cyrilzakka/clinical-trials huggingface dataset:
A Registry of Participants With Prostate Cancer in Asia

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.

This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), longitudinal, observational registry (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions \[as in an interventional study\])of PC participants. The following 3 participant cohorts will be enrolled: high-risk localized PC, non-metastatic biochemically recurrent PC, and metastatic PC. This is an observational study and treatment decisions and clinical management of participants will follow routine clinical practice. Medical care given to participants will not be influenced by participation in the study. Enrolled participants will be prospectively followed throughout their course of treatment, during which data on PC treatment, clinical progression, and outcomes (including death) will be collected. At the end of registry medical resource utilization (MRU) will also be collected. The maximum observational period will be 5 years. Safety will be monitored throughout the study for participants being treated with JNJ products.

Eligibility Criteria:
Inclusion Criteria:

* Male aged 21 years or older
* Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic, biochemically recurrent PC; Metastatic PC
* Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable representative
* Agree to be followed-up for PC per routine clinical care

Exclusion Criteria:

* No specific exclusion criteria's were defined
Medication Adherence in Rheumatic Diseases

The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* all providers at Southpoint Rheumatology All patients with a rheumatic disease diagnosis currently prescribed at least one rheumatic medication will be included in the analysis

Exclusion Criteria:

* new patients, those who are not prescribed any rheumatic disease medications, or do not have available pharmacy refill data
Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade

State of the art treatment for idiopathic macular holes consists of pars plana vitrectomy, internal limiting membrane staining with a blue colouring dye, internal limiting membrane peeling and filling of the vitrectomized space with a specific tamponade such as air and SF6. Air and SF6 have previously shown similar closure rates, although there was a trend towards lower closure rates in large diameter IMH (Idiopathic Macular Holes) using air. IMH with diameters \< 600 μm are currently believed to have similar closure rates with air and SF6. The investigators want to assess possible effects of the used tamponade (air or SF6) on closure rates and perfusion parameters represented by OCTA (Optical coherence tomography angiography). IMH eyes with a minimum diameter \> 600 μm will be excluded. Two idiopathic macular hole patient groups will therefore be formed: The first group (group 1) will receive air after vitrectomy and membrane peeling, the second group (group 2) will receive 10% SF6 (and 90% air) after vitrectomy and membrane peeling. After recruitment, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCT (Optical coherence tomography) and OCTA.

Note: The trial was registered retrospectively on Clinicaltrials.gov after start of recruitment.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be able and willing to give informed consent.
* Patient must be between 18 and 100 years of age.
* Patient must not have any significant media opacity which interferes with the examination.
* Patient must have an (stage 1-4) idiopathic macular hole requiring surgery.

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Under 18 or over 100 years of age
* Significant media opacities
* Systemic pathologies making an examination difficult or cumbersome to the patient
* Primary and/or secondary epiretinal membranes (ERM), except incipient ERMs not affecting the foveal contour and not requiring surgery
* Full-thickness idiopathic macular hole \> 600 μm in minimum diameter
* Nonclosure
* Lamellar holes not requiring surgery
* Pseudo holes
* Glaucoma
* Diabetes
* Anisometropia \> 2 diopters
* High myopia (spherical equivalent \> 6 diopters and/or axial length \> 26 mm
* Other retinal or ophthalmic pathologies except moderate cataract
* OCTA scan signal strength \< 5
* Low image quality
* Failure of automatic layer segmentation
Comparative Analysis of Core Body Temperature Measurement

Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 years and above, but under 70 years

Exclusion Criteria:

* Cases where there were serious side effects during a previous examination performed under sedation or anesthesia
* Currently undergoing treatment for a diagnosed disease
* Diagnosed with esophageal varices or having a history of esophagitis
* Having undergone esophageal and gastric resection surgery
The Effects of Plant Bioactives on Platelet Function

Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. The mechanism by which polyphenols exert this effect is not clearly understood but research has focused on their potential to affect platelet function. The purpose of this study is to quantify the anti-clotting activity of a range of plant food extracts and component compounds.

A single sample of whole blood will be collected from 15 male or female volunteers aged between 18 and 65 years. After collection whole blood will be treated with a range of flavonoids to evaluate their effects on platelet function.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Aged 18 - 65 years.
* BMI \> 19.5 and \< 35
* Non-smokers

Exclusion Criteria:

* Pregnancy or have been pregnant within the last 12 months
* Parallel participation in another research project which involves dietary intervention
* Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
* Has donated or intends to donate blood within 16 weeks prior to during the Study period.
* Depressed or elevated blood pressure measurements (\<90/50 or 95/50 if symptomatic or \>160/100)
* Any person related to or living with any member of the study team
* Diabetics
* Taking regular prescribed and/or non-prescribed medication (excluding oral contraceptive and HRT).
* Known bleeding disorders.
A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib

Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Metformin, an OCT2 Substrate, in Healthy Subjects When administered Alone and in Combination with a Single Oral Dose of Vandetanib (CAPRELSA) 800 mg

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females aged 18 to 50 years with a weight of at least 50 kg and a body mass index between 18 and 30 kg/m2 inclusive.
* Females must have a negative pregnancy test at screening, must not be lactating and must be of non-childbearing potential.
* Volunteers will be wild type for the OCT2 gene (as tested for within the last 6 months prior to Day 1 in Period 1)

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic, or renal disease or any medically significant disorder.
* History of or ongoing severe allergy/hypersensitivity to drugs with a similar chemical structure or class to vandetanib or metformin.
* Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center.
* Known or suspected history of drug abuse.
* Screening supine blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute.
* Clinically significant current active skin disease (eg moderate to severe acne, psoriasis, eczema).
* Any positive result on screening for serum hepatitis B, surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants

The main purpose of the study is to confirm how long ALXN1840 stays in the body of Japanese and non-Japanese healthy participants (that is, pharmacokinetic \[PK\] profile).


Eligibility Criteria:
Key Inclusion Criteria: - Body weight ≤80 kilograms (kg) and body mass index (BMI) within the range 18-25 kg/m\^2, inclusive, at screening. - Negative serum pregnancy test. - Female participants of childbearing potential and male participants with a female spouse or partner of childbearing potential must be willing to follow protocol-specified contraception guidance starting at least one menstrual cycle before first study drug administration and continuing for up to 3 months after the end of systemic exposure of the study drug (that is, 3 months after end of study visit).

Key Exclusion Criteria: - Current or recurrent/chronic disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic, or gastrointestinal (GI) or other conditions) that or could affect clinical assessments or clinical laboratory evaluations. - Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the study drug or study procedures. - Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk. - History of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical). - Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of Alexion. - Use of non-prescription/ over-the-counter medications including vitamins and dietary or herbal supplements, within 7 days prior to dosing on Day 1. - Donated or lost 400 milliliters (mL) blood or more within the last 16 weeks preceding the first day of dosing.
Submassive Pulmonary Embolism Experience With EKOS

This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE

Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.

Eligibility Criteria:
Inclusion Criteria:

1. Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
2. RV dysfunction as evidenced by RV/LV ratio \> 0.9 on echo
3. Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
4. PE symptom duration \< 21 days
5. Age \>18 years
6. And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat \< 90% RA, or inability to maintain a HR \<100, or inability to maintain a Systolic Bp \> 100. Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR\<100 or BP \>100)..

Exclusion Criteria:

1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
2. Recent (within one month) or active bleeding from a major organ
3. Hemoglobin (Hgb) \< 8.0
4. Platelets \< 60 thousand/µL
5. Major surgery within seven days
6. Clinician deems high-risk for catastrophic bleeding
7. History of heparin-induced thrombocytopenia (HIT)
8. Pregnancy
9. Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
10. Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
11. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
12. Evidence of irreversible neurological compromise
13. Life expectancy \< 30 days
14. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease

This is a 26 week randomized controlled study. The study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples will also be collected at these visits for microbiological and inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect information regarding compliance with the use of the Lung Flute, adverse events and exacerbation history.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing.
2. Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following criteria for stage ll - IV disease:

   a) Subjects must have a post-bronchodilator FEV1/FEV ratio \<70% and FEV1 of \<80% of the predicted value for age, height, and sex using the NHANES III standards (Hankinson, 1999).
3. Subjects must have a smoking history of at least 10 pack-years.
4. Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period.

   -

Exclusion Criteria:

1. History of an exacerbation or other significant disease instability during the month preceding enrollment.
2. A primary diagnosis of asthma or bronchiectasis.
3. Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.
4. Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject.
5. Pregnant or nursing females or females intending to become pregnant during the course of the study.
6. Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit.
7. Inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol.
8. Patients currently using the Lung Flute. -
MoKaRi II Intervention Study

The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose \> 5.6 ≤ 7 mmol/l).

The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides \> 1.5 mmol/l) and participants with impaired glucose tolerance (glucose \> 5.6 ≤ 7 mmol/l).

The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D).

The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products.

Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D).

The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.

Eligibility Criteria:
Inclusion Criteria:

Voluntary participation with documented consent

* Willingness and ability to adhere to study protocol
* Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
* BMI: ≥ 20 ≤ 40 kg/m2
* No or moderate alcohol consumption (≤ 2 glasses/week)
* non-smoker (if possible)
* Group A, B: triglycerides: \> 1.5 mmol/l
* Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L

Exclusion Criteria:

Concomitant diseases:

* Hypercholesterolemia (genetic defect / familial predisposition)
* Diabetes mellitus
* Thyroid dysfunction (hyper- or hypothyroidism)
* Food intolerances/allergies to ingredients in the study foods
* Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
* Dietary supplements: especially n-3 fatty acids, vitamin E
* Extremely high physical activity (daily)
* Alcohol abuse (daily)
* (smokers) \[if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible\]
* Uncontrolled organic diseases
* Alcohol, medication or drug abuse
* Participation in other observational clinical studies during or 4 wk. before starting this study
* Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance
* Pregnancy, lactation and unsafe contraception
* Other reasons considered important by the investigator
Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects from 40-80 years (inclusive) of age
* Subjects have a clinical diagnosis of COPD
* Smokers or Ex-smokers with a smoking history of at least 20 pack years
* Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
* Post-bronchodilator FEV1/FVC ratio \< 70%
* History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
* Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
* Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
* Able to provide written informed consent prior to study participation.
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

* COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
* History of lung reduction surgery
* Any undiagnosed nodule on chest x-ray
* Presence of certain medical conditions as specified by the protocol
* Subjects requiring oral or parenteral corticosteroids equivalent to \> 10 mg/day or \> 20 mg every other day of prednisone or prednisolone
* Documented homozygous alpha-1 antitrypsin deficiency.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
* A known hypersensitivity to drugs similar to the study drug.
* History of immunocompromise, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.
5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.


Eligibility Criteria:
Inclusion Criteria

* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
* High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA \> 20 ng/mL
* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

* Prior pelvic radiotherapy
* Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
* Diagnosis of bleeding diathesis
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
* Evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
* Hip prosthesis