cyrilzakka/clinical-trials huggingface dataset:
Risk-adapted Stereotactic Body Radiotherapy for Early Non-Small Cell Lung Cancer Using the VERO Stereotactic Body Radio Therapy System

The purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. SBRT regimens used will be 4 fractions of 12 Gy or 3 fractions of 17 Gy depending on tumor location in a risk-adapted approach.


Eligibility Criteria:
Inclusion Criteria:

1. Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
2. Maximal tumor diameter of 6 cm
3. Only T3 lesions based upon thoracic wall involvement, only 1 lesion
4. Informed consent is required
5. Life expectancy of at least 6 months
6. Age \>/= 18 y.
7. Karnofsky score ≥ 70 or ECOG score ≤ 2
8. Inoperable patients or patients refusing surgery
9. Patients with measurable lesion (according to RECIST criteria)

Exclusion Criteria:

1. Diagnosis of small cell lung cancer
2. Lymph node involvement
3. Prior radiotherapy to the chest and/or mediastinum
4. No chemotherapy and/or targeted treatment within 3 months before SBRT
5. Pregnant or lactating women
6. Known allergy for CT contrast
7. No FDG-PET
8. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
9. Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.


Eligibility Criteria:
Inclusion Criteria:

* The participant has had at least 1 episode of moderate or severe CE-COPD over the past 12 months before screening.
* The participant must be able to demonstrate appropriate use of albuterol from the ABS eMDPI.
* The participant is currently using a short-acting beta agonist (SABA) reliever plus at least one of the following: long-acting beta agonist (LABA), an inhaled corticosteroid (ICS)/LABA, a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA.
* The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device.
* The participant is willing to discontinue all other rescue or maintenance SABA or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.
* Women of childbearing potential (not surgically sterile or greater than or equal to \[≥\]2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (IMP).

  * Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.
* The participant has any other confounding underlying lung disorder other than COPD.
* The participant has used an investigational drug within 5 half-lives of it being discontinued or within1 month of Visit 2 (Baseline \[Day 1\]), whichever is longer.
* The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.
* The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose \[milk protein\]). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator's medical discretion.
* The participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis.

  * Additional criteria apply, please contact the investigator for more information.
Applying Speed of Processing Training to Individuals With Multiple Sclerosis

This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Multiple Sclerosis (MS), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with MS with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with MS utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the MS population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in MS could have a profound impact on the population and society as a whole.


Eligibility Criteria:
Inclusions:

* diagnosis of Multiple Sclerosis
* fluent in English
* processing speed impairment (based on evaluation).

Exclusions:

* currently taking steroids and /or benzodiazepines
* prior stroke or neurological disease
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
* significant alcohol or drug abuse history
Immunogenetic Factors of Coronary Heart Disease

To assess the association of immunogenetic factors with onset of coronary heart disease and the interrelationship of these factors with standard coronary heart disease risk factors.

BACKGROUND:

Although the familial clustering of coronary heart disease has been well documented, it is unclear as to whether the familial clustering can be explained by shared environmental factors by members of a family or by clustering of risk factors having a genetic component such as blood pressure, familial hyperlipidemia and/or diabetes. Studies indicate that a family history of coronary disease may be an independent risk factor. Major histocompatibility complex genetic markers to identify individuals at risk within a family may be useful. In 1985 when the study began, there was a paucity of data dealing with the interrelationship of family history, genetic markers, immunological markers, and traditional risk factors.

DESIGN NARRATIVE:

In this case-control study, the study population consisted of incident cases who presented to the Georgia Heart Clinic in La Grange, Georgia with coronary heart disease. The majority of the subjects were from three counties in mideastern Alabama and from counties in midwestern Georgia. All subjects had undergone diagnostic coronary angiography. A determination was made in patients and controls of the association of major histocompatibility complex genetic markers HLA-A, -B, -C, -DR, C4 and BF, C3, the restriction fragment length polymorphisms (RFLP's) flanking the apolipoprotein AI and insulin genes, presence of autoantibodies, and family history of coronary disease, diabetes, or hypothyroidism. The frequency of these variables was compared with the standard coronary risk factors of family history, hypertension, lipid abnormalities, lifestyle, Type A behavior, obesity and with diseases such as diabetes and hypothyroidism. An analysis was made of the strength of these variables for predicting those individuals at risk and whether there were variables which predict severity of disease based on 1, 2, or 3 vessel involvement.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.


Eligibility Criteria:
Inclusion Criteria:

* Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.
* Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
* Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.

Exclusion Criteria:

* Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason.
* Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment.
* Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test

Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to \< 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (\>10\^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment.

A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.


Eligibility Criteria:
Inclusion Criteria:

- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL

Exclusion Criteria:

* major systemic disease
* Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
* Pregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus
* Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
* Pregnant woman whose amniocentesis reveals any genetic abnormality
The Scandinavian AED and Mobile Bystander Activation Trial

Sudden cardiac death is a major health problem in the western world. In Europe alone nearly 300 000 patients are affected annually. The majority of victims suffering from an Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is too long and survival averages 10 %.However, when laymen operated Automated External Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive.

The aim of "The Scandinavian AED and Mobile Bystander Activation" (SAMBA) trial is to evaluate if a Mobile Phone Positioning system and a smartphone application will increase the proportions of patients with an attached Automated External Defibrillator (AED) before arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone application will be used identify and recruit nearby CPR-trained lay people and automated external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA). The system is currently running in Stockholm Sweden and in the Gothenburg region.

Early defibrillation in out-of-hospital cardiac arrest is associated with high survival rates. If the operator at the dispatch center suspects an out-of-hospital cardiac arrest he or she will activate the mobile positioning system (MPS) wich is integrated in the operators computer environment.

After activation, the system will locate all CPR-trained volunteers nearby the suspected OHCA. By computer based 1:1 randomization lay volunteers will be alerted and dispatched in 50 % of all suspected OHCAs in where the system is triggered by the dispatchers. In the intervention group, the activation of the system is supposed to result in lay volunteers to be alerted and directed to fetch the nearest AED and commence early defibrillation. Dependent on geographical and logistical circumstances, at a minimum one lay volunteer or more will be alerted to provide bystander CPR only.

In the control group the MPS will be activated and lay responders will be dispatched to suspected OHCA to perform CPR only. In both groups the ordinary EMS services are dispatched in a regular fashion.

Eligibility Criteria:
Inclusion Criteria:

* All EMS-treated OHCAs within the Stockholm County, Copenhagen and VGR area and in whom the mobile positioning system is activated at the emergency dispatch center

Exclusion Criteria:

* Crew witnessed OHCAs
* Patients \<8 years of age
* OHCAs due to trauma, intoxication, or suicide
* OHCAs not treated by the EMS due to ethical reasons or obvious signs of death.
* No OHCA cases
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Eligibility Criteria:
Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

* 6 to \< 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
* 12 to \<18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH \[fluorescence in situ hybridization\] analysis was allowed).

Exclusion criteria:

* Patient who have received more than 18 months of imatinib therapy
* Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
* Prior treatment with greater than 400 mg/day imatinib.
* Uncontrolled or significant cardiovascular disease.
* Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
* Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066

The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.


Eligibility Criteria:
Inclusion Criteria:

* obese and overweight, BMI 25-50, HbA1C \<10%

Exclusion Criteria:

* Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply
Correlation of Endoscopic Findings and Symptoms in Patients Undergoing the First Upper Gastrointestinal Endoscopy

Endoscopy is the best means of finding early stage of upper gastrointestinal diseases, especially early cancer and benign ulcers. Currently, most people still undergo upper gastrointestinal endoscopy due to discomfort, rather than a regular physical examination at a certain age. This study prospectively investigated the reason for undergoing the first upper gastrointestinal endoscopy in patients and found the correlation of endoscopic findings and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing the first upper gastrointestinal endoscopy.

Exclusion Criteria:

* The patients had previously performed endoscopy and any esophageal, gastric or duodenal surgery.
* The patients couldn't complete the questionnaire survey under the guidance of physicians at the appointment of the upper gastrointestinal endoscopy.
Can Protein Intake be Increased Using Whole Foods Post-treatment in Cancer Patients?

Cancer and its treatments often result in severe toxicities and side effects that, over the course of treatment, results in weight loss and depletion of key nutrients. Loss of muscle mass and strength during cancer treatment is a critical problem because it negatively affects patient response and tolerance to therapy and post-treatment recovery. To restore the nutritional status, it is imperative to stimulate muscle protein anabolism. Eggs are high quality protein source, popular and well tolerated by cancer patients. Therefore, the objective of this study is to determine whether a nutritional intervention of ≥2 eggs can aid in restoring nutritional status and improving immune function and quality of life of cancer patients' post-treatment. It is an 8- week randomised clinical trial with parallel arm assignment. Half of the participants will receive the nutritional intervention (Early Intervention) and the other half will be on standard of care or usual diet for first 4 weeks. Starting from week 5, all participants will receive the nutrition intervention till week 8 (Delayed Intervention). Dietary intake (foods and nutrients), cumulative protein intake (g protein/kg body weight), immunological measures, physical performance and quality of life has been planned to be assessed over time and between groups to evaluate the feasibility of an egg intervention in meeting recommended protein intakes for patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
* ≥18 years of age
* Histopathologically confirmed cancer with receipt of a platinum chemotherapy during treatment; active treatment has concluded.
* Capable of volitional oral semi-solid intake at baseline; able to maintain oral intake over the trial.

Exclusion Criteria:

* Fed by nasogastric tube, gastrostomy, or total parenteral nutrition
* Cancer of the brain, Cancer of the regions which impact an individual's ability to consume food.
* A known hypersensitivity / allergy to eggs.
* Enrolment in any other clinical protocol or investigational study that may interfere with study procedures.
* Poorly controlled chronic illnesses or other inflammatory diseases (e.g. Chronic Obstructive Pulmonary Disease(COPD), uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
* In a clinician opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
Glucose Oxidase as Treatment Against Common Cold

Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies.

In the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. The study is randomized and placebo controlled.

Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms.

Before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the WURSS-21 protocol. After this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. Every day the included persons fill in the WURSS-21 protocol.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of a common cold within the last 24 hours

Exclusion Criteria:

* Use of a nasal steroid due to allergy