cyrilzakka/clinical-trials huggingface dataset:
The Basket Study of Pyrotinib Maleate for HER2-Postive Solid Tumor

This is an open-label, Phase 2 study exploring the efficacy and safety of 马来酸Pyrotinib Maleate Tablets in patients with solid tumors with activating（harmful） HER2 mutations or with HER2 gene amplification or immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive.


Eligibility Criteria:
Inclusion Criteria

1. Patients between the ages of 18 and 75;
2. ECOG physical status score 0-2 points;
3. The estimated total survival period is not less than 12 weeks;
4. Patients with HER2-positive solid tumors confirmed by pathology and identified as advanced tumors by clinicians or centers;
5. HER2 positive: refers to standard immunohistochemical staining (IHC) assay showing HER2 is 3+ and / or fluorescence in situ hybridization (FISH) positive or after second generation sequencing shows HER2 amplification and copy number ≥ 3, or There is a HER2 activating mutation identified by the Molecular Oncology Committee (confirmed by the investigator at the test center) ;
6. Imaging studies have at least one measurable lesion with a diameter ≥ 10 mm;
7. Pilotinib has not been used for the past 3 months;
8. The main organs function normally, they meet the following criteria:

   1. Blood routine examination criteria are to comply with:

      ①.Hb≥100 g/L; ②.ANC ≥ 1.5 × 109 / L; ③.PLT≥75×109 /L;
   2. Biochemical tests are subject to the following criteria

      ①.TBIL ≤ 1.5 × ULN (upper limit of normal value);

      ②.ALT and AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;

      ③.Serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 50ml / min (based on Cockroft and Gault formula);
   3. Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 50%;
9. The patient or his legal guardian understands the test procedure and content and signs an informed consent form (ICF) to provide true and effective information in accordance with the research and follow-up procedures;

Exclusion Criteria:

1. There is a third interstitial fluid that cannot be controlled by drainage or other methods, such as pleural effusion and ascites;
2. It has many factors affecting the oral and absorption of drugs (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction);
3. Those who have been confirmed to be allergic to the drug components of this program;
4. Patients who are known to be pregnant or planning to become pregnant, or gestational age patients who are unwilling to take effective contraceptive measures throughout the trial;
5. Patients with severe concomitant diseases or those considered by the investigator to be unsuitable for inclusion.
6. The investigator believes that the subject may not be able to complete the study or may not be able to comply with the requirements of the study (for administrative reasons or for other reasons).
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction

The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute myocardial infarction.

Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial infarction will be evaluated for eligibility in this study. Eligible subjects will undergo standard treatment after admission to the hospital and will then undergo liposuction under local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRC's or placebo.

Eligibility Criteria:
Key Inclusion Criteria:

* Acute myocardial infarction (AMI)
* Clinical symptoms consistent with AMI for a minimum of 2 and a maximum of 12 hours from onset of symptoms to Percutaneous Coronary Intervention (PCI), and unresponsive to nitroglycerin
* Successful revascularization of the culprit lesion in the major epicardial vessel
* Area of hypo- or akinesia corresponding to the culprit lesion, as determined by left ventriculogram at the time of primary PCI
* Left ventricular ejection fraction (LVEF) ≥30% and ≤50% by Left Ventricular Angiography at the time of successful revascularization.
* Ability to undergo liposuction

Key Exclusion Criteria:

* Prior MI, prior known cardiomyopathy, or prior hospital admission for congestive heart failure (CHF)
* More than 24 hours after acute PCI
* Significant valvular disease
* More than twelve hours between the onset of first symptoms of AMI and revascularization
* Hemodynamic instability within 24 hours prior to randomization
* Neoplasia
* Acute or chronic bacterial or viral infectious disease
* Pacemaker, ICD or any other contra-indication for MRI
* LVEF \<30% or \>50% by Left Ventricular Angiography
* Moderate or severe COPD
Evaluation of Pupil Dilation Speed With the MAP Dispenser

1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation

After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.

Pupil dilation for each treatment will be compared at each time interval.

Eligibility Criteria:
Inclusion Criteria:

1. Photopic screening pupil diameter ≤ 3.5 mm in each eye

Exclusion Criteria:

1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
3. History of closed-angle glaucoma.
4. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
5. Ocular surgery or laser treatment of any kind prior to the Screening Visit.
6. History of iris trauma, surgery, or atrophy.
7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
Evaluation of the "ActiveWaiting App" Encouraging Active Exercise-related Use of Waiting Time

The goal of this study (waitlist control study) is to evaluate the effectiveness of the ActiveWaiting App on increasing physical activity and improving quality of life in physically inactive adults in Austria.

The main questions it aims to answer are:

1. Does the provision of the ActiveWaiting App lead to increased physical activity behaviour, compared to a no-intervention control group?
2. Does the provision of the ActiveWaiting App lead to increased health-related quality of life, compared to a no-intervention control group? Participants will use the ActiveWaiting App over a period of seven days. During this period, they will answer daily questionnaires (3 - 6 questions) in order to gather their actual physical activity behaviour. Before and after the intervention period additional questionnaires on health-related quality of life will be sent to the participants.

Participants in the waitlist control group will have a control period (seven days) before using the app.

Researchers will compare the intervention group with the waitlist control group to see if the ActiveWating App has an effect

* on physical activity behaviour and
* on quality of life.

A randomized waitlist control design will be chosen to answer the research question. Participants will be randomly assigned to the intervention group or to the waitlist control group. Block randomization with permutated block sizes will ensure that both study arms are recruited evenly over time. Allocation to the groups will be concealed. The waitlist control group will have the opportunity to use the ActiveWaiting App after the control period. Intervention and control period will be 1 week. Demographic data will be collected before randomization.

Additionally to the primary research questions, the following research questions will be addressed for explorative purposes:

* How much is the ActiveWaiting App used for active waiting and breaking time?
* Which category of exercises are used for this purpose?

Eligibility Criteria:
Inclusion Criteria:

* a sedentary lifestyle (expressed in a full to part-time sedentary job)
* using a smart phone seven days a week
* ability to operate an app on the smart phone
* age between 18 and 65 years

Exclusion Criteria:

* prior usage of the ActiveWaiting App
* achieving the World Health Organization (WHO) recommendations for physical activity (assessed via Rapid Assessment of physical Activity RAPA)
Randomized Trial of Healthy Eating Interventions

Interventions to increase the consumption of fruits and vegetables to date have shown promise, but many have limited public health impact due to the lack of scalability of their designs. The investigators propose to examine the effectiveness and feasibility of an intervention for promoting increased consumption of fruits and vegetables by incentivizing their purchase. Collaborating with UpLift Solutions, the investigators will enroll shoppers in this Randomized Clinical Trial using the research infrastructure called the Way to Health platform. (called the Way to Health platform, and approved as a Prime protocol by the IRB as reference # 811860).

Hypothesis: providing patients with financial incentives can promote healthier behaviors (e.g.: eating healthier).

This is a pilot study under the IRB-approved umbrella protocol number 811698 named Penn-CMU Roybal Center on Behavioral Economics and Health. Interventions to increase the consumption of fruits and vegetables to date have shown promise, but many have limited public health impact due to the lack of scalability of their designs. Many interventions only provided information on what constitutes healthier eating or provided discounts on specific products.Other interventions were limited in generalizability due to utilization of very specific eating establishments or vending machines.By contrast, the investigators propose to examine the effectiveness and feasibility of an intervention for promoting increased consumption of fruits and vegetables by incentivizing their purchase where the overwhelming majority of food is sold: grocery stores. Collaborating with Brown's Super Stores and UpLift Solutions leadership, the investigators will enroll shoppers in this Randomized Clinical Trial using our the web-based research infrastructure called the Way to Health platform.

The primary aim of this project is to generate preliminary evidence of the efficacy of two financial incentive structures in promoting the allocation of a greater percentage of ones grocery budget to the purchase of fresh fruits and vegetables (hereafter, produce). Secondary aims are to evaluate these interventions effects on (1) self-reported consumption of produce, and (2) weight. Salutary goals of this pilot study are to document feasibility of using Price Plus cards for incentive studies, and to expand the functionality of the Way Health platform.

Eligibility Criteria:
Inclusion Criteria:

* Current Parkside Brown's Super Stores shoppers who use a Price Plus Card
* Have regular internet access
* Spend at least $30 per household member per week on groceries
* Spend 10% or less of their grocery budget on produce
* 18 years of age or older
* weekly grocery shoppers

Exclusion Criteria:

* Plan to move in the next 4 months
* Plan to stop shopping at Brown's Super Stores in the next 4 months
* Plan to stop using their Price Plus card in the next 4 months
* Receive any assistance like SNAP or WIC
DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)

Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.


Eligibility Criteria:
Inclusion Criteria:

• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.

Exclusion Criteria:

* PCI with DES struts thickness \>100μm
* PCI with DEB and thin-DES in the same procedure
* PCI of other vascular territories during the same procedure
* PCI in saphenous vain graft or internal mammary artery
Noninvasive Prenatal Diagnosis: Using Fetal Cells From Maternal Blood

This purpose of this study is to develop noninvasive methods of prenatal diagnosis. Fetal cells can be found in maternal blood. This study is designed to isolate these fetal cells from a sample of the pregnant woman's blood and use those cells to test for fetal chromosome abnormalities.

Fetal cells can be recovered from maternal blood, suggesting that noninvasive prenatal diagnosis is possible. However, recovery and analysis of fetal cells from maternal blood is complex and sensitivity is low because of the rarity of these cells in the maternal circulation. This study was designed to develop a noninvasive, safe, relatively inexpensive, and accurate technique for the prenatal diagnosis of genetic disorders in the first trimester.

The study included a systematic evaluation of variables involved in separating and enriching fetal cells isolated from maternal blood through fluorescence activated cell sorting (FACS) and magnetic activated cell sorting (MACS) followed by fluorescent in situ hybridization (FISH) with chromosome-specific DNA probes. The results of these tests were compared to those obtained from amniocentesis or chorionic villus sampling (CVS) on the same women. No clinical decision was made based on the results of the experimental diagnostic/screening technique.

Even if the biological risks associated with reproductive genetic technologies are reduced, it is possible that other risks (or benefits) are associated with the procedures. Some of these factors may be: increased or diminished maternal anxiety, increased adjustment or maladaption to the pregnancy, increased feelings of coercion to undertake the procedure, and increased or decreased comfort with reproductive decision-making. The study also assessed whether there were any nonbiological or psychological effects on the women undergoing prenatal diagnostic testing.

After the first five years of the study, preliminary analysis of the data showed that the sensitivity of aneuploidy detection using fetal cell analysis from maternal blood is comparable to single marker prenatal serum screening, but technological advances are needed before fetal cell analysis has clinical application as part of a multiple maker method for noninvasive prenatal screening. Target cell recovery and fetal cell detection were better using MACS than with FACS. The detection rate of finding at least one aneuploid cell in cases of fetal aneuploidy was 74.4%.

Eligibility Criteria:
Inclusion Criteria

* Pregnant
* Abnormal serum marker profile (alpha-fetoprotein, hCG, estriol)
* Ultrasound abnormalities of the fetus
* Any high risk indicator for aneuploidy as determined by physician
Functioning Disturbance in Chronic Back Pain: Altered Muscle Metabolism

The main objective of this study is to investigate the muscle metabolism in individuals with chronic non-specific low back pain (CNSLBP) to enhance our understanding of chronic back pain.


Eligibility Criteria:
The NSCBP group:

* At least 6 patients will be included in this study.
* All patients referred to Vestfold Hospital Trust, Kysthospitalet, diagnosed with chronic NSCBP \>3 months duration will be invited to participate in the study. The invitation will be in a written form.

Exclusion Criteria:

* anamnesis of medical or drug abuse,
* surgery on the musculoskeletal system of the trunk,
* known congenital malformation of the spine or scoliosis,
* body mass index \> 27 kg/m2,
* systemic-neurological-degenerative disease,
* history of stroke,
* psychiatric disorder,
* pregnancy and abnormal blood pressure. The subjects will be asked not to use any medications except for paracetamol preparations one week before examination and instructed not to perform any back-straining exercise for 48 h prior to the study, except for ordinary daily working and/or leisure activities.
Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI)

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.

The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.

If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).

The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).

A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment (for left breast radiation therapy, active breath control is used - in deep inspiration or respiratory gating).

Eligibility Criteria:
Inclusion Criteria:

* Breast-conserving surgery
* Invasive ductal carcinoma
* Age ≥ 50
* Tumor size ≤ 3 cm
* R0 resection
* Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
* pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
* Hormone receptor status - any
* Histological grade G1 or G2

Exclusion Criteria:

* Neoadjuvant systemic therapy
* TNBC (triple-negative breast cancer)
* Extensive intraductal component (EIC)
* Lymphovascular invasion (LVI)
* associated DCIS \> 2.5 cm in size or high nuclear grade
Infection Prophylaxis in Total Joint Replacement

Osteoarthritis (OA) is the most common cause of disability in older adults worldwide affecting 7% of the global population, or more than 500 million people globally. Total joint replacements (TJR) can help bring relief to those with osteoarthritis when other treatment options are no longer helpful. Infection is the main reason hip and knee replacements "fail". Failure leads to repeat surgeries that are often more complicated and less likely to be successful than the first surgery. Reducing the risk of infection is extremely important, antiseptic washes and antibiotics may help us do that. After joint replacement surgery, orthopaedic surgeons wash and clean the surgical wound to lower the risk of infection. The goal of this clinical trial is to determine if the use of antiseptic solutions to wash the surgical site and placing an antibiotic directly into the wound will reduce the number of infections requiring reoperation. Patients having total joint replacements will be randomized (like flipping a coin) to receive 6 possible combinations of washes and / or antibiotics. Participants will be followed for one year after TJR to compare the rate of infection in each group.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older.
2. Undergoing primary or aseptic revision TJR.
3. No contraindications to study interventions.
4. Informed consent (participant or substitute decision maker) obtained and willing to comply with the protocol.

Exclusion Criteria:

1. Received antibiotics for any reason in the two weeks prior to their TJR.
2. Chronic or acute infection at or near the TJR site.
3. Prior history of periprosthetic joint infection including any reoperation due to infection.
4. Undergoing surgery for a diagnosis of a fracture.
5. Open infected wounds on affected limb.
6. Undergoing bilateral TJR.
7. Currently enrolled in a study that does not permit co-enrollment.
8. Prior enrollment in the trial including the pilot study
9. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.
The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger

The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors.

The main questions it aims to answer are:

* Maturation rate (Metaphase II/ Total number of COCs collected)
* Fertilization rate
* Embryo quality day 3
* Fragmentation rate embryo day 3
* Blastulation rate (Day5/6/7)
* Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)

Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18 - 25
* AMH: 1-3ng/ml
* AFC: 15
* Peak E2 in previous ovarian stimulation cycle: \< 4000 pg/ml
* Ovarian response in first stimulation cycle: \< 20 follicles over 10mm in total, at time of triggering
* Peak E2 in study cycle: \< 4000 pg/ml
* Suboptimal response to trigger medication at first stimulation cycle
* Male age \< 50 years old with normospermia

Exclusion Criteria:

* Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)