cyrilzakka/clinical-trials huggingface dataset:
A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS

This study evaluates the effects and biological mechanisms of Dingkundan，Diane-35 and the combination of Dingkundan and Diane-35 in the treatment of polycystic syndrome(PCOS) in adults women. One third of participants will receive Dingkundan capsules, one third of participants will receive Diane-35 Pills, and the another third will receive Dingkundan capsules and Diane-35 in combination.

Dingkundan,Diane-35 each ameliorate PCOS, but they do so by different mechanisms. We generally treat PCOS patients without immediate fertility requirement by short-acting contraceptives,Diane-35 is one of the most commonly used drugs.

Dingkundan consists of multiple chinese herbs including ginseng,Panax notoginseng,deer antlers,Carthamus tinctorius L.,Radix Paeoniae Alba,prepared Radix Rehmanniae,Angelica etc., which gains widespread application in the treatment of gynecological diseases. Based on the characteristics above, we try to explore its clinical application value in PCOS and its biological mechanisms.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a female between the age of 18 and 40.
* Subject diagnosed as PCOS by the 2003 Rotterdam criteria.
* Subject provides written informed consent.

Exclusion Criteria:

* Subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, Cushing's syndrome,thyroid diseases and hyperprolactinemia.
* Subject has received related medical or surgical treatment in the past 3 months.
* Subject suffered from substance abuse or dependence(such as alcohol or drugs);
* Subject is a heavy smoker(reaching or more than 20 cigarettes a day).
* Subject is pregnant or lactating or within 1 year after delivery.
* Subject has a severe systemic disease, such as cardiovascular system
* Subject has a history of malignancy or radiotherapy.
* Subject has an allergic history to the drugs used in the study.
* Subject has mental disorder incapable of elementary cooperations.
* Subject has participated in other clinical researches of medicine within 3 month prior to randomization.
New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial

With the increase in life expectancy of the general population and advances in medicine, there is now a population with a higher amount of cardiovascular diseases that lead to an increased risk of sudden cardiac arrest. In most cases, this occurs in extra-hospital settings such as family homes, shopping centres, public transport and before people without any knowledge or training in basic life support. On the other hand, for every minute that passes without adequate attention of the victim, the probability of surviving or continuing to live with neurological severe sequelae decreases by 10%.

In developed countries, public policies have been created to encourage basic life support education to the general population. In Colombia, because of the high prevalence of these diseases and the need for public health strategies, a law was issued to provide access to automatic external defibrillators (AEDs) in public places. However, it has not been developed strategies for education on this subject.

For that reason, the investigators created an educational strategy of self-learning, which consists of a complete basic life support course based in new Information and Communication technologies with tools to manufacture a mannequin and a homemade DEA, which will allow continuous training, with a very low cost compared to traditional life support training.

The clinical trial will compare that two educational strategies, evaluating as primary aid, which approach has higher knowledge retention of life support chain at 6 months in students after the workshop. As secondary objectives, the investigators would evaluate the efficient in terms of response times, costs and student satisfaction.

This study will be carried out in high school students from two different high schools, without prior training in Life support. Both strategies will be distributed randomly. The experimental group will carry out the self-learning strategy based on ICT (Information and Communication Technologies), with which they will be retrained every month, and the control group will carry out the conventional training only once as usual. Subsequently, each of the objectives will be evaluated at six months.

It is proposed that the self-learning strategy is superior compared to conventional training, requiring fewer resources to perform it and allows constant retraining, which improves retention and quality in a resuscitation process.


Eligibility Criteria:
Inclusion Criteria:

* Senior students over 14 years in high school.

Exclusion Criteria:

* Cognitive disorders.
* Cardiovascular o pulmonary diseases.
* Any condition that prevents physical activities.
* To have any previous training in basic life support.
Probiotic Beer to Enhance Gut Health and Immune System Function

This study investigates the immunological and gut microbiome effects of moderate probiotic beer consumption.

Studies have shown that moderate alcohol consumption and probiotics have each shown immunomodulatory anti-inflammatory effects. However, to our knowledge, the effect of adding a probiotic strain to a beer drink, together with moderate alcohol consumption, on immunity and gut microbiome has yet to be studied. The probiotic beer used in this study taps on this unexplored research area and may potentially serve as a more healthful option to consumers than normal beer in the future, given the vast popularity of this beverage and probiotics.

Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent.
* 21 - 60 years of age (inclusive) at screening.
* Healthy male, as determined by medical history, physical examination and laboratory results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Race must be Chinese.
* Willing to consume 1 beer can per day for 14 days.
* Not on any regular medications (western/ traditional).
* No family history of alcoholism.

Exclusion Criteria:

* Female.
* A current smoker, have smoked, or is a user of tobacco products for the past 2 years.
* History or presence of current lipid and cardiovascular disorders, respiratory, hepatic, renal, gastrointestinal, endocrine, lipid disorder, haematological, malignancy or neurological disorders capable of significantly altering the performance of the biomarker panel; or of interfering with the interpretation of data.
* History of alcoholism, alcohol dependence, alcohol abuse, alcohol allergy and/or any other alcohol use disorders.
* History of Type 1/ Type 2 diabetes and use of anti-diabetic medications in the past.
* Regular use of medication that are known to have an effect on immune function.
* Regular use of aspirin.
* A naïve alcohol drinker.
* Persons with known or ongoing psychiatric disorders or drug abuse within 3 years.
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to first visit of the study.
* Treatment with any investigational drug, or biological agent within one (1) month of screening or plans to enter into an investigational drug/ biological agent study during the duration of this study.
* Significant change in weight (+/- 5%) during the past month.
* Antibiotic use in the past 2 months.
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects

This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be a healthy male or female of non-childbearing potential
* Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2
* To be eligible for the Japanese cohort, subjects must have 4 biological grandparents who are Japanese that were born in Japan

Exclusion Criteria:

* Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)
* Use of prescription or non-prescription drugs
* A QTc-interval \>450msec or a QRS interval \>120msec
* Pregnant or breastfeeding females, females of childbearing potential, and males who are unwilling or unable to use an effective method of contraception for the duration of the study and for 90 days after the last dose of palbociclib in the study
Optimizing Vitamin D in the Elderly

Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D supplementation. The limited data available show marked inter-individual variability in response to vitamin D supplementation in very old, frail elderly with almost 25% remaining vitamin D deficient (25-OH D \< 20 ng/mL) when receiving the currently recommended 800 IU/day vitamin D. This proposal is for exploratory research on the use of a wide range of oral vitamin D3 doses in frail elderly living in controlled living environments.

The investigators will determine the dose response relationship of circulating total and unbound 25-OH vitamin D3 to supplemental vitamin D3 at daily doses of 800 (currently recommended for the elderly), 2000, and 4000 IU or 50,000 IU/weekly in a randomized blinded investigation of 16 weeks duration. The investigators will also compare the efficacy of each dosing regimen in achieving 25-OH vitamin D levels \>20 ng/mL (50 nmol/L) and identify covariates that contribute to inter-individual variation in the dose response relationship. In patients with osteoporosis, relationships between unbound vs. total 25-OH on intact parathyroid hormone and a marker of bone resorption (beta-Ctx) will be analyzed. The investigators will also examine responses of inflammatory cytokines.

Note: as of April 8,2014, there will be no further enrollment in the 50,000 IU/weekly dose group

Eligibility Criteria:
Inclusion Criteria:

* age over 65
* medically stable
* residing in long-term care or assisted living

Exclusion Criteria:

* hypercalcemia or high risk for hypercalcemia
* active cancer or malignancy other than non-melanoma skin cancer
* severe renal disease (eGFR \<30 ml/mkin/M2)
* small bowel resection or intestinal bypass surgery
* hyperparathyroidism
* granulomatous disease
* clinically unstable (changes in medications or diagnoses within a month, hospitalizations, within 6 months)
* allergy to vitamin D
Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Open-loop electrical stimulation has been found to reduce spike activity and seizures, but determining the optimal parameters to achieve these effects requires a brute force trial-and-error approach that relies on subjective physician discretion. We will compare the performance of stimulation parameters identified in rodent models to the recommended parameters for neuromodulation used in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

- Undergoing intracranial EEG investigation at Massachusetts General Hospital during presurgical epilepsy evaluation

Exclusion Criteria:

- Baseline spike ripple rate \< 0.5/min.
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.


Eligibility Criteria:
Inclusion Criteria:

* Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
* Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
* Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.

Exclusion Criteria:

* Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
* Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
* Concurrent medications:

  * Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
  * Has or is likely to receive an epidural block during the treatment period
Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI

Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal absorption, and hence will improve the prevention of platelet aggregation.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female older than 18 years old with non-ST myocardial infarction

Exclusion Criteria:

* Current treatment with anticoagulation medication, any type of cerebro vascular event in the past, active bleeding, active peptic ulcer disease, pregnant women, any inability to sign an informed consent of participate in the study
LUMIERE on the PLACENTA

The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the principal mechanism, far in front of other maternal or fetal causes. This placental insufficiency is also now recognized as an essential risk factor for cardiovascular and metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero development is thus further increased by the short-, medium- and long-term consequences of placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at 1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ structure in children and adults (brain, kidney, heart, etc.). Their application for evaluation of perfusion and placental structure, although still confined to research, is very promising. The investigator's team has extensive experience, in animals or in children, in the use of these sequences that could be used to evaluate placental function in vivo. The ASL (Arterial Spin Labeling) in particular is the most encouraging functional imaging technique because it allows today to measure an organ blood flow quantitatively and without injection of contrast medium.

The inclusion will take place at the earliest at 20 weeks after the completion of the standard morphological ultrasound of the 2nd trimester (carried out at 20-24SA) and at the latest at 35 SA, within the framework of one of the 2 clinical subgroups of patients considered (high risk and low risk).

The objectives of this study will be achieved by the prospective setting up of a LUMIERE cohort on PLACENTA.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy without fetal malformation seen on ultrasound. Group 1: High risk IUGR patients

  * EPF\<10th perc or PA\<10th perc and Doppler ombilical IP\> 95th percentile,
  * EPF or PA\<3th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW,

Group 2: Low risk IUGR patients

• EPF et PA\>20th perc reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW

Exclusion Criteria:

* - Contraindication to MRI
* Impossible subsequent follow up
* Maternal status contraindicates continuation of pregnancy
* Participation in another search
* "Protected" patient
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer

Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.


Eligibility Criteria:
Inclusion Criteria:

* Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm.
* Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS) and axillary staging procedure (clearance, sampling or SNB)
* T2 tumors with one risk factor or T1 tumors with any of the following two high risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age \< 35 years.
* Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated)
* Written, informed consent

Exclusion Criteria:

* Any pTis/3/4, M1 patients
* Patients who have any pathologically involved axillary nodes (micro-metastasis may be allowed)
* Patients who have undergone neoadjuvant systemic therapy.
* Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix
* Pregnancy
* Bilateral breast cancer
* Not fit for surgery, radiotherapy or adjuvant systemic therapy
* Unable or unwilling to give informed consent
Eicosapentaenoic Acid Cerebral Vasospasm Therapy Study

Cerebral vasospasm following subarachnoid hemorrhage (SAH) is the most common cause of morbidity and mortality. Recent studies indicate that Rho-kinase play an important role in the occurrence of such cerebral vasospasm. Eicosapentaenoic acid (EPA) inhibits sphingosylphosphorylcholine (SPC)-induced Rho-kinase activation in vitro. So this study examines whether EPA prevents cerebral vasospasm occurrence after SAH in patients.

Cerebral vasospasm occasionally seen after subarachnoid hemorrhage (SAH) due to a ruptured intracranial aneurysm is the most common cause of morbidity and mortality in these cases. Recent studies indicate that Rho-kinase plays an important role in such cerebral vasospasm and that numerous agents, such as thromboxane A2 (TXA2), sphingosylphosphorylcholine (SPC) and arachidonic acid (AA), can activate Rho-kinase directly or through receptors in the cell membrane; among these agents, SPC has been described as a novel messenger for Rho-kinase-mediated Ca2+ sensitization of vascular smooth muscle contraction. Eicosapentaenoic acid (EPA) has recently been reported to inhibit SPC-induced Rho-kinase activation in vitro, and thereby vascular smooth muscle contraction, through the inhibition of Src family protein tyrosine kinases translocation. Moreover, the concentration of AA increases in the cerebrospinal fluid of patients with SAH, suggesting that this substance has a potential role in the occurrence of cerebral vasospasm following SAH, while EPA is known to change the constitution ratios of AA and EPA in cell membrane phospholipid, resulting in the inhibition of TXA2 synthesis. These observations lead us to hypothesize that EPA may inhibit cerebral vasospasm following SAH through the inhibition of Rho-kinase activation.

Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage (SAH)
* The ruptured cerebral aneurysms conformed by cerebral angiography
* The patients with treated by craniotomy and clip application within 72h after the onset of SAH

Exclusion Criteria:

* Traumatic or mycotic aneurysms
* A history or complication of serious stroke
* Moya Moya disease
* A history of SAH
* Complication of serious heart or hepatic disease or infection or renal failure
* Malignant tumor
* Patients judged to be inappropriate by physician in charge