorafenib
* CNS involvement.
The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer (MK-8669-050)

This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score among participants with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participant has operable Stage I-IIIa invasive breast cancer of the following subtype: ER-positive, HER2-negative tumor with histologic grade 2 or 3 and Ki67 ≥ 15%
* Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
* Participant consents to provide an existing tissue sample or to have a core needle biopsy before drug administration
* Participant consents to provide tissue samples following drug administration by a second core needle biopsy or from a surgical specimen
* Participant must have adequate organ function

Exclusion Criteria:

* Participant has received any prior chemotherapy, biological therapy or radiotherapy for breast cancer
* Participant has a known hypersensitivity to the components of study drugs or their analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin, erythromycin, azithromycin).
* Participant has poorly controlled diabetes mellitus, or requires insulin for glucose control.
* Participant is unable to swallow capsules and/or absorb oral medications
* Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study.
* Participant is known to be Human Immunodeficiency Virus (HIV)-positive
* Participant has known history of active Hepatitis B or C.
* Participant is concurrently using growth hormone (GH) or growth hormone inhibitors
* Participant has significant or uncontrolled cardiovascular disease, including heart failure, unstable angina, or a myocardial infarction within the last 6 months
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.

Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.

Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.

Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing microfracture surgery for the repair of articular cartilage
* Osteochondral defect Grade III or IV
* Age 18 to 68 years
* Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
* Written informed consent
* Ability to speak, read and write English or Spanish

Exclusion Criteria:

* Inability to speak, read and write English or Spanish
* Evidence of malignant disorder/neoplasm in past 24 months
* History of basal cell carcinoma
* History of smoking and not committed to give up
* Chronic skin conditions
* Connective, metabolic or skin disease
* Evidence of active infection
* Pregnancy or lactating for female subjects
* Diabetes Type I or II
* Current steroid use
* Immunosuppressive medication
* Renal failure (creatine \> 1.8 mg/dL)
* Hepatic failure (AST, ALT \>2 times normal values; bilirubin \>2.0 mg/dL)
* Inflammatory joint diseases of the knee that indicate additional, conflating therapies
* Joint infection within the past 6 months
* Meniscal resection of greater than 50% prior to, or at time of procedure
* Uncorrected joint instability
* Joint malalignment \> 5 degrees
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer

To test the effects of a 10-wk stress management interventions vs. a 5-wk control condition on positive psychosocial adaptation in women being treated for breast cancer. Participants assigned to either of the stress management groups will show better positive psychosocial adaptation compared to those in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 70 years
* Newly diagnosed breast cancer patients in stages I, II, or III (with no prior history of cancer)
* Literate, without significant cognitive impairments
* Capable of writing and expressing themselves in Chinese

Exclusion Criteria:

* Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
* Currently participating in other breast cancer-related psychotherapy studies
Vitamin D and Physical Function in Older Adults

Projections from NHANES III indicate that approximately 12,000,000 U.S. adults ≥ 60 years of age have vitamin D insufficiency (serum 25(OH)D \< 50 nmol/L). A growing body of evidence suggests that vitamin D status may be important in biologic processes involved in the maintenance of physical function. To test the hypothesis that vitamin D insufficiency is associated with poorer muscle strength and physical performance, we propose to evaluate the role of vitamin D status (serum 25(OH)D) on physical function and falls in the CHS All Stars cohort, a population of advanced age. The specific aims are as follows:

Specific Aim 1. To describe the prevalence and correlates of vitamin D insufficiency in adults of advanced age.

Specific Aim 2. To examine the cross-sectional association between vitamin D status and muscle strength (leg and grip strength), physical performance (3 m/15 ft walk time, repeated chair stands, and standing balance), self-reported physical function (mobility, ADL and IADL disability), and falls.

Specific Aim 3. To examine the longitudinal association between vitamin D status at baseline and incident disability (mobility, ADL and IADL disability) over 3 years of follow-up.

Research Hypotheses: Low vitamin D status (25(OH)D \< 50 nmol/L) will be associated with (a) lower levels of muscle strength and physical performance; (b) higher levels of self-reported limitations in physical function and falls; and (c) greater odds of incident disability.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the main CHS study

Exclusion Criteria:

* Not willing to give consent
Acute Effects of HIIT and SSMIT on Intraocular Pressure Among Sedentary Individuals

Purpose to study the acute effects of both forms of aerobic exercise (HIIT and SSMIT) on intraocular pressure among healthy sedentary individuals

40 participants were recruited and divided into 2 groups. Each group performed 2 exercise protocols with a 4 day washout period between them.

The intraocular pressure was measured before the exercise and after the exercise in 5 minute periods up until 30 minutes post exercise.

The intraocular pressure was measured using a handheld rebound tonometer.

Eligibility Criteria:
Inclusion Criteria:

* all University hospital staff

Exclusion Criteria:

* previous ocular trauma
* surgery in the eligible eye
* known case of glaucoma or glaucoma suspect (IOP \> 21mmHg)
* history of glaucoma laser procedure/surgery within 6 months in eligible eye
* unable to undergo IOP measurements
* undiagnosed visual condition
* any uncontrolled medical condition such as end stage renal failure, uncontrolled diabetes and uncontrolled hypertension
Assessment of a Health Informatics System on Insulin-treated Diabetic Patients

Modern medicine provides many solutions that are intended to help control the patient's blood glucose level: insulin and other medications to lower it, glucose tablets or glucagone to raise it when it gets dangerously low, glucometers to quickly measure the blood glucose level, pumps and pens to inject insulin or other injectable medicine, etc.The objective of this trial is proving the concept and the feasibility of using a medical informatics system comprised of computer hardware, software and a smartphone application to achieve better outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or 2 diabetics diagnosed at least 12 months prior to study enrollment.
2. Treated with insulin (basal only or basal + bolus) for at least 6 months prior to study enroment.
3. HbA1c lower than 12% With or without other anti-diabetic drugs.
4. 18-80 years of age.
5. Male or female.
6. Own an Android phone.
7. Able to handle mobile applications, technology-friendly
8. Able and willing to understand and comply with the study procedures.
9. Provide signed written and informed consent form prior to enrolment in the study.

Exclusion Criteria:

1. Using an insulin pump.
2. Pregnant or planning to be pregnant within the period of the study.
3. Active substance abuse.
4. Psychosis or schizophrenia under active care.
5. Uncorrected severe hearing or visual impairment.
6. Any other condition that is not acceptable to the investigator.
Vacuum Myofascial Therapy Device in Treatment of Muscle Fibrosis

We present the case of a 24-year-old professional soccer player, with no personal history of interest, who came to the X-Ray diagnosis service due to severe pain in the right quadriceps muscle after a 10-month evolution of muscle rupture occurred during sports practice.

PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms, both in the entire muscle and in muscle fibrosis.

Seven days later, after PHYSIUM System® session with the same parameters of the previous treatment, ultrasound elastography was performed.

Eligibility Criteria:
Inclusion criteria.

* 24-year-old professional soccer player.
* No personal medical history of interest
Technology-assisted Blended Learning on Motivational Interviewing for Mental Health Nurses and Its Clinical Impact

Medication adherence is the primary care to stabilize the symptoms of patients with schizophrenia, but more than half of community patients still do not adhere to medication. According to the latest research of our team, the motivational interviewing may be more effective in promoting medication adherence than the insight. In the past, there was a lack of theoretical and empirical motivational interviewing and integrated medication adherence program. Therefore, the first year of this plan has completed the construction of integrated medication adherence. Considering the current lack of training and promotion of the blended learning model assisted by convenient and effective mobile technology.

Aim: To develop and evaluate the effectiveness of an integrated program combining technology-assisted blended learning on motivational interviewing knowledge, skills, and self-efficacy for psychiatric mental health nurses, and its clinical impact.


Eligibility Criteria:
Inclusion Criteria:

* mental health registered Nurse who take care of patients.

Exclusion Criteria:

* expected to leave the job within two months
* over 65 years old
Dentomaxillofacial Paediatric Imaging: An Investigation Towards Low Dose Radiation Induced Risks

Cone Beam Computed Tomography (CBCT) is an emerging X-ray technology that has found wide applications in dentomaxillofacial imaging. The ability to provide high-resolution 3D images has resulted in a significant increase in the volume of dental radiology procedures. Although CBCT is associated with higher radiation risk to the patient than conventional dental X-ray imaging (intraoral or panoramic), it is considered to be 'low dose' imaging as defined by the High Level Expert Group (HLEG) with doses ranging from a few microsieverts (μSv) to millisieverts (mSv) per examination.

This proposal is set to tackle important issues raised by the HLEG and the Multidisciplinary European Low Dose Initiative (MELODI) platform. In particular, as deduced by the name DIMITRA (Dentomaxillofacial paediatric imaging: an investigation towards low dose radiation induced risks), the project focuses on the uncertainties associated with radiation-induced health risks at low doses in paediatric dentistry and is a multidisciplinary effort to approach the involved risks from different yet interrelated perspectives: radiobiological characterisation, dosimetric quantification, epidemiological surveying and image quality \& dose optimization. A unique Monte Carlo simulation (MC) framework will be used to accurately calculate organ doses in dental CBCT imaging, to quantify the radiation induced risk and to feed the radiobiology team with the appropriate data towards the identification, development and validation of biomarkers for radiation induced health effects. Furthermore, it will constitute the basis upon setting up a gender and age related epidemiology study. The balance between image quality and dose levels will be explored aiming at reducing the risk through image quality optimization.

It is expected that DIMITRA's outcomes and deliverables can be presented to a wider forum via a dissemination meeting, leading to further recommendations and potential future adaptations for the use of CBCT in paediatric dentistry.


Eligibility Criteria:
Inclusion Criteria:

* Prospective study with saliva sampling: Patients referred for a CBCT scan from their doctor
* Retrospective study: recorded patients (age 0 - 22) referred to UZ Leuven in the last 2 years including cleft palate patients

Exclusion Criteria:

-
Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

In this open-label, dose escalation and dose expansion single ascending dose (SAD) and multiple ascending dose (MAD) phase 1 study, adult subjects with recurrent or metastatic histologically confirmed GRPR-expressing tumors will be enrolled. In the dose escalation portion, a classic 3+3 design will be utilized. Dose escalation may proceed until the recommended MAD dose is determined. Up to four cohorts are expected to be enrolled. Once the recommended MAD dose is determined, no additional subjects will be enrolled in the SAD escalation portion and the MAD portion of the study will commence. Subjects will be treated with up to four cycles administered every 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years old with the following histologically confirmed metastatic or recurrent GRPR-expressing tumors:

  1. Metastatic castrate resistant prostate cancer (mCRPC);
  2. HR+/HER2- breast cancer;
  3. Colorectal cancer;
  4. Cervical cancer;
  5. Cutaneous melanoma;
  6. Non-small-cell lung cancer (NSCLC).
* Biopsies must demonstrate the following on immunohistochemistry (IHC):

  * 51-80% positively staining cells; and
  * Moderate intensity of staining.
* Subjects with recurrent disease must have progressed on at least 2 prior systemic therapies.
* Presence of at least 1 site of measurable disease per RECIST 1.1 within 1 month prior to Cycle 1 Day 1. For subjects with prostate cancer, bone lesions may be used to fulfill the eligibility requirements per PCWG3 in lieu of measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) status 0-2.
* Sufficient bone marrow capacity and organ function as defined by:

  1. White blood cell (WBC) ≥2,500/ mm³
  2. Absolute neutrophil count (ANC) ≥1500/mm³
  3. Platelets ≥75,000/mm³
  4. Hemoglobin (HgB) ≥9.0 g/dL;

Exclusion Criteria:

* Previous whole-body radiotherapy or peptide receptor radionuclide therapy (PRRT) with either alpha or beta emitters, or subjects with mCRPC who have received radium-223 (²²³Ra).
* Known hypersensitivity to any component of ²¹²Pb-DOTAM-GRPR1.
* Exposure to any other GRPR-targeting therapeutic agents.
* History of chronic pancreatitis
* History of pneumonitis.
* Impaired cardiac function defined as:

  1. New York Heart Association (NYHA) class III or IV;
  2. QTc \> 470 msec for females and QTc \>450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome;
  3. Acute myocardial infarction or unstable angina pectoris \< 3 months prior to study enrollment.
* Cyclical chemotherapy, radiotherapy, or biologic therapy (e.g. antibodies), continuous or intermittent, small molecule therapeutics, or any investigational agents within a period which is ≤ 5 half-lives or ≤ 4 weeks (whichever is longer) prior to Day 1.
Educating the Educator to Reduce Risk of Dance Student Injury

A group of dance educators will attend two dance injury prevention workshops hosted by the Harkness Center for Dance Injuries (HCDI), NYU Langone Medical Center, during which participants will learn strategies to help them train their students in safe ways and impart injury prevention information through their dance classes to their students. The educators will take pre- and post-workshop tests to assess knowledge and perceptions of dance medicine. Several weeks later, participants will take a follow-up survey to assess knowledge implementation and workshop effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Teach dance to children in at least one private dance school
* Must be able to receive email and complete a survey online
* Must believe that students lack access to dance injury prevention resources
* Must teach at least one group of students that takes class from them a minimum of twice a week and must teach those students regularly in September and October, 2017.

Exclusion Criteria:

* Under the Age of 18
Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy

The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.

A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients ≤ 60years old
2. Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
3. BMI ranges from 18.5 to 27.9kg/m2;
4. Informed consent signed by the subject himself or his legal representative.

Exclusion Criteria:

1. Pregnant and lactating women;
2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
3. Preoperative examination for malignant possibility
4. Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed;
5. Patients known to have severe hepatic or renal dysfunction;
6. Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\&#39;s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
8. patients with acute infection;
9. Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
10. who cannot sign the informed consent;
11. For those with known or suspected poor compliance who could not complete the trial.