cyrilzakka/clinical-trials huggingface dataset:
A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

A phase II study to evaluate the safety and efficacy of oral sapacitabine in previously treated advanced non-small cell lung cancer (NSCLC).

This is an open label, single arm, phase II study to evaluate the safety and efficacy of oral sapacitabine administered twice daily for 5 consecutive days every week for 2 weeks followed by 7-day rest in patients who have had one prior chemotherapy regimen for advanced Non-Small Cell Lung Cancer (NSCLC).

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed recurrent NSCLC
* Age of 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measurable disease according to RECIST
* Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only.
* Adequate bone marrow function
* Adequate renal function
* Adequate liver function
* At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities
* At least 3 weeks from major surgery
* Patient must be able to swallow capsules
* Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* NSCLC histology contains a component of small cell lung cancer
* Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study
* Pregnant or lactating women
* Known to be HIV-positive
Systematic Multi-domain Alzheimer's Risk Reduction Trial

The primary goal of this randomized controlled trial (RCT) is to pilot-test a personalized, pragmatic, multi-domain Alzheimer's disease risk reduction intervention in a U.S. integrated healthcare delivery system.

We propose to randomize 200 higher-risk older adults (age 70-89 with low-normal performance on cognitive testing and 2+ modifiable risk factors that will be targeted by our intervention) to a two-year Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) intervention or a Health Education (HE) control.

The SMARRT team will work with participants randomized to the intervention arm to develop a tailored action plan to address risk reduction. Targeted areas will include: increasing physical, mental and social activities; controlling cardiovascular risk factors (diabetes, hypertension); quitting smoking; reducing depressive symptoms; improving sleep; neuroprotective diet; and decreasing use of potentially harmful medications. HE participants will receive periodic handouts on these topics by mail.

Changes made to the protocol due to COVID-19, i.e. switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.

Eligibility Criteria:
Inclusion Criteria:

* 70-89 Years of Age
* Fluent in the English Language
* Low-normal performance on a brief telephone cognitive screen, measured using the Cognitive Abilities Screening Instruments (CASI). Low-normal scores are defined as 26-29.
* Has at least two additional risk factors that will be targeted by the intervention.

Exclusion Criteria:

* Residing in a skilled nursing or rehabilitation facility
* Receiving palliative care or hospice services
* Charlson comorbidity index score of greater than 5
* Bipolar illness or schizophrenia
* Current alcohol or drug use disorder
* Receiving chronic opioid therapy
* Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis
* Severe visual or hearing impairment
* Requests not to be contacted or not to have their medical record reviewed for research
* Prior evidence of dementia
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions

One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.

1. Single-center, prospective, pilot study
2. De novo,coronary artery, single vessel and single lesion
3. Sample size = 45
4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years
5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital
6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month

Eligibility Criteria:
Inclusion Criteria:

1. 18yrs≤Age≤75yrs .
2. De novo lesion at native coronary artery.
3. Single target vessel and single target lesion.
4. Lesion length ≤32mm.
5. RVD 2.5mm～4.0mm.
6. DS%≥70% by visual estimation.
7. Target lesion could be covered by only one stent.
8. Subjects are willing to follow the specified requirements follow-up.
9. A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.

Exclusion Criteria:

1. AMI within one week.
2. CTO(TIMI0),LM lesion,ostial lesion,graft vessel lesion,bifurcation (side branch RVD≥2.5mm),ISR,mutivessel disease need to be treated.
3. Severe calcified lesion unable to predilate.
4. extremely tortuous proximal to the lesion that is inadequate to stent delivery.
5. NYHA≥Ⅲ or LVEF≤40%.
6. Prior stenting within 1 year.
7. Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
8. Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers at least 1 year.
9. There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (\< 1 year).
10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
11. Serious liver and kidney function is not complete person.
12. The investigators think that do not fit to enroll the study.
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients

Patients meet Baveno VI criteria (with a liver stiffness \<20kPa and with a platelet count \>150,000 are considered to have very low risk of having varices requiring treatment, but whether these patients can be followed up by repetition of this criteria lacks sufficient evidence. This study aimed to assess the value of Baveno VI criteria for following up and monitoring of varices needing treatment in patients with compensated cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with liver cirrhosis diagnosed according to clinical or pathological criteria;
2. No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function;
3. Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy;
4. Patients meet Baveno VI criteria (with a liver stiffness \<20kPa and with a platelet count \>150,000) at baseline, or patients don't meet Baveno VI criteria (with a liver stiffness ≥ 20kPa or with a platelet count ≤150,000) at baseline, but don't have varices requiring treatment (proved by endoscopy).
5. Voluntarily signed the informed consent.

Exclusion Criteria:

1. Patients with liver carcinoma;
2. Patients with portal vein thrombosis;
3. Patients with varices requiring treatment confirmed by gastroscopy during the screening period;
4. Patients who have received propranolol, ligation, sclerosis, splenectomy, transcatheter splenic arterial embolization, transjugular interhepatic portosystemicstent-shunt and other treatments to decrease portal hypertension in the past.
TSH Receptor Antibody Heterogeneity in Children and Adolescents With Graves' Disease

Graves' disease, the most common form of hyperthyroidism in children, is caused by Thyrotropin (TSH) Receptor Antibodies (TRAbs) that mimic the action of TSH. The disease leads to significant morbidity in children both due to the prolonged course of antithyroid medication often required for sustained immunological remission and the high risk of relapse when medication is withdrawn. The ability to predict which patients are most likely to fail medical management would greatly improve the choice of therapy. In the past, large goiter size, age at diagnosis, increased biochemical severity, and decreased body mass index have all been associated with a poorer prognosis, but these clinical indicators lack sensitivity and specificity. Preliminary data suggest that the new TRAb assays are both sensitive and specific for the measurement of TRAbs in children with Graves' disease. In addition, variation in these antibodies over time is not the same in all patients. The goal of this proposal will be to prospectively follow children with newly diagnosed Graves' disease and use microarray technology to determine if there are genes whose expression differ in patients who respond to medical therapy versus those who will need more definitive therapy earlier in their disease.

In the present grant proposal, we plan to utilize two new assays (binding and bioassay) in order to identify additional predictors of Graves' disease and apply them to a well characterized group of patients with Graves' disease followed prospectively. More specifically, we plan to further investigate the antibodies by measuring lambda: kappa light chain antibody ratios in pediatric patients. We will assess epitope heterogeneity by using novel chimeric proteins in which specific portions of the TSH receptor have been replaced with the closely related LH receptor. We will utilize microarray technology to determine if there are differences in gene expression profiles in responders versus non responders. It is hoped that these methods will lead to an improved ability to follow disease progression and to monitor efficacy of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-21 years
* Suppressed Thyroid Stimulating Hormone (TSH)
* Elevated Triiodothyronine (T3), Thyroxine (T4)

Exclusion Criteria:

* Pregnancy
* Toxic Nodule
* Currently receiving steroids or thyroid hormone replacement
* Bacterial, Viral, Radiation, or Autoimmune thyroiditis
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.

Patients will be randomized into 2 groups:

* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.

Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic cholecystectomy
* Acceptance to participate in the study and sign of informed consent form

Exclusion Criteria:

* A gallstone larger than 10mm observed at preoperative ultrasonography
* Coexistence of umbilical hernia or previous umbilical hernioplasty
* Previous laparotomy involving the umbilical region
* Emergency surgery
Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients

The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.


Eligibility Criteria:
Inclusion Criteria:

* Recent implant of DR pacemaker according to current guidelines
* Sinus Rhythm at enrollment

Exclusion Criteria:

* Pregnant women
Salt Intake, Microbiota, Immune Response and Endothelial Function in Hypertension

Hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. Salt intake is essential in the development and progression of hypertension. A reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. The mechanisms involved in the association between salt intake and blood pressure are a topic of discussion. Increased salt intake can modify cardiovascular function, inducing endothelial dysfunction, modyfing the activity of the immune system and increasing inflammation or oxidative stress.

In recent years, dietary salt intake has been linked to intestinal depletion of certain genera of bacteria such as Lactobacillus. Tryptophan metabolites formed by these bacteria have been shown to modulate the activity of pro-inflammatory cells such as Th17/CD4+, interleukin 17a producing cells. Studies in animal models have demonstrated that interleukin 17a is able to raise blood pressure by hindering endothelium-dependent vasodilation mechanisms. It is also able to cause sodium and water retention, increase albuminuria, induce renal microvascular injury and vasoconstriction and promote vascular stiffening, cardiac hypertrophy and fibrosis.

The main objective of this trial is to describe the relationship between salt intake, gut commensal microbiota, Th17 activity, endothelial dysfunction and blood pressure evolution in a sample of patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Diagnosis of primary hypertension on treatment for at least 12 months with an ACEI or ARB-II in monotherapy.
* Able to understand the study objectives and to provide written informed consent.

Exclusion Criteria:

* Severe hypertension, defined as a sitting systolic blood pressure ≥200 mmHg, a sitting diastolic blood pressure ≥115 mmHg or a maximum-minimum difference of ≥20 mmHg in systolic blood pressure or ≥10 mmHg in diastolic blood pressure between the right and left arms after three measurements on each arm.
* Suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age \<30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly,
* Treated with antihypertensive drugs other than ACEIs or ARBs.
* Use of drugs that affect diuresis or natriuresis.
* Poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or HbA1c ≥9%.
* History of cardiovascular disease, defined as acute myocardial infarction, ischemic transient attack or stroke, congestive heart failure, peripheral vascular disease or cardiac arrhythmias.
* Chronic obstructive pulmonary disease.
* Liver or kidney disease.
* Pregnant or lactating women.
* Legal incapacity or impossibility to understand the study objectives.
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
* Able to be fit with and wear contact lenses within the available range of sphere \& cylinder power and axes.
* Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).
* Other exclusion criteria may apply.
Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch

This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED).


Eligibility Criteria:
Inclusion Criteria: have a clinically ordered cardiac MRI exam at University of Michigan -

Exclusion Criteria: pregnant; contraindication to MRI

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Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study

The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction


Eligibility Criteria:
Inclusion Criteria:

* Age:18 to 60 years old (man or female);
* confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
* Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
* Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Major organ function has to meet the following criteria:

HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; Alanine Transaminase (ALT) and Aspartate Transaminase(AST)≤2.5×ULN, but\<≤5×ULN if the transferase elevation is due to liver metastases； Total Bilirubin(TBIL)\<1.5×ULN； Serum creatinine ≤1.5×ULN;Serum albumin ≥ 30g / L

* Life expectancy greater than or equal to 6 months;
* Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

* Allergic to trastuzumab, capecitabine and oxaliplatin;
* severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
* A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
* Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
* Coagulant function abnormality (International Normalized Ratio(INR) \> 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) \> 1.5 ULN), with bleeding tendency;
* Pregnant or lactating women;
* Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
* History of psychiatric drugs abuse and can't quit or patients with mental disorders;
* Less than 4 weeks from the last clinical trial;
* The researchers think inappropriate.
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma

In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI). This conventional 3+3 phase I trial will increase the dose of TMI until the maximum tolerated dose (MTD) is reached. Initial patients enrolled will receive the lowest possible dose of 3Gy. Maximum dose will be 12Gy.

To establish the maximal tolerated dose of total marrow irradiation which can be added to high dose melphalan conditioning in patients with multiple myeloma undergoing autologous stem cell transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients meeting criteria for symptomatic myeloma
2. Patients must be high or intermediate risk of disease progression as defined by having one of the following criteria: 2.1 ISS stage 2 or 3 disease 2.2 Abnormal metaphase cytogenetics 2.3 Presence of FISH abnormalities aside from hyperdiploidy
3. Patients who have received at least 2 cycles of systemic treatment of any kind in the preceding 12 months
4. Patient age 18-75 years at time of enrollment
5. Karnofsky performance status of ≥70
6. Cardiac function: LVEF \>40%
7. Hepatic: Bilirubin \<2x upper limit of normal and ALT and AST \< 2.5x the upper limit of normal
8. Renal: Creatinine clearance of ≥30mL/min, estimated or calculated
9. Pulmonary: DLCO, FEV1, FVC \>50% of predicted (after correction for hemoglobin)

Exclusion Criteria:

1. Patients with diagnosis of plasma cell leukemia
2. Patients with myeloma who have had any disease progression prior to enrollment
3. Patients with truly non secretory myeloma (patients with light chain disease are eligible)
4. Pregnant or breast-feeding
5. Uncontrolled viral, fungal or bacterial infection Note: Infection is permitted if there is evidence of response to medication. Eligibility of HIV infected patients will be determined on a case-by-case basis.
6. Patients who have undergone prior allograft or autologous transplant
7. Prior solid organ transplant
8. Patients receiving prior radiation to more than 20% of bone marrow containing areas