cyrilzakka/clinical-trials huggingface dataset:
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Histologically documented non-small cell lung cancer (NSCLC).
* Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
* Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Patients of reproductive potential must agree to use effective contraception.

Exclusion Criteria:

* Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
* Prior treatment with any monoclonal antibody therapy.
* Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
* Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
* Pre-existing interstitial lung disease.
* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
* Pregnant or lactating women.
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants

The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.

For complete information about the clinical trial, see link in the reference section.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral primary breast augmentation-dissatisfaction with breast size
* Bilateral replacement augmentation-has had previous silicone saline-filled or gel-filled breast implants

Exclusion Criteria:

* Diagnosis of active cancer of any type
* Has ever been diagnosed with breast cancer
* Has pre-malignant breast disease
* Has tissue characteristics incompatible with an implant
* Has unrealistic or unreasonable expectations of the procedure results
Smart Phone App for COLOnoscopic PREParation

This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies. The investigators will be comparing the smartphone application to traditional instructions for bowel preparation. The quality of bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.

This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies at an academic teaching hospital in Kingston, Ontario.

The intervention under investigation is the use of a novel smart phone application which serves as an automated reminder system for patients undergoing outpatient colonoscopies. The application requires the patients to enter the date and time of the colonoscopy appointment and automatically populates the patients' phones with calendar reminders as well as pre-recorded messages regarding cessation of solid food intake, the need for clear fluid intake, as well as timing of their bowel regimens starting 7 days prior.

The design of this study is a prospective, randomized controlled trial with single blinding (endoscopist). Eligible participants will be randomized into either the control (routine paper instructions) or the intervention group (smart phone application). Those who are randomized into the intervention group will be provided with specific instructions to download and setup the smart phone application at least 7 days prior to their scheduled appointment. Upon arrival to their appointment, participants in both groups will be asked to complete a survey confirming the adherence to either paper instructions or instructions provided by the smart phone application.

The primary outcome of this study is the adequacy of the bowel preparation, as assessed by using the Ottawa and Aronchick bowel preparation scales, which have been previously validated and are in common usage for colonoscopy procedures. Secondary outcomes include rate of polyp detection, rate of cecal intubation, and patient reported ease of use and adherence to the bowel regimen instructions.

Eligibility Criteria:
Inclusion Criteria:

* Access to smart phone with the ability to download smart phone application
* Outpatient screening colonoscopy

Exclusion Criteria:

* Patient refusal
* Bowel preparation other than pico-salax or GoLytely
* Urgent/Emergent Colonoscopy
* Patient requiring combined upper and lower endoscopic evaluation
* No access to smart phone or inability to download smart phone application
* Surveillance colonoscopy for previously resected cancer
* Inflammatory bowel disease
Paraspinal Muscle Remodeling

Lumbar disc herniation is the most common diagnosed degenerative pathology in the lumbar spine with a prevalence of 2 to 3% in the adult population. Unilateral lumbar disc herniation is characterized by compression or irritation of the lumbar nerve roots or dural sac by either protrusion, extrusion or sequestration of the nucleus pulposus, mostly in the posterolateral region. Compression or irritation of the lumbar nerve roots and dural sac can induce unilateral sensory and motor symptoms. Therefore, it is the principal cause of lumbar spinal surgery.

Different imaging studies have investigated asymmetry of the paraspinal muscles in patient with unilateral low back pain due to lumbar discus herniation. Both animal and human studies indicate a reduction in total muscle cross-sectional area, increased fat infiltration and fibrosis within the lumbar multifidus at the affected side.

Increased fat infiltration is clinically important because there is a correlation between the amount of intramuscular fat and lumbar muscle dysfunction. Not only fat infiltration correlates with lumbar dysfunction, also a lower multifidus cross-sectional area is associated with and predictive for low back pain. This indicates that there is an association between paraspinal muscle changes/ remodeling and muscle dysfunction that could lead to low back pain.

The aim of this research is to quantify the decrease in muscle and muscle fibre size, the amount of fat infiltration, and the amount of fibrosis present within the multifidus muscle at the herniated side in relation to the unaffected side. The second aim is to investigate the possible role of different cell types in the process of muscle remodeling. The last aim of this study is to correlate these muscular changes with long-term functional outcomes such as pain, fear and disability. This information can possibly contribute to the etiology of paraspinal muscle changes, and provide a handgrip to future research.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral lumbar disc hernia (diagnosed using MRI)
* Age between 18-55
* Understanding the Dutch language

Exclusion Criteria:

* Spinal surgery within the last year
* Degenerative or other spinal pathology (except disc hernia)
* Contraindications to undergo a MRI
* Other known pathologies that might affect muscle biology/ morphology
Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD

On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Aspirin exacerbated respiratory disease.
* Controled asthma
* No actual systemic corticosteroid treatment
* No antileucotriene treatment.

Exclusion Criteria:

* Patients who do not complete both phases of the study
* Patients unable to perform adecuate spyrometric testing
* Patients who present severe asthmatic reactions with high salycilate foods
Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy

This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2, to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.

The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma. Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage.

Trabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a distinct role in the fibrotic process of bleb closure.

Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled for trabeculectomy with Mitomycin C
* Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma

Exclusion Criteria:

* History of relevant ocular trauma \< 6 months or ocular infection/inflammation \< 3 months
* severe central visual field loss within 6 months unrelated to glaucoma
* pregnant or nursing women or subjects not using adequate contraception
* history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluations, procedures or interpretation
Application of Economics & Social Psychology to Improve Opioid Prescribing Safety Trial 1: EHR Nudges

The opioid epidemic has had a tremendous negative impact on the health of persons in the U.S. The objective of the trial 1 of Application of Economics \& Social psychology to improve Opioid Prescribing Safety (AESOPS-T1), is to discourage unnecessary opioid prescribing through the application of "behavioral insights"-empirically-tested social and psychological interventions that affect choice.

A multisite study, AESOPS-T1 randomizes clinics to behavioral intervention or control. Clinics randomized to the behavioral intervention arm receive electronic health record (EHR)-based nudges. Eligible participants are clinicians who practice ambulatory primary care at the participating clinical sites in Illinois and California. At the time of opioid prescribing, clinicians in clinics randomized to the intervention group will be prompted with an EHR nudge when the prescribing history for the patient falls into one of the following three mutually exclusive categories: Opioid naïve, At-risk for long-term use, or Long-term opioid recipient. These EHR-based nudges include accountable justification, defaults and precommitments. The control arm receives no EHR-based intervention. Both arms receive guideline education. The primary outcome is the change in clinician aggregate weekly milligram morphine equivalent (MME) dose and the secondary outcome is the proportion of dosages that equal or exceed 50 MME per day. These outcomes will be estimated by treatment arm with an intent-to-treat difference-in-differences framework using a mixed-effects regression model on clinician MME daily dose. The intervention period will be 18-months, with a 6-month follow-up period to measure the persistence of effects after the interventions conclude.

Eligibility Criteria:
Inclusion Criteria:

* Providers of clinics that see patients ≥ 18 years old and for whom clinic leadership agrees to participate.

Exclusion Criteria:

* Visits will be excluded from intervention when the patient has active cancer.
Efficacy and Safety of Low-concentration Atropine for Myopia Control in Chinese Children and Adolescents

To investigate the efficacy and safety of three low-concentration atropine sulfate eye drops (0.01%, 0.025% and 0.05%) in controlling the progression of myopia in Chinese children and adolescents through a two-year clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. The age of the screening stage is 3-15 years, both sexes;
2. One eye met the diagnosis of myopic refractive error, the spherical equivalent was between -0.50D and -8.00D, the astigmatism was ≥-3.00D, and the best corrected far vision was at least 0.8;
3. Have normal thinking and language communication ability, and can actively cooperate with treatment and follow-up as required;
4. Informed consent from the guardian and the child.

Exclusion Criteria:

1. strabismus, amblyopia or other ocular abnormalities;
2. The presence of systemic disease abnormalities;
3. have taken myopia control treatment in the past month;
4. Allergic to low concentration atropine or sulfuric acid drugs.
Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis

The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital.

It is anticipated that this new model of care will improve:

1. The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients
2. The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AS or PsA
* Referral for initiation of biological therapy by patients regular consultant
* Age 18 years or older
* Willing and able to give informed consent

Exclusion Criteria:

· Unable to comply with study procedures
Flotetuzumab Expanded Access Program

The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.

MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.

Eligibility Criteria:
Inclusion Criteria:

* Weight of at least 17 kilograms
* CD123-positive hematologic malignancy
* Adequate organ reserve
* Provider and site are trained on study protocol using flotetuzumab

Exclusion Criteria:

* AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
* Primary induction failure
* Early relapse (less than 6 months after first complete remission )
* Three prior lines of therapy, including maximum of 1 prior salvage attempts
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed SCLC;
4. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.

Exclusion Criteria:

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Evidence and history of severe bleeding tendency;
3. History of severe cardiovascular diseases within 6 months;
4. Current presence of severe superior vena cava syndrome and spinal cord compression;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.
Clinical Features of COVID-19 Patients

The data were retrospectively collected during the first and the second wave of epidemic in COVID-19 patients with Severe Acute Respiratory Syndrome Coronavirus 2, at the moment of intensive care unit admission and during the in intensive care unit staying.

At the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans, arterial blood gas parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation), and pain assessed by using numeric rating scale.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients
* Acute respiratory distress syndrome
* needing of ventilatory support

Exclusion Criteria:

* asymptomatic COVID-19 patients
* few symptoms
* mild symptoms
* without needing of ventilatory support
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer

Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented adenocarcinoma of the colon or rectum.
* Advanced and/or metastatic disease, incurable with standard therapy.
* Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale).
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Age: over 18 years.
* Adequate haematological, renal and hepatic functions
* Patient consent must be obtained according to local REB requirements.
* Patients must be accessible for treatment and follow up.

Exclusion Criteria:

* Previous or concurrent malignancies
* Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration.
* Concurrent treatment with other experimental drugs or anticancer therapy.
* Previous chemotherapy for advanced and/or metastatic disease.
* Previous adjuvant therapy with irinotecan or oxaliplatin.
* Previous full dose curative pelvic radiation therapy.
* Patients with documented brain metastases.
* Serious illness or medical condition.
* Gilbert's disease
* Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites

The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin alone or Endostar alone in patients with malignant pleural effusion or ascites.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of thoracic or abdominal tumor
* At least medium amount of malignant pleural effusion or ascites
* ECOG Performance Status 0-2
* Life expectancy ≥ 2 months
* Adequate hematologic, cardiac, renal, and hepatic function
* No major surgery within 4 weeks prior to this study
* Written informed consent

Exclusion Criteria:

* Patients with central nervous system (CNS) metastases
* Evidence of bleeding diathesis, serious infection
* Evidence of myocardial infarction, unstable angina or cardiac insufficiency
* Presence of serious COPD and/or respiratory failure
* Allergic to study drug
* Pregnant or lactating women
* Participation in other clinical trials within 30 days prior to this study
Safety of Insulin Detemir in Children With Type 1 Diabetes

This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least one year
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
* HbA1C below 11.0%
* Willing to comply with Investigator's instructions
* Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total daily insulin dose of more than 2.00 IU/kg
* Current treatment or expected at the screening to start treatment with systemic corticosteroids