cyrilzakka/clinical-trials huggingface dataset:
The Effects of High-intensity and Moderate-intensity Exercise on Polycystic Ovary Syndrome

This study will investigate the impact of high- and moderate-intensity exercise on the cardiometabolic and brain health of women with Polycystic Ovary syndrome (PCOS). The aim is to measure and compare normal, healthy women without PCOS, to those with the condition.

All participants will undergo a blood test. The investigators will then assess the participants cardiovascular fitness by means of a maximal exercise test and measure body composition through height, weight, and hip-to-waist ratio.

Participants will undergo an MRI, where the investigators will assess the participants brain structure and how the brain responds to a number of tests. The investigators will also conduct some tests that will assess the participants cognition, such as IQ, memory etc.

The investigators will measure the blood vessels leading to the brain and the blood flow through them to measure how much blood the brain receives when rested, using ultrasound.

The investigators will use a number of tests to look at brain function, measure the responses to these tests, and compare them between the normal, healthy women and those with PCOS. This will show if women with PCOS have a similar brain function when rested and when their brains are tested to those without the condition.

The investigators will use exercise as an intervention, where the aim will be to investigate whether women with PCOS respond similarly to those without the condition to both high-intensity and moderate-intensity exercise. The tests of brain function will be repeated following the exercise, and see if both normal, healthy women and those with PCOS have a similar response to the brain function tests.

All tests and measures will be compared between the PCOS group, and the healthy control group to establish any potential differences or similarities as a result of the condition.


Eligibility Criteria:
Inclusion Criteria:

* Polycystic Ovary Syndrome as diagnosed by any recognised criteria.
* Inactive (less than 40 mins of structured exercise per week).

Exclusion Criteria:

* Pregnant or breastfeeding.
* Congenital adrenal hyperplasia, Cushing's syndrome, thyroid disease, hyperprolactinaemia and androgen secreting tumours.
* Known history of cardiovascular disease.
* Contraindications to MRI (fitted with ferromagnetic devices).
A Phase I/II Study of HE3235 in Patients With Prostate Cancer

This is a phase I/II, open-label, dose escalation study of HE3235 administered orally to patients with advanced prostate cancer who have failed hormone therapy and at least one taxane based chemotherapy regimen.


Eligibility Criteria:
Main Inclusion Criteria:

* Patient is male and at least 18 years of age, at the time of screening;
* Patient has metastatic disease (any T, any N, M1);
* Patient has failed at least 1 taxane regimen; or Patient has symptomatic or asymptomatic CRPC and is chemotherapy-naïve
* Patient has histologically or cytologically confirmed adenocarcinoma of the prostate;
* Patient has progression of disease despite adequate hormone therapy, demonstrated by one of the following:

  * PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions, at least 1 week apart.
  * Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria;
  * Progression of metastatic bone disease on bone scan with \> 2 new lesions
* Patient has ECOG (Eastern Cooperative Oncology Group) performance status of 0-2;

Main Exclusion Criteria:

* Patient has symptomatic parenchymal brain metastases or active epidural disease requiring whole-brain irradiation Treated epidural disease is allowed
* Patient has active infection;
* Patient having a history of clinically significant cardiovascular disease (such as CHF), clinically significant hepatic, respiratory or renal abnormalities;
* Patient who has any clinically significant abnormalities in laboratory results at screening
* Patient who has a history of clinically significant neurological or psychiatric condition;

Additional criteria are applicable to expansion cohorts.
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.

The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.

This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).

Eligibility Criteria:
Inclusion Criteria:

At study entry

1. A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
2. Full term gestation (\>=37 weeks).
3. Birth weight of the subject should be \>=2.5 kg.
4. Healthy subjects as established by medical history and clinical examination before entering into the study.
5. Did not use any dose of Rota virus vaccine.
6. Written informed consent obtained from the parent or guardian of the subject.

At dose 2

1. Received dose 1.
2. Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

Exclusion Criteria:

At study entry

1. Has a chronic disease (cardiovascular, liver, kidney disease).
2. Acute disease at the time of enrolment.
3. Administering corticosteroids (\> 1mg/kg/day).
4. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
5. Immunosuppressive or immunodeficient condition.
6. Family has immunosuppressive or immunodeficient condition medical history.
7. History of high fever convulsion.
8. Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
9. Preterm of gestation delivery (gestation period \< 37 weeks).
10. Low birth weight (\<2.5 kg).
11. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
12. Malnutrition.
13. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
14. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

At dose 2

1. Acute disease at the time of 2nd dose.
2. Administering corticosteroids (\> 1mg/kg/day).
3. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
4. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
5. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
6. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
7. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
A Multicenter Clinical Study of Ultrasound Multimodal Imaging in the Evaluation of Heart Transplantation

The aims of this study are to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection (AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.

This study will enrolled 1000 HT patients and 500 healthy controls, and the cardiac structure and function will be evaluated by ultrasound multimodal imaging. And the study aimed to 1. Assess the preoperative and postoperative atrial and ventricular structure and function comprehensively in heart transplantation; 2. Explore the early, accurately and non-invasively indicators for evaluating myocardial fibrosis in end-stage heart failure, as well detecting acute rejection(AR),coronary allograft vasculopathy(CAV) and adverse clinical events in heart transplant patients by using conventional and the advanced echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* had history of hypertension, diabetes mellitus, renal failure or other organic diseases based on physical examinations, biochemical tests, electrocardiogram, echocardiography
Prospective Evaluation of the Role of MRI in Ovarian Masses During Pregnancy

Ovarian cancer represents 7% of all cancers in pregnant women. Characterizing an ovarian mass during pregnancy is essential to avoid unnecessary treatment and if treatment is required, to plan it accordingly. Ultrasound is the first line modality in these patients and various tools such as IOTA and ADNEX have been validated in non-pregnant patients to accurately categorize ovarian masses according to their malignant potential. A prospective multicentre study, in which Fondazione Policlinico Gemelli is involved, is currently ongoing aiming to validate these tools in pregnant Patients (p-IOTA).

Given the high contrast resolution and the absence of ionizing radiation, Magnetic Resonance Imaging is the preferred second-line modality. It increases the positive predictive value (PPV) of US from 7-50% to 70%, demonstrating a negative predictive value (NV) of 98%. In non-pregnant women, the Ovarian-Adnexal Reporting and Data System-MRI (ORADS-MRI) risk stratification system and the Non-Contrast MRI Score (NCMS) are commonly employed to assess the risk of malignancy in adnexal lesions with accuracies of 92% and 94%, respectively. Recently, both scoring systems have proven effective in retrospectively stratifying benign and malignant adnexal masses in pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients \&gt; 18 years old
* Ability to understand and sign informed consent
* Patient with adnexal mass detected during pregnancy with either multilocular morphology or solid component at ultrasound examination
* Availability of MR imaging (1.5T and 3.0T MR scanner)
* Availability of histopathological reports obtained during pregnancy or within 3 months from delivery or at least one US follow-up examination 6-12 months after MRI examination

Exclusion Criteria:

* Patients lacking or with low quality MRI
To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C714 and C714R in Healthy Adults

To evaluate the safety and pharmacokinetic characteristics of AJU-C714 and C714R in healthy adults


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult over 19 years of age and under 65 years of age.
2. Weight ≥ 50 kg (man) or 45 kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2.
3. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests.
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial.
6. Those who agree to contraception during the participation of clinical trial.

Exclusion Criteria:

1. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month or the first administration of clinical trial drug within 10 days.
2. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug.
3. Those who donated whole blood within 8 weeks, received apheresis within 2 weeks, blood transfusion within 1 month or can't refrain from donating blood from the time of written consent until the end of the study.
4. Those who has a history of gastrointestinal disease or surgery which may affect the absorption of the drug.
5. Those who exceeding an alcohol consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL or liquor: 30mL), Smoke: 20 cigarettes/day.
6. Those who has under

   * Those who are hypersensitive to component of the Investigational product and have the medical history
   * Those with active liver disease or persistent elevation of aminotransferase levels of unknown
   * Those with myopathy
   * Those taking cyclosporin
   * Those with renal impairment with severe renal failure
   * Those with Hypothyroidism
   * Those who has Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
7. Those who has a history of mental illness.
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons.
9. Women who are pregnant or who may be pregnant and breastfeed.
The Effect of Controlled Hypotension

Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).

The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.

Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).

In the literature, various definitions of controlled hypotension exist. It is commonly defined as maintaining the Mean Arterial Pressure (MAP) between 50-65 mmHg, Systolic Arterial Pressure (SAP) between 80-90 mmHg, or reducing MAP by 30% compared to baseline values. In our study, we plan to maintain the MAP within the range of 55-75 mmHg and compare the effects of two different MAP levels on perioperative cerebral oxygen saturation, anesthetic and surgical parameters, and postoperative cognitive functions.

The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* ASA I-III risk group
* BMI between 18-40
* Baseline blood pressure below 140/90 mmHg
* Scheduled to undergo spinal surgery (2-4 level instrumentation)

Exclusion Criteria:

* Below 18 or above 65 years old
* Advanced comorbidities
* ASA IV or higher
* Baseline blood pressure above 140/90 mmHg
* History of bleeding diathesis
* Use of anticoagulant medications
* BMI below 18 or above 40
* History of previous spinal surgery
Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording

The PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the WIM-PC™ device for wheeze detection during dynamic bronchial situations in asthmatic adult.

Asthma is defined by the National Asthma Education and Prevention Program (NAEPP) guideline as a 'Chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The asthma guideline states that inflammation causes recurrent episodes of wheezing, breathlessness and chest tightness that are associated with widespread but variable airflow obstruction.

Wheeze quantification by lung sounds analysis methods is objective, non invasive and has been shown to correlate with clinical status in asthma and bronchiolitis. The recording procedure is simple, requiring only the attachment of 4 ECG-size sensors to the chest wall. A 30-second recording is often adequate to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.

Karmel Sonix Ltd has developed the PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the PulmoTrack® 2010 with WIM-PC™ Technologies device for wheeze detection during dynamic bronchial situations in asthmatic adults.

Eligibility Criteria:
Inclusion Criteria:

* Asthmatic or healthy subjects;
* Age 18 and up;
* Not smoking for at the last two years;
* Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria:

* Chest burns;
* COPD;
* Pregnant or lactating;
* Mechanically ventilatory;
* Homodynamic instability;
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening;
* Acute infection requiring intravenous antibiotics at the time of screening;
* Uncontrolled bleeding and coagulation disorders;
* Uncontrolled diabetes mellitus: IDDM or NIDDM;
* HIV positive or any other immunosuppressive disorder;
* Subject objects to the study protocol;
* Concurrent participation in any other clinical study;
* Physician objection.
Evaluation of Intubation Rescue Techniques on Management of Difficult Airway

When difficult airway/intubation occurs in the OR the anesthesiologist needs rescue techniques and equipment. The algorithms about management of the difficult airway don't provide adequate data. In current study researchers aim to determine most preferred rescue techniques and success rate of the chosen technique.

In anesthesia setting Failed tracheal intubation, leading mortality and morbidity is very important. In operation room when a Difficult intubation occured with concurrent difficult mask ventilation rapid manipulation and quick decision are lifesaving. The Presence of assistant medical personnel or rescue equipment and crisis management of physician is crucial. In anesthesia practice when difficult airway occured rescue techniques are used to facilitate the intubation but difficult airway algorithms do not provide adequate information which rescue technique should be used in a state of emergency in OR thereby current trial was designed to determine which rescue techniques are used in everyday practice to manage difficult intubation, success and complication rates of chosen techniques.

Aim of the study

1. Most preferred rescue technique of the anesthesiologist When a difficult airway or difficult intubation ventilation occured
2. success rate of the chosen technique
3. Incidence of possible complications
4. Most preferred rescue technique of the anesthesiologist on presence of the difficult mask ventilation

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* patient underwent surgery under general anesthesia

Exclusion Criteria:

* pediatric patients
* patients who will intubate due to rapid serial intubation protocol
Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )

Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
* Patients were at least 18 years of age as of the first diagnosis for mCRPC.
* Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
* First injection of Radium-223 must have started between periods

  1-January-2014 to 30-June-2014 or 15-November-2014 to present.
* Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.

Exclusion Criteria:

* Patients who received Radium-223 as part in an interventional clinical trial
* Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)

This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed adenocarcinomas of the prostate.
* Evidence of metastatic disease
* Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
* PSA level is greater or equal to 7 ng/ml.
* ECOG performance status less than or equal to 1

Exclusion Criteria :

* Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
* Prior chemotherapy for prostate cancer
* Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
* Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
* Patient has pain related to prostate cancer that warrants the initiation of chemotherapy