cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer

A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men, 18yrs and older
* Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic)
* Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma

Exclusion Criteria:

* Prior radiotherapy to bone metastases within 4 weeks prior to screening
* any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy
* Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.
Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia

This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
* Patients must complain of mild to moderate arthralgia.
* Ability to understand and sign informed consent.
* Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.

Exclusion Criteria:

* Inability to comply with study requirements.
* Metastatic breast cancer.
* Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
* Rheumatoid arthritis.
* History of MI, angina or congestive heart failure.
* Pregnant or lactating females.
* Patients that are high risk for moderate exercise based on ACSM risk classification.
* Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.
* Morbidly obese with BMI ≥ 40
Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease

Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health

90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.

One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.

The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.

The secondary endpoint is:

1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；
2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；
3. The maximum walking distance of 6-minute walk test;
4. Changes of Seattle Angina Questionnaire;
5. Hamilton Depression Scale/ Hamilton Anxiety Scale.

The safety evaluation criteria is:

1. Adverse event and serious adverse event;
2. Vital signs;
3. Resting 12 lead ECG;
4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).

Eligibility Criteria:
Inclusion Criteria:

* Age 40 \~ 75, gender is not limited
* Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis
* Sign the informed consent voluntarily

Exclusion Criteria:

* History of hospitalization for acute coronary syndrome in past 3 months
* Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（\<90/60mmHg）
* History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months
* In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth
* Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate \<60bpm) or atrioventricular block
* Severely allergic constitution, known or likely to be allergic to the test drug or its components
* Known bleeding tendency or hemorrhagic disease
* Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors
* Any other situations that researchers believe may affect the clinical research
Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children

SDB has been identified as an important risk factor for insulin resistance and the metabolic syndrome.

In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).

In children, there are only 3 studies that have examined the relations between SDB, obesity and the metabolic syndrome.

In order to further understand the relative contribution of SDB to the development of impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence and severity of SDB in children with T2DM compared to obese children without T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among obese children with T2DM compared with the general obese pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with T2DM
* obese

Exclusion Criteria:

-
Effects of Ketogenic Diet in Body Builders

the study sought to investigate the influence of 8 weeks of a very low carbohydrate ketogenic diet on body composition, muscle strength, muscle area and blood parameters in competitive natural body builders.

nineteen natural body builders were randomly assigned to a ketogenic diet (KD) group or to a normal diet group (ND) with a traditional meal pattern. The two diets were isocaloric and included the same amount of protein per kg of body weight; but differed in the distribution of fats and carbohydrates; the latter were kept below 5% daily (less than 50g/day) in the KD group while represented 55% of the caloric intake in the WD group During the experimental period, training loads were similar in the two groups. Athletes were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, muscle strength and blood parameters were measured.

Eligibility Criteria:
Inclusion Criteria:

* at least 5 years of training experiences
* competing in recognized body building category

Exclusion Criteria:

* adherence to special diets
* use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
* use of medications (steroids)
* diabetes or metabolic diseases
Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.


Eligibility Criteria:
Inclusion criteria

* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
* With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
* Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL.

Exclusion criteria

* Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug.
* Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
* The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
* Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol

This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP).

Recently, astronauts in long-duration spaceflight have been found to have a syndrome consisting of swelling of the optic nerve, impaired vision, and elevated cerebrospinal fluid pressure (also known as intracranial pressure \[ICP\]) via lumbar puncture (LP), which is similar to the syndrome of idiopathic intracranial hypertension (IIH). In astronauts, this syndrome is called Visual Impairment/Intracranial Pressure (VIIP). It is not possible to perform an LP on astronauts in space. Noninvasive methods of estimating ICP exist but have not been tested against continuous ICP methods in a patient cohort that is physiologically similar to that of astronauts.

The primary objective of this study is to determine the validity, reliability, accuracy, and precision of two noninvasive methods of ICP measurement (tympanic membrane displacement (TMD, Marchbanks Measurements Systems, UK) and distortion product otoacoustic emissions (DPOAE) in comparison to a reference standard, invasive ICP measurement, in human subjects undergoing diagnostic cerebrospinal fluid (CSF) infusion testing.

The two noninvasive methods are based on the responses of the inner ear and middle ear to changes in ICP. The first method is TMD, which measures tiny movements of the ear drum, and the second is DPOAE, which is routinely used for newborn hearing screening.

Adults with hydrocephalus, shunt malfunction, or other disorders of CSF circulation who have been recommended on the basis of standard clinical criteria to have CSF infusion testing are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of suspected hydrocephalus or shunt malfunction
* CSF infusion testing has been recommended on the basis of standard clinical criteria
* Capable of providing valid signed informed consent
* Normal middle-ear function as determined by tympanometry
* DPOAE meet criteria that are required for the research
* Acoustic stapedial reflex meets criteria that are required for the research
* Subject is willing and able to participate in the study

Exclusion Criteria:

* Subject is pregnant
* Subject lacks decision-making capacity
* Subject is unwilling to participate in the study
* Prior middle-ear disease or surgery, with the exception of tympanostomy tubes that have been removed and are healed
* Participating in the study would significantly delay or interfere with the subject's healthcare
* Subject has excess ear wax that cannot be removed safely and could potentially be pushed onto the ear drum by insertion of the ear plugs needed for the testing
* The TMD or DPOAE do not respond to a change in posture from lying flat to standing up, which means that the anatomic connection between the inner ear and the CSF is absent
A Clinical Study to Evaluate the Efficacy and Safety of Monopolar Radiofrequency Combined With SkinCeuticals A.G.E and Skinceuticals CE FERULIC for Improving Facial Skin Elasticity, Tightening and Fading Fine Lines

A Prospective, Single-center, Single-blind, Randomized split-face, controlled trial will be conducted. The goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with SkinCeuticals A.G.E and Skinceuticals CE FERULIC for improving facial skin elasticity, tightening and fading fine lines


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled in the study:

  1. Healthy women, skin quality is not limited, aged 25 \~ 65 years old face old \~ moderate aging group;
  2. subjects facial skin rough, loose, lack of elasticity;
  3. Subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening;
  4. Subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment;
  5. Be able to cooperate well with the tester and maintain the regularity of life during the study;
  6. Be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (ICF);
  7. Agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial;

Exclusion Criteria:

* Subjects were not included in the study if they met any of the following exclusion criteria:

  1. Subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to A.G.E./CE use (or allergies to other skin care components);
  2. Subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results;
  3. Subjects with hypertrophic scar or scar constitution;
  4. Subjects who have experienced tightening medical treatment (Gemma, Fotona 4D, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months;
  5. Subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks;
  6. Subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week;
  7. Pregnant or lactating women, or recent plans to prepare for pregnancy;
  8. Other subjects who are not suitable for participating in this study as assessed by the investigator.
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial)

This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.

This is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18years
* Candidate to cardiac surgery but cardiac transplantation
* Informed consent

Exclusion Criteria:

* Atrial fibrillation
* Candidate to cardiac transplantation
* Severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit)
* Serum creatinine \> 2.5 mg/dL
* Preoperative elevation of CK or known myopathy
* Known chronic intestinal diseases or blood dyscrasias
* Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method
* Hypersensitivity to colchicine
* Treatment with colchicine for any cause
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥ 2 years to \<12 years of age, at the time of signing the informed consent.
* Participants who have history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.
* Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for \>6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
* Body weight within ≥5 kg to \<60 kg.
* Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Underlying etiology for chronic urticarias other than CSU.
* Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
* Participants with a diagnosis of chronic inducible cold urticaria.
* Participants with active AD.
* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.
* Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated.
* Diagnosed with, suspected of, or at high risk of endoparasitic infection.
* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
* Known or suspected immunodeficiency.
* Active malignancy or history of malignancy within 5 years before the baseline visit.
* History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment

To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage.

Patients' safety can be compromised in the transition of care between healthcare sectors. Optimal information flow across healthcare sectors and individualized medication treatment tailored to each patient is key to prevent adverse events and optimize patient treatment. Particularly, the inclusion of the general practitioner is important in this process; it could become a challenge to keep medication changes if this communication link is missing. The framework for complex intervention allows flexibility and adaption in meeting patients' needs by implementing tailored, possibly complex interventions in different healthcare settings. To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan. The primary outcome is the proportion of potentially inappropriate medications. Secondary outcomes include patient-reported outcomes i.e., quality of life and medication burden. Additional outcomes include the patient's individual Medication Risk Score, if the patients are readmitted, and if the patients have contacted the staff at the hospital unit after the hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* all hospitalized patients, who are prescribed at least five medications specified in the Electronic Patient Journal (EPJ) used at ward

Exclusion Criteria:

* unable to communicate in Danish, cognitively impaired e.g. suffering from dementia or Alzheimer's, or cannot cooperate due to e.g. hallucination or aggressive behavior
Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome

A case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (PIOS) is presented.This syndrome can be diagnosed with the DIOS definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.

Distal Intestinal Obstruction Syndrome is a rare complication in cystic fibrosis patients characterized by the accumulation of viscid fecal material, combined with sticky mucous secretions located in the distal ileum, adhered to the intestinal wall. Only few cases have been reported in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Adult \>18 years
* Cystic fibrosis
* Bowel obstruction

Exclusion Criteria:

* Pediatric patient \<18 years
* Unknown cause of bowel obstruction
ELEVATE - (Empower Lupus Erythematosus Patients Via Allowing RemoTe Evaluation)

To explore the potential for use of DxTerity's AIP IFN-1 test as personalized guided care and monitoring module in patients with Systemic lupus erythematosus(SLE) using consented patient health information

Explore and demonstrate concordance between self-collected samples and traditional phlebotomist venous draw for DxTerity AIP module and biomarkers like C3, C4, anti dsDNA and CRP in SLE participants with self-reported outcomes and medical record data.

The study will collect blood samples and self-reported information for SLE subjects, up to 5000 participants in Phase I, with a subset of 1000 continuing to Phase II with Medical records. Study participants will be recruited using a combination of digital media (including social media, advertising, bloggers, emails). Enrollment and qualification will be done along with consented retrieval of medical records using a study specific mobile app.

Eligibility Criteria:
Inclusion Criteria: (PHASE I)

1. Individuals aged 18 years or older.
2. Must reside in United States
3. Have a clinical diagnosis of SLE
4. Willingness to consent to provide electronic medical records (EMR)
5. Provide written informed consent and comply with the study procedures.

(PHASE II)

1. Verified diagnosis (Medical records or /and Physician Questionnaire) for SLE
2. Report one or more of the following (record all that apply):

   1. Worsening or changes in symptoms or flare
   2. Changes in treatment regimen
   3. On standard of care treatment
   4. On biologics

Exclusion Criteria:

1. Participants unable to complete study requirements
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who completed GENA-05 in accordance with the study protocol

Exclusion Criteria:

1. Severe liver or kidney disease
2. Concomitant treatment with any systemic immunosuppressive drug;
3. Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).
Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation

Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used.

The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation
* Healthy lungs

Exclusion Criteria:

* Discontinued procedure due to adverse events.