cyrilzakka/clinical-trials huggingface dataset:
Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs

This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.

In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.

These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact

Eligibility Criteria:
Inclusion Criteria:

* progressive keratoconus or ectasia

Exclusion Criteria:

* cornea thinner than 400um
* K readings greater than 60D
* Central corneal scarring
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction

This is a multi-center, non-randomized, 3-cohort, phase II trial, evaluating a triplet combination of docetaxel, oxaliplatin and fluorouracil for gastric cancer with peritoneal carcinomatosis and inoperable malignant bowel obstruction.

The primary study hypothesis is that the regimen will provide a clinically meaningful bowel obstruction clearance. This trial has 3 paralleled cohorts with the same experimental regimen: Cohort A (first-line therapy) will include 35 participants who have not received any palliative chemotherapy; Cohort B (second-line therapy) will include 22 participants who progress after the first-line therapy; Cohort C (third- or later-line therapy) plans to include 22 cases who have received two or more prior therapies for their metastatic disease.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age;
* ECOG PS ≤3;
* pathologically diagnosed gastric or gastroesophageal junctional adenocarcinoma;
* peritoneal carcinomatosis established by imaging data or pathological evidence;
* MBO below the Treitz ligament based on clinical grounds or radiological findings;
* considered as inoperable MBO by two independent surgical consultants;
* Hb≥60g/L, WBC ≥4×10E9/L, ANC≥2×10E9/L，PLT≥100×10E9/L;
* Cr≤ Upper Normal Limit(UNL);
* Tbil≤1.5 UNL,AST≤1.5 UNL, ALT≤1.5 UNL, ALP≤1.5 UNL;
* Written informed consent form paticipants.

Exclusion Criteria:

* treated by a combination regimen containing all the study drugs;
* allergy to any of the study drugs;
* HER-2 amplification or overexpression, mismatch repair protein expression deletion (dMMR), or genetic testing suggestive of high microsatellite instability (MSI-H);
* strangulated intestinal obstruction;
* active gastrointestinal bleeding;
* uncontrolled active infection;
* unstable heart diseases with severe ECG abnormalities or affect clinical treatment (such as cardiac insufficiency, myocardial infarction, angina);
* severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc);
* mental disorders that affect clinical treatment or central nervous system diseases;
* concomitant cerebral parenchymal or meningeal metastasis;
* HIV infection or untreated active hepatitis;
* bowel surgery or stenting required due to obstruction;
* pregnant or lactating women;
* other conditions that are not suitable for participation in the study.
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically proven pancreatic cancer that is borderline resectable
* No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
* Age \>18 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
* Woman of child bearing potential must have a negative pregnancy test.
* Must use an acceptable form of birth control while on study.
* Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Had major surgery within the last 28 days
* Had an investigational drug or device within the past 28 days
* Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc)
* Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
* Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
* Other cancer diagnosis requiring treatment within two years
* History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide, GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of the GVAX vaccine) in this study.
* Patients receiving growth factors within the last 14 days.
* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
* Pregnant or breastfeeding.
* Have known history of infection with HIV, hepatitis B, or hepatitis C.
* Unwilling or unable to follow the study schedule for any reason.
* Presence of tissue or organ allograft, regardless of need for immunosuppression (including corneal allograft)
* Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells \>30%
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's

Exclusion Criteria:

* Pacemaker dependent patients with ICD's
* Patients with other contraindication to MRI
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer.
* Has read, understood and signed an information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
* Has clear corneas and no active ocular disease.
* Has had an ocular examination in the last two years.
* Is a current soft lens wearer, replacing their lenses every two weeks to one month.
* Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
* Has astigmatism less than or equal to -1.00 DC.

Exclusion Criteria:

* Has any signs or symptoms of dry eye.
* Has any clinically significant blepharitis.
* Has undergone corneal refractive surgery.
* Is aphakic.
* Has any active ocular disease.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that may affect ocular health.
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Is pregnant or lactating.
* Is participating in any other type of clinical or research study.
* Currently wears daily disposable lenses.
* Currently wears lenses on an extended wear basis.
Diagnosis Of Vertigo With New Imaging

The purpose of this study is to determine the potential usefulness of new functional MRI in diagnostic assessment of patients presenting with vertigo.

The incidence of vertigo has been reported to be as high as 1.5% in the general population and some reports suggest that more than 5% of adults experience some kind of vertigo each year. In 80% of affected individuals, this symptom resulted in a medical consultation, interruption of daily activities, or sick leave. Therefore, vertigo can have a significant impact on health and well being. Unfortunately, there is not yet any satisfactory objective method for diagnosis of vertigo. At present, the diagnosis usually depends on medical history, vestibular function tests, Dix-Hallpike positioning tests done in the office, and, to some extent imaging studies doen to look for such abnormalities such as acoustic tumor, brain tumor, and evidence of multiple sclerosis. A number of recent studies support the possibility of using functional MRI (fMRI), particularly a new diffusion tensor fiber tracking (DTT) technique, as a new tool for diagnosis of disorders that can cause vertigo. In this study, our hypothesis is that there is an alteration in the activity in neural pathways of patients with vertigo that can be detected by fMRI. To test this assumption, our objective in this study is to determine whether there is a difference between the fMRI images obtained in normal subjects versus those in patients with vertigo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer or patient with symptom of vertigo

Exclusion Criteria:

* Evidence of mental impairment
* Any type of bioimplant or any type of ferromagnetic bioimplant
* Pregnant females
* Exhibit noticeable anxiety and/or claustrophobia
* History of serious disease in central nervous and cerebrovascular systems.
A Prospective Comparison of Cardiac Troponin T and Troponin I in the Diagnosis of Myocardial Infarction

The rising number of patients with chest pain without myocardial infarction has made accurate diagnosis important. Unnecessary invasive coronary angiographies are increasingly prevalent. These are both costly and lead to rare but serious adverse events. Recent studies suggest cardiac Troponin I is more cardiac specific than cardiac Troponin T. In this study we will investigate whether using cardiac Troponin I lead to fewer unnecessary procedures in clinical practice (i.e. invasive coronary angiography and non-invasive tests)


Eligibility Criteria:
Inclusion Criteria:

* Admitted to either Herlev-Gentofte or Amager-Hvidovre Hospital
* Clinically suspected of NSTEMI
* Referred to invasive coronary angiography (ICA)
* Recieved at least one measurement of either troponin

Exclusion Criteria:

-
Long-term Usage of the Fitbit® Among Medical Residents

This is a one year follow up survey study after a Fitbit® challenge study to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine if residents continue to use the Fitbit® after one year.

Medical training is notoriously stressful. The combination of long work hours, sleep deprivation, clinical responsibilities, and academics leaves little time for residents and fellows to consider their own health maintenance, particularly with regards to physical activity. This is problematic for both the physician and the physician's patients. Numerous studies have shown that physicians who exercise regularly and maintain normal body mass are more likely to counsel their patients on these issues. Additionally, they are more experienced in the benefits of exercise and can counsel their patients on how to incorporate exercise into a busy schedule. This is a one year follow up survey study after a Fitbit® challenge study among TriHealth residents. The purpose of the initial Fitbit® challenge study was to to determine if wearing a Fitbit® motivates residents to increase their physical activity. This study seeks to determine the long-term usage of the Fitbit®.

Eligibility Criteria:
Inclusion Criteria:

* Residents in training 18 years of age or older
* Residents who participated the initial Fitbit® challenge study

Exclusion Criteria:

* Physical impairment inhibiting the ability to walk or complete the validated questionnaires
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery

This study seeks to answer the question: Does a single pre-operative dose of tranexamic acid have a statistically significant reduction in blood loss during orthognathic surgery?

If it does, this drug may begin to be used routinely during orthognathic surgery to reduce blood loss in our patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing either

  * Bilateral saggital split osteotomy (lower jaw surgery)
  * Lefort 1 osteotomy (upper jaw surgery)
  * Combination of BSSO and Lefort
* Patients between with ages of 16-65
* No cardiac comorbidities (hypertension, congenital heart malformation)
* No known coagulopathy
* No regular prescription medication altering normal blood coagulation (NSAIDs, other anticoagulants)
* ASA I and II patients

Exclusion Criteria:

* Patients younger than 16 and older than 40
* Patients with known coagulopathy
* Patients with cardiac comorbidities
* Patients with a family history of bleeding disorders
* Patients who have undergone previous orthognathic surgery
* ASA III patients or higher
Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants

This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female volunteers of non-childbearing potential. The first part of the study will compare the bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference capsule (Periods 1 and 2). The second part of the study will assess the effect of GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).


Eligibility Criteria:
Inclusion Criteria:

* Healthy female participants between 30 and 65 years of age, inclusive;
* Within body mass index range 18.0 to 35.0 kilograms per square meter (kg/m\^2), inclusive;
* Female participants will be of non-childbearing potential;
* In good health, determined by no clinically significant findings from medical history, 12-lead echocardiogram (ECG), and vital signs;
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the investigator;
* Normal ophthalmology assessment.

Exclusion Criteria:

* Males and females of childbearing potential;
* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator;
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator;
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs;
* History of GI bleeding or GI ulcers;
* Any personal or family history of bleeding disorders, and any personal use of drugs known to affect blood clotting within 30 days of dosing;
* Any acute or chronic medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the subject's safe participation in and completion of the study.
Medication Adherence in Older Adults With Serious Mental Illness

The goal of this pilot study is to learn about how well older people with serious mental illness (including schizophrenia, schizoaffective disorder, bipolar disorder, major depression) follow prescribed medication regimens, and to evaluate a manualized intervention designed to enhance medication management skills and adherence, the Using Medications Effectively program. The following four hypotheses will be tested:

1. Medication adherence will be associated with several variables including insight, memory, medication management skill, knowledge about medications, attitudes about medications.
2. People who receive the program will have better medication adherence compared to those who do not receive the program as measured by pill counts.
3. People who receive the program will develop better medication management skills compared to those who do not receive the program.

Individuals who are already participating in a study of a combined skills training and health care management intervention for older people with serious mental illness are invited to join this study. Half of the individuals have already been randomly assigned to receive the intervention and half have already been randomly assigned to continue receiving their usual care. The people receiving the intervention receive the skills training module, Using Medications Effectively, in 8 group sessions over 8 weeks. The module includes information about common medications used for psychiatric and medical illnesses; training on using devices to help take medications properly; and instruction on strategies to help incorporate medication taking into a daily routine. A trained research assistant conducts pill counts and interview sessions with all participants after they sign an informed consent form, 8 weeks later, and 3 months after the second interview.

Eligibility Criteria:
Inclusion Criteria:

Participation in Rehabilitation and Health Care for Older People with SMI Serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, major depression) and functional impairment Receiving mental health services for 3 months or more Age 50 or older Ability to provide informed consent or guardian consent -

Exclusion Criteria:

Currently residing in an institution Psychiatric illness caused by co-morbid medical condition Dementia or score\<20 on Mini Mental State Exam

-
Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with RA


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA \< 5 years
* Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria.
* Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD)
* Joint count of 10 or more swollen and 12 or more tender.
* Erythrocyte Sedimentation Rate (ESR) \> - 28mm/rr or norning stiffness \> - 45 minutes.

Exclusion Criteria:

* Women and men who are not willing to use an accepted form of contraception.
* Active vasculitis
* Treatment with another investigational drug within 30 days
* History of asthma, angioedema, or anaphylaxix
Short-course Radiotherapy Based TNT Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer

TORCH is a prospective, multicentre, randomized phase II trial. 130 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B. Group A receives SCRT (25Gy/5Fx) followed by 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives 2 cycles of ToriCAPOX followed by SCRT and 4 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, 3-year DFS rate, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological confrmed adenocarcinoma
2. Clinical stage T3-4 and/or N+
3. The distance from anal verge ≤12 cm
4. Without distance metastases
5. Age 18-70 years old, female and male
6. KPS \> =70
7. Baseline blood and biochemical indicators meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90 g/L, PLT≥100×10\^9/L, ALT/AST≤2.5 ULN, Cr≤1 ULN
8. With good compliance and signed the consent form

Exclusion Criteria:

1. Pregnancy or breast-feeding women
2. Known history of other malignancies within 5 years
3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc
4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy)
5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction
6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
7. Uncontrolled infection which needs systemic therapy
8. Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents
9. Known history of human immunodefciency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
10. Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (i.e., HBsAg positive or HBV DNA positive, HCV RNA positive if anti-HCV antibody testing positive)
11. Allergic to any component of the therapy